m2000rt Operations Manual v6

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Operations Manual

List No. 9K25-06

©2012 Abbott Laboratories

Abbott Molecular Inc.


1300 E. Touhy Ave.
Des Plaines, IL 60018
200680-106—October 2012
NOTES

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200680-106—October 2012
Revision Status

Document Control Revision Section(s) Software


Number(s) Date Revised Version

200680-101 03/05 Original Issue Version 1.0


200680-102 06/06 All Sections Version 2.0
200680-103 07/08 All Sections Version 3.0
200680-104 07/10 All Sections, except for 3, Version 4.0
6, and 8
200680-105 10/11 All Sections, except 8 Version 5.0
200680-106 10/12 Sections 5-10, and the Version 6.0
Appendix

m2000rt Operations Manual iii


200680-106—October 2012
NOTES

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200680-106—October 2012
Revision Log

Instructions: Use this log as a permanent record to document the revised section(s) which have
been added to this manual.

1. Write the document control number in the first column. This number is in the footer of
each section or tab. Make an entry for each section or tab placed in the manual.
2. Write the revision date, also found in the footer, in the second column.
3. Write the version of the software for the revised pages or sections in the third column.
4. Sign in the fourth column to verify that revised pages have been added to the manual.
5. Record the date that the revised section was incorporated in the fifth column.

Document Revision Software Revision Date


Control Date Version (If Incorporated Incorporated
Number applicable) by

m2000rt Operations Manual v


200680-106—October 2012
NOTES

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200680-106—October 2012
Foreword
Congratulations on the purchase of the ABBOTT® m2000rt
System. The m2000rt uses fluorescent-based PCR chemistries
to provide quantitative and qualitative detection of nucleic
acid sequences using real-time analysis.
The m2000rt is backed by dedicated professionals who excel in
engineering, technical support, and training. Abbott
Molecular looks forward to assisting you in any way possible.
This service is available by calling your Area Abbott
Representative.
The following information can be found in this introduction:
• Customer Support, page ix
Lists contact information for Abbott representatives.
• Proprietary Statement, page ix
Describes conditions for use of the information,
documents, and graphics in this manual.
• Pictorial Disclaimer, page x
Explains that printouts, graphics, displays, screens,
etc., used in this manual are for illustration and
information, only.
• Master Table of Contents/Index Disclaimer, page x
Cautions that manual updates may cause changes in
page numbering.
• Intended Use, page xi
Explains the intended use of the m2000rt instrument.
• Abbott Instrument Warranty, page xii
Presents m2000rt System warranty information.
• Abbott Label License, page xiv
Presents label license information.
• Licensing and Copyright Summary, page xvi
Presents licensing and copyright details.
• Instrument Labeling, page xix
Lists instrument labeling information.

m2000rt Operations Manual vii


200680-106—October 2012
• Trademark Statements, page xxv
Provides trademark statements associated with the
m2000rt System.

viii m2000rt Operations Manual


200680-106—October 2012
Customer Support
If you have any questions, please contact your Area Abbott
Customer representative.

Proprietary Statement
The Abbott® m2000rt System software programs and System
documentation are protected by copyright. All rights reserved.
Printed in the United States of America. No part of this media
may be reproduced, stored, retrieved, or transmitted in any
form or by any means without the prior written permission of
Abbott Molecular.
The information, documents, and related graphics published
herein (the “Information”) are the sole property of Abbott
Molecular. Permission to use the Information is granted,
provided that:
• the copyright notice appears on all copies;
• use of the Information is for the operation of Abbott
products by Abbott-trained personnel or informational
use only;
• the Information is not modified in any way; and
• no graphics are used separate from accompanying text.
Each person assumes full responsibility and all risks arising
from use of the Information. The Information is presented “as
is” and may include technical inaccuracies or typographical
errors. Abbott Molecular reserves the right to make additions,
deletions, or modifications to the Information at any time
without any prior notification.
ABBOTT LABORATORIES MAKES NO REPRESENTATIONS OR WARRANTIES
OF ANY KIND OR NATURE WITH RESPECT TO THE INFORMATION. IN NO
EVENT SHALL ABBOTT LABORATORIES BE LIABLE FOR ANY DAMAGES OF
ANY KIND OR NATURE, INCLUDING, WITHOUT LIMITATION, DIRECT,
INDIRECT, SPECIAL (INCLUDING LOSS OF PROFITS), CONSEQUENTIAL OR
INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE
EXISTENCE OR USE OF THE INFORMATION, REGARDLESS OF WHETHER
ABBOTT LABORATORIES HAS BEEN ADVISED AS TO THE POSSIBILITY OF
SUCH DAMAGES.

m2000rt Operations Manual ix


200680-106—October 2012
Pictorial Disclaimer
All samples (printouts, graphics, displays, screens, etc.) are for
information and illustration purposes only, and shall not be
used for clinical or maintenance evaluations. Data shown in
sample printouts and screens do not reflect actual patient
names or test results.
Abbott Molecular is not engaged in rendering medical advice
or services.

Master Table of Contents/Index Disclaimer


Incremental manual updates may cause the Master Table of
Contents or Master Index page numbering to change.

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200680-106—October 2012
Intended Use
The ABBOTT® m2000 system is intended for use in performing
nucleic acid testing in clinical laboratories. It is comprised of
the ABBOTT m2000sp and the ABBOTT m2000rt instruments.
• The ABBOTT m2000sp is an automated system for
performing sample preparation for nucleic acid testing.
• The ABBOTT m2000rt is an automated system for
performing fluorescence-based PCR to provide
quantitative and qualitative detection of nucleic acid
sequences.

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Abbott Instrument Warranty
Abbott Molecular warrants the m2000rt System (“the
Instrument”) to be free from defects in workmanship and
materials during normal use by the original purchaser. This
warranty shall continue for a period of one (1) year from the
date of delivery to the original purchaser, or until title is
transferred from Abbott Molecular to the original purchaser,
whichever occurs first (the “Warranty Period”).
If any defects occur during the Warranty Period, contact your
Area Abbott Customer Service Representative immediately,
and be prepared to furnish information including the serial
number, the model number, and pertinent details concerning
the defect.
The Warranty does not cover defects or malfunctions which:
(1) are not reported to Abbott during the Warranty Period and
within one week of occurrence; (2) result from chemical
decomposition or corrosion; (3) are caused primarily by failure
to comply with any requirements or instruction contained in
the applicable Abbott Operations Manual; or (4) result from
maintenance, repair, or modification, performed without
Abbott’s authorization.
Abbott’s liability for all matters arising from the supply,
installation, use, repair, and maintenance of the Instrument,
whether arising under this Warranty or otherwise, shall be
limited solely to the repair or (at Abbott’s sole discretion)
replacement of the Instrument or of components thereof.
Replaced parts shall become the property of Abbott Molecular.

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200680-106—October 2012
THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT
LABORATORIES REGARDING THE INSTRUMENT, AND ABBOTT
SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR
IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING,
WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, OR ANY WARRANTY OF NON-
INFRINGEMENT. NO REPRESENTATION OR OTHER AFFIRMATION OF
FACT, INCLUDING, BUT NOT LIMITED TO, STATEMENTS REGARDING
CAPACITY, SUITABILITY FOR USE OR PERFORMANCE OF INSTRUMENT,
WHETHER MADE BY ABBOTT EMPLOYEES OR OTHERWISE, THAT IS NOT
CONTAINED IN THIS MANUAL, OR EXPRESSLY AGREED TO AS A
WARRANTY BY ABBOTT IN WRITING, WILL BE DEEMED TO BE A
WARRANTY BY ABBOTT FOR ANY PURPOSE. IN NO EVENT SHALL
ABBOTT BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL
OR SPECIAL DAMAGES OR LOSSES OF ANY NATURE WHATSOEVER
(INCLUDING, WITHOUT LIMITATION, LOST REVENUE, LOST PROFITS, OR
LOST BUSINESS) ARISING OUT OF THE USE OF THE INSTRUMENT.

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200680-106—October 2012
Abbott Label License
THE PURCHASE OF THIS PRODUCT ALONE DOES NOT IMPLY ANY
LICENSE UNDER PATENTS OWNED BY ROCHE MOLECULAR SYSTEMS,
INC., OR F. HOFFMANN-LA ROCHE LTD COVERING NUCLEIC ACID
AMPLIFICATION OR DETECTION, EXCEPT FOR CERTAIN LIMITED
RESEARCH RIGHTS AS SET FORTH BELOW.

LIMITED RESEARCH RIGHTS - AUTHORIZED THERMAL CYCLER


This instrument, Serial No________, is an Authorized Thermal
Cycler. Its purchase price includes the up-front fee component
of a license under United States Patent Nos. 4,683,195,
4,683,202 and 4,965,188, owned by Roche Molecular Systems,
Inc., and under corresponding claims in patents outside the
United States, owned by F. Hoffmann-La Roche Ltd, covering
the Polymerase Chain Reaction (“PCR”) process to practice the
PCR process for internal research and development using this
instrument. The running royalty component of that license
may be purchased from Applied Biosystems or obtained by
purchasing Authorized Reagents. This instrument is also an
Authorized Thermal Cycler for use with applications licenses
available from Applied Biosystems. Its use with Authorized
Reagents also provides a limited PCR license in accordance
with the label rights accompanying such reagents. Purchase of
this product does not itself convey to the purchaser a complete
license or right to perform the PCR process. Further
information on purchasing licenses to practice the PCR
process may be obtained by contacting the Director of
Licensing at Applied Biosystems, 850 Lincoln Centre Drive,
Foster City, California 94404, USA.

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200680-106—October 2012
DISCLAIMER OF LICENSE. No rights for any application,
including an in vitro diagnostic application, are conveyed
expressly, by implication or by estoppel under any patent or
patent applications claiming homogeneous or real-time
detection methods, including patents covering such methods
used in conjunction with the PCR process or other
amplification processes through purchase of this instrument.
The 5' nuclease detection assay and certain other
homogeneous or real-time amplification and detection
methods are covered by United States Patent Nos. 5,210,015,
5,478,972, 5,804,375 and 5,994,056, owned by Roche
Molecular Systems, Inc.; by corresponding patents and patent
application outside the United States, owned by F. Hoffmann-
La Roche Ltd; and by United States Patent Nos. 5,538,848 and
6,030,787, and corresponding patents and patent applications
outside the United States, owned by Applera Corporation.
Purchase of this instrument conveys no license or right under
the foregoing patents. Use of these and other patented
processes in conjunction with the PCR process requires a
license. For information on obtaining licenses, contact the
Director of Licensing at Applied Biosystems, 850 Lincoln
Centre Drive, Foster City, California 94404, or The Licensing
Department, Roche Molecular Systems, Inc., 1145 Atlantic
Avenue, Alameda, California, 94501, USA.

DIAGNOSTIC RIGHTS. See label license accompanying Abbott


Laboratories diagnostic assay products for a statement of
patent rights granted by the purchase of those products.

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Licensing and Copyright Summary
Apache Software copyright and disclaimer as follows:
Copyright © 1999 The Apache Software Foundation. All rights
reserved.
This product includes software developed by the Apache
Software Foundation.
THIS SOFTWARE IS PROVIDED “AS IS” AND ANY EXPRESSED OR IMPLIED
WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE APACHE
SOFTWARE FOUNDATION OR ITS CONTRIBUTORS BE LIABLE FOR ANY
DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR
CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO,
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE,
DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED
AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT
LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING
IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF
THE POSSIBILITY OF SUCH DAMAGE.

MIT License and disclaimer for the Nullable Types library as


follows:
Copyright © 2003 Luca Minudel
THE SOFTWARE IS PROVIDED “AS IS”, WITHOUT WARRANTY OF ANY
KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS
OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR
OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR
OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE
SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.

The User agrees not to and shall not decompile, disassemble,


reverse engineer or otherwise decode or derive the source code
from the Abbott Molecular Software.

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PDFTron™ Systems, Inc.’s license and disclaimer for PDFNet
SDK as follows:
By accepting delivery of the m2000 Product, the End User
agrees to be bound by the restrictions set forth in the
following paragraphs:
(a) the End User:
(i) will use the Software only as an integral
component of the m2000 Product; “Software” means the
Object Code for the PDFTronTM Systems, Inc.’s
(“PDFTron’s) computer software developer’s kit known as
PDFNet SDKTM Custom License [PDF View Only] licensed
hereunder only for the Windows platform; and
(ii) will not access, install, download or otherwise
benefit from using the functionality of the Software
(“Use”) the Software for development, compilation,
debugging and similar design-time purposes.
(b) the End User will not Use, copy, modify, or transfer the
Software, or any copy, adaptation, transcription, or merged
portion thereof, except as expressly permitted by PDFTron.
The End User's rights will be non-exclusive and non-
assignable. If the End User transfers possession of any copy of
the Software to any other party (except to a successor in
interest of the End User's business that assumes all of the End
User’s obligations with respect to the Software), the End User's
rights in the Software will be automatically terminated;
(c) PDFTron will have the exclusive ownership of all right,
title, and interest in and to the Software, including ownership
of all Intellectual Property Rights and Confidential
Information pertaining thereto, subject only to the rights and
privileges expressly granted by PDFTron hereunder;
(d) under no circumstances will the End User reverse-compile,
reverse-engineer or reverse-assemble the Object Code of the
Software;
(e) the End User's obligations hereunder remain in effect for as
long as it continues to possess or use the Software, and such
obligations will be for the benefit of PDFTron and will be
enforceable by PDFTron as a third party beneficiary against the
End User; and

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200680-106—October 2012
(f) the terms of Abbott's sublicense to the End User:
(i) limit product and performance warranties with
respect to the Software, if any, to that contained in this
document; and
(ii) expressly disclaim all other express or implied
warranties and conditions, including any warranty or
conditions of merchantability, durability, or fitness for a
particular purpose. The liability of Abbott to an End User
for the failure of the Software to satisfy such warranties
will be limited to a return by Abbott of the amount paid
by the End User for the m2000 Product.

IDAutomation.com License and disclaimer as follows:


The m2000 software contains barcode components licensed
from IDAutomation.com, Inc. These products may only be
used as part of and in connection with the m2000 software.

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Instrument Labeling
Symbols and Text Used on Instrument Labeling
The symbols in the following table are used on the
instrument’s labeling.
Table 1: Key to Symbols Used on Instrument Labeling

Key to Symbols Used on Instrument Labeling

Symbol Definition Symbol Definition


Catalog number Caution

Serial number Caution, risk of


electric shock

Batch code/ Caution, hot surface


Lot number

Unit Biological Risks

Item In vitro diagnostic


medical device

Quantity Use by

Size Temperature
limitation

Manufacturer Alternating current

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200680-106—October 2012
Key to Symbols Used on Instrument Labeling
Date of Stand-by
manufacture
(Indicates the ON/
OFF position of a
push-push main
power switch)

Authorized Consult instructions


Representative for use.
in the European
Community

Waste Electrical Global Trade Item


and Electronic Number
Equipment GTIN
(WEEE)

NOTE: EC Directive. The European Commission has


released the Directive on Waste Electrical and
Electronic Equipment (WEEE; 2002/96/EC).
Since August 2005, producers have been responsible for taking
back and recycling electrical and electronic equipment.
ATTENTION:

Negative environmental impacts associated with the treatment


of waste.
• Do not treat electrical and electronic equipment as
unsorted municipal waste.
• Collect waste electrical and electronic equipment
separately.

xx m2000rt Operations Manual


200680-106—October 2012
Table 2: Key to Text Used on Instrument Labeling

Key to Text Used on Instrument Labeling

Text Definition Text Definition

U, f Indicates the Fuse Indicates the


voltage replacement fuse
frequency range rating. Fuse should
be replaced only by
an Abbott Service
Representative.

P Indicates the
power rating of
the instrument.

Symbols used in this Manual


Table 3: Key to Symbols Used in this Manual

Symbol Definition

NOTE. This precedes additional information that


could be helpful to the operator.

! IMPORTANT. This precedes information or


instruction that is critical to the operator.

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Safety and Electromagnetic Compatibility (EMC) Standards

U.S. and Canadian Safety Standards


This instrument has been tested to and complies with
Standard 61010A-1.
This instrument has been tested to and complies with
Standard CAN/CSA C22.2 no. 61010-1.

Canadian EMC Standard


This instrument has been tested to and complies with
ICES-001, Issue 4: Industrial, Scientific, and Medical Radio
Frequency Generators.

European Safety and EMC Standards

Safety
This instrument meets European requirements for safety (Low
Voltage Directive 2006/95/EC). This instrument has been
tested to and complies with standards EN 61010-1:2001,
“Safety Requirements for Electrical Equipment for
Measurement, Control and Laboratory Use, Part 1: General
Requirements” and EN 61010-2-010, “Particular Requirements
for Laboratory Equipment for the Heating of Materials.”

EMC
This instrument meets European requirements for emission
and immunity (EMC Directive 2004/108/EC). This instrument
has been tested to and complies with standard EN 61326
(Group 1, Class B), “Electrical Equipment for Measurement,
Control and Laboratory Use – EMC Requirements.”

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IVDD 98/79/EC
If the following label is on the instrument, the instrument is
CE marked for IVD Directive.

U,f 100-240 VAC, 50/60 Hz


P 1080 VA
12.5A, 250V SB (T)
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden, Germany
+49-6122-580
CAUTION: Prior to any repair or maintenance job disconnect main power cord. / ACHTUNG: Vor
Reparatur- oder Wartungsarbeiten immer den Netzstecker ziehen. / ATTENTION : Avant toute
procédure de réparation ou de maintenance, débrancher le cordon secteur. / ATENCIÓN: Antes
de llevar a cabo alguna reparación o procedimientos de mantenimiento, desconecte el cable de
corriente principal. / ATTENZIONE: Prima di eseguire interventi di riparazione o manutenzione,
sconnettere il cavo di alimentazione principale. / ATENÇÃO: desligar o cabo de alimentação
principal antes de iniciar a reparação ou manutenção.

LISTED: Laboratory Use Electrical Equipment 3Z77, EN61326, group 1 Class B /


KONFORMITÄT: Elektrisches Zubehör für den Laborbereich 3Z77, EN61326, Gruppe 1 Klasse B /
CONFORMITÉ : Equipement électrique de laboratoire 3Z77, EN61326, groupe 1 classe B /
CONFORMIDAD: Equipo eléctrico para uso en laboratorios 3Z77, EN61326, grupo 1 clase B /
CONFORMITÀ: Equipaggiamento elettrico da laboratorio 3Z77, EN61326, gruppo 1 classe B /
CLASSIFICAÇÃO: Equipamento eléctrico para uso laboratorial 3Z77, EN61326, grupo 1 Classe B

For In Vitro Diagnostic Use. / Zur In-vitro-Diagnostik / Pour diagnostic in vitro /

4349090 C
Para uso en diagnóstico in vitro / Per uso diagnostico in vitro / Para utilização in vitro

EU Reach
For information related to Article 33 of the EU REACH
regulation (EC No.1907/2006), please refer to
pmis.abbott.com. If you have issues logging into the website,
contact Abbott at abbott.REACH@abbott.com.

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Responsible Parties
Table 4: Parties Responsible for the Instrument
In Vitro Diagnostic 98/79/EC
Directive

Authorized ABBOTT
Representative in MAX-PLANCK-RING
the European 2
Community 65205 WIESBADEN
GERMANY
+49-6122-580

Manufacturer ABBOTT MOLECULAR


1300 E. TOUHY AVE.
DES PLAINES, IL
60098 USA

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Trademark Statements
All Abbott Laboratories product names and trademarks are
owned by or licensed to Abbott Laboratories, its subsidiaries,
or affiliates. No use of any Abbott trademark, trade name,
trade dress, or product name may be made without the prior
written authorization of Abbott Laboratories, except to
identify the product or services of Abbott Laboratories. All
other trademarks, brands, product names, and trade names are
the property of their respective companies. All rights reserved.
Except as permitted above, no license or right, express or
implied, is granted to any person under any patent, trademark,
or other proprietary right of Abbott Laboratories.
m2000, m2000sp, and m2000rt are trademarks of the Abbott
Group of Companies in various jurisdictions. All other
trademarks are the property of their respective owners.

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NOTES

xxvi m2000rt Operations Manual


200680-106—October 2012
Master Table of Contents

Section 1. Use or Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Section 2. Installation Procedures and User Configuration . . . . . . . . . . 2-1

Section 3. Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Section 4. Performance Characteristics and Specifications . . . . . . . . . 4-1

Section 5. Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Section 6. Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Section 7. Operational Precautions and Limitations. . . . . . . . . . . . . . . . 7-1

Section 8. Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Section 9. Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Section 10. Troubleshooting and Diagnostics. . . . . . . . . . . . . . . . . . . . 10-1

Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1

Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-1

Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1

m2000rt Operations Manual Master Table of Contents-1


200680-106—October 2012
NOTES

Master Table of Contents-2 m2000rt Operations Manual


200680-106—October 2012
Section 1

Section 1: Use or Function

Use or Function

Section 1 Table of Contents


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
System Control Center (SCC) and Software . . . . . . . . . . . . . 1-9
System Control Center (SCC) . . . . . . . . . . . . . . . . . . . . 1-10
Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
On-line Documentation Features . . . . . . . . . . . . . . . . . 1-18
Toolbar Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Information Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Tooltip Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Software Column Sorting . . . . . . . . . . . . . . . . . . . . . . . 1-23
Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25

m2000rt Operations Manual Table of Contents-1


200680-106—October 2012
Use or Function Section 1

NOTES

Table of Contents-2 m2000rt Operations Manual


200680-106—October 2012
Section 1 Use or Function

Section 1: Use or Function

Use or Function

Overview
The ABBOTT® m2000rt System provides the operator with an
intuitive software interface and display of system statuses.
These features minimize system interaction through
automated result calculation and optical calibrations.
The following topics are included:
• Structure on page 1–3
Identifies the primary components of the m2000rt
System, and their arrangement.
• Function on page 1–9
Describes the operation of the system control center
(SCC) and the system software menu structure.
• Instrument Overview on page 1–25

Identifies instrument hardware assembly and


fundamental activities performed by the m2000rt System.
• Consumables on page 1–25
Lists the consumables necessary to using the m2000rt
System.

m2000rt Operations Manual 1-1


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Use or Function
Use or Function Section 1

NOTES

1-2 m2000rt Operations Manual


200680-106—October 2012
Use or Function
Section 1 Structure

Structure

System Overview
The m2000rt System provides for real-time measurement of the
stages of the polymerase chain reaction (PCR). Real-time PCR
measures PCR amplification as it occurs, cycle-by-cycle,
allowing quantitative measurements to be made during the
highly reproducible exponential phase of PCR.
Compared to traditional techniques, real-time PCR enables
more rapid, precise, and accurate quantitation, and requires
only minimal hands-on time. In addition, the sealed plate
format minimizes the risk of contamination and eliminates all
post-PCR processing.

Laboratory-Defined Functionality
The m2000sp and m2000rt instruments are capable of
performing laboratory-defined applications.
The m2000sp instrument is capable of performing sample
extractions for open-mode protocols. Reagent and Sample
Addition activities are performed manually by the user.
The m2000rt instrument is capable of PCR thermal cycling and
real time reading for laboratory-defined applications.
Laboratory-defined functionality is discussed in detail in the
m2000rt Laboratory-Defined Applications Guide.
Contact your Abbott representative for more information.

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Use or Function
Structure Section 1

Front of m2000rt
Figure 1.1: m2000rt Instrument, Front

Access door

Tray drawer

Power switch

The front of the instrument features functionality for turning


the instrument ON and OFF and for accessing the tray that
holds the PCR plates.
Table 1.1: Features of Instrument Front
Access door Permits access to
• halogen lamp
• heated cover
• thermal block
Power switch Powers the instrument ON and OFF
Tray drawer Opens to permit access to tray holder for
placement or removal of PCR plate

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200680-106—October 2012
Use or Function
Section 1 Structure

Back of m2000rt
At the back of the instrument are ports for connecting power
supply and the USB (universal serial bus) computer cable.
Figure 1.2: m2000rt Instrument, Back

Fan
Fan vent

USB port

Cable

Fuses

Power
cord port

Table 1.2: Features of Instrument Back


Fan vents Vents for three fans which cool the
instrument
USB ports Provides for connection to the system
control center (SCC) [computer]
Fuses Two alternating current (AC) slow blow
fuses (12.5 A, 250 V) which can
interrupt the flow of electrical current
when overload occurs
Power cord port Provides for connecting power cord

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Use or Function
Structure Section 1

Figure 1.3: m2000rt Instrument, Behind Access Door


Fan

Lamp

Heated cover

Tray drawer

Behind Access Door of m2000rt


Table 1.3: Features Behind Access Door
Fan Cooling fan
Lamp Generates white visible light including
the 450-700 nm wavelength band
necessary to instrument function
Heated cover Heats the top of the PCR plate
Thermal block Provides heat necessary during PCR
process
Plate holder Provides positioning of the PCR plate to
the thermal block and optical blocking
between wells

CAUTION: Hot Surface. Power OFF the instrument


and allow the block and lamp to cool before opening
the access door and accessing the thermal block/lamp.

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Section 1 Structure

About the System


Light from a tungsten-halogen lamp is directed through an
excitation filter on a filter wheel onto the PCR plate held
securely in place in the thermal block. The excitation light
excites fluorescent dyes in each well of the PCR plate. The
emitted fluorescence light is detected by a charged coupled
device (CCD) camera through a series of optical lenses and
through a corresponding emission filter.
Five excitation/emission filter pairs are contained in the filter
wheel assembly. By indexing the filter wheel assembly during
the read process, up to five dye signals may be monitored in
each sample well of the PCR plate.
PCR amplification is carried out by periodically cycling the
temperature of the thermal block. The block heating and
cooling is controlled by peltier assemblies in thermal contact
with the block. The heated lid assembly is held at a high,
constant temperature to prevent condensation on the plate
lid. The heated lid assembly also contains optical elements to
aid in collection of fluorescent light and suppression of light
coming from areas other than the individual wells.
The entire thermal and optical/detection system is under
computer control and constantly monitored for proper
operation.

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Use or Function
Structure Section 1

NOTES

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Use or Function
Section 1 Function

Function

System Control Center (SCC) and Software


The SCC controls the m2000rt System and stores real-time PCR
data collected from the reaction plate. Each run consists of a
single plate. The software includes a user interface navigated
by the mouse (pointing device) and/or keyboard. The
following functions can be performed:
• Manual entry of patient, calibrator, and control
information
• Import and create a test order
• Performance of maintenance procedures
• View results (Assays and Calibrations)
• Calibrate the optics
• Calibrate the pure dyes
• Maintain Application Specification files
• Configure the system
• Manage user accounts

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Function Section 1

System Control Center (SCC)


The m2000rt SCC consists of these primary components:
• Monitor
• Keyboard
• Mouse
• CD/DVD Drive
• Computer (central processing unit [CPU])

Optional accessories include:


• Printer
• Stand
• Hand-held bar code scanner
NOTE: Prior to operating the hand-held bar code
scanner, review the Abbott Molecular Bar Code
Scanner User’s Guide.
NOTE: The keyboard and bar code scanner must
be configured in the same language for English,
French, German, Italian, and Spanish. For other
languages, it is recommended that the bar code
scanner not be used unless both it and the
keyboard are configured to English. See the
Abbott Molecular Bar Code Scanner User’s
Guide for details on configuring the bar code
scanner.

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Section 1 Function

Figure 1.4: m2000rt System Control Center (SCC)


Monitor

Computer
(CPU) with
CD drive

Keyboard

Mouse

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Use or Function
Function Section 1

Software Overview
The SCC stores real-time PCR data collected from the PCR
plate. Each run consists of a single plate.
The figure below illustrates the menu options of the software.
Figure 1.5: Software Overview

Overview Orders Results System Help

Instrument View By System


Test Orders About
Status Plate Logs

Message On-line
View Assay
Logon History Log Documentation
Calibrations

Process Log
Logoff View Quality
Control
Results System
System Calibration
Shutdown
Application
Specifications

Settings

Audible Alert
User Accounts LIS
Configuration
Serial Number
Change Password Configuration
Time & Date
Configuration
Account Management Language and
Locale
Network
Configuration
Database Management License
Configuration
Network Data Store Result Units
Management Configuration

Printer Queue

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Section 1 Function

<Overview> menu
The <Overview> menu offers these options to the operator:

Table 1.4: <Overview> Menu


<Instrument Navigates to the <Instrument Status>
Status> screen where the operator can view the
current status of the instrument,
in-process plate data, temperatures, and
lamp status.
<Logon> Provides the operator with appropriate
user access to log on to the system.
<Logoff> Permits the operator to log off, but not
shut down the m2000rt application.
<System Permits the operator to shut down the
Shutdown> m2000rt application.

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Function Section 1

<Orders> Menu
The <Orders> menu permits the operator to create, import,
and run a test order for a PCR plate.
Table 1.5: <Orders> Menu
<Test Orders> Displays a screen that permits the
operator to select from additional
commands associated with <Create
Tasks>, <Run Tasks>, and <Order
Management Tasks>
<Create Tasks> <New Order>
<Import Order>
<Run Tasks> <Set Up Run>
<Import and Set Up Run>
<Order <View Order Details>
Management <Edit Order>
Tasks>
<Delete Order>

<Results> menu
The <Results> menu leads the operator to two methods of
viewing assay results.
Table 1.6: <Results> Menu
<View by Plate> Permits the operator to view results of a
selected PCR plate:
View Results
Release Results
Delete Results
Archive Results
Export Results
Print Result Lists and Details
<View Assay Permits the operator to view details of
Calibrations> assay calibrations
<View Quality Permits the operator to view control
Control Results> results for all or selected assays over a
user-selected date range

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Use or Function
Section 1 Function

<System> menu
The <System> menu offers eight options to the operator:
Table 1.7: <System> Menu
<System Logs> Allows the operator to view logs of
messages and processes carried out on
the m2000rt System:
• <Message History Log> lists all
messages accumulated on the system,
starting with the most recent message
• <Process Log> lists all the steps of a
PCR run
<System Permits Administrators to perform
Calibration> optical/pure dye calibrations and
change the lamp. Permits General Users
to perform background calibrations and
contamination checks.
<Application Affords access to Application
Specifications> Specification management
• <Application Specifications>
Permits operator with appropriate
access to import/delete Application
Specifications onto or off of the
m2000rt System, and view or change
assay result units
<Settings> • <Audible Alerts> Operator can
configure audible alerts for errors,
warnings, and information
• <LIS Configuration> General Users
can configure the settings for release
mode and Administrators can
configure the serial port settings
• <Serial Number> Abbott
Representative can configure system
serial number
• <Time and Date> Operator can
configure current system date and/or
time

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Function Section 1

• <Language and Locale>


Administrators to configure the
following to meet regional
preferences:
- the software interface language
- the date and time display format
- the numeric format for test results
featured in reports
- On-line documentation format
- Keyboard language
• <Network Configuration> Abbott
<Settings> Representative can set the method of
continued data transfer to the m2000rt.
• <License Configuration> Permits
Administrators to configure
laboratory-defined application license
settings. (Contact your Area Abbott
Customer Service for more
information.)
• <Result Units Configuration>
Permits Administrators to configure
the settings for reporting secondary
result units for qualitative and
quantitative assays. General Users may
view the settings only.
<User Accounts> • <Change Password> Permits the
operator to change passwords
• <Account Management> Displays
a screen with associated commands,
including <Create User Account>,
<Delete User Account>, and
<Reset Password>
<Database • Allows user to create system backups
Management> of the database
• Allows Abbott Customer Support and
Abbott Representative users to restore
saved database

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Section 1 Function

• Lists all files exported from the


m2000sp to the Network Data Store
<Network Data until those files are either imported
Store for an m2000rt run or deleted
Management> • Allows users with Administrator
access to delete old files that are no
longer needed
<Printer Queue> • Shows current print jobs
• Permits user to delete jobs

<Help> menu
The <Help> menu features the following options:
• <About>, which lists the current software version on the
m2000rt System
• <On-line Documentation>, which features an on-line
version of this manual, including addenda loaded on to
the system by an authorized Abbott Representative. Refer
to On-line Documentation Features on page 1–18.

!! IMPORTANT: Any addendum issued either after


initial software installation, or in between site
visits by an Abbott Representative, might not be
present in the on-line documentation.
Always refer to the latest hard-copy
version of the m2000rt Operations Manual
addenda.

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Function Section 1

On-line Documentation Features


The <On-line Documentation> screen includes the tools
shown in the following illustration:
Figure 1.6: <On-line Documentation> Screen Features

<Contents> menu

<Navigation> bar

<Zoom> options

<Search> option

1. The <Contents> menu has clickable links to the various


sections of the document and expandable/collapsible
nodes for more in-depth searching.

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Section 1 Function

2. The <Navigation> bar allows the user to


• move forward/backward one page at a time by
clicking the center arrows
• move all the way back to the first page or forward to
the last page by clicking the outside arrows
Figure 1.7: <Navigation> Bar
Center Arrows

Outside Arrows

3. The <Zoom> options allow the user to enlarge or reduce


the size of the page shown depending on the button
selected.
Figure 1.8: <Zoom> Options

The first button enlarges the page incrementally.


Every time it is selected, the view gets larger until
it reaches 200%.
The second button reduces the page
incrementally.
The third button forces the document into a
single, full-page view
The fourth button forces the page to fit the width
of the viewer space

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Use or Function
Function Section 1

4. The <Search> option features a text field that allows the


user to type in a search word. When the <Find Text>
button is clicked, the software takes the user to the next
page that word occurs on.
Figure 1.9: <Search> Field

Clicking <Find Text> again, takes the user to the next


occurrence after that.

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Use or Function
Section 1 Function

Toolbar Buttons
Many functions of the m2000rt System software can be quickly
accessed by using the following buttons from the system
toolbar:
Table 1.8: Toolbar Buttons

Toolbar Button Command


<Back>
Navigates to the previous screen

<Forward>
Navigates to the next screen

<Home>
Navigates to the <Instrument Status>
screen

<Orders>
Navigates to the <Test Order> screen

<PCR Plate Results>


Navigates to the <PCR Plate Results>
screen

<Assay Calibrations>
Navigates to the <Assay
Calibrations> screen

<Message History Log>


Navigates to the <Message History
Log> screen

<Process Log>
Navigates to the <Process Log> screen

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Use or Function
Function Section 1

<System Calibration>
Navigates to the system calibration
screen

<Application Specification>
Navigates to the Application
Specifications screen

<Settings>
Navigates to the System Settings screen

Information Icons
The m2000rt System software displays icons to signal certain
kinds of details:
Table 1.9: Information Icons

Information
Explanation
Icon
Information
Informational alert for the operator

Warning
Alerts the operator to potential problem

Error
Alerts the operator that an error has
occurred on the system

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Use or Function
Section 1 Function

Tooltip Icon
If any text runs beyond it’s border on the screen and displays
ellipses (...), hold the mouse pointer over the text to display
the entire text.
Figure 1.10:Tooltip icon

Software Column Sorting


Most of the list fields in the m2000rt software feature columns
that are sortable. By clicking on a column heading, the
operator can select the specific category to sort by and in what
order the information should be displayed.
A narrow triangular icon indicates which column has been
selected by the operator and in what order the listing occurs.
Figure 1.11:Sort Icon Examples

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Use or Function
Function Section 1

NOTES

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Use or Function
Section 1 Instrument Overview

Instrument Overview

The m2000rt System uses fluorescent-based chemistries to


provide quantitative and qualitative detection of nucleic acid
sequences using real-time PCR analysis.
The m2000rt allows the operator to perform assays using plates
in the 96-well format.

Consumables
The m2000rt instrument makes use of the following
consumables:
• ABBOTT® 96-Well Optical Reaction Plate
• ABBOTT Optical Adhesive Cover

Accessories
• ABBOTT Optical Adhesive Cover Applicator
• ABBOTT Splash Free Support Base
• m2000rt Halogen Lamp
• m2000rt Plate Holder
• m2000rt Universal Serial Bus (USB) Communication Cable
• Universal Voltage Kit (Australian, British, European, North
American, and Japanese Power Cords)
• m2000rt Optical Calibration Kit, containing:
– ROI Calibration Plate
– Background Plate
– Pure Dye Plates (Cy™5, FAM™, JOE™, NED™, ROX™,
SYBR®, TAMRA™, and VIC®)

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Instrument Overview Section 1

ABBOTT® Optical Adhesive Cover


Figure 1.12:ABBOTT Optical Adhesive Cover

ABBOTT 96-Well Optical Reaction Plate and ABBOTT Splash


Free Support Base
Figure 1.13:ABBOTT 96-Well Optical Reaction Plate and
Splash Free Support Base

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Section 1 Instrument Overview

ABBOTT® Optical Adhesive Cover Applicator


Figure 1.14:ABBOTT Optical Adhesive Cover Applicator

Applicator

m2000rt Halogen Lamp


Figure 1.15:m2000rt Halogen Lamp (12V, 75W)

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Use or Function
Instrument Overview Section 1

m2000rt Plate Holder


Figure 1.16:m2000rt Plate Holder

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Section 2

Section 2: Installation Procedures and User Configuration

Installation Procedures and


User Configuration

Section 2 Table of Contents


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
m2000rt System Installation . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Where to Place the m2000rt . . . . . . . . . . . . . . . . . . . . . . 2-3
Hardware Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Software Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
m2000rt Logon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Operator Access Levels . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Alert Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Region of Interest (ROI) Calibration . . . . . . . . . . . . . . . . 2-6
Background Calibration . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Uniformity Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Pure Dye Plate Calibrations . . . . . . . . . . . . . . . . . . . . . . 2-7
Instrument Installation Verification . . . . . . . . . . . . . . . . 2-8
Account Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Create User Account . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Delete User Account . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Reset Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Change Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Audible Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
LIS Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Release Mode Configuration . . . . . . . . . . . . . . . . . . . . 2-21
Serial Ports Configuration . . . . . . . . . . . . . . . . . . . . . . . 2-24
LIS Configuration / View . . . . . . . . . . . . . . . . . . . . . . . 2-26
Releasing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
Cancel Result Transmission . . . . . . . . . . . . . . . . . . . . . 2-28
Serial Number Configuration . . . . . . . . . . . . . . . . . . . . . . . 2-29
Time and Date Configuration . . . . . . . . . . . . . . . . . . . . . . 2-30
To Set Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
To Select a Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Language and Locale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32
To Change <Language> . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
To Change <Input Languages> . . . . . . . . . . . . . . . . . . . 2-34
To Change <Document Language> . . . . . . . . . . . . . . . 2-35
To Change <Locale> . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36

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Installation Procedures and User Configuration Section 2

Network Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38


License Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40
Result Units Configuration . . . . . . . . . . . . . . . . . . . . . . . . 2-41

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200680-106—October 2012
Section 2 Installation Procedures and User Configuration

Section 2: Installation Procedures and User Configuration

Installation Procedures and


User Configuration

Overview
To ensure accurate results and maximum performance, the
ABBOTT® m2000rt System must be installed properly.

Installation procedures include the following topics:

• m2000rt System Installation on page 2–3


Details the procedures the Abbott Representative
performs while installing the instrument.
– Where to Place the m2000rt on page 2–3
– Hardware Installation on page 2–3
– Software Installation on page 2–4
– m2000rt Logon on page 2–4
– Operator Access Levels on page 2–5
– Alert Dialog on page 2–5
• System Setup on page 2–6
Describes the system calibrations the Abbott
Representative performs.
– Region of Interest (ROI) Calibration on page 2–6
– Background Calibration on page 2–6
– Uniformity Calibration on page 2–7
– Pure Dye Plate Calibrations on page 2–7
– Instrument Installation Verification on page 2–8
• Account Management on page 2–9
Describes how Administrators can manage user accounts.
– Create User Account on page 2–11
– Delete User Account on page 2–13
– Reset Password on page 2–14

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Installation Procedures and User Configuration
Installation Procedures and User Configuration Section 2

– Change Password on page 2–17


• System Settings on page 2–18
Describes how to setup System Configurations.
– Audible Alert on page 2–19
– LIS Configuration on page 2–21
– Serial Number Configuration on page 2–29
– Time and Date Configuration on page 2–30
– Language and Locale on page 2–32
– Network Configuration on page 2–38
– License Configuration on page 2–40
– Result Units Configuration on page 2–41

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Installation Procedures and User Configuration
Section 2 Installation

Installation

m2000rt System Installation


CAUTION: Improper installation may result in damage
! to the System.
• The m2000rt must be installed by an Abbott
Representative.
• If the m2000rt must be moved, contact your local
Abbott Representative.

Where to Place the m2000rt


Before the m2000rt System can be installed, its location must
meet environmental and electrical requirements. Refer to
Section 4, Performance Characteristics and Specifications for
additional information.

Hardware Installation
The Abbott Representative installs the m2000rt hardware.
Installation includes the following steps:
• Unpack the System
• Unpack the accessory kit
• Position the m2000rt and its peripherals
• Assemble the m2000rt
• Connect the cables
• Confirm proper seating; secure connections of all circuit
boards, power supplies, and other hardware
• Install software
• Perform initial system calibrations
• Verify System

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Installation Procedures and User Configuration
Installation Section 2

Software Installation
The Abbott Representative installs the m2000rt software,
including System software.

m2000rt Logon
To operate the m2000rt it is necessary to receive a
<User Name> and to establish a <Password> to enter on
the <User Logon> screen.
The <User Name> determines what tasks the operator can
perform. The <Password> helps maintain m2000rt security
and functional integrity.
Figure 2.1: <User Logon> Screen

Entering incorrect information on the <User Logon> screen


results in an alert message.
For additional information, see Section 10, Troubleshooting
and Diagnostics.

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Installation Procedures and User Configuration
Section 2 Installation

Operator Access Levels


Logon authorization and actions possible at corresponding
access levels for the m2000rt are presented in the table below.
Operators of the system must have an access level equal to or
higher than the level set for the functions.
Table 2.1: Logon Authorization and Actions Possible

Logon Actions Possible at


Authorization Corresponding Access Level
General User • Initiate assay runs
• Create / import test orders
• Review, print, and export results
• Perform contamination check
• View logs and configuration
information
• Perform system backup
• Archive results
• Configure audible alert
• Perform Background calibration
Administrator • Install and delete Application
(Additional Specifications
Capabilities) • Delete process logs, results, and plates
• Delete individual results and plates
• Perform system calibrations
• Configure result units
• Configure format preferences for time
and date, and language and locale
• Replace lamp
• Configure date and time, localization,
and LIS
• Manage Administrator and General User
accounts

Alert Dialog
The Alert Dialog displays when the system needs to notify the
operator of the outcome of the current task. The Alert Dialog
presents information and asks the operator to acknowledge
the message by clicking a button.

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Installation Procedures and User Configuration
Installation Section 2

System Setup
After completing the m2000rt installation, the Abbott
Representative ensures the instrument is operating properly by
performing the following system calibration procedures:
• Region of Interest Calibration
• Background Calibration
• Uniformity Calibration
• Pure Dye Calibrations
• Instrument Installation Verification
These procedures are described briefly below. For specific
calibration instructions, refer to System Calibration on page
6–3 of Section 6, Calibration Procedures.

Region of Interest (ROI) Calibration


Data gathered during the ROI calibration allow the m2000rt
software to map the positions of the wells on the sample block
so that, during instrument operation the software can
associate increases in fluorescence with specific wells of the
PCR plate.
Since the m2000rt uses a set of optic filters to separate the
fluorescent energy during runs, a calibration image must be
generated for each individual filter to account for minor
differences in the optical path.

Background Calibration
Background calibration measures the level of ambient
fluorescence in the m2000rt instrument. During the
Background calibration run, the m2000rt performs multiple
reads of a Background plate.

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Section 2 Installation

Fluorescence collected by the m2000rt instrument includes a


fluorescent signal inherent to the system, commonly referred
to as “background” fluorescence. This background component
is a composite signal found in all spectral data. It consists of
fluorescence from several sources including:
• background electrical signal
• contaminants in the thermal block
• fluid inside the background plate
• the plastic consumable

Because the background signal can interfere with the precision


of the data the instrument collects, the m2000rt is engineered
to minimize the background signal, and the software is
designed to use the calibration data to compensate for any
residual signal.

Uniformity Calibration
Data collected from the Uniformity calibration are used to
compensate for the small differences in Fluorescent response
across the 96 well locations. The Uniformity calibration uses
the ROI calibration plate.

Pure Dye Plate Calibrations


Before operating the m2000rt, pure spectra data must be
generated. This is accomplished by performing a Pure Dye
calibration.
A Pure Dye calibration consists of a set of runs during which
the software collects spectral data from a series of dye
standards. The software stores the spectral information for the
pure dye standards used on the m2000rt instrument.

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Installation Procedures and User Configuration
Installation Section 2

The m2000rt uses the data obtained from the Pure Dye
calibrations to distinguish the individual contribution of each
dye in the collective fluorescence gathered by the instrument
during a run. After each run, the software receives the run data
in the form of a raw spectra signal for each reading. To
interpret the raw data, the software determines the
contribution of each fluorescent dye used in the sample by
comparing the raw spectra to a set of pure dye standards.
The following Pure Dyes can be calibrated on the m2000rt
instrument:
• FAM™ • ROX™ • SYBR® Green
• JOE™ • TAMRA™ • Cy™5
• NED™ • VIC®

In addition, up to five user-defined dyes can be calibrated for


laboratory-defined applications. Refer to the m2000rt
Laboratory-Defined Applications Guide for details.
Contact your Abbott representative for more information on
laboratory-defined functionality.

Instrument Installation Verification


After all system calibrations are performed, the Abbott
Representative carries out the Instrument Installation
Verification procedure.

The Instrument Verification plate is run to verify that the


m2000rt instrument has been correctly installed for the
purpose of detection and quantitation.

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Installation Procedures and User Configuration
Section 2 Installation

Account Management
Administrators can create and delete user accounts for
Administrators and General Users, and reset passwords.
To perform account management, select <System>, then
<User Accounts>, and then <Account Management>.
Figure 2.2: <System> Menu, <Account Management>
Option

NOTE: To change a password, select <Change


Password> on the same option list. Refer to Change
Password on page 2–17 for details.
The <Account Management> screen displays the current
<User Names>, their access level (Administrator or General
User), and a description.
Figure 2.3: <Account Management> Display

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From the <Account Management Tasks> menu, users with


Administrator access can:
• <Create User Account> -- Create user accounts
• <Delete User Account> -- Delete existing accounts
• <Reset Password> -- Reset passwords for existing
accounts
Figure 2.4: <Account Management Tasks> Menu

Accounts displayed in red are new accounts or accounts that


have had their passwords reset.

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Create User Account


1. To create a new user account, select <System>, then
<User Accounts>, and then <Account
Management>.
Figure 2.5: <System> Menu, <Account Management>

2. From the <Account Management Tasks> menu, select


<Create User Account>, and the <Create User
Account> screen displays.
Figure 2.6: <Create User Account> Display

3. Enter the user name (1 to 20 characters).


NOTE: The initial password will be set to the user
name. During their first login, the user will be
prompted to change their password.

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4. Select the Access Level for the user:


• <General User>
• <Administrator>
Figure 2.7: <Create User Account> Display

5. If desired, enter a description (this is an optional field).


NOTE: The fields designated by a red asterisk (*)
are required fields.

6. When the entries are complete, select <OK>.


The <Account Management> screen displays with the
new user added to the list.

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Delete User Account


1. To delete a user account, select <System>, then <User
Accounts>, and then <Account Management>.
Figure 2.8: <System> Menu, <Account Management>

2. Select the account to delete.


3. From the <Account Management Tasks> menu, select
<Delete User Account>.
An alert message displays, requesting the operator to
confirm the intention to delete the user account.
Figure 2.9: Delete a User, Request for Confirmation

4. Select <Yes>.
The <Account Management> screen displays the
updated list of current user accounts.

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Reset Password
1. To reset a user password, select <System>, then <User
Accounts>, and then <Account Management>.
Figure 2.10:<System> Menu, <Account Management>

2. Select the user account password to be reset.


3. From the <Account Management Tasks> menu, select
<Reset Password>.
Figure 2.11:Resetting a Password

An alert message displays requesting the operator to


confirm the intention to reset the password for the
selected user account.
4. Select <Yes> to reset the password.

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An alert message displays, stating that the password for


the user account (user name) has been reset to the user
name.
Figure 2.12:Password Reset, Confirmation Message

5. Select <Close> to close the alert message.

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6. The next time the user logs on to the m2000rt system, the
system will require that the user change their password.
Figure 2.13:Password Change, Popup Message

7. The user enters the current password (same as user name).


8. The user then enters the new password and re-enters the
new password as confirmation.
NOTE: The minimum length of the password is 1
(one) character, and the maximum length is 20
characters, but it cannot contain the following
characters: \ / “ [ ] : | < > + = ; , ? * @.

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Change Password
Both Administrators and General Users can change their own
password.
To change a password, select <System>, <User Accounts>,
then <Change Password>.
Figure 2.14:<System> Menu, <User Accounts> Option

The <Change Password> screen displays. Only the user


currently logged onto the system will be able to change their
password.
Figure 2.15:<Change Password> Display

To change the password, the user enters their current


password, then enters a new password, and re-enters the new
password as confirmation.
When the password has been changed, the screen returns to
the previous screen display.

NOTE: The minimum length of the password is 1 (one)


character, and the maximum length is 20 characters,
but it cannot contain the following characters: \ / “ [ ] :
| < > + = ; , ? * @.

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System Settings
This subsection provides information on configuring the
Abbott m2000rt System settings to meet your site-specific
requirements.
To access the Configuration screen, select <System>, then
<Settings> from the dropdown menu. The Configuration
screen for <System Settings> is displayed.
Figure 2.16:System Settings Screen

The <System Settings> screen allows you to select one of the


following categories to view or edit:
• Audible Alert, discussed on page 2–19
• LIS Configuration, discussed on page 2–21
• Serial Number Configuration, discussed on page 2–29
• Time and Date Configuration, discussed on page 2–30
• Language and Locale, discussed on page 2–32
• Network Configuration, discussed on page 2–38
• License Configuration, discussed on page 2–40
• Result Units Configuration, discussed on page 2–41

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Audible Alert
This function of the m2000rt allows the operator to enable or
disable the audible alert, and adjust the volume for operator
notifications.
1. To configure the audible alert, select <System>,
<Settings>, and then <Audible Alert>.
Figure 2.17:<System Settings> Screen; Select
<Audible Alert>

2. From the <Setting Tasks> menu, select <Configure>.


3. On the <Audible Alert Configuration> screen, select
a sound scheme for each message type to be enabled:
• <Error>
• <Warning>
• <Information>
To disable a sound scheme, choose <none> from the
respective message type’s dropdown menu.
Figure 2.18:Choosing a sound scheme

Click here to reveal


the dropdown menu

Click here to hear


the sound sample

Select [none] to disable


sound for this message

4. Select <Test> to hear the selected sound scheme.

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5. Choose the volume level desired by using the arrows on


the <Volume> toggle at the top of the screen. The
volume setting can be verified by clicking <Test>.
Figure 2.19:<Audible Alert Configuration> Display

NOTE: The volume on the monitor may also need


to be adjusted.
NOTE: Contact your Abbott Representative if
external speakers are desired.

6. Click <Save> at the bottom right of the screen.

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LIS Configuration
From the <System Settings> screen, select <LIS
Configuration>. This screen allows the user to either view or
configure the settings for the LIS.
Figure 2.20:System Settings Screen

Selecting <Configure> from the <Setting Tasks> menu


allows the General User to configure the settings for release
mode. A system Administrator can also configure the serial port
settings.

Release Mode Configuration


A General User can configure most of the LIS communication
settings, except Number Format.
Figure 2.21:LIS Configuration: Release Mode Screen

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Table 2.2: Release Mode Configuration


1 Communication: Allows the General
User to enable the host mode, so the
system can transmit results to a host
computer.

Options:
• On
• Off (Default)

NOTE: Turning
<Communication> OFF allows
you to clear all results waiting to
be sent to the host.
2 Release Mode: Allows the General User to
select the release mode for results.

Options:
• Manual - All results must be manually
selected and released (Default).
• Automatic - Results are released
automatically at the time the run is
completed.
3 Transmit to LIS host: Allows the General
User to define the types of results for
transmitting to the host computer along
with patient results.

Options:
• Assay control result
• Test exception (incomplete result)
• Genotype result
• Laboratory Defined Application result

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4 Number Format: Allows the


Administrator to define how numeric
results are displayed.

Options:
• Invariant - (standard) Results are
formatted using a period as the
decimal separator and no thousands
separator (e.g., 1000.00).
• Localized - Results are formatted to
match locale configuration settings.
Refer to Language and Locale on page
2–32. The thousands separator can be
configured as a comma, period, or no
character; the decimal separator can
be configured as a period or comma
(e.g., 1,000.00 or 1.000,00 or
1000,00).

!! IMPORTANT: Verify
configuration can be supported
by LIS system.
5 Save: Accepts the selection(s) and
returns to the Configuration screen.
6 Cancel: Cancels the selection(s) and
returns to the Configuration screen.

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When the LIS <Communications> is configured <ON>,


“LIS” will appear at the bottom center of the screen. A
<Results Transmitting> message will also be displayed
when results are in queue to the LIS.
Figure 2.22:System Settings Screen

Serial Ports Configuration


Administrators can configure communication settings for the
serial ports.
Figure 2.23:Configure Serial Ports

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Table 2.3: Serial Port Configuration


1 Port ID: Displays the unique ID for the
port.

Options:
• COM1
2 Baud rate: Allows selection of the baud
rate for the selected port.

Options:
• 1200
• 2400
• 4800
• 9600 (Default)
• 19200
• 38400
• 57600
• 115200
3 Parity: Allows selection from the
following parity options:

• None (Default)
• Odd
• Even
4 Data bits: Allows selection from the
following options:

• 7
• 8 (Default)

WARNING: If 7 bits is selected for


transmission, the use of upper code page
characters (ASCII codes 128-255) will
not be mapped properly during the
transmission.

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5 Stop bits: Allows selection from the


following stop bit options:

• 1 (Default)
• 2
6 Save: Accepts the selection(s) and
returns to the Configuration screen.
7 Cancel: Cancels the selection(s) and
returns to the Configuration screen.

LIS Configuration / View

Release Mode Configuration Details


Communications: <ON> or <OFF>
Release Mode: <Automatic> or <Manual>
Transmit to LIS:
• Assay control results
• Text exceptions
• Genotype result
• Laboratory-defined application result
• Number format: <Invariant> or <Localized>.

Serial Port Configuration Details


Table 2.4: Serial Port Configuration Details
Port ID Displays the unique port ID supported
by the system. Select the list button to
view all ports.
Baud Rate Displays the selected baud rate.
Parity Displays the selected parity.
Data Bits Displays the selected data bits.
Stop Bits Displays the selected stop bits.

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Releasing Results
The system allows the user to manually release plate or
individual results to the LIS system.
To manually release plate results, go to <Results>, <View by
Plate>. Then, highlight the plate to be released and select
<Release> from the <Plate Tasks> menu.
To release selected results, highlight the result(s) to be released,
then select <Release> from the <Results Tasks> menu.
Figure 2.24:Plate Results with LIS Tasks

The screen will display <Results Transmitting> in the


lower right-hand corner.
Figure 2.25:Results Transmitting

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Cancel Result Transmission


Perform this procedure to clear all results that are pending
transmission to the host.
To cancel result transmission:
1. Select <LIS Configuration> from the <System
Setting> screen.
2. Select <Configure>.
The LIS Configuration screen displays.
3. Select the <Communications: OFF> option, and then
select <Save>.
A message displays when results are pending transmission
to the host.
4. Select <Yes> to cancel result transmission.
NOTE: If you select <No>, rather than <Yes>, and
leave communications on, the results pending
transmission remains until transmission is
successful.
Results with a status of Pending Transmission go to a
Release status of Cancelled.
NOTE: To resume host communication, configure
the LIS communications option to <ON>.

If the LIS is already configured OFF, perform the following


steps:
1. Configure the LIS ON by selecting <LIS Configuration>
from the <System Setting> screen.
2. Select <Configure>, followed by the
<Communications:ON> option and check all the boxes
for results transmission.
3. Select <Save>.
4. Shutdown the m2000rt SCC.
5. Power on the SCC. The LIS icon and the number of results
pending transmission displays in the status bar.
6. Configure the LIS to OFF following the instructions above
to cancel the results transmission.

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Serial Number Configuration


From the <System Settings> screen, select <Serial Number
Configuration>. The serial number is configured by an
Abbott representative only. Operators can select <View> to see
the serial number.
Figure 2.26:Serial Number View

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Time and Date Configuration


Administrators can set the correct time and date, and time
zone, by selecting <Settings> from the <System> menu,
highlighting <Time and Date>, and choosing <Configure>
from the <Setting Tasks> menu.
Figure 2.27:<Time and Date Configuration>

To Set Time and Date


Select the desired field, and then use the arrows at the right to
move the setting up or down as necessary. Click <Save> when
finished.
Figure 2.28:Setting Time and Date

NOTE: Daylight savings settings that are different than


Microsoft settings must be configured by the Abbott
FSE.
NOTE: The date and time formats can be changed to
meet regional preferences. See Language and Locale on
page 2–32.
NOTE: Daylight saving time may have changed in your
area. In these areas, the time settings may need to be
adjusted a second time.

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To Select a Time Zone


Click on the dropdown menu arrow at the end of the
<System Time Zone> field to reveal the list of choices.
Figure 2.29:Setting the Time Zone

Dropdown menu

Scroll up or down, as needed, and select the desired time zone.


Click <Save> when finished.

NOTE: If time zone is changed, the time must also be


changed.

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Language and Locale


Figure 2.30:<Language and Locale> screen

On the <Language and Locale> screen, Administrators can


change the following to meet regional preferences:
• <Language>, which determines what language the
various system menus and messages will appear in. See To
Change <Language> on page 2–33.
• <Input Language>, which determines what regional
keyboard layout is used with the system. See To Change
<Input Languages> on page 2–34.
• <Document Language>, which determines what
language the on-line documentation (e.g., the m2000rt
Operations Manual) will display in when accessed
through the <Help> menu. See To Change <Document
Language> on page 2–35.
• <Locale>, which determines:
– how numeric data are presented in reports and screens
– how the date and time is displayed and entered
See To Change <Locale> on page 2–36.

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To make changes, first select <Settings> from the <System>


menu, highlight <Language and Locale>, and choose
<Configure> from the <Setting Tasks> menu. Then,
proceed with the instructions given in the applicable section
below.

To Change <Language>
1. On the <Language and Locale> page, go to the
<Language> field and click on the dropdown menu to
select a language preference.
Figure 2.31:<Language> Field

The following languages are supported:


• German
• English
• Spanish
• French
• Italian
• Portuguese
• Russian
2. Select <Save>.
3. A message displays explaining that the change requires a
system restart. Select <Yes>.
After the system restarts, the display will be in the chosen
language.

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To Change <Input Languages>


Changing the keyboard preference is a two-part process:
• Changing the preference on the SCC
• Installing the new keyboard

Changing the Preference on the SCC


1. On the <Language and Locale> page, go to the <Input
Language> field and click on the dropdown menu to
select a keyboard layout preference.
Figure 2.32:<Input Language> Field

2. Select <Save>. In the lower right corner of the screen, the


new language setting will appear.
Figure 2.33:Language Setting Display

NOTE: Holding down the Ctrl key and then


clicking the Shift key will cause the keyboard to
toggle back to English. Repeating this step (or
restarting the system) will bring it back to the
configured input language.

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Installing the New Keyboard


1. Unplug the original keyboard from the back of the
computer.
2. Plug the new keyboard into the back of the computer,
being careful not to disturb the other cables.
NOTE: If a handheld bar code reader is installed,
plug it into the new keyboard.

To Change <Document Language>


1. On the <Language and Locale> page, go to the
<Document Language> field and click on the
dropdown menu to select a language preference for the
on-line documentation, such as the m2000rt
Operations Manual.
Figure 2.34:<Document Language> Field

2. Select <Save>.
The on-line documents, found under the <Help>,
<On-line Documentation> menu, will now appear in
the language selected if it is available on the system.
NOTE: If the Abbott Representative has not
loaded the specific language manual, the manual
will display in English, if loaded.

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To Change <Locale>
1. On the <Language and Locale> page, go to the
<Locale> field and click on the dropdown menu to select
a regional display preference.
2. Scroll down the list and make the selection that best fits
your preferences.
Figure 2.35:Choose a preference

3. The <Examples> section below the dropdown menu will


show examples of how dates, times, and numerical data
will be depicted in the m2000rt Software.
Figure 2.36:Examples of New Formats

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If these new formats are acceptable, and if all other


changes have been made to the settings on this screen,
select <Save>.

NOTE: Changes made to the <Locale> setting


require a system restart to implement. It is best to
make all desired changes to the other settings on
the <Language and Locale> screen before
selecting <Save> here.
NOTE: Only results generated after a change made
to the <Locale> setting will be generated with the
new locale information.

4. A message displays explaining that the change requires a


system restart. Select <Yes>.
After the system restarts, the date and time will be
displayed in the new format.
Figure 2.37:Reformatted Date and Time Display

Reformatted
Date and Time

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Network Configuration
The m2000rt can be connected to multiple m2000rt’s and
m2000sp’s for the purpose of importing Test Orders from any
connected m2000sp System.
Users may view the settings and test applicable connections by
selecting <Settings> from the <System> menu, highlighting
<Network Configuration>, and choosing <View> from
the <Settings Tasks> menu.
Figure 2.38:<System Settings> screen

The <Network Configuration> screen shows the data


transfer method chosen.
Figure 2.39:<Network Configuration> screen

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This page offers three connectivity options:


• <No network connection (import via CD only)>,
which leaves the instrument unconnected to an m2000sp;
in this case, Test Orders can only be imported via CD
NOTE: Importing Test Orders via CD is always an
option regardless of what network configuration
option has been selected.

• <Get from local machine>, when a single m2000sp is


connected to the m2000rt via a crossover cable. The Test
Orders are stored on the m2000rt.
• <Get from network data store>, when one or more
m2000sp instrument(s) is connected to one or more
m2000rt instrument(s) via a network cable. AbbottLink
may or may not be connected. The Test Order data is
stored on one of these networked systems. The IP address
is used to identify that system. All systems should point to
the same IP address.

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License Configuration

This screen is used in laboratory-defined operations only.


Laboratory-defined functionality is discussed in detail in the
m2000rt Laboratory-Defined Applications Guide.
Contact your Abbott representative for more information.
Figure 2.40:License Configuration Screen

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Result Units Configuration


This screen allows Administrators to configure the settings for
reporting secondary result units for selected closed mode
qualitative and quantitative assays. General users may view the
settings only.
NOTE: Secondary result units are defined by editing
the Application Specification. Refer to Application
Management <Edit> on page 5–24 for details.
Figure 2.41:<Result Units Configuration> Screen

The four setting options allow:


• <Archive>, which archives the configured secondary
results, along with the primary results, to CD.
• <Display>, which shows the configured secondary results
along with the primary results on the result screens.
• <Release to LIS>, which allows the transmission of both
the configured primary and secondary results to the LIS.

!! IMPORTANT: Verify that your LIS system can


handle multiple results for the same sample prior
to configuring.
• <Report>, which includes the configured secondary
results in all printed reports.

To configure these settings, do the following:


1. Highlight <Result Units Configuration> on the
<System Settings> screen, and then select
<Configure> from the <Setting Tasks> menu.
2. Check the desired destination(s) for the additional
secondary result in the <Secondary Result Unit
Configuration> field.
3. When finished, select <Save>.

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NOTES

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Section 3

Section 3: Section 3: Principles of OperaPrinciples of Operation

Principles of Operation

Section 3 Table of Contents


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Real-Time PCR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
PCR Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Real-time PCR Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Analysis of Real-Time PCR . . . . . . . . . . . . . . . . . . . . . . . 3-7
Advantages of Using Real-time PCR . . . . . . . . . . . . . . . 3-12
Real-time PCR Assay Testing . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Processing PCR Assays . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Spectra for Pure Dyes . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

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Section 3

NOTES

Table of Contents-2 m2000rt Operations Manual


200680-106—October 2012
Section 3 Principles of Operation

Section 3: Principles of Operation

Principles of Operation

Overview
The ABBOTT® m2000rt System uses fluorescent-based PCR
chemistries to provide quantitative and qualitative detection
of nucleic acid sequences.
This section reviews the principles of the m2000rt, and
addresses the following topics.
• Real-Time PCR, page 3–3
Presents principles of PCR and real-time PCR, and the
general advantages and applications for real-time
PCR.
• Real-time PCR Assay Testing, page 3–13
Provides information about spectra for pure dyes used
in the m2000rt system.

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NOTES

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Section 3 Principles of Operation

Real-Time PCR
PCR Theory
PCR (polymerase chain reaction) is a common technology
used in molecular diagnostics to provide qualitative or
quantitative assessment of nucleic acid target sequences in test
specimens. PCR amplifies specific target DNA sequences
through the use of reagents containing target-specific
oligonucleotide sequences (or primers), individual nucleic acid
triphosphate bases and polymerase enzymes. (RNA target
sequences must first be converted to cDNA [complementary
DNA] sequences before PCR can occur.)
Through the process of cycling the reaction mixture between
high and low temperatures (thermal cycling), these reagents
replicate the target nucleic acid sequence. Ideally, after each
cycle the target sequence would double in concentration. Over
the course of 30 or more cycles, the original target can be
amplified over a billion-fold. As little as one copy of a
particular sequence can be specifically amplified and detected
through PCR. Multiple target sequences can be amplified in
the same reaction by including the appropriate combination
of target specific oligonucleotide primer sequences.

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The PCR reaction exhibits three phases of growth:


exponential, linear, and plateau. What happens in each phase
is described in the following table:

Table 3.1: PCR Run Phases


Phase of Run What Happens
exponential • exact doubling of product
accumulates at every cycle
(assuming 100% reaction
efficiency)
• reaction is specific and precise
linear • reaction is slowing due to
accumulating product
• reaction components are being
consumed
plateau • reaction-limiting reagents are
depleted
• reaction is effectively
completed, no more specific
products are being made

Theoretically, as long as the PCR reaction is efficiently


amplifying the target sequences (exponential phase), a
quantitative relationship exists between the amount of
starting target sequence, and the amount of PCR product at
any given cycle. As the reaction progresses, the amount of
target produced becomes significant and it begins to compete
with the primers for binding to the complementary target
sequence. This causes the reaction to slow. This corresponds to
the onset of the linear phase.
As the reaction continues, reagents begin limiting the
reaction, which corresponds to the onset of the plateau phase.
In this way the kinetics of the PCR reaction are translated into
the PCR growth curve. If the kinetic process is modified during
the course of the reaction, such as by reaction inhibition, that
is reflected in the PCR growth curve. Typically, inhibition of
the PCR reaction results in either a delay of the growth curve
in time, or a suppression of the response, or both.

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Real-time PCR Theory


Detection of the PCR product can occur by several means
including, for example, gel electrophoresis, and
post-processing of the reaction to determine the amount of
product via enzyme immunoassay. More common today is the
use of fluorescence labeled oligonucleotide probes. These
probes are fluorescent when bound to a specific target
sequence and quenched, or non-fluorescent, in the absence of
target. The fluoresce/quench property of the PCR probes
allows for homogeneous PCR reactions in which all necessary
reagents are added to the sample prior to amplification and
enables the detection of a specific PCR product as it
accumulates during PCR. Given a suitable thermal cycling
process, the probes will bind to the target sequence during the
amplification process, providing a fluorescent measure for the
amplification product. This is the basis for real-time PCR
assays. No additional reagents are required for detection, so
the reaction can be sealed which, thereby, reduces the
potential for contamination in the laboratory.
Real-time PCR integrates an optical detection system with the
thermal cycling hardware. This allows the detection system to
measure the progress of the PCR reaction as it occurs (that is,
on a cycle-by-cycle basis) through the use of the fluorescent
probes bound to the amplified target sequence. Fluorescence
response data are collected throughout the cycling process,
resulting in detection of PCR fluorescence growth curves.

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Principles of Operation Section 3

Real-time Amplification Plot


An amplification plot is the plot of fluorescence signal, or PCR
fluorescence growth curve, in relation to cycle number. In the
initial cycles of PCR, the PCR reaction progresses with
exponential growth, but the number of target copies is small.
Therefore, there is little or no detectable change in
fluorescence signal. This region is commonly called the
baseline region for the amplification plot. As cycling
progresses, the fluorescence signal will rise above the baseline
and grow exponentially. The rate of growth will begin to slow
and exhibits several cycles of linear growth. Ultimately the
signal growth slows further, entering the plateau phase.
A typical real-time amplification plot is shown below,
identifying the characteristic phases of the growth curve.
Figure 3.1: Real-time PCR Amplification Plot

Sample
Plateau Phase

Linear Phase
Rn

Exponential Phase
No Template Control

Baseline Region

Cycle Number

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Section 3 Principles of Operation

Analysis of Real-Time PCR


The real-time amplification plot contains very specific
information about the PCR reaction, including information
about the concentration of the input target sequence and the
efficiency of the PCR reaction. The process of data reduction
extracts relevant information from these curves that allows for
determining a qualitative or quantitative response for the
reaction. The m2000rt data analysis method provides two
principal responses for each PCR amplification plot. One
response is an efficiency related value called maxRatio
(maximum ratio) value, which is used to differentiate positive
from negative reactions, and is based on the unique curve
shape of the amplification plot. The second response is a cycle
number, which is used for quantitation and relates to the
input number of target copies in the reaction.
The data reduction software provides for two basic types of
analysis for assay reactions:
• a traditional threshold-based cycle number
determination, commonly referred to as the CT (threshold
cycle) method
• a method that uses curve shape analysis to determine a
(fractional) cycle number, or FCN, associated with the
maxRatio response

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Principles of Operation Section 3

CT - Threshold Cycle Determination

Cycle Number Calculation and Quantitation


The parameter CT (threshold cycle) is defined as the fractional
cycle number at which the PCR fluorescence growth curve
raises a fixed amount above the baseline fluorescence level. To
perform this determination, the baseline region is identified
and the slope and offset removed to generate a baselined
amplification response. This response is compared to a fixed
threshold to determine the CT value. This analysis assumes
that for all baselined fluorescence intensities at the threshold
level, the same amount of amplified target is present.
Figure 3.2: Baselined Amplification Plot

Sample

Threshold

CT No Template

The PCR growth equation in the exponential phase at cycle N


is:

[target PCR product]N = [target]0 x (1 + efficiency)N

• [target]0 is the target sample concentration before


amplification
• efficiency is the average amplification efficiency through
N thermal cycles

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Section 3 Principles of Operation

If the target PCR product concentration is set equal to a


constant, then the cycle number N is defined as the threshold
cycle or CT value.

Constant = [target]0 x (1 + efficiency)CT

Rearranging the equation gives the following equation:

log ([target]0) = log(Constant) - CT x log(1 + efficiency)

This equation indicates that plot of the log of initial target


copy number versus CT for a set of samples is a straight line.
The slope of this line is the -log of 1 + average amplification
efficiency. When calibrators of known concentration are run
and analyzed in this manner, the slope and intercept
determined establish an assay calibration curve.

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Principles of Operation Section 3

maxRatio Analysis
maxRatio analysis is an alternative and complimentary
analysis method to CT analysis. It provides a robust reactive
versus non-reactive determination, as well as several measures
of assay performance.
The PCR amplification plot displays the measured fluorescence
intensity throughout the thermal cycle process, as illustrated
in the Real-time PCR Amplification Plot (Figure 3.1).
When the ratio of fluorescence growth from cycle to cycle is
calculated, the following plot is obtained:
Figure 3.3: Ratio Plot

MR

The height of the peak Sample


in the maxRatio plot is
referred to as MR.

(positive) FCN

(negative)

This is the Ratio plot. The ratio increase in fluorescence at a


cycle is given by

Ratio(N) = Intensity(N + 1)- – 1


-------------------------------------
Intensity(N)

There are five basic parts of this curve:


• The early cycles where the ratio function is near zero: the
fluorescence growth is undetectable
• The ratio function is increasing: the signal growth is in the
exponential phase
• The ratio function peaks: the MR and FCN value (see
below) are determined

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Section 3 Principles of Operation

• The ratio function is decreasing: the signal growth is in the


linear phase
• The later cycles where the ratio function approaches zero:
the signal growth is in the plateau phase
The shape of this function is determined by the kinetics of the
PCR reaction. In particular, the maximum ratio value on this
curve is related to the efficiency of the PCR reaction. This is
the maximum ratio value, or MR value, for the reaction. This
value is used to distinguish positive and negative amplification
reactions. If the MR value is greater than a predetermined
value, then the amplification reaction is positive. If the MR
value does not reach the predetermined value, the reaction is
negative.
The interpolated cycle at which the MR occurs for a positive
reaction is called the maxRatio fractional cycle number (FCN)
value.
In the situation which an amplification response exhibits
significant signal suppression in the growth (exponential and
linear) and plateau phases of the PCR amplification plot, an
adjustment to the FCN value (FCN-A) has been found to
provide improved accuracy. This adjustment is defined by the
following equation:

FCN-A = FCN - Log2(maxRatio)

The FCN and FCN-A values can be used in the same fashion as
other cycle numbers to determine reaction concentration.

Figure 3.4: maxRatio Curve as displayed on the m2000rt

(or FCN)

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Principles of Operation Section 3

Advantages of Using Real-time PCR


Advantages of using real-time PCR include:
• collection of data throughout the PCR reaction, rather
than measurement at the end-point (plateau) only
• use of the entire kinetic curve for data analysis, including
assessment of reaction inhibition
• linear quantitation; the cycle number at which the
amplicon is detected is proportional to the amount of
starting target in the sample
• increase in dynamic range of detection
• homogenous reaction; no need for physical manipulation
of the reaction for detection purposes
• improved quantitation precision

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Section 3 Principles of Operation

Real-time PCR Assay Testing


Processing PCR Assays
PCR assay processing occurs on the m2000rt system, an
amplification/detection system that provides real-time PCR
technology with multiplex fluorescence capability of up to five
distinct dyes per reaction. The m2000rt system provides
thermal cycling temperature control with optical read
capability every cycle throughout the amplification protocol.
The m2000rt system supports performance of quantitative and
qualitative assay types using plates in the 96-well format.
Temperature control for assay reactions is accomplished by
simultaneously heating or cooling all sample wells in the
thermal cycler per the assay-specific protocol. Detection of
fluorescent dyes in the reaction is accomplished by
simultaneously illuminating all wells in the plate using the
tungsten-halogen lamp.
The optical filters inside the m2000rt are arranged in five
excitation and emission filter pairs. The excitation and
emission center wavelength and bandpass are designed to
preferentially excite individual dyes in the reaction mixture. A
schematic representation of the excitation and emission
pathways is illustrated in the figure below.
Figure 3.5: Filter Module
To CCD camera

Filter assembly module

Emission filter

Lamp
Emission

Excitation
Dichroic
beam-
splitter

Excitation filter

To 96-well plate

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Principles of Operation Section 3

Spectra for Pure Dyes


An optical reading consists of a set of five fluorescence
intensity measurements by a CCD camera, one for each of the
five filter assembly modules. The five pairs of filters are
calibrated for their response to each dye used in the assay
using calibration dye plates. The choice of filters allows for the
use of the following dyes on the system: FAM™, SYBR®, VIC®,
NED™, TAMRA™, JOE™, ROX™, and Cy™5. The center
wavelength for each excitation and emission filter pair is listed
in the table below. Dyes are listed in relation to the filter
module where their fluorescence is maximum.

Table 3.2: Filter Module - Dye Relationship


Filter Excitation Emission
Dye
Module Wavelength Wavelength
FAM™
A 470 nm 520 nm
SYBR®
JOE™
B 520 nm 558 nm
VIC®
NED™
C 550 nm 586 nm
TAMRA™
D 580 nm 623 nm ROX™

E 640 nm 682 nm Cy™5

In addition, up to five user-defined dyes can be calibrated for


laboratory-defined applications. Refer to Section 3,
Calibrations, in the m2000rt Laboratory-Defined
Applications Guide. Contact your Abbott representative for
more information on laboratory-defined functionality.

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Section 4

Section 4: Performance Characteristics and Specifications

Performance Characteristics and


Specifications

Section 4 Table of Contents


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Product Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
m2000rt Instrument System Placement . . . . . . . . . . . . . 4-3
Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Supply, Interfaces, Connections . . . . . . . . . . . . . . . . . . . 4-4
Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . 4-6
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Location of System Control Center . . . . . . . . . . . . . . . . 4-7

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200680-106—October 2012
Section 4

NOTES

Table of Contents-2 m2000rt Operations Manual


200680-106—October 2012
Section 4 Performance Characteristics and Specifications

Section 4: Performance Characteristics and Specifications

Performance Characteristics
and Specifications

Overview
This section introduces the ABBOTT® m2000rt and its main
components. It contains technical data and system placement
requirements.
These topics include:
• Product Identification, page 4–3
Identifies the main components of the instrument
• Technical Data, page 4–3
Provides the dimensions, weights, electrical
specifications, environmental conditions, and ventilation
and waste collection requirements

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Performance Characteristics and Specifications
Performance Characteristics and Specifications Section 4

NOTES

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Performance Characteristics and Specifications
Section 4 Performance Characteristics and Specifications

Product Identification
Product identification may be read from the serial number
plate that is located at the rear of the m2000rt.

Technical Data
m2000rt Instrument System Placement
Verify that the table on which the instrument is placed
supports at least 54.5 kg (120 lb).

Dimensions and Weights

Overall Dimensions
The dimensions and weights of the system components are
indicated below. Ensure that the installation site (floor space
and/or bench space) can accommodate the dimensions and is
able to support the weights.

Table 4.1: ABBOTT® m2000rt System Overall


Dimensions
Width Depth Height Weight
Component
(cm/in) (cm/in) (cm/in) (kg/lb)
m2000rt 34 cm/13.4 in 45 cm/17.8 in 49 cm/19.3 in 34.1 kg/75.0 lb
Instrument
Computer (CPU) 33 cm/13 in 35.6 cm/14 in 12.7 cm/5 in 10 kg/22 lb
Monitor 37.3 cm/14.7 in 20.6 cm/8.1 in 48.3 cm/19 in 6.8 kg/15.0 lb
Keyboard 45.7 cm/18 in 17.8 cm/7 in 5.1 cm/2 in 0.9 kg/2.0 lb

NOTE: Computer, monitor, and printer specifications


are approximations.

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Performance Characteristics and Specifications
Performance Characteristics and Specifications Section 4

Clearances
Required clearances for the m2000rt System are as follows:

• Clearance on all sides – At least 15.2 cm (6 in) of


clearance for ventilation, service access, and cable routing.

NOTE: Allow space for the Abbott Representative


to move the instrument to obtain access to its back
and sides.

• Vertical clearance – At least 30.5 cm (12 in) of


unobstructed vertical clearance above the top of the
m2000rt Instrument to allow the top to be lifted during
service.

Supply, Interfaces, Connections


The m2000rt System is shipped to customers with up to three
power connectors. These connectors require standard 15A wall
receptacles with proper grounding. Do not use extension
cords.

System Electrical Requirements


The m2000rt System can be configured for operating voltages
between 100 and 240 VAC at 50 or 60 Hz. The system can be
used with an uninterruptible power supply (UPS) if needed.

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Performance Characteristics and Specifications
Section 4 Performance Characteristics and Specifications

Table 4.2 provides electrical specifications for the m2000rt


System. For all indicated input voltages, a 15A circuit is
required.

Table 4.2: Electrical Specifications for the m2000rt


Instrument System
Input Nominal
Frequency
Voltage Current Power (W)
(Hz)
(VAC) Draw (A)
60 9 950
100
50 9 950
60 9 950
120
50 9 950
60 4 950
220
50 4 950
60 4 950
240
50 4 950

Power Line Regulator


In areas where the supplied power is subject to voltage
fluctuations exceeding ±10% of the nominal value, a power
line regulator may be needed. High or low voltages can
adversely affect the electronic components of the instrument.

NOTE: Contact your Abbott Laboratories


Representative for information on a recommended
UPS.

Halogen Lamp
The m2000rt Instrument is shipped with a halogen lamp
(12V, 75W). The lamp should be replaced after approximately
1000 hours of usage.

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Performance Characteristics and Specifications
Performance Characteristics and Specifications Section 4

Environmental Conditions

Altitude
The m2000rt System is for indoor use only and for altitudes
not exceeding 3000 m (9800 ft) above sea level.

Temperature and Humidity Requirements


Ensure that the installation site is maintained under the
following conditions:

Table 4.3: Required Temperature and Humidity


Condition Acceptable Range
Temperature • 15 to 30°C (59 to 86°F)
Humidity • 30% to 80% relative humidity,
noncondensing

Avoid placing the system adjacent to heaters, cooling ducts, or


in direct sunlight.

Pollution
The m2000rt System has a Pollution Degree rating of II and
may be installed in an environment that has nonconductive
pollutants (dust, wood chips, etc.) only.

Ventilation

Venting Hot-Air-Only Exhaust


The hot air exhaust fans dissipate heat produced by the
instrument. The maximum thermal output of the m2000rt
instrument is 3241.5 BTU/h (950 W). Consult your facilities
department to determine if the laboratory ventilation system
can maintain room temperature with this level of thermal
output. If it can maintain room temperature during
instrument operation, the fan can be vented directly to room
air.

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Performance Characteristics and Specifications
Section 4 Performance Characteristics and Specifications

Location of System Control Center


The m2000 System Control Center (SCC) is commercial in
design and not intended for use at any time in a Residential
Environment.

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Performance Characteristics and Specifications
Performance Characteristics and Specifications Section 4

NOTES

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200680-106—October 2012
Section 5

Section 5:

Operating Instructions

Section 5 Table of Contents


Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Power On the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
System Control Center (SCC) . . . . . . . . . . . . . . . . . . . . . 5-4
Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Power Off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
System Control Center . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Menu Access Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
User Logon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Instrument Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Application Management . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Application Management <Install> . . . . . . . . . . . . . . . 5-18
Application Management <Delete> . . . . . . . . . . . . . . . 5-20
Application Management <View> . . . . . . . . . . . . . . . . 5-23
Application Management <Edit> . . . . . . . . . . . . . . . . . 5-24

Run an Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26


Prepare the ABBOTT® 96-Well Optical Reaction Plate . . . . 5-26
Prepare the Plate Using the m2000sp . . . . . . . . . . . . . . 5-26
Prepare the Plate Manually . . . . . . . . . . . . . . . . . . . . . . 5-26
Seal the Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Test Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Test Orders: <Create Tasks> . . . . . . . . . . . . . . . . . . . . . . . . 5-35
<New Order> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
<Import Order> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Test Orders: <Run Tasks> . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57
<Set Up Run> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57
<Import and Set Up Run> . . . . . . . . . . . . . . . . . . . . . . . 5-61
During the Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
After the Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-70
Test Orders: <Order Management Tasks> . . . . . . . . . . . . . . 5-73
<View Order Details> . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73

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200680-106—October 2012
Section 5

<Edit Order> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-77


<Delete Order> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-78

Results Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81


View By Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81
<Plate Tasks> Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-85
<Result Tasks> Menu . . . . . . . . . . . . . . . . . . . . . . . . . 5-114
<View Assay Calibrations> . . . . . . . . . . . . . . . . . . . . . . . . 5-120
<View Calibration Details> . . . . . . . . . . . . . . . . . . . . . 5-121
<Fail Calibration> . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-125
View Quality Control Results . . . . . . . . . . . . . . . . . . . . . . 5-126
Printing Quality Control Results . . . . . . . . . . . . . . . . 5-128
Exporting Quality Control Results . . . . . . . . . . . . . . . 5-129
m2000rt Quality Control Report Description . . . . . . 5-130
Managing the Network Data Store . . . . . . . . . . . . . . . . . . 5-133

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200680-106—October 2012
Section 5 Operating Instructions

Section 5: Operating Instructions

Operating Instructions

Overview

This section describes the operating elements and available


operating modes of the ABBOTT® m2000rt System, and
provides instructions for its proper and safe operation.
The following topics are included:
• Operation on page 5–3
Describes specific operation procedures for the m2000rt.
– Safety Instructions on page 5–3
– Power On the System on page 5–4
– Power Off the System on page 5–5
– Menu Access Levels on page 5–7
– User Logon on page 5–8
– Instrument Start-up on page 5–10
– Application Management on page 5–15
• Run an Application on page 5–26
Describes the procedures for running a real-time assay
plate.
– Prepare the ABBOTT® 96-Well Optical Reaction Plate on
page 5–26
– Test Orders on page 5–32
• Results Management on page 5–81
Describes how to view and analyze the plate results.
– View By Plate on page 5–81
– Managing the Network Data Store on page 5–133

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Operating Instructions
Operating Instructions Section 5

NOTES

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200680-106—October 2012
Operating Instructions
Section 5 Operation

Operation

Operation procedures described in this section are specific for


closed-mode protocols on the m2000rt.

NOTE: Laboratory-defined functionality is discussed in


detail in the m2000rt Laboratory-Defined
Applications Guide. Contact your Abbott
representative for more information.
NOTE: Reagent identification functionality is discussed
in detail in the m2000rt Reagent Identification
Guide. Contact your Abbott representative for more
information.

Safety Instructions
BIOLOGICAL RISKS: All clinical specimens, controls,
and used consumables, such as reaction plates that
contain human-sourced material, should be considered
potentially infectious. Handle all potentially infectious
materials in accordance with the OSHA (Occupational
Safety and Health Administration) Standard on
Bloodborne Pathogens. The operator should use
Biosafety Level 2 or appropriate biosafety practices for
materials that contain or are suspected of containing
infectious agents.

CAUTION: Contamination Control. To minimize


! the risk of contamination, the following procedures are
recommended:
• Use powder-free gloves.
• Wear the appropriate personal protective equipment,
such as gloves, lab coats and protective eye wear,
before starting a protocol run on the m2000rt.
• Ensure proper sealing of the PCR plate.

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Operating Instructions
Operation Section 5

Power On the System


Under normal operating conditions, the m2000rt system is left
in the powered ON state.

System Control Center (SCC)


Power ON the m2000rt SCC by pressing the power switch.
Figure 5.1: SCC Power Switch

NOTE: The power ON time will increase by 60 seconds


if the m2000sp and m2000rt instruments are connected
via network cable.

Instrument
Power ON the m2000rt by pressing the On/Off power switch at
the lower right front of the instrument.
Figure 5.2: Power Switch, Tray Drawer Release

Tray drawer
release (dimple)

Power switch
(embossed icon)

NOTE: It is important to distinguish between the


On/Off switch, and the tray drawer release, which
is located adjacent to the On/Off switch.

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200680-106—October 2012
Operating Instructions
Section 5 Operation

Power Off the System


Under normal operating conditions, the m2000rt system is left
in the ON state. The following situations may require the
m2000rt instrument to be powered OFF:
• perform maintenance
• replace components
• troubleshoot problems

The following situations may require the SCC to be powered


OFF:
• troubleshoot problems

NOTE: Powering OFF the SCC and/or the m2000rt


instrument will cause a loss of information if a run
is currently in progress.

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200680-106—October 2012
Operating Instructions
Operation Section 5

System Control Center


1. Select <Overview>.
2. Select <System Shutdown>. The SCC will automatically
power OFF.
Figure 5.3: SCC Power Switch

Instrument
1. Power OFF the m2000rt by pressing the On/Off power
switch at the lower right front of the instrument.
Figure 5.4: Power Switch, Tray Drawer Release

Tray drawer
release (dimple)

Power switch
(embossed icon)

NOTE: It is important to distinguish between the


On/Off switch, and the tray drawer release, which
is located adjacent to the On/Off switch.

NOTE: If the m2000rt instrument system is turned


Off, the instrument start-up procedure will be
performed prior to running an assay or performing
system calibrations.

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Operating Instructions
Section 5 Operation

Menu Access Levels


To access the system, the operator must first complete a logon
screen by entering name and password identification. Using
this identification, the system determines the level of menu
access available to the operator. Access levels are as follows:
Table 5.1: Operator Access Levels

Operator Menu Access Level


• Initiate assay runs
• Create / import test orders
• Review, print, and export results
• Perform contamination check
• View logs and configuration
<General User>
information
• Perform system backup
• Archive results
• Configure audible alert
• Perform Background calibration
• Install and delete Application
Specifications
• Delete process logs, results, and plates
• Delete individual results and plates
• Perform system calibrations
<Administrator
• Configure result units
>
(Additional • Configure format preferences for time
Capabilities) and date, and language and locale
• Replace lamp
• Configure date and time, localization,
and LIS
• Manage Administrator and General User
accounts

Users of the system must have an access level equal to or


higher than the level set for the functions. Menus enable only
those options that are available for the current access level.
Routine procedures require an access level of General User. If a
higher level is required, the level is stated in the procedure.

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Operating Instructions
Operation Section 5

User Logon
Power ON the SCC and the m2000rt instrument. When the
<User Logon> displays:
1. Enter <User name>.
2. Enter <Password>.
NOTE: The password is case sensitive.

Figure 5.5: <User Logon> Display

NOTE: The <User Logon> can be accessed at any


time while the system is powered ON. This allows
different user levels access to needed procedures
without having to cycle power on the instrument
and the SCC.

3. Select <OK>.
If an invalid <User name> and/or <Password> is
entered, an error message displays.
For more information, see Section 10, Troubleshooting
and Diagnostics.

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Operating Instructions
Section 5 Operation

4. Following correct user logon, the <Instrument Status>


screen displays.
Figure 5.6: <Instrument Status> Display

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Operating Instructions
Operation Section 5

Instrument Start-up
After the <User name> and <Password> are accepted during
logon, the <Instrument Status> screen displays:
Figure 5.7: <Instrument Status> Display

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Operating Instructions
Section 5 Operation

The <Instrument Status> screen displays five categories of


information:
Table 5.2: <Instrument Status> Display
<Start> -- initiates instrument
initialization
<Instrument Tasks>
<Stop> -- halts a process currently
running
Current state of the instrument:
• <OFFLINE>
• <STOPPED>
• <INITIALIZING>
<Instrument Status> • <READY>
• <RUNNING>
(For more information, see the
<Instrument Status> Details table
below.)
Current information about an
assay or calibration run, including:
• application name
• PCR plate name
• run name
• start time
<Current Process> • estimated completion time
• stage, step, cycle, time, state

NOTE: A time of “ ∞”
(infinity) indicates the run
is in a hold. The user must
press <Stop> to terminate
the hold.

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Operating Instructions
Operation Section 5

Temperature registered at each


<Temperatures> phase of an assay run and during
idle times
• Lamp status (Refer to Determine
Lamp Status on page 9–39 of
Section 9, Service and
Maintenance for Lamp Status
details)
<Lamp Information> <Normal>
<Replace Soon>
<Expired>
<Unknown>
• Lamp usage (in hours)

Five states are displayed in the <Instrument Status>


category, as shown in the following table:
Table 5.3: <Instrument Status> Details
Instrument and SCC are not
<OFFLINE> communicating

• Instrument has not been


initialized
or
• Mechanisms are in an
<STOPPED>
unknown state
or
• Instrument has been idle for
more than 4 hours
Instrument is initializing
<INITIALIZING>
mechanisms, heaters, and lamp
<READY> Instrument is available for use

<RUNNING> An assay run is in progress

NOTE: Do not attempt to open the Tray Drawer


while the instrument is in the <INITIALIZING>
or <RUNNING> state.

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Operating Instructions
Section 5 Operation

To bring the instrument to the <READY> status from the


<Instrument Tasks> menu, select <Start>.
Figure 5.8: <Instrument Status> Display, <Instrument
Tasks> Menu

The <Instrument Status> displays <INITIALIZING>.


Figure 5.9: <INITIALIZING> Status

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Operating Instructions
Operation Section 5

Initialization of the instrument takes up to 15 minutes and


includes the following checks:
• instrument firmware version is checked
• access door and tray drawer are verified to be closed
• thermal block is lowered to correct position
• thermal block temperature is set to its Idle temperature
• lamp is powered On and warmed up; lamp current is
checked within range
• motors are homed and in correct position
• lid temperature is brought to its Idle state temperature

When initialization is complete and successful, the


<Instrument Status> displays <READY>. An assay or
calibration run may now be ordered and processed.

NOTE: Do not attempt to open the Tray Drawer while


the instrument is in the <INITIALIZING> or
<RUNNING> state.
Figure 5.10:<READY> Status

NOTE: The m2000rt system will go to a <STOPPED>


state after the instrument has been in the <READY>
state for four hours or longer. To bring the instrument
to the <READY> state prior to processing an assay run,
repeat the above process.

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Operating Instructions
Section 5 Operation

Application Management
Application Specifications contain all the necessary parameters
to perform the real-time PCR process run and perform
appropriate data reduction.
When the operator initiates the installation of an Application
Specification, the m2000rt application:
• reads the file contents
• performs validation
• installs the specified application on the system

To access the <Application Management> screen, select


<System> then <Application Specification>.
Figure 5.11:<Application Management> Display

The <Application Management> display lists all currently


installed applications, along with the following details:
Table 5.4: <Application Management> Details

<Name> Name of the application

<Version> Numbered version of the application

<Description> Details of the application

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Operating Instructions
Operation Section 5

Common application types:


• m2000—Shared m2000sp/m2000rt
closed-mode application. PCR plate
data can be exported from the
m2000sp and imported on the
m2000rt.
• m2000rt—This is an m2000rt-only
application. User must manually
create a Test Order.
• m2000 Genotype—Shared with
m2000sp/m2000rt closed-mode
Genotype application. PCR plate data
can be exported from the m2000sp
and imported on the m2000rt.
• m2000rt Genotype—This is an
m2000rt Genotype only application.
User must manually create a Test
<Type> Order.
• m2000rt Open—Abbott-defined open
m2000 application.
• LDA—Laboratory-defined m2000rt
application.
NOTE: Laboratory-defined
functionality is discussed in
detail in the m2000rt
Laboratory-Defined
Applications Guide. Contact
your Abbott representative for
more information.

Other application types:


In addition to the more common types
listed above, other assay-specific
application types (such as Multi-Target)
can appear in the <Type> column.

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Operating Instructions
Section 5 Operation

The <Application Management Tasks> menu includes:


Table 5.5: <Application Management Tasks>

Permits Administrator to install an


application onto the system. Refer to
<Install>
Application Management <Install> on
page 5–18.

Permits Administrator to delete an


application from the system. Refer to
<Delete>
Application Management <Delete> on
page 5–20.

Permits a General User to view assay


<View> units. Refer to Application
Management <View> on page 5–23.

Permits Administrator to edit assay


<Edit> units. Refer to Application
Management <Edit> on page 5–24.

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Operating Instructions
Operation Section 5

Application Management <Install>


An operator with Administrator privileges can install an
application by performing the Application Specification Install
procedure.
NOTE: When installing a new Application
Specification, proceed to step 1 below. If installing a
new revision to an existing Application Specification,
the older Application Specification must be deleted
prior to installing the new Application Specification.
(Refer to Application Management <Delete> on page
5–20 for instructions.) All new Application
Specifications will require recalibration of the
associated assay.
1. From the menu, select <System>, and then
<Application Specifications>.
Figure 5.12:<System> Menu, <Application
Specifications> Option

Alternatively, select the <Application Specifications>


icon from the toolbar.
Figure 5.13:<Application Specifications> Menu Option

The <Application Management> screen displays, and


shows an <Application Management Tasks> menu.

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Operating Instructions
Section 5 Operation

2. To install an application, select <Install> from the


<Application Management Tasks> menu.
Figure 5.14:<Application Management Tasks> Display

3. Place the Application Specification CD into the CD drive.


The <Application Install> screen displays. The drive
where the application is located: <Compact Disc (CD)>
drive is displayed.
Figure 5.15:<Application Install> Display

4. Select the application to be installed. Select <OK> at the


bottom of the screen. Refer to the assay package insert for
the application file to be installed.
5. The m2000rt reads the Application Specification file and
installs the application on the system.
• Successful installation of the application is indicated
when the name of the newly installed application
appears in the application list.
• Unsuccessful installation of the application is
indicated by an alert message. For more information,
see Section 10, Troubleshooting and Diagnostics.

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Operating Instructions
Operation Section 5

Application Management <Delete>


An operator with Administrator privileges can delete an
application by selecting it from the list and choosing
<Delete> from the <Application Management Tasks>
menu.

!! IMPORTANT: Deleting an application will delete all


the stored calibration curves for assays contained on
the application. Recalibration of the associated assays
will be required.
1. From the menu, select <System>, and then
<Application Specifications>.
Figure 5.16:<Application Specifications> Menu Option

Alternatively, select the <Application Specifications>


icon from the toolbar.
Figure 5.17:<Application Specifications> Toolbar Icon

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Operating Instructions
Section 5 Operation

The <Application Management> screen displays. This


screen lists all currently installed applications and
displays the <Application Management Tasks>
menu, including <Install>, <Delete>, <View>, and
<Edit>.
Figure 5.18:<Application Management Tasks> Display

2. Select the application to be deleted. Select <Delete> from


the <Application Management Tasks> menu. An
alert message displays asking the operator if they are sure
they want to delete the application.
Figure 5.19:<Delete> Command

3. To delete the application, select <Yes>. The list of


available applications is updated, and the system returns
to the <Application Management> screen.
NOTE: If an application is in use by a test order in
the pending list, the operator will be unable to
delete the application and an error message will
display. Delete the Pending Test Order. Then delete
the Application Specification.

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Operating Instructions
Operation Section 5

4. Unsuccessful deletion is followed by an alert message.

For more information, see Section 10, Troubleshooting


and Diagnostics.

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Operating Instructions
Section 5 Operation

Application Management <View>


An operator with General User access is able to view assay units
for closed-mode qualitative and quantitative assays.
To view assay units, select <System>, then <Application
Specifications>. From the <Application Management>
screen, highlight the desired Application Specification. Then
from the <Application Management Tasks> menu, select
<View>.

The <Assay Unit Specifications> screen displays:


• <Application Specification>—Name of the
Application Specification

• <Version>—Version of the Application Specification

• <Description>—Description of the Application


Specification

• <Assay Name>—Selectable list of all the assays contained


in the application

• <Units for Selected Assay>—The units currently used


(both primary and secondary, if configured) will be shown

Figure 5.20:View <Assay Unit Specifications>

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Operating Instructions
Operation Section 5

Application Management <Edit>


An operator with Administrator access is able to edit assay units
for closed-mode quantitative and qualitative assays only.
To edit assay units, select <System>, then <Application
Specifications>. From the <Application Management>
screen, highlight the desired Application Specification. Then
from the <Application Management Tasks> menu, select
<Edit>.
Figure 5.21:Edit <Assay Unit Specifications>

To edit the assay units:


1. Select the assay name (if not already displayed) from the
<Assay Name> dropdown menu.
2. In the <Primary Unit> field, select a primary reporting
unit configuration from the options provided by the assay.
NOTE: Refer to the assay package insert for details
and unit conversions.
NOTE: No previously generated results will be
affected by the unit change.

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Section 5 Operating Instructions

3. If desired, select a secondary reporting unit configuration


from the <Secondary Unit> options provided by the
assay.
NOTE: The secondary unit must be different from
the primary unit.
NOTE: Administrators must determine how
secondary result units will be reported by selecting
from the options found on the <Result Units
Configuration> screen. Refer to Result Units
Configuration on page 2–41 for details.

4. Select <Save> to save the selection. The screen returns to


the <Application Management> screen.

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Operating Instructions
Run an Application Section 5

Run an Application

Prepare the ABBOTT® 96-Well Optical Reaction Plate


ABBOTT 96-Well Optical Reaction Plates (PCR plates) can be
prepared (one plate at a time) using the m2000sp instrument
(automated sample preparation) or manually. Refer to the
assay package insert for supported sample preparation
methods.

!! IMPORTANT: To prevent an incorrect read when


scanning a prepared plate using the optional hand-held
bar code scanner, Caps Lock and Shift Lock on the
keyboard must be off and no other keys can be pressed
during the scan.

Prepare the Plate Using the m2000sp

Materials Required
• ABBOTT 96-Well Optical Reaction Plate
• ABBOTT Optical Adhesive Covers
• ABBOTT Optical Adhesive Cover Applicator

NOTE: See the m2000sp Operations Manual


for complete instructions on preparing the plate
on the m2000sp. After ensuring the plate is tightly
sealed, carefully remove the prepared plate from
the m2000sp system and place it in the m2000rt
instrument, along with the m2000sp exported PCR
plate data.

Prepare the Plate Manually

Materials Required
• ABBOTT 96-Well Optical Reaction Plate
• ABBOTT Optical Adhesive Covers
• ABBOTT Optical Adhesive Cover Applicator
• ABBOTT Splash Free Support Base

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Operating Instructions
Section 5 Run an Application

When preparing the plate manually:


• Ensure appropriate internal controls, calibrators, controls,
and/or specimens are in the correct wells.
• Ensure there are no drops of reagent or sample above the
wells of the PCR plate. Liquid above the wells could cause
contamination of other samples and prevent proper
sealing of the plate.
• Ensure the ABBOTT® Optical Adhesive Cover has been
applied using the ABBOTT Adhesive Cover Applicator
while the PCR plate is held securely in the Splash Free
Support Base.

Seal the Plate


The ABBOTT Optical Adhesive Cover uses a pressure-sensitive
adhesive backing to ensure adherence of the cover to the PCR
plate. It is imperative that enough force is used to activate the
pressure-sensitive adhesive to prevent evaporation losses from
the wells. Users should not expect the ABBOTT Optical
Adhesive Cover to be very tacky or sticky to the touch on the
side that adheres to the PCR plate.
NOTE: Proper sealing is required to prevent
cross-contamination and help ensure accurate results.
Follow the steps below to seal the filled wells with an optical
adhesive cover.

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Operating Instructions
Run an Application Section 5

1. Wearing powder-free gloves, and with the plate resting in


the ABBOTT Splash Free Support Base to prevent
contamination, remove a single ABBOTT Optical Adhesive
Cover from the box, being careful to touch only the
tabbed edges, so that the seal remains clean.
Figure 5.22:Optical Adhesive Cover for Plate Wells

NOTE: Hold the cover so that the white protective


backing is up. Notice that the backing side has the
matte finish.
2. Keeping the cover away from surfaces which might
contaminate it, fold back one of the protective backing’s
end tabs at the solid cut line. Notice that the solid cut line
is closer to the perforation.
Figure 5.23:Fold Back the End Tab

Protective backing

End tab

Seal

3. Without touching the center sealing surface, in one


continuous movement, peel back the cover’s white
protective backing from the center sealing surface.
NOTE: If the backing is removed improperly, it
can result in a hazy appearance on the seal. This
haze will not affect results, and will disappear
when the seal comes in contact with the m2000rt’s
heated cover.

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Operating Instructions
Section 5 Run an Application

4. Hold the cover by the end tabs and position it over the
reaction plate to exactly fit over all wells and edges with
the adhesive side facing the plate. Lower the cover onto
the plate.
Figure 5.24:Carefully Position the Cover onto the Plate

5. Use the ABBOTT® Adhesive Cover Applicator to seal the


PCR plate. Drag the applicator slowly over the cover to
ensure good contact between the cover and the entire
plate surface.
Figure 5.25:Ensure a Tight Seal

Ensure that the cover is held


firmly when beginning to
drag the applicator over the
cover so there is no
movement of the cover

NOTE: The ABBOTT Adhesive Cover Applicator


(List Number: 9K32) can wear out after long-time
use or be damaged by incidental mechanical
contact. Visually inspect all edges and corners of
the applicator before each use. A working
applicator should have straight, smooth, and even
edges. Do not use a deficient applicator, as it can
damage the Optical Adhesive Cover and cause
leaking. See Figure 5.26 on page 5-30.

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Operating Instructions
Run an Application Section 5

Figure 5.26:Defective applicator

6. Use the applicator to hold the edge of the cover in place,


while grasping the center of the end-tab and pull away
firmly. Repeat for the other end-tab.
NOTE: Removing end-tabs with a top-to-bottom
motion may tear the cover.
Figure 5.27:Tear Off End Tabs

7. Repeatedly drag the applicator firmly and slowly over the


cover until contact between the cover and the plate is
secure around each individual well.
NOTE: Sometimes a good, uniform seal requires
multiple sweeps of the applicator. While
maintaining firm pressure, move the applicator
slowly across the film from left to right and back,
and then from top to bottom and back. Repeat this
process as needed.

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Operating Instructions
Section 5 Run an Application

8. Using the edge of the applicator, apply pressure to the


surface surrounding the outer wells, so that the seal is tight
around the edges of the plate.
Figure 5.28:Seal the Plate Edges

9. Inspect each well to make sure that each of the well edges
is imprinted on the ABBOTT® Optical Adhesive Cover.
NOTE: The ABBOTT Splash Free Support Base
should be cleaned after each use. Refer to Clean
the Splash Free Support Base on page 9–35 of
Section 9, Service and Maintenance.

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Operating Instructions
Run an Application Section 5

Test Orders
Test Orders are defined on a plate basis. Each plate well
location can be identified as
• a control
• a patient sample
• a calibrator
• unused
Test Orders can be manually created or imported from the
m2000sp instrument. Individuals with General User privileges
and above can create, import, display, delete, and run Test
Orders.
To access Test Order options, select <Orders> from the menu,
and <Test Orders> from the associated dropdown menu.
Figure 5.29:<Test Orders> Command

Alternatively, select the <Orders> icon from the toolbar.


Figure 5.30:<Orders> Toolbar Icon

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Operating Instructions
Section 5 Run an Application

The <Pending Test Order> screen displays.


Figure 5.31:<Pending Test Orders> Tasks Menu

This screen features three task menus, which are described


below.
Table 5.6: Pending Test Order Task Menus
<New Order>
• Allows the operator to
manually create a new Test
<Create Tasks> Order
(See Test Orders: <Create <Import Order>
Tasks> on page 5–35)
• Allows the operator to
import an m2000sp Test
Order from the CD or
Network drive
<Set Up Run>
• Displays Test Order details
• Requests operator
confirmation of run and
supplies instructions
<Run Tasks>
• Initiates testing operation by
(See Test Orders: <Run
initializing run
Tasks> on page 5–57)
<Import and Set Up Run>
This option combines the
<Import Order> and <Set
Up Run> options discussed
above.

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Operating Instructions
Run an Application Section 5

<View Order Details>


• Displays details of the Test
Order
<Order Management <Edit Order>
Tasks>
(See Test Orders: <Order • Permits the operator to edit
Management Tasks> on details of a manually created
page 5–73) order
<Delete Order>
• Removes an existing Test
Order

Test Order items are enabled based on the current system


status and the selection from the <Pending Test Orders>
list.

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Operating Instructions
Section 5 Run an Application

Test Orders: <Create Tasks>


The <Create Tasks> menu contains two options:
• <New Order>, which allows the user to manually create
a new Test Order
• <Import Order>, which allows the user to import a Test
Order from CD or network drive

<New Order>
NOTE: The application selected from the Application
Selection list will include specific control/calibrator
assay requirements.

!! IMPORTANT: To prevent an incorrect read when


scanning a prepared plate using the optional hand-held
bar code scanner, Caps Lock and Shift Lock on the
keyboard must be off and no other keys can be pressed
during the scan.
To create a new order:
1. From the <Create Tasks> menu on the <Pending Test
Orders> screen, select <New Order>.
Figure 5.32:<Create Tasks> Menu, <New Order> Option

The <Create Test Order: Application Selection>


screen displays.
2. Enter the following information:
• <PCR Plate Information>
– <Plate Name> -- Plate name (Bar code
identification present on the PCR plate)
– <Plate Comments> [Optional] Comments
regarding the plate/run

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Operating Instructions
Run an Application Section 5

• <Sample Preparation Reagents> [Optional]


– <Lot Number> -- Sample preparation reagent
lot number
– <Expiration Date> -- Sample preparation
reagent expiration date (month and year). This
date must be valid; that is, it must not have
already expired.

NOTE: Required fields are followed by a red *


(asterisk) next to the box.

3. Select the Application Specification to run from the


<Select Application Specification> list.
Figure 5.33:<Create Test Order: Application Selection>

4. Select <Next> to proceed with Test Order creation.


NOTE: The <Next> button does not become
active until all required information has been
entered.
The <Create Test Order: Assay Details> screen
displays. This screen lists the defined calibrators, controls,
and parameters that are applicable to the specific
application file (see Figure 5.34 and Figure 5.35 on page
5–37).
NOTE: If using a stored calibration curve, the
assay lot number must match the lot number of
the stored curve. The lot number is not case
sensitive. Select the dropdown box located next to
the Assay Lot Number and select the stored lot
number.

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Section 5 Run an Application

Figure 5.34:<Assay Details> screen displaying


calibrators

Figure 5.35:<Assay Details> screen displaying


parameters

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Operating Instructions
Run an Application Section 5

5. Complete the applicable fields in the <Create Test Order:


Assay Details> screen as directed below:

NOTE: The correct concentrations and values must be


entered on the screen where indicated below.
Concentration data are lot specific. For applications
that require specific concentrations to be entered, refer
to the assay package insert and control or calibrator kit
cards.
NOTE: The expiration dates must be entered in the
format configured for the system. Refer to the format of
the date in the upper-left corner of the screen.

• <PCR Assay Reagents> field


All information in this field is required.
– <Lot Number> – Enter the assay reagent lot number.
The last 4 lot numbers are stored. Operators can enter
a new lot number or select from the list.
– <Expiration Date> – Enter the assay reagent
expiration date. This date must be valid; that is, it
must not have already expired.

• <Control Information> field


The information included in this field will vary from
assay to assay. Listed below are all the possibilities for this
field; not all of these items will appear for every assay. A
red asterisk next to a window or column indicates
required information.
– <Kit Lot Number> (Optional) – Enter the control
material lot number
– <Expiration Date> (Optional) – Enter the control
material expiration date
– <Levels>
Level information displayed in this window will vary
by assay.
• <Bar code> – Displays the control level name, bar
code ID, as defined by the assay

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Section 5 Run an Application

• <Actual Concentration> – Enter the actual


control level log concentration values (log units
up to two decimal places for each control). Refer to
the assay control kit card.
NOTE: If the lot number of the control was
previously used, and the operator selected
the stored lot number at the dropdown box
located next to the control <Kit Lot
Number> window, the control values will
be entered automatically.
CAUTION: For applications that require
! specific log concentrations, entry of
incorrect values can result in incorrect
patient results.
• <Target Concentration> – Enter the target
control concentration, as defined by the assay
• <Replicates> – Enter the minimum number of
control replicates, as defined by the assay

• <Calibrator Information> field


This field is not applicable to all assays. It will appear only
if it applies to the Application Specification selected on
the <Create Test Order: Application Selection>
screen. A red asterisk next to a window or column
indicates required information.
NOTE: The m2000rt software only stores a
calibration curve based on the amplification lot
number. If the curve fails on the plate and there is
an active curve for that assay/lot, the software will
use that curve.
– <Kit Lot Number> (Optional) – Enter the calibrator
kit lot number
– <Expiration Date> (Optional) – Enter the calibrator
kit expiration date
NOTE: To use a stored calibration curve after
the calibrator kit’s expiration date, do not
enter an expiration date in this field. This field
is optional. If an expiration date is entered, a
new calibration run cannot be performed after
the calibrator kit’s expiration date.

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Operating Instructions
Run an Application Section 5

– <Levels>
• <Bar code> – Enter the calibrator level name, bar
code ID, as defined by the assay.
• <Actual Concentration> – Enter the actual
calibrator level log concentration values (log units
up to two decimal places for each calibrator). Refer
to the assay calibrator kit card.
NOTE: If the lot number of the calibrator
was previously used, and the operator
selected the stored lot number at the
dropdown box located next to the calibrator
<Kit Lot Number> window, the calibrator
values will be entered automatically.
CAUTION: For applications that require
! specific log concentrations, entry of
incorrect values can result in incorrect
patient results.
• <Target Concentration> – Displays the target
calibrator level concentration, as defined by the
assay.
• <Replicates> – Displays the minimum number of
calibrator replicates, as defined by the assay in
order to give valid results.

• <Parameter Information>
This field is not applicable to all assays. It will appear only
if it applies to the Application Specification selected on
the <Create Test Order: Application Selection>
screen. A red asterisk next to a window or column
indicates required information.
– <Bar code> – Lists the control parameter bar code ID,
if applicable, as defined by the assay. Those
parameters that are associated directly with the assay
reagents (and not controls) might not have a bar code
listed.
– <Parameter> – Lists the name of the expected
parameters for the selected Application Specification.

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Operating Instructions
Section 5 Run an Application

– <Actual> – Enter the actual parameter values as


indicated in the lot-specific kit card. Refer to the assay
reagent or control kit card.
NOTE: If the lot number of the control was
previously used, and the operator selected
the stored lot at the dropdown box located
next to the control <Kit Lot Number>
window, the control values will be entered
automatically for those parameters that are
directly associated with controls.
NOTE: If the lot number of the reagents
was previously used, and the operator
selected the stored lot at the dropdown box
located next to the PCR Assay Reagents
<Lot Number> window, the values will be
entered automatically for those parameters
that are directly associated with the assay
reagents.
Figure 5.36:<Create Test Order: Assay Details> screen

Selecting a stored lot here will


populate the reagent-associated
values below

Selecting a stored lot


here will populate the
control values below

CAUTION: For applications that require


! lot-specific parameters, entry of incorrect
values can result in incorrect patient results.
– <Target> – Enter the target parameter value, as
defined by the assay.

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6. For multi-assay plates, select <Next> for the next assay


and repeat Step 5.
7. After all assay details are complete for all assays, select
<Next> to proceed with Test Order creation.
The <Create Test Order: Plate Information> screen
displays an empty plate so that the operator can
• select the plate locations and
• assign each occupied well location to a calibrator,
control, or patient.
NOTE: Wells that are shaded when this screen
first appears, received an error during the m2000sp
sample preparation run and are uneditable.
8. Select a plate location to assign.
NOTE: For some assays, the test order layout is
fixed, meaning that controls and patient samples
must be placed on particular sections of the plate,
as indicated by the software.
Several plate locations can be simultaneously highlighted
by
• dragging the mouse over the locations
• highlighting a column or row, or
• holding down the Ctrl key and highlighting the plate
locations

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Figure 5.37:<Create Test Order: Plate Information>


Display with Selected Plate Locations

Plate locations selected for use

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9. From the <Sample Type> dropdown menu, select the


sample type:
• <Unused> -- Unused plate well
• <Calibrator> -- Well identified as a calibrator (the
well is shown outlined in blue)
• <Control> -- Well identified as a control (well is
shown outlined in green)
• <Patient> -- Well identified as a patient (well is
shown outlined in gray)
Figure 5.38:<Sample Type> Menu

NOTE: In a fixed test order layout, the allowed


sample type will be determined by the location of
the highlighted wells.

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NOTE: For a Genotype assay, one (1) to 12 wells


may be used for each sample ID.
Figure 5.39:Genotype Sample Wells

Genotype reactions

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NOTE: For the Multiplex assays, multiple assays


are assigned per well.
Figure 5.40:Multiplex Sample Wells

Assay designation
from assay list

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10. From the <Sample ID> dropdown, select the sample ID


for defined calibrators and controls or enter the sample ID
for patient samples:
NOTE: The options available on the <Sample
ID> pull-down menu vary with the operator’s
selection of Application Specification and of
Sample Type. See the following table showing
options associated with an assay-related
application.
Table 5.7: Example of Sample Type/ID Correlations

<Sample Type> <Sample ID> Options

<Unused> This option is used to clear contents of a well

Lists all defined calibrator levels; the user must select from the list

<Calibrator>

Lists all control levels; the user must select from the list

<Control>

The user must manually enter the sample identification number.

If the text for the sample ID runs beyond the well border on the screen,
<Patient> holding the mouse pointer over the well will display the entire name.

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!! IMPORTANT: To prevent an incorrect read when


scanning a prepared plate using the optional
hand-held bar code scanner, Caps Lock and Shift
Lock on the keyboard must be off and no other
keys can be pressed during the scan.

NOTE: Be sure to create the appropriate number


of replicates for the calibrators and controls.

11. Enter <Comments>. [Optional]

12. Repeat for each defined well.


NOTE: If any well requires additional information
for the operator to complete the Test Order
creation, the <Create Test Order: Plate
Information> screen displays a red <X> in that
well and the <Next> option will not be available.
Figure 5.41:Red X Signals Need for Additional
Information

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13. Select <Next>. The <Create Test Order: Errors and


Warnings> screen displays.
Figure 5.42:<Create Test Order: Errors and Warnings>

If any control or calibrator errors have been detected, the


screen will display what has been entered and under the
<Message> column will state the impact. The operator
can select <Back>, correct the Test Order, and select
<Next>. If no errors/warnings are detected, select
<Finish>. The following table describes possible errors.

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Table 5.8: Errors and Warnings Messages

Sample
Message Corrective Action
Type

Calibrator The number of replicates present • Be sure a sufficient number of


(1) for the Calibrator Level (0) is calibrators and replicates are
less than required (2) and no present and identified in the Test
stored curve is supported for this Order.
assay. No results will be generated.

0 = Calibrator level
1 = Number of replicates
2 = Required replicates
Calibrator The number of replicates present • Be sure a sufficient number of
(1) for the Calibrator Level (0) is calibrators and replicates are
less than required (2). Results will present and identified in the Test
be generated using stored curve. Order.

0 = Calibrator level
1 = Number of replicates
2 = Required replicates
Controls The number of replicates present • Be sure a sufficient number of
(1) for the Control Level (0) is less controls and replicates are present
than required (2). All results will and identified in the Test Order.
be flagged or invalidated.

0 = Control level
1 = Number or replicates
2 = Required replicates
Genotype & The number of replicates present • Be sure a sufficient number of
Multi-target (1) for the Control Level (0) is less controls and replicates are present
than required (2). All results will and identified in the Test Order.
be flagged or invalidated.

0 = Control level
1 = Number or replicates
2 = Required replicates

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NOTE: If the calibrator on the plate fails and a stored


calibration curve exists for the same reagent lot, the
results will be calculated based on the stored curve. All
of the results will be flagged with a CAL flag.
The Test Order is now displayed in the <Pending Test
Orders> list with a source of <Manual>.

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<Import Order>
Importing a Test Order is available only from an m2000sp
initiated run.

NOTE: For successful closed-mode Test Order import,


the Application Specification ID and the version on
both the m2000sp and the m2000rt must be identical.
NOTE: Failure to import a Test Order can result when:
• an application has not been installed for closed
mode
• a plate order with the same plate name is already
pending in the Test Order list

To import a Test Order:


1. Select <Orders> from the menu, and <Test Orders>
from the associated dropdown menu.
2. From the <Create Tasks> menu, select <Import
Order>.
Figure 5.43:<Pending Test Orders> Display, <Import
Order> Command

The <Import Test Order: Order Selection> screen


displays. The <Select Test Orders directory> on this
screen permits the operator to import a Test Order from
the CD drive or Network.

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3. Select the source from which to import the Test Order. (If
a CD is to be used, place it in the CD drive now.)
Figure 5.44:<Import Test Order> Screen

Choose the
import source

The <Network Drive> option allows users to import


from an accessible network drive on the SCC or from the
Network Data Store, if configured. (Refer to Managing the
Network Data Store on page 5–133 for more information.)

4. From the <Test Order> list on this screen, select the Test
Order to be imported.
Figure 5.45:Selected Test Order

The <Test Order Contains> field allows users to search


longer lists of importable test orders, such as might be
found on networked drives. Information can be entered
into this field manually or scanned in via the optional
hand-held bar code scanner.
To enter the plate identifier data manually, do
the following:
a. Type all or a section of the plate identifier in the
<Test Order Contains> field.
NOTE: The plate identifier is a combination of
the PCR plate name and the run name used on
the m2000sp.

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b. Select the <Filter> button and the list of available


Test Orders is reduced to:
• the plate desired (if the plate name, the time and
date stamp, or the entire identifier is entered)
• to only those plates that share the part of the
string that is entered (if only the application name
is entered)

To use this feature with a hand-held bar code


scanner, do the following:
Figure 5.46:Bar Code Scanner

!! IMPORTANT: To prevent an incorrect read when


using the optional hand-held bar code scanner,
Caps Lock and Shift Lock on the keyboard must be
off and no other keys can be pressed during the
scan.

a. Highlight the <Test Order Contains> field.


b. Scan the PCR plate name (label).
Figure 5.47:PCR Plate

PCR plate label

c. Select the <Filter> button and the list of available


Test Orders is reduced to the plate desired.

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5. Select the correct Test Order and then click <Next> at the
bottom right of the screen.
6. The m2000rt reads the Test Order data and displays the
details. If the assay on the plate does not contain
calibrators, the system verifies there is a stored curve for
the assay/assay reagent lot.
NOTE: The m2000rt software only stores a
calibration curve based on the amplification lot
number. If the curve fails on the plate and there is
an active curve for that assay/lot, the software will
use that curve.

!! IMPORTANT: The user must:


• Verify that the plate being loaded on the
m2000rt matches the PCR plate name and
associated data shown on the screen.
• If the wrong plate was selected, navigate to the
Test Order selection list by selecting <Back>.
Figure 5.48:<Import Test Order: Order Details> Display

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7. To add the Test Order to the pending Test Order list, click
<Finish> at the bottom right of the screen.
NOTE: If the selected Test Order was processed
more than 24 hours ago, a prompt will display.
• To continue with the selected Test Order, select
<Yes>
• To cancel and select a different Test Order,
select <No>.
The <Pending Test Orders> screen displays with the
new Test Order added to the pending Test Order list.
Figure 5.49:<Pending Test Orders> Display, <Order
Management Tasks>

The pending Test Order list displays Test Orders imported from
the m2000sp or manually created. These Test Orders have not
yet been processed.

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Test Orders: <Run Tasks>


NOTE: Before the operator initiates a run, these
conditions must be met:
• The m2000rt instrument must be in the
<READY> state.
• Calibration status for the Region of Interest (ROI),
Uniformity, Background, and Pure Dye
calibrations for the specific assays must show
<Active>. See <View Assay Calibrations> on page
5–120.
The <Run Tasks> menu contains two options:
• <Set Up Run>, which allows the user to start a run using
a Test Order already in the system
• <Import and Set Up Run>, which allows the user to
import a Test Order via CD or network drive and then start
a run

<Set Up Run>
1. Select <Orders> from the menu, and <Test Orders>
from the associated dropdown menu.
The <Pending Test Orders> screen displays.
Figure 5.50:<Pending Test Order> Screen

2. From the list of pending orders, select the Test Order to be


run.

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3. From the <Run Tasks> menu on the <Pending Test


Orders> screen, select <Set Up Run>.
The <Run Test Order: Order Details> screen displays.
Figure 5.51:<Run Test Order: Order Details> Display

!! IMPORTANT: Verify that the selected Test Order


is the correct one by viewing the PCR plate name
and the m2000sp completion time, if applicable. If
the wrong plate was selected, navigate to the Test
Order selection list by selecting <Back>.
4. Select <Next>.
The <Run Test Order: Run Start> screen displays.
Figure 5.52:<Run Test Order: Run Start> Display

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5. Open the instrument tray drawer.


Figure 5.53:Open Tray Drawer

6. Load the plate into the plate holder in the instrument tray
drawer.
NOTE: The A1 plate well is at the top left side of
the plate. If the plate is put into the drawer
backwards, the drawer will not close. DO NOT
FORCE the tray drawer to close.
Figure 5.54:A1 Plate Well

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7. Close the tray drawer.


NOTE: When closing the tray drawer, apply
pressure, at an angle, at the circular depression at
the right side of the tray’s front edge.
Figure 5.55:Close Tray Drawer

8. Select <Start> to initiate the run.The application


navigates to the <Instrument Status> screen and
displays instrument status <INITIALIZING>, and then
<RUNNING> during the run.
NOTE: When the run has begun, the Pending Test
Order is deleted from the database.
NOTE: Do not attempt to open the tray drawer
while the instrument is in the <RUNNING> state.
NOTE: For a description of the information
displayed on the <Instrument Status> screen
while the instrument is running, refer to During
the Run on page 5–67.
9. Proceed to After the Run on page 5–70 for a discussion of
information and necessary operator actions at the close of
a run.

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<Import and Set Up Run>


The operator can import and run a Test Order by selecting
<Import and Set Up Run> from the <Run Tasks> menu
on the <Pending Test Orders> screen.
NOTE: This option is applicable only if the run
was initiated from the m2000sp. The same
application and version must be loaded on both
systems, the m2000sp and the m2000rt, for
closed-mode applications.

1. Select <Orders> from the menu, and <Test Orders>


from the associated dropdown menu.
Figure 5.56:<Test Orders> Command

The <Pending Test Orders> screen displays.

2. From the <Run Tasks> section of the menu on the


<Pending Test Orders> screen, select <Import and
Set Up Run>.
Figure 5.57:<Import and Set Up Run> Command

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The <Import and Run Test Order: Order


Selection> screen displays. The <Select Test Orders
directory> on this screen permits the operator to import
a Test Order from a CD/Network.

3. Select the source from which to import the Test Order. (If
a CD is to be used, place it in the CD drive now.)
Figure 5.58:<Import and Run Test Order> Screen

Choose the
import source

The <Network Drive> option allows users to import


from an accessible network drive on the SCC or from the
Network Data Store, if configured. (Refer to Managing the
Network Data Store on page 5–133 for more information.)
4. From the <Test Order> list on this screen, select the Test
Order to be imported.

!! IMPORTANT: Verify that the selected Test Order


is the correct one by viewing the PCR plate name
and the m2000sp completion time, if applicable. If
the wrong plate was selected, navigate to the Test
Order selection list by selecting <Back>.
Figure 5.59:Selected Test Order

The <Test Order Contains> field allows users to search


longer lists of importable test orders, such as might be
found on networked drives. Information can be entered
into this field manually or scanned in via the optional
hand-held bar code scanner.

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To enter the plate identifier data manually, do


the following:
a. Type all or a section of the plate identifier in the
<Test Order Contains> field.
NOTE: The plate identifier is a combination of
the PCR plate name and the run name used on
the m2000sp.
b. Select the <Filter> button and the list of available
Test Orders is reduced to:
• the plate desired (if the plate name, the time and
date stamp, or the entire identifier is entered)
• to only those plates that share the part of the
string that is entered (if only the application name
is entered)
To use this feature with a hand-held bar code
scanner, do the following:
Figure 5.60:Bar Code Scanner

!! IMPORTANT: To prevent an incorrect read when


using the optional hand-held bar code scanner,
Caps Lock and Shift Lock on the keyboard must be
off and no other keys can be pressed during the
scan.

a. Highlight the <Test Order Contains> field.


b. Scan the PCR plate name (label).

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Figure 5.61:PCR Plate

PCR plate label

c. Select the <Filter> button and the list of available


Test Orders is reduced to the plate desired.
5. When the Test Order is selected, click <Next> at the
bottom right of the screen.
NOTE: If the selected Test Order was processed
more than 24 hours ago, a prompt will display.
• To continue with the selected Test Order, select
<Yes>
• To cancel and select a different Test Order,
select <No>.
Figure 5.62:Test Order Confirmation Prompt

6. From the <Import and Run Test Order: Order


Details> screen, click <Next>.

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7. Open the instrument tray drawer.


Figure 5.63:Open Tray Drawer

8. Load the plate into the plate holder in the instrument tray
drawer.
NOTE: The A1 plate well is at the top left side of
the plate. If the plate is put into the drawer
backwards, the drawer will not close. DO NOT
FORCE the tray drawer to close.
Figure 5.64:A1 Plate Well

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9. Close the tray drawer.


NOTE: When closing the tray drawer, apply
pressure, at an angle, at the circular depression at
the right side of the tray’s front edge.
Figure 5.65:Close Tray Drawer

10. Select <Start> at the bottom right corner of the <Run


Test Order: Run Start> screen. After the run has begun,
the system returns to the <Instrument Status> screen,
and the instrument status changes to <RUNNING>.
NOTE: Do not attempt to open the tray drawer
while the instrument is in the <RUNNING> state.
NOTE: For a description of the information
displayed on the <Instrument Status> screen
while the instrument is running, refer to During
the Run on page 5–67.
11. Proceed to After the Run on page 5–70 for a discussion of
information and necessary operator actions at the close of
a run.

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During the Run


Figure 5.66:<RUNNING> Status

The m2000rt <Instrument Status> screen includes the


following fields:
• <Current Process>, which provides details for the
current run. See Table 5.9 on page 5–68 for details.
• <Temperatures>, which displays the current
temperatures at specific locations. See Table 5.10 on
page 5–68.
• <Lamp Information>, which provides lamp status
and total usage hours. See Table 5.11 on page 5–69.

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Table 5.9: <Current Process> Details

Category Description

<Application> Name of Application Specification

<Plate ID> PCR plate name

Name of run now taking place (PCR assay


<Run Name>
or system calibration)
<Start Time> Approximate time the run started

<Est. Completion Time> Estimated time that the run will finish

<Stage> Stage of the assay thermal protocol

<Step> Number of the step within the stage

<Cycle> Current cycle number within the stage

<Time> Time remaining in step

• Ramping
• Holding
• Warming lamp
<State> • Warming cover
• Optimizing
• Ready
• Processing

Table 5.10:<Temperatures> Details

Location Item measured


Estimated temperature of the sample
<Sample>
within the well
<Block> Temperature of the thermal block

<Cover> Temperature of the heated cover

<Heat Sink> Temperature of the heat sink

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Table 5.11:<Lamp Information> Details

Category Description
• Blank -- Instrument is OFFLINE, status is
unknown
• Normal -- Lamp hours and lamp current
are within range
• Expired -- Lamp hours have exceeded
<Status>
1000
• Replace Soon -- Lamp current is outside
the acceptable range
• Failed -- Lamp current is below
operational limit
<Usage> Number of hours the lamp has been in use

12. Proceed to After the Run on page 5–70 for a discussion of


information and necessary operator actions at the close of
a run.

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After the Run


In most cases, when the run is complete, the screen displays
an alert dialog box, stating that the run was successful. Select
<Close>.
Figure 5.67:Run Complete

However, some assays require the instrument to “hold” rather


than end the run after PCR data has been acquired. For these
assays, the following message appears:
Figure 5.68:Hold Initiated

Until the operator ends the run by selecting <Stop> from the
<Instrument Tasks> menu, the hold will continue
indefinitely and the screen will display an infinity ( ∞ ) icon in
the <Time> field.

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Figure 5.69:Indefinite Hold Icon

NOTE: The operator can select <Stop> at any time


during the hold.

If the run does not complete successfully, an alert dialog box


displays. Select <Close>. Refer to Section 10,
Troubleshooting and Diagnostics for information.

!! IMPORTANT: After the m2000rt completes its


operation, the software can take up to a few minutes to
process and store the data. Do not open the tray drawer
or turn off the instrument until the system returns to
the <Ready> state.

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When the run has completed successfully, and the


<Instrument Status> screen has returned to the <Ready>
state, do the following:
1. Open the instrument tray drawer by applying pressure at
the circular depression at the right side of the tray’s front
edge, but take care not to power off the system.
Figure 5.70:Open Tray Drawer

Tray drawer release Power button


(press here to open) (DO NOT PRESS)

2. Remove the plate from the instrument.


NOTE: Place the used plastic PCR plate in a
sealable plastic bag and discard in accordance with
local, state, and federal regulations. Take care
when handling the PCR plate as it might be hot. If
the run was not successful, the samples need to be
reprocessed for the failed run.
NOTE: Autoclaving the sealed reaction plate will
not degrade the amplified product, and may
contribute to the release of the amplified product
by opening the sealed plate. The laboratory area
can become contaminated with amplified product
if the waste materials are not carefully handled
and contained.
3. Push the tray drawer closed by applying even pressure at
the circular depression at the right side of the tray’s front
edge.
4. If no other plates are to be run, select <Stop> from the
<Instrument Tasks> menu. (If additional plates are to
be run, begin that process without selecting <Stop>.)
5. Navigate to the <Results> screen to view the completed
plate data.

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Test Orders: <Order Management Tasks>


The <Order Management Tasks> menu contains three
options:
• <View Order Details>, which allows the user to view
Test Order plate details
• <Edit Order>, which allows the user to edit Test Order
plate details
• <Delete Order>, which allows the user to delete a Test
Order

<View Order Details>


To view the plate details:
1. Select <Orders> from the menu, and <Test Orders>
from the associated dropdown menu.
Figure 5.71:<Test Orders> Command

Alternatively, select the <Orders> icon from the toolbar.


Figure 5.72:<Orders> Toolbar Icon

The <Pending Test Orders> screen displays.

2. Select a Test Order from the list of pending Test Orders.

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3. From the <Order Management Tasks> menu, select


<View Order Details>.
Figure 5.73:<Order Management Tasks> Menu, <View
Order Details> Command

The <Test Order Details> screen displays.


Figure 5.74:<Test Order Details> Display

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Table 5.12:<Test Order Details> Plate Information

Plate name
<PCR Plate Name> Bar code on the PCR plate, or
name given to the plate
<RT Application m2000rt Application
Name> Specification to be run

m2000sp serial number that


<SP Serial Number> prepared the PCR plate, if
applicable
m2000sp Application
<SP Application
Specification that was run, if
Name>
applicable
<SP Run Completion m2000sp run completion time,
Time> if applicable

Identification of the operator


<SP Operator Id> who performed the m2000sp
run, if applicable

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Table 5.12:<Test Order Details> Plate Information


(Continued)
Comments entered for the
<Comment>
PCR plate
• <Location>
PCR plate well location
• <Sample Id>
Sample identification
• <Sample Type>
Type of sample being run:
control, calibrator, patient
specimen (blank)
• <Assay Reagent Name>
Name/number of the assay
reagent
• <Assay Reagent Lot>
Lot number of the assay
reagent
<Sample List> • <Status>
Status of the sample:
-- Warning - m2000sp
warning occurred; test will
be flagged. Refer to Section
10, Troubleshooting and
Diagnostics of the
m2000sp Operations
Manual
-- Error - Error received on
m2000sp; test will not be
processed
-- [Blank] - Valid; good test
• <Code> - Error code
associated with the error or
warning

4. Select <Close> at the bottom right of the screen to return


to the <Test Order> screen.

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<Edit Order>
Administrators and General Users can edit a manually created
Test Order.
NOTE: Closed-mode Test Orders created on the
m2000sp instrument cannot be edited on the m2000rt
instrument.
To edit a Test Order, select <Orders>, and then <Test
Orders>. From the <Order Management Tasks> menu,
select <Edit Order>.
The <Edit Test Order: Application Selection> screen
displays.
Figure 5.75:<Edit Test Order: Application Selection>
Display

Make the necessary edits. Select <Next> to continue to the


next screen, or select <Finish> when the edits are complete.

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<Delete Order>
Administrators and General Users can delete Test Orders.
A Test Order can be deleted by
• selecting it from the <Pending Test Orders> list,
followed by
• selecting <Delete Order> from the <Order
Management Tasks> menu.

1. Select <Orders> from the menu, and <Test Orders>


from the associated dropdown menu.
Figure 5.76:<Test Orders> Command

The <Pending Test Orders> screen displays.

2. From the list of pending orders, select the Test Order to be


deleted.

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3. From the <Order Management Tasks> menu, select


<Delete Order>.
Figure 5.77:<Pending Test Orders> Display

A dialog box displays, asking the operator to confirm the


intention to delete the Test Order.

4. Select <Yes> to delete the Test Order. The Test Order is


deleted from the database and the pending list. If the
operator selects <No>, the application returns to the Test
Order screen.

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NOTES

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Results Management

The <Results> menu has the following options:


• <View By Plate>, which allows the user to view plate
results (see discussion below)
• <View Assay Calibrations>, which allows the user to
view assay calibrations (see <View Assay Calibrations> on
page 5–120)
• <View Quality Control Results>, which allows the
user to view control results for all or selected assays over a
user-selected date range (see View Quality Control Results
on page 5–126)

View By Plate
By selecting <Results> and then <View By Plate>, the
screen displays result data by plate. When reviewing data by
plate, the screen displays a list of running and completed
plates (by last completed plate), and the results associated with
the selected plate appear below.

1. To review individual plate results, select <Results>, then,


from the associated dropdown menu, select the <View by
Plate> menu option.
Figure 5.78:<View By Plate> Command

Alternatively, select the <PCR Plates> icon from the


toolbar.
Figure 5.79:<PCR Plates> Toolbar Icon

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The <Plate Results> screen displays the plates and the


results for the selected plate.
Figure 5.80:<Plate Results> Display

Table 5.13:<Plate Results> Detail

<Plate Name> Name of PCR plate

<Run Date and Time> Time of run completion

<COMPLETED> -- Run completed


successfully
<Status>
<RUNNING> -- Run in progress
<FAILED> -- Run has failed
<Archived> -- Plate results have been saved
<Archive Status>
to a CD
<Application Name> Name of application that is, or was, processed

Table 5.14:<Results for Selected Plates> Detail


<Location> Location of well in the PCR plate

<Sample Id> Identification of the sample

Type of sample calibrator, control, or patient


<Sample Type>
(blank)
<Assay> Type of assay being run

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Table 5.14:<Results for Selected Plates> Detail


<Result> Result for the sample; see assay package insert

Interpretation of the result; see the assay


<Interpretation>
package insert.
NNC - No negative control was found on plate
NPC - No positive control was found on plate
+QC - Positive control was out of range, failed,
or not found on the plate
-QC - Negative control was reactive, failed, or
not found on the plate
-IC - Negative control internal control failed
IC - Internal control failed
+IC - Positive control internal control failed
SP - m2000sp warning, see Section 10 of the
<Flags> m2000sp Operations Manual for details.
AEXP - Assay amplification reagents have
expired
GEXP - Sample preparation reagents have
expired
CAL - Calibration on plate failed; results
generated using a stored curve
SIM - Internal Abbott flag
RUO - Research use only
IUO - Investigational use only
LDA - Laboratory-defined application
Code that identifies a reason for the
incomplete test.
<Error Code>
See Section 10, Troubleshooting and
Diagnostics of this manual

The side menus on <Plate Results> screen are described in


the following sections:
• <Plate Tasks> Menu on page 5–85
• <Result Tasks> Menu on page 5–114

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View Result Details: Multi-Target Assays


For multi-target assays, additional details are provided. Click
on the box to the left of each well location to reveal the
reaction details for a sample.
Figure 5.81:Multi-Target <Plate Results> Display: Genotype
Example

Table 5.15:Multi-Target Result Additional Details


Location of well in the PCR
<Location>
plate
<Assay> Reaction name

Result for the sample; see assay


<Result>
package insert
Code that identifies a reason for
an incomplete test.
<Error Code> See Section 10,
Troubleshooting and
Diagnostics

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<Plate Tasks> Menu


The <Plate Tasks> menu gives the operator options to:
• <View Details> -- View a selected plate’s details
• <View Result Details> -- View the result details for the
selected plate
• <Release> -- Release the plate results to the LIS
• <Archive> -- Archive one or more plate results to a CD
• <Export> -- This option is applicable to
laboratory-defined application operations only
• <Print Result List> -- Print the plate result list report for
the selected plate
• <Print Result Details> -- Print the result details report
for the selected plate
• <Print Errors> -- Print the error details for the selected
plate
• <Delete> -- Delete the selected plate results from the
system
• <Analyze> -- This option is applicable to
laboratory-defined application operations only

Figure 5.82:<Plate Tasks> Menu

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<View Details>
1. To view plate details, select the plate to be reviewed.
2. Select <View Details> from the <Plate Tasks> menu.
The <Plate Details> screen displays:
• <Plate Information>
• <Graph Settings>

<Plate Information>

Figure 5.83:<Plate Details> <Graph Settings> Target


Baselined

Parameter details will


appear in this location
when applicable to the
assay

Plate information available on this screen includes:


• <Plate Name> -- Name assigned to the PCR plate
• <Plate Status> -- Status of the PCR plate (completed,
running, failed)
• <Run Completion Time> -- Time the run was
completed
• <Amplification & Detection Application> -- Version
of the Application Specification used for the m2000rt
process

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• <Operator> -- Operator who initiated the m2000rt run


• <m2000sp Reagent Lot/Exp Date> -- m2000sp sample
preparation reagent lot number and expiration date
• <Plate Comments> -- Plate comments can be
added/edited and saved by selecting the <Save> button in
the lower right-hand corner of the screen.

<Graph Settings>
Graph settings display the plate layout. The calibrator, control,
sample, and empty wells are color-coded.
• Blue: Calibrator
• Green: Control
• Gray: Patient
• Light Gray: Unused

The operator is able to position the mouse pointer over a well


to identify the location, sample type (calibrator, control,
sample, or empty well), and assay.
Figure 5.84:<Plate Details> <Graph Settings> Well ID

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The operator is also able to highlight (select) a single well to


display the graph associated with that well/sample.
Figure 5.85:<Plate Details> Well ID <Graph Settings> Single
Graph Line

Each dye is presented in a different color.

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The operator can highlight (select) several wells to display the


associated graphs by holding down the mouse button and
dragging the cursor over the wells, or by holding down the
Control (Ctrl) key and clicking on specific wells.
Figure 5.86:<Plate Details> <Graph Settings> Selecting
Multiple Wells to Show Graph

Figure 5.87:<Plate Details> tooltip views

Graph tooltip view: by holding the mouse pointer over a Plate depiction tooltip view: the
single graph line, the operator is able to view the well ID operator is able to view the well ID,
and sample type sample type, and assay name

NOTE: In cases where there are multiple assays on


the graph view, the graph tooltip will also show
the assay name.

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The Graph Settings offers several ways to select and view the
graphs:
• <Assay> -- Lists all the assays present on the plate (see
discussion below)
• <Curve> -- Displays a specific dye in the curve to be
displayed
• <Type> -- Displays the type of curve to be displayed
• <Y-Axis Scale> -- Displays the type of Y-Axis scale to be
displayed
The Graph Settings can be set to display in any combination as
needed by the operator.

<Assay>
For applications that allow multiple assays on a single plate,
the operator is able to use the dropdown box to select the
assay to view.
Selecting <All> displays all assays for the selected well.
NOTE: If a single assay is on the plate, the list contains
only one assay.
Figure 5.88:Example of <Assay> dropdown box

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<Curve>
Allows selection of curves associated with different dyes.
Figure 5.89:Example of <Curve> dropdown box

• <Target>
Displays the amplification curve for the assay analyte
(target).
• <Control>
Displays the amplification curve for the internal control,
if applicable.
• <Reference>
Displays the amplification curve for the reference dye.
• <Quencher>
Displays the amplification curve for the quencher dye, if
applicable.
• <Target and Control>
Displays the amplification curves for both the target and
internal control.

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<Type>
Provides four types of curves to be displayed:
Figure 5.90:Example of <Type> dropdown box

• <Baselined>
Displays the normalized, baselined fluorescence curve.
• <Normalized>
Displays the normalized fluorescence curve.
• <maxRatio>
Displays the maximum ratio value as a dot on the graph.
• <Fluorescence>
Displays the raw fluorescence curve.

<Y-Axis Scale>
Provides two methods for viewing the Y-Axis Scale:
Figure 5.91:Example <Y-Axis Scale> dropdown box

• <Linear>
Displays the curve with a linear Y-Axis.
• <Logarithmic>
Displays the curve with a logarithmic Y-Axis.

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Graph
The user is able to zoom in on a portion of the graph by
dragging the mouse across it. The <Reset> button will reset
the graph back to its original format.
Figure 5.92:Enlarged Graph Section View

By holding the mouse pointer over a single graph line, the


operator is able to view the well ID and sample ID, as shown
above.

Exit the <Plate Details> View


If any comments were entered into the <Plate Comments>
field, select <Save> to return to the <Plate Results> screen.
Otherwise, select <Cancel> or use the “back” arrow at the top
of the screen to return to the <Plate Results> screen.

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<View Result Details>


To view result details, select the plate, and then select <View
Result Details> from the <Plate Tasks> menu.
Figure 5.93:<View Result Details> Option

When selecting <View Result Details> each result of the


selected plate is displayed individually (Result: 1 of ##).
Figure 5.94:<Result Details> Display for Calibrator Sample

Saves any
comments
entered above

Advances to the next


result in the plate

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The <Result Details> screen displays:

• <Sample Information> -- Information for the specific


sample result
– <Sample Id> -- Identification assigned to the sample
– <Sample Type> -- Type of sample (patient, control,
calibrator)
– <Location> -- Well location of the sample on the
PCR plate
– <Run Completion Time> -- Time the run
completed
– <Result Comment> -- Any comments that were
entered. Additional comments can be entered and
then saved by selecting <Save>.

For calibrator samples, the following additional


information is displayed:
– <Calibrator Lot/Expiration> -- Calibrator lot
number and expiration date
– <Log Concentration> -- Log concentration of the
calibrator

For control samples, the following additional information


is displayed:
– <Control Lot/Expiration> -- Control lot number
and expiration date
– <Range> -- Control range in log concentration

• <Test Information> -- Information for the test


– <Result> -- Result of the sample, see assay package
insert
– <Interpretation> -- Interpretation of the result, see
assay package insert
– <Flags> -- Flags on the result; refer to Table 5.14 on
page 5–82
– <Target Cycle Number> -- Target cycle number for
the result

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– <Target MR> -- Target maximum ratio value (refer to


maxRatio Analysis on page 3–10 of Section 3,
Principles of Operation, for more information)
– <IC Cycle Number> -- Internal control (IC) cycle
number
– <IC MR> -- The internal control’s maximum ratio
value
– <Release Status> -- LIS (Laboratory Information
System) release status for the result
• Cancelled: result transmission cancelled
• Transmitted: result sent to LIS successfully
• Pending Transmission: result waiting to be
transmitted to LIS
– <Error Code / Description> -- Error code and
description for the result; see Section 10,
Troubleshooting and Diagnostics of this manual.
– <Assay Name / Version> -- Name of assay and
version number
– <Assay Calibration Time> -- Time the assay was
calibrated
– <Reagent Lot / Expiration> -- Assay reagent lot
number and expiration date

• <Graph Settings> -- Graph settings that can be


selected/viewed for the result
– <Curve> -- Type of curve displayed
– <Target> -- Displays the amplification curve for
assay analyte (target)
– <Control> -- Displays the amplification curve for
the internal control, if applicable
– <Reference> -- Displays the amplification curve
for the reference dye
– <Quencher> -- Displays the amplification curve
for the quencher, if applicable
–<Target and Control> -- Displays the
amplification curve for the target and internal
control
– <Type> -- Type of curve displayed

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– <Baselined> -- Displays the normalized,


baselined fluorescence curve.
– <Normalized> -- Displays the normalized
fluorescence curve.
– <Fluorescence> -- Displays the raw fluorescence
curve.
– <Y-Axis Scale> -- Type of Y-Axis Scale displayed
– <Linear> -- Displays the curve with a linear
Y-axis.
– <Logarithmic> -- Displays the curve with a
logarithmic Y-axis.
– <Scale> -- Scale settings that can be selected/viewed
for the result
– <Automatic> -- Sets the axis to display the entire
single curve
– <Fixed> -- Fixes the y-axis to include all results on
a plate for easier result-to-result comparison.
• The <Next> button is used to advance to the next result.
• The <Save> button is used to save any comments made in
the <Result Comment> box.
• The user is able to zoom in on a portion of the graph by
dragging the mouse across it. The <Reset> button will
reset the graph back to its original format.
Figure 5.95:Enlarged Graph Section View

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View Result Details: Multi-Target Assays


Multi-target assays (such as Genotype) display individual
results that can be accessed by selecting a tab at the top.
Figure 5.96:Multi-Target Result Details: Genotype Example

Tabs

Individual Genotype Results

Figure 5.97:Multi-Target Result Details

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Figure 5.98:Multi-Target Result Detail: Well Location

When applicable to the


assay, <Control Range>
will appear here

The view above shows the information displayed on a typical


individual well view tab. The information displayed might
vary from assay to assay. The table below describes all of the
possible categories of information that can be displayed.

Table 5.16:Multi-Target Result Detail

Category Description

<Result> Result for the final target reaction

<Interpretation> Interpretation of the result; see the assay package insert (this
category appears only on the first tab view, not on
individual result views)

<Well Location> Location of well in the PCR plate

<Flags> Any flags for that sample; refer to Table 5.14 on page 5–82

<Error Code/Description> Code and a description of the error code; see Section 10
Troubleshooting & Diagnostics

<Reagent Lot/Expiration> Assay reagent lot number and expiration date

<Assay Name/Version> Name and version of the assay

<Release Status> Release status to the LIS for the result (this category appears
only on the first tab view, not on individual result views)

<Target Cycle Number> Target cycle number for the result

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<IC Cycle Number> Internal control cycle number for the results

<Target MR> Target maximum ratio value (refer to maxRatio Analysis on


page 3–10 of Section 3, Principles of Operation, for more
information)

<IC MR> Internal control maximum ratio value

<Control Range> The actual control level value

Exit the <Result Details> View


If any comments were entered into the <Result Comment>
field, select <Save> to return to the <Plate Results> screen.
Otherwise, select <Cancel> or use the “back” arrow at the top
of the screen to return to the <Plate Results> screen.

<Release>
The system allows the user to <Release> results to an LIS
system. Release is only available when the LIS
communications is configured to ON.
NOTE: For complete information, refer to LIS
Configuration on page 2–21 of Section 2,
Installation Procedures and User Configuration.
To release a result, highlight the plate and select <Release>
from the <Plate Tasks> menu.

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<Archive>
The operator can archive a single plate of results to a CD, or
select multiple plates and archive them together.
To archive plate results, select <Results>, and then <View By
Plate>.
1. Highlight (select) one or more plates to be archived.
2. Select <Archive> from the <Plate Tasks> menu.
NOTE: When multiple plates are selected, archive
is the only task available.
The <Archiving Plate Results> screen displays.
Figure 5.99:<Archiving Plate Results> Display

The following information is given:


• <Plate Name> -- Name assigned to the PCR plate
• <Completion Date> -- Date the plate was completed
• <Archive File Name> -- Name assigned to the
archive file
– File name format: m2000rt serial number_PCR
plate name_date_time.txt
or
– <Multiple Plates Selected for Archive>
• <Instructions> -- Instructions for archiving
– 1. Insert the CD into the CD drive.
– 2. Click on <Start> button when the CD drive
status is <READY>.

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• <CD Drive Status> -- Status of CD drive:


– Ready: CD in drive, ready for archive
– Not Ready: No CD found
3. Insert the CD into the CD drive.
4. Select <Save>.

The data is written to the CD, and a message asks the operator
to wait.
Figure 5.100:<Archiving Plate Results> Display, Wait
Message

When archiving is complete, the system returns to the <Plate


Results> screen and displays a message that the archiving was
successful.
If the archiving process was unsuccessful, a message will
display.
NOTE: For more information, refer to Section 10,
Troubleshooting and Diagnostics.

The selected plate(s) will now display as <Archived> in the


<Archive Status> column on the <Plate Results> display.
Each plate will be written to a separate file.
The file(s) copied to the CD is in a tab-delimited format and
can be viewed and/or imported into a text viewer or
spreadsheet.

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<Print Result List>


To print a result list report for an entire PCR plate:
1. Select <Results>, then <View By Plate>.
2. Select the desired PCR plate.
3. From the <Plate Tasks> menu, select <Print Result
List>. The results for the selected plate will print. Refer to
Figure 5.101 on page 5–104.

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Figure 5.101:Plate Results List Report Template

Operator ID: 


1
m2000rt Results List Report Instrument Serial #: 2

m2000rt Application Name: 3

m2000rt Application Version: 4

m2000rt Run Completion Time: 5

Sample Extraction Application Name: 6

Sample Extraction Application Version: 7

Reagent Addition Application Name: 8

Reagent Addition Application Version: 9

10
Plate Name:
Deep Well Plate Name: 11

12 Sample Extraction Reagent Lot:


Sample Extraction Reagent Expiration: 13
14 Sample Extraction Completion Time:
Master Mix Addition Completion Time: 15
16 Parameter Names/Values
Assay: 17

18
(Assay dependent; only appears
Control Lot / Expiration: 
19 Control Levels / Concentrations:
when applicable)

20 Calibrator Lot / Expiration: 


21 Assay Calibration Time
22 Calibrator Levels / Concentrations:
(Assay dependent; only appears
when applicable)

23 24 24 26 27 28 29 30

Well Sample ID Assay Name Assay Lot Sample Result/Unit Flags Code
Expiration Type Interpretation

A1 Assay1_NEG Assay1 LOT4 Control Not detected


12/31/2010

B1 Assay1_NEG Assay1 LOT4 Control Not detected


12/31/2010

NOTE: The numbered sections of the report above


are discussed in Table 5.17 on page 5–105.

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Table 5.17:Results List Items

Item Category Explanation


1 <Operator ID> Operator that printed the report
2 <Instrument Serial #> Serial number of the m2000rt
3 <m2000rt Application Name> Name of the m2000rt Application
Specification file
4 <m2000rt Application Version> Version of the m2000rt Application
Specification file
5 <m2000rt Run Completion Completion time of the m2000rt run
Time>
6 <Sample Extraction Application Name of the m2000sp sample extraction
Name> Application Specification file
7 <Sample Extraction Application Version of the m2000sp sample extraction
Version> Application Specification file
8 <Reagent Addition Application Name of the m2000sp reagent addition
Name> Application Specification file
9 <Reagent Addition Application Version of the m2000sp reagent addition
Version> Application Specification file
10 <Plate Name> Name of the PCR plate
11 <Deep Well Plate Name> Name of the deep well plate
12 <Sample Extraction Reagent Lot number of the sample preparation
Lot> reagents
13 <Sample Extraction Reagent Expiration date of the sample preparation
Expiration> reagents
14 <Sample Extraction Completion Time the sample extraction run completed
Time>
15 <Master Mix Addition Time the master mix addition run completed
Completion Time>
16 <Parameter Names/Values> Parameter name and actual value.
17 <Assay> Name of the assay for each calibrator and
control
*18 <Control Lot / Expiration> Lot number and expiration date for the assay
control material
*19 <Control Levels / Name and concentrations for the assay
Concentrations> controls

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Item Category Explanation


*20 <Calibrator Lot / Expiration> Lot number and expiration date for the
calibrator material
NOTE: Calibrator lot, expiration,
levels, and concentrations are from
the calibrator information entered by
the user for the calibrators present in
the report.
*21 <Assay Calibration Time> Date and time stamp of the calibration curve
that was used to generate the results on the
report
*22 <Calibrator Levels/ Name and concentrations for the calibrators
Concentrations> NOTE: Calibrator lot, expiration,
levels, and concentrations are from
the calibrator information entered by
the user for the calibrators present in
the report.
23 <Well> Well location of the sample on the PCR plate
24 <Sample ID> Sample identification
25 <Assay Name> Name of the assay
26 <Assay Lot/ Expiration> Lot number and expiration date for the assay
reagents
27 <Sample Type> Type of sample (calibrator, control, patient)
28 <Result/Unit Interpretation> Assay result / interpretation of the result; see
assay package insert
29 <Flags> Any flags that may accompany the sample
result; refer to Table 5.14 on page 5–82
30 <Code> Any error code that may accompany the
sample result; see Section 10,
Troubleshooting & Diagnostics

* These items are included only if calibrators and controls are


selected for printing.

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<Print Result Details>


The Result Details Report provides detailed information for the
entire PCR plate. The results for the selected plate will print
one result per page. There are two types of detailed reports:
• Standard (applicable to most assays)
• Genotype
NOTE: The user does not need to select which
report type is required; the report type is
assay-dependent and automatically assigned.
To print the Result Details Report:
1. Select <Results>, then <View By Plate>.
2. Select the desired plate.
3. From the <Plate Tasks> menu, select <Print Result
Details>.
• For an example and description of the Standard report
type, refer to Figure 5.102 on page 5–108.
• For an example and description of the Genotype
report type, refer to Figure 5.103 on page 5–110.

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Figure 5.102:Standard Plate Result Details Report

1 2

3 4
5
6
7 9
8
11 10
12
13
15
14
16

17 18 19

20
21
22
23

24 25

Table 5.18:Standard Result Detail Items

Ite
Category Explanation
m
1 <Instrument Serial #> Serial number of the m2000rt
2 <Operator> Operator that printed the report
3 <Sample ID> Sample identification
4 <Sample Type> Type of sample (patient, control,
calibrator)
5 <Well Location> Location of the sample on the PCR
plate
6 <Assay Name> Name of the assay
7 <Assay Version> Version of the assay

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Ite
Category Explanation
m
8 <Assay Calibration Time> Time the assay was calibrated
9 <Plate Name> Name of the PCR plate
10 <Application Name> Name of the Application
Specification file
11 <Assay Reagent Lot> Lot number of the assay reagent
12 <Assay Reagent Expiration> Expiration date of the assay reagent
13 <Sample Preparation Sample preparation reagent lot
Reagent Lot> number
14 <Sample Preparation Expiration date of the sample
Expiration> preparation reagent
15 <Application Version> Version of the Application
Specification file
16 <Run Completion Time> Time the run was completed
17 <Result/Unit> The final result; see assay package
insert
18 <Interpretation> Interpretation of the result; see assay
package insert
19 <Flags> Any flags that may accompany the
result; refer to Table 5.14 on page
5–82
20 <Target Cycle #> Target dye cycle number
21 <IC Cycle #> Internal control cycle number
22 <Target MR> Target maximum ratio value
23 <IC MR> Internal control maximum ratio
value
24 <Result Comment> Any result comments made by the
user
25 <Error Code> Any error code that may accompany
<Error Description> the result and a description of the
error code; see Section 10,
Troubleshooting & Diagnostics

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Figure 5.103:Genotype Result Details Report

1
Operator ID: Fencik
m2000rt Result Details Report Instrument Serial #: m2000rt45 2

3 Sample ID: 6121993RNA 4 Sample Type: Control


5 m2000rt Application Name: Assay

6 m2000rt Application Version: 0.09

7 m2000rt Run Completion Time: 5/27/2010 3:20:26PM

8 Sample Extraction Application Name:

9 Sample Extraction Application Version:

10 Reagent Addition Application Name:

11 Reagent Addition Application Version:

12 Plate Name: 6548_72


13 Deep Well Plate Name:

14 Assay Reagent Lot: 12345RU00


15
Assay Reagent Expiration: 6/30/2010
16 Sample Extraction Reagent Lot: 123456
17
Sample Extraction Reagent Expiration: December 2011
18 Sample Extraction Completion Time:
Master Mix Addition Completion Time: 19
20 Control Lot: 369852
21 Control Lot Expiration: 7/16/2010
Parameter Names / Values: ABC Cycle Number / 31.5 DEF Cycle Number / 42.15 GHI Cycle Number / 38.44
22

23 Well Assay Name Result/Unit 26 Target Cycle # IC Cycle # Flags Code


24 25
Interpretation 27 28 29
C1 Assay1 4919

C1 Assay2 12.69 CN 12.69

C2 Assay2 12.93 CN 12.93

C3 Assay3 12.47 CN 12.47 4919

30
Printed On: 5/27/2010 3:27:52PM m2000 ™ Page 1 of 2

Table 5.19:Genotype Result Detail Items

Item Category Explanation


1 <Operator> Operator that printed the report
2 <Instrument Serial #> Serial number of the m2000rt
3 <Sample ID> Sample identification

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Item Category Explanation


4 <Sample Type> Type of sample (patient, control,
calibrator)
5 <m2000rt Application Name> Name of the Application
Specification file
6 <m2000rt Application Version number of the Application
Version> Specification file
7 <m2000rt Run Completion Time the run was completed
Time>
8 <Sample Extraction Name of the sample extraction
Application Name> Application Specification
9 <Sample Extraction Version number of the sample
Application Version> extraction Application Specification
10 <Reagent Addition Name of the Master Mix Addition
Application Name> Application Specification
11 <Reagent Addition Version number of the Master Mix
Application Version> Addition Application Specification
12 <Plate Name> Name of the PCR plate
13 <Deep Well Plate Name> Name of the deep well plate
14 <Assay Reagent Lot> Lot number for the assay reagents
15 <Assay Reagent Expiration Expiration date for the assay
Date> reagents
16 <Sample Extraction Reagent Lot number for the sample
Lot> extraction reagents
17 <Sample Extraction Reagent Expiration date for the sample
Expiration> extraction reagents
18 <Sample Extraction Time sample extraction was
Completion Time> completed
19 <Master Mix Addition Time Master Mix Addition was
Completion Time> completed
*20 <Control Lot> Lot number for the control
*21 <Control Lot Expiration> Expiration date for the control
*22 <Parameter Names/Values> Parameter name and actual value
23 <Well> Location of the sample on the PCR
plate

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Item Category Explanation


24 <Assay Name> Name of the assay
<Result/Unit> The final result; see assay package
insert
25
<Interpretation> Interpretation of the result; see assay
package insert
26 <Target Cycle #> Target dye cycle number
27 <IC Cycle #> Internal control cycle number
28 <Flags> Any flags that may accompany the
result; refer to Table 5.14 on page
5–82
29 <Code> Any error code that may accompany
the result and a description of the
error code; see Section 10,
Troubleshooting & Diagnostics
30 <Printed On> Date and time the report was
generated

* These fields are not applicable to all assays. They will appear
on the report only when they are applicable to the assay or
assays involved.

<Print Errors>
The <Print Errors> option on the <Plate Tasks> menu
allows the operator to print a report that lists only the wells
with errors. This report follows the same format as the
standard m2000rt Results Lists Report (see Figure 5.101
on page 5–104), including a description of each error.
To print the error report, select <Print Errors> from the
menu and then select <Yes> on the confirmation prompt.
NOTE: Just as with the standard report, the operator
can view the status of a print job by selecting <Printer
Queue> from the <System> menu.

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<Delete>
NOTE: The operator must have Administrator access to
delete plates.
To delete a plate:
1. Select <Results> and <View By Plate>.
2. Select the plate to be deleted.
3. From the <Plate Tasks> menu, select <Delete>.
An alert message displays, requesting confirmation that the
operator wants to delete the selected plate.
Results remain on the system until they are manually deleted
or the system capacity is reached. The system will hold up to
500 plates of results. When the capacity has been reached, the
oldest completed plate is automatically deleted when the
running plate completes.

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<Result Tasks> Menu


The <Result Tasks> menu gives the operator options to:
• <View Details> -- View the details of a selected result
• <Release> -- Release the selected results
• <Print List> -- Print the result list report for the selected
results
• <Print Details> -- Print the result details report for the
selected result
• <Delete> -- Delete the selected results

Figure 5.104:<Result Tasks> Menu

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<View Details>
To review details of a result:
1. Select <Results>, <View By Plate>
2. Select the desired plate, then highlight one or more results
3. From the <Result Tasks> menu, select <View Details>
To view the individual graph, the operator is able to set
the <Curve>, <Type>, and <Y-Axis Scale> and/or
<Scale>.
Figure 5.105:<Result Details> Screen

The <Result Details> screen displays:

• <Sample Information> -- Information for the specific


sample result
– <Sample Id> -- Identification assigned to the sample
– <Sample Type> -- Type of sample (patient, control,
calibrator)
– <Location> -- Well location of the sample on the
PCR plate
– <Run Completion Time> -- Time the run
completed

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– <Result Comment> -- Any comments that were


entered. Additional comments can be entered and
then saved by selecting <Save>.

For calibrator samples, the following additional


information is displayed:
– <Calibrator Lot/Expiration> -- Calibrator lot
number and expiration date
– <Log Concentration> -- Log concentration of the
calibrator

For control samples, the following additional information


is displayed:
– <Control Lot/Expiration> -- Control lot number
and expiration date
– <Range> -- Control range in log concentration

• <Test Information> -- Information for the test


– <Result> -- Result of the sample, see assay package
insert
– <Interpretation> -- Interpretation of the result, see
assay package insert
– <Flags> -- Flags on the result; refer to Table 5.14 on
page 5–82
– <Target Cycle Number> -- Target cycle number for
the result
– <Target MR> -- Target maximum ratio value (refer to
maxRatio Analysis on page 3–10 of Section 3,
Principles of Operation, for more information)
– <IC Cycle Number> -- Internal control (IC) cycle
number
– <IC MR> -- The internal control’s maximum ratio
value
– <Release Status> -- LIS (Laboratory Information
System) release status for the result
• Cancelled: result transmission cancelled
• Transmitted: result sent to LIS successfully

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• Pending Transmission: result waiting to be


transmitted to LIS
– <Error Code / Description> -- Error code and
description for the result; see Section 10,
Troubleshooting and Diagnostics of this manual.
– <Assay Name / Version> -- Name of assay and
version number
– <Assay Calibration Time> -- Time the assay was
calibrated
– <Reagent Lot / Expiration> -- Assay reagent lot
number and expiration date

• <Graph Settings> -- Graph settings that can be


selected/viewed for the result
– <Curve> -- Type of curve displayed
– <Target> -- Displays the amplification curve for
assay analyte (target)
– <Control> -- Displays the amplification curve for
the internal control, if applicable
– <Reference> -- Displays the amplification curve
for the reference dye
– <Quencher> -- Displays the amplification curve
for the quencher, if applicable
–<Target and Control> -- Displays the
amplification curve for the target and internal
control
– <Type> -- Type of curve displayed
– <Baselined> -- Displays the normalized,
baselined fluorescence curve.
– <Normalized> -- Displays the normalized
fluorescence curve.
– <Fluorescence> -- Displays the raw fluorescence
curve.
– <Y-Axis Scale> -- Type of Y-Axis Scale displayed
– <Linear> -- Displays the curve with a linear
Y-axis.
– <Logarithmic> -- Displays the curve with a
logarithmic Y-axis.

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– <Scale> -- Scale settings that can be selected/viewed


for the result
– <Automatic> -- Sets the axis to display the entire
single curve
– <Fixed> -- Fixes the y-axis to include all results on
a plate for easier result-to-result comparison.
• The <Next> button is used to advance to the next result.
• The <Save> button is used to save any comments made in
the <Result Comment> box.
• The user is able to zoom in on a portion of the graph by
dragging the mouse across it. The <Reset> button will
reset the graph back to its original format.

<Release>
The system allows the user to <Release> selected results to an
LIS system. Release is only available when the LIS
communications is configured to ON.
NOTE: For complete information, refer to LIS
Configuration on page 2–21 of Section 2,
Installation Procedures and User Configuration.
To release a result, highlight the plate and select <Release>
from the <Plate Tasks> menu.

<Print List>
To print the result list report for selected results:
1. Select <Results>, then <View By Plate>.
2. Select the desired plate, then highlight the desired
result(s).
3. From the <Result Tasks> menu, select <Print List>.
The results from the selected plate will print. Refer to
Figure 5.101 on page 5–104 and Table 5.17 on page 5–105
for a complete description.

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<Print Details>
The Result Details Report provides detailed information for the
entire PCR plate. The results for the selected plate will print
one result per page. There are two types of detailed reports:
• Standard (applicable to most assays)
• Genotype
NOTE: The user does not need to select which
report type is required; the report type is
assay-dependent and automatically assigned.
To print the Result Details Report:
1. Select <Results>, then <View By Plate>.
2. Select the desired plate, then highlight the desired
result(s).
3. From the <Result Tasks> menu, select <Print Details>.
• For an example and description of the Standard report
type, refer to Figure 5.102 on page 5–108.
• For an example and description of the Genotype
report type, refer to Figure 5.103 on page 5–110.

<Delete>
NOTE: The operator must have Administrator access to
delete plates.
To delete a selected result(s):
1. Select <Results> and <View By Plate>
2. Select the desired plate, then highlight the desired results
3. From the <Result Tasks> menu, select <Delete>
An alert message displays, requesting confirmation that the
operator wants to delete the selected result(s).

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Results Management Section 5

<View Assay Calibrations>


The operator can view inactive, active, and failed assay
calibrations.
Select <Results>, and then <View Assay Calibrations>.
The <Assay Calibrations> screen displays:
• <Assay Name> -- Name of the assay
• <Reagent Lot> -- Lot number of the assay reagent used
to generate the calibration curve
• <Status> -- Status of the calibration: Active, Inactive, or
Failed
• <Calibration Time> -- Date and time of the calibration
• <Error Description> -- Error description for the failed
calibration

The <Assay Calibration Tasks> menu permits the operator


to:
• <View Calibration Details> -- View calibration details
• <Fail Calibration> -- Fail calibration
Figure 5.106:<Assay Calibrations> Display

Each assay can store two curves, one for each of the two
different assay reagent lots.
NOTE: The m2000rt software only stores a calibration
curve based on the amplification lot number. If the
curve fails on the plate and there is an active curve for
that assay/lot, the software will use that curve. All
results on the plate for that assay will be flagged with a
CAL flag.

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<View Calibration Details>


The operator can view the details of an individual assay
calibration by:
1. Selecting <Results>, <View Assay Calibrations>.
2. From the <Assay Calibration Tasks> menu, select
<View Calibration Details>.
NOTE: There are two possible screen views, one
for Quantitative assays and one for Qualitative.
See Figure 5.107 and Figure 5.108 on page 5–123.
The <Assay Calibration Details> screen displays:
• A calibration graph (for Quantitative assays) featuring:
– <Cycle Number> rows showing cycle stage
– <Log Concentration> columns showing log
concentration levels
– <Slope> display showing the rounded slope of the
calibrator curve
– <Intercept> display showing the rounded intercept
value of the calibrator curve
• <Assay Name> -- Name of the assay
• <Reagent Lot Number> -- Lot number of the assay
reagent
• <Calibration Time> -- Date and time the calibration
was generated
• <Calibrator Lot / Expiration> -- Calibrator lot,
number, and expiration date
• <Status> -- Status of the calibration
– <Active> -- Referred to as a stored curve. Can be used
by subsequent runs.
– <Inactive> -- Plate calibration curve used to generate
results on the plate; the calibration is not used on
other runs
– <Failed> -- Calibration validity failed or user
manually failed the calibration
– <Cutoff> -- Calculated cutoff value for qualitative
assay.

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In the box to the left of the calibration graph are:


• <Calibrator ID> -- Calibrator level name
• <Log Concentration> -- Log concentration of each level
• <Median CN> -- Mean or median cycle number of all cal
level replicates
This box features expansion nodes on the left side that reveal:
• <Replicate Result> -- Final result for each replicate
• <Replicate Response> -- Cycle number for each
replicate

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Figure 5.107:<Assay Calibration Details> Quantitative


Assay Display

Figure 5.108:<Assay Calibration Details> Qualitative Assay


Display

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Operating Instructions
Results Management Section 5

To return to the <Assay Calibrations> screen, select


<Close>.

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<Fail Calibration>
Administrators can manually fail an assay calibration so it
cannot be used in further processing.
1. To manually fail a calibration, select <Results> and then
<View Assay Calibrations>.
2. Select the calibration to be failed.
3. Select <Fail Calibration>.
An alert message displays, requesting confirmation that
the operator wants to fail the calibration curve.
Figure 5.109:<Assay Calibrations> Display, <Fail
Calibration> Option

4. Select <Yes> to fail the calibration curve.


The <Assay Calibration> screen displays with the
selected curve highlighted in red. The <Error
Description> column reports that the user manually
failed the calibration, and the <Status> is changed to
<Failed>.
Figure 5.110:<Assay Calibrations> Display, Manually
Failed Calibration

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Operating Instructions
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View Quality Control Results


The <Quality Control Results> screen allows the user to
view control results for all or selected assays over a
user-selected date range. To access this function, select
<Results>, and then select the <View Quality Control
Results> menu option.
Figure 5.111:<View By Plate> Command

Figure 5.112:<Quality Control Results> screen

Optional
fields
The <All> buttons in
these fields toggle all
checked selections
ON or OFF

To view control results, do the following:


1. In the <Assay Names> window, select either the <All>
box (to see control results for all assays) or the boxes for
individual assays of interest.
2. In the <Control Names> window, select either the <All>
box (to see all controls for the selected assays) or the boxes
for individual controls.
3. In the <Assay Reagent Lot #’s> window, select either
the <All> box (to see all lots for the selected assays and
controls) or the boxes for individual lot numbers.

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4. If desired, enter the start date for the search in the <Start
Date> field under <Date Range>. This field is optional.
5. If desired, enter the end date for the search in the <End
Date> field. This field is also optional.
6. Select the <Generate Results> button. The screen will
change to a report display of the generated results.
NOTE: If there are no results available for the
specified selection criteria, a message will display
indicating this.
Figure 5.113:Quality Control Results displayed

The center arrows


move the view
This option allows forward/backward
the user to type in a one page at a time
search word.
Selecting the <Find The outside arrows
Text> button then move the view to
takes the user to the the first page or
next page that word last page
occurs on.

The first zoom button This button forces the


enlarges the page page to fit the width of
incrementally the viewer space

This button reduces This button forces the


the page incrementally document into a
single, full-page view

NOTE: Refer to m2000rt Quality Control Report


Description on page 5–130 for a description of the
information contained in the report.

The <Result Tasks> menu includes the following


options:

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Results Management Section 5

• <Select Results>, which takes the user back to the


<Quality Control Results> screen in order to begin
another search.
• <Print Results>, which allows the user to print the
results report. (See Printing Quality Control Results on
page 5–128.)
• <Export Results>, which allows the user to export
the result report to a CD. (See Exporting Quality
Control Results on page 5–129.)

Printing Quality Control Results


1. To print the result report, select <Print Results> from
the <Result Tasks> menu.
2. Select <Yes> on the confirmation message that follows.
Figure 5.114:Print confirmation message

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Exporting Quality Control Results


1. To export the result report, select <Export Results> from
the <Result Tasks> menu.
Figure 5.115:<Exporting Quality Control Results>

NOTE: The system automatically generates an


export name in the <Export Name> field, but the
user has the option to edit this name or change it
completely.
2. Insert a CD into the CD drive.
3. Select the <Start> button after the <CD Drive Status>
field reads <READY>. A message will appear stating that
the export is in progress.
4. Wait until a second message indicates the export has
completed (either successfully or unsuccessfully) before
removing the CD.

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Operating Instructions
Results Management Section 5

m2000rt Quality Control Report Description

The majority of this report includes the information shown in


Figure 5.116 and described in Table 5.20. The last page of
the report is a summary of the search criteria selected by the
user (see Figure 5.117 on page 5-132).

Figure 5.116:Typical report page

1
2
3
4
5 7
6

8 9 10 11 12 13 14 15

16

Table 5.20:Result Detail Items

Ite
Category Explanation
m

1 <Operator ID> Operator that printed the report

2 <Instrument Serial #> Serial number of the m2000rt

3 <Assay Name> Name of the assay

4 <Assay Version> Version of the assay

5 <Control Name> Name of the control

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Ite
Category Explanation
m

6 <Reagent Lot #> Lot number of the assay reagent

7 <Expiration Date> Expiration date of the assay reagent

8 <Control Lot #> Lot number of the control

9 <Expiration Date> Expiration date of the control

10 <Min Range> Minimum acceptable control result


that is valid

11 <Max Range> Maximum acceptable control result


that is valid

12 <Result> Actual control results and units

13 <Run Date> Date of the plate run

14 <Plate Name> Name of plate that was run

15 <Error Code> Any error code that may accompany


the result

16 <Printed On> Date and time the report was


generated

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Operating Instructions
Results Management Section 5

Figure 5.117:Last page of report (search criteria)

1 2

Table 5.21:Result Detail Items

Ite
Category Explanation
m

1 <Start Date> Beginning of search range


established by the user (optional)

2 <End Date> End of search range established by


the user (optional)

3 <Assay Name(s)> List of all assays included in the


search

4 <Control Name(s)> List of all controls included in the


search

5 <Assay Reagent Lot> List of all assay reagent lots included


in the search

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Managing the Network Data Store


NOTE: This option is only available to Administrators.

In situations where multiple m2000sp instruments are


connected to a network with one or more m2000rt
instruments, the Network Data Store acts as a repository for all
exported files. These files are stored here until they are
imported for an m2000rt run or, if never imported, deleted by
an Administrator.
To access the Network Data Store, select <Network Data
Store Management> from the <System> menu.
Figure 5.118:<System> Menu

This screen lists all of the m2000sp instruments currently on


the network, and the unprocessed Test Order files exported
from each m2000sp. The instrument list features
collapsible/expandable nodes, one for each m2000sp.
Figure 5.119:<Network Data Store Management> Screen

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Results Management Section 5

The sortable <Test Order File> column lists the file name for
each test order. The file name consists of:
a. the plate name
b. the application name and version
c. the date and time or run completion.

The sortable <Time Stamp> column lists the time and date the
Test Order was exported.

The <Delete Test Order Tasks> menu has three possible


options:
• <All>, which allows the user to delete all files in the
Network Data Store; this option is always active
• <All for Selected Instruments>, which allows the user
to delete all files for the specific m2000sp instruments
highlighted; this option is active only when an
instrument is highlighted
Figure 5.120:<All for Selected Instruments> Active

• <Selected>, which allows the user to delete only those


files that have been highlighted; this option is active only
when at least one file is highlighted.
Figure 5.121:<Selected> Option Active

NOTE: As a matter of good practice, unused Test Order


files should be deleted on a routine basis.

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Section 6

Section 6: Calibration Procedures

Calibration Procedures

Section 6 Table of Contents


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
System Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
ABBOTT® m2000rt Optical Calibration Kit . . . . . . . . . . 6-6
Region of Interest (ROI) Calibration . . . . . . . . . . . . . . . . . . 6-7
When to Perform ROI Calibration . . . . . . . . . . . . . . . . . 6-7
Assemble Required Materials . . . . . . . . . . . . . . . . . . . . . 6-8
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Conduct the Region of Interest Calibration . . . . . . . . . . 6-9
Background Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
When to Perform Background Calibration . . . . . . . . . 6-17
Assemble Required Materials . . . . . . . . . . . . . . . . . . . . 6-18
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Conduct the Background Plate Calibration . . . . . . . . . 6-19
Creating a Background Plate . . . . . . . . . . . . . . . . . . . . . 6-27
Uniformity Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
When to Perform Uniformity Calibration . . . . . . . . . . 6-31
Assemble Required Materials . . . . . . . . . . . . . . . . . . . . 6-31
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
Conduct the Uniformity Calibration . . . . . . . . . . . . . . 6-32
Pure Dye Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39
When to Perform Pure Dye Calibration . . . . . . . . . . . . 6-40
Assemble Required Materials . . . . . . . . . . . . . . . . . . . . 6-40
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41
Conduct the Pure Dye Calibration . . . . . . . . . . . . . . . . 6-41

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Calibration Procedures Section 6

NOTES

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200680-106—October 2012
Section 6 Calibration Procedures

Section 6: Calibration Procedures

Calibration Procedures

Overview
This section describes calibration procedures for the m2000rt.
The following topics are included:
• Region of Interest (ROI) Calibration on page 6–7
Provides an overview and procedure for performing the
Region of Interest calibration.
• Background Calibration on page 6–17
Provides an overview and procedure for performing the
Background calibration.
• Uniformity Calibration on page 6–33
Provides an overview and procedure for performing the
Uniformity calibration.
• Pure Dye Calibration on page 6–41
Provides an overview and procedure for performing the
Pure Dye Plate calibrations.

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Overview Section 6

NOTES

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Calibration Procedures
Section 6 System Calibration

System Calibration
System calibrations must be active before executing an assay
run. The <System Calibration Status> screen displays the
status and details all of the system calibrations.
Figure 6.1: <System Calibration Status> Display

The <Calibration Tasks> menu includes the following


system calibrations:
• <Run Region of Interest>, discussed on page 6–7
• <Run Background>, discussed on page 6–17
• <Run Uniformity>, discussed on page 6–33
• <Run Pure Dye>, discussed on page 6–41

NOTE: The pure dyes that need to be calibrated to run


an assay are outlined in the assay specific package
insert. At a minimum, the system will need to be
calibrated for FAM™ and ROX™.

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Calibration Procedures
System Calibration Section 6

The items in the <Calibration Tasks> menu are enabled


based on the system calibration dependency, user access level,
and instrument status.
NOTE: The operator must log in with administrative
privileges (except for the Background Calibration,
which a General User may perform) and the instrument
must be in the <READY> state before any system
calibrations can be performed.

The <System Calibration Status> details are shown in the


table below.

Table 6.1: <System Calibration Status> Detail

Status Detail Explanation


Name of the calibration
• Region of Interest
<Name> • Background
• Uniformity
• Pure Dye [dye name]
Status of the calibration
• <No Calibration>
<Status>
• <Active>
• <Running>
Type of calibration run
(Region of Interest,
<Type>
Background, Uniformity, Pure
Dye)
Completion time of the
<Completion Time>
calibration
Lot number of the calibration
<Lot Number>
plate
Expiration date of the
<Plate Expiration>
calibration plate
Operator who performed the
<Operator>
calibration

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200680-106—October 2012
Calibration Procedures
Section 6 System Calibration

System calibrations are dependent on each other.


For example:
• <Run Region of Interest> is enabled when the
instrument is in the <READY> state.
• <Run Background> is enabled when the instrument is
in the <READY> state and the Region of Interest
calibration is active.
• <Run Uniformity> is enabled when the instrument is in
the <READY> state and the Region of Interest and
Background calibrations are active.
• <Run Pure Dye> is enabled when the instrument is in
the <READY> state and the Region of Interest,
Background calibration, and Uniformity calibration are
active.

If a calibration fails, refer to Section 10, Troubleshooting


and Diagnostics.

Calibration Duration
Estimated duration of each type of calibration is shown in the
table below.

Table 6.2: Calibration Status Detail

Approximate
Calibration Duration
(in minutes)
Region of Interest (ROI) 9

Background 13

Uniformity 8

Pure Dye 9 for each dye

NOTE: ROI calibration requires performing


Background, Uniformity, and Pure Dye calibrations, as
well.

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200680-106—October 2012
Calibration Procedures
System Calibration Section 6

ABBOTT® m2000rt Optical Calibration Kit

Intended Use
The intended use of the optical calibration kit is for the optical
calibration of the m2000rt system.

The Optical Calibration Kit (List Number 4J71-93) contains:


• ROI Calibration Plate
– 1 plate
– 96 wells, 0.1 mL/well, 0.2 μM Dye in a buffered
solution

• Background Plate
– 1 plate
– 96 wells, 0.05 mL/well, buffered solution

• Pure Dye Plates (Cy™5, FAM™, NED™, ROX™, and VIC®)


– 1 plate, each Dye
– 96 wells, 0.05 mL/well, 0.2 μM Dye in a buffered
solution
NOTE: In addition to those listed above, the
calibration kit might also include the following
dyes: JOE™, SYBR®, and TAMRA™. These dyes are
not required for calibration.

Figure 6.2: ABBOTT Optical Calibration Kit

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200680-106—October 2012
Calibration Procedures
Section 6 Region of Interest (ROI) Calibration

Region of Interest (ROI) Calibration

!! IMPORTANT: Before running an ROI calibration, it is


recommended that the user performs a Fluorescence
Contamination Check, see page 9–13 for details. If the
thermal block is contaminated, the ROI calibration will
fail.
Before operating the m2000rt instrument or performing other
system calibrations, generate ROI data by performing an ROI
calibration.
Data gathered during the calibration allow the m2000rt
software to map the positions of the wells on the sample
block. During instrument operation, the software associates
increases in fluorescence with specific wells of the reaction
plate.

When to Perform ROI Calibration


Perform ROI calibration at these times:
• during m2000rt System installation
• after lamp replacement
• after moving the m2000rt
• as part of regular system maintenance

NOTE: ROI calibration requires performing


Background, Uniformity, and Pure Dye calibrations, as
well.

NOTE: To run this, or any, calibration, the instrument


must first be in the <READY> state.

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200680-106—October 2012
Calibration Procedures
Region of Interest (ROI) Calibration Section 6

Assemble Required Materials


Assemble the following materials necessary for performing the
calibration:
• ABBOTT® m2000rt ROI Calibration Plate
• Centrifuge with plate adapter

NOTE: Centrifuge parameters:


• Time = 1 minute
• 1200 - 1500 x g

• Powder-free gloves
• ABBOTT Splash Free Support Base

NOTE: The Splash Free Support Base should be


cleaned after each use. For cleaning procedure,
refer to Section 9, Service and Maintenance,
Cleaning the Splash Free Support Base.

Getting Started
NOTE: Region of Interest calibration requires
approximately 9 minutes to complete.

To perform the calibration:


• obtain the tools and materials required for installation,
listed above in Assemble Required Materials.
• begin the calibration, as explained below in Conduct the
Region of Interest Calibration.

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200680-106—October 2012
Calibration Procedures
Section 6 Region of Interest (ROI) Calibration

Conduct the Region of Interest Calibration

NOTE: Wear powder-free gloves when handling the


ROI calibration plate. Handle the plate by the edges to
prevent fluids and other contaminant from adhering to
the bottom of the plate.

1. Retrieve the ABBOTT® Optical Calibration Kit from


storage, and remove the prepared ROI calibration plate.
2. Return the Optical Calibration Kit to storage.
3. Allow the ROI calibration plate to warm to room
temperature (at least 5 minutes).

NOTE: Do not remove the ROI calibration


plate from its packaging until it is time to
run the calibration. The fluorescent dye
contained in the wells of the plate is
photosensitive. Prolonged exposure to light can
diminish the fluorescent signal strength of the
plate.

4. Remove the ROI calibration plate from its packaging.


• Carefully open the ROI calibration plate packaging,
but do not discard the packaging. The plate can be
used up to ten (10) times if it is stored in the freezer in
its original packaging sleeve.
• Visually check that the plate is thawed prior to
centrifuging.
• Be sure to write the date opened on the packaging
sleeve label.

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200680-106—October 2012
Calibration Procedures
Region of Interest (ROI) Calibration Section 6

NOTE: Do not discard the calibration plate.


If stored in its packaging sleeve at -10°C or colder,
the plate can be used for a specific time after initial
use as indicated by the calibration plate label or
until the expiration date, whichever comes first.
Maximum number of uses is ten (10).

Always keep the plate clean by placing it in an


ABBOTT® Splash Free Support Base when it is
outside of its packaging or the instrument. Fluids
and other contaminants that adhere to the bottom of the
plate can contaminate the sample block and cause an
abnormally high background signal.

Figure 6.3: Set Plate in Splash Free Support Base

5. Centrifuge with Splash Free Support Base.


NOTE: Centrifuge parameters:
• Time = 1 minute
• 1200 - 1500 x g

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200680-106—October 2012
Calibration Procedures
Section 6 Region of Interest (ROI) Calibration

6. Verify that the ROI calibration dye in each well of the ROI
plate is positioned at the bottom of the well, and that no
bubbles are present. To detect bubbles, examine the plate
carefully from all angles.
If necessary, re-centrifuge the plate for a longer period of
time.
Figure 6.4: Correct Position of Dye in Plate Well

7. From the m2000rt menu, select <System> and then


<System Calibration>.
NOTE: The instrument should be in the
<READY> state.
Figure 6.5: <System> Menu

m2000rt Operations Manual 6-11


200680-106—October 2012
Calibration Procedures
Region of Interest (ROI) Calibration Section 6

8. From the <Calibration Tasks> menu, select <Run


Region of Interest>.
Figure 6.6: <Run Region of Interest> Task

9. The <Calibrate Region of Interest: Plate


Information> screen displays. Enter the lot number and
expiration date of the ROI plate. Select <Next>.
Figure 6.7: ROI Plate Information

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200680-106—October 2012
Calibration Procedures
Section 6 Region of Interest (ROI) Calibration

10. The <Calibrate Region of Interest: Calibration


Start> screen displays.
Figure 6.8: <Calibrate Region of Interest: Calibration
Start> Display

11. Press the release to open the tray drawer.


Figure 6.9: Open the Tray Drawer

m2000rt Operations Manual 6-13


200680-106—October 2012
Calibration Procedures
Region of Interest (ROI) Calibration Section 6

12. Load the ROI calibration plate carefully into the plate
holder so as not to cause splashing within the wells.
NOTE: The A1 position is at the top left side of the
plate. If the plate is put into the drawer backwards,
the drawer will not close. DO NOT FORCE the
tray drawer to close.
Figure 6.10:A1 Plate Well

A1 position

13. Close the tray drawer.


NOTE: When closing the tray drawer, apply
pressure, at an angle, at the circular depression in
the drawer on the right side of the tray’s front
edge.
Figure 6.11:Close the Tray Drawer

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200680-106—October 2012
Calibration Procedures
Section 6 Region of Interest (ROI) Calibration

14. Select <Start> to begin the run. The <Instrument


Status> screen displays <Region Of Interest> and is
shown to be <RUNNING>.
Figure 6.12:<Region Of Interest> is <RUNNING>

When the calibration process has completed, a message


displays, alerting the user if the calibration has passed or
failed.

15. The <System Calibration Status> screen is updated to


reflect the new ROI calibration.

16. If the ROI calibration fails, an alert message displays and


these results occur:
• The instrument status changes to <STOPPED>.
• The <System Calibration Status> list is not
updated.
• If an active ROI calibration exists, its ROI calibration
remains unchanged.
NOTE: Refer to Section 10, Troubleshooting
and Diagnostics.

m2000rt Operations Manual 6-15


200680-106—October 2012
Calibration Procedures
Region of Interest (ROI) Calibration Section 6

17. Press the release to open the tray drawer.


Figure 6.13:Open the Tray Drawer

18. Remove the ROI calibration plate from the m2000rt


instrument.

19. Place the ROI calibration plate inside its packaging sleeve,
and return the repackaged plate to the ABBOTT® Optical
Calibration Kit. Be sure to write the date opened on the
packaging sleeve label.
NOTE: Do not discard the calibration plate.
If stored in its packaging sleeve at -10°C or colder,
the plate can be used for a specific time after initial
use as indicated by the calibration plate label, or
until the expiration date, whichever comes first.
Maximum number of uses is ten (10).

20. Perform Background, Uniformity, and Pure Dye


calibrations, following the steps detailed in the section for
each of these calibration types.

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200680-106—October 2012
Calibration Procedures
Section 6 Background Calibration

Background Calibration
Background calibration measures the signal level of ambient
fluorescence in the m2000rt instrument.
Fluorescence data collected by the m2000rt instrument include
a signal inherent to the system, commonly known as
“background.” Background is a composite signal found in all
optical data. It consists of signal from several sources,
including:
• background electrical signal
• contaminants in the thermal block
• fluid inside the background plate
• the plastic consumable
Because the background signal can interfere with the precision
of the data collected by the m2000rt, the instrument is
engineered to minimize the background signal, and the
m2000rt software is designed to use the calibration data to
compensate for any residual signal.
NOTE: If a Background plate from an ABBOTT®
Optical Calibration Kit is not available, a Background
plate can be prepared from an ABBOTT 96-Well Optical
Reaction Plate, following the steps detailed below in
Creating a Background Plate on page 6–28.

When to Perform Background Calibration


Perform Background calibration at these times:
• during m2000rt System installation
• as part of regular m2000rt System maintenance
• after ROI calibration
• prior to performing Uniformity or Pure Dye calibrations
• after performing thermal block cleaning or
decontamination

NOTE: To run this, or any, calibration, the instrument


must first be in the <READY> state.

m2000rt Operations Manual 6-17


200680-106—October 2012
Calibration Procedures
Background Calibration Section 6

Assemble Required Materials


Assemble the following materials necessary for performing the
calibration:
• Centrifuge with plate adapter
NOTE: Centrifuge parameters:
• Time = 1 minute
• 1200 - 1500 x g
• Background calibration plate
• Powder-free gloves
• ABBOTT Splash Free Support Base
NOTE: The Splash Free Support Base should be
cleaned after each use. For cleaning procedure,
refer to Clean the Splash Free Support Base on
page 9–35 of Section 9, Service and
Maintenance.

Getting Started
NOTE: Background calibration requires approximately
13 minutes to complete.

To perform the calibration:


• obtain the tools and materials required for installation,
listed above in Assemble Required Materials.
• follow the steps below in Conduct the Background
Plate Calibration.

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200680-106—October 2012
Calibration Procedures
Section 6 Background Calibration

Conduct the Background Plate Calibration

NOTE: Wear powder-free gloves when handling the


Background plate. Handle the plate by the edges to
prevent fluids and other contaminants from adhering
to the bottom of the plate.

1. Retrieve the ABBOTT® Optical Calibration Kit from the


freezer, and remove the prepared Background plate.
2. Return the Optical Calibration Kit to storage.
3. Allow the Background plate to warm to room temperature
(at least 5 minutes).
NOTE: Do not remove the Background plate from
its packaging until it is time to run the calibration.

4. Remove the Background plate from its packaging.


• Carefully open the Background plate packaging, but
do not discard the packaging. The plate can be used
up to ten (10) times if it is stored properly in its
original packaging sleeve.
• Be sure to write the date opened on the packaging
sleeve label.
• Visually check that the plate is thawed prior to
centrifuging.

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200680-106—October 2012
Calibration Procedures
Background Calibration Section 6

NOTE: Always keep the plate clean by


placing it in the Splash Free Support Base
when it is outside of its packaging or the
instrument. Fluids and other contaminants that
adhere to the bottom of the plate can contaminate
the sample block and cause an abnormally high
background signal.
Figure 6.14:Set Plate in Splash Free Support Base

NOTE: Do not discard the calibration plate.


If stored in its packaging sleeve at -10°C or colder,
the plate can be used for a specific time after initial
use as indicated by the calibration plate label, or
until the expiration date, whichever comes first.
Maximum number of uses is ten (10).

5. Centrifuge with Splash Free Support Base.


NOTE: Centrifuge parameters:
• Time = 1 minute
• 1200 - 1500 x g

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200680-106—October 2012
Calibration Procedures
Section 6 Background Calibration

6. Verify that the liquid in each well of the Background plate


is positioned at the bottom of the well and that no bubbles
are present. To detect bubbles, examine the plate carefully
from all angles.
If necessary, re-centrifuge the plate for a longer period of
time.
Figure 6.15:Correct Position of Liquid in Plate Well

7. From the m2000rt menu, select <System>, then <System


Calibration>.
NOTE: The instrument should be in the
<READY> state.
Figure 6.16:<System> Menu

m2000rt Operations Manual 6-21


200680-106—October 2012
Calibration Procedures
Background Calibration Section 6

8. From the <Calibration Tasks> menu, select <Run


Background>.
Figure 6.17:<Calibration Tasks> Menu

9. The <Calibrate Background: Plate Information>


screen displays. Enter the lot number and expiration date
of the Background plate. Select <Next>.
Figure 6.18:<Calibrate Background: Plate
Information>

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200680-106—October 2012
Calibration Procedures
Section 6 Background Calibration

m2000rt Operations Manual 6-23


200680-106—October 2012
Calibration Procedures
Background Calibration Section 6

10. The <Calibrate Background: Calibration Start>


screen displays.
Figure 6.19:<Calibrate Background: Calibration Start>

11. Press the release to open the tray drawer.


Figure 6.20:Open the Tray Drawer

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200680-106—October 2012
Calibration Procedures
Section 6 Background Calibration

12. Carefully load the Background plate into the plate holder
so as not to cause splashing within the wells.
NOTE: The A1 position is at the top left side of the
plate. If the plate is put into the drawer backwards,
the drawer will not close. DO NOT FORCE the
tray drawer to close.
Figure 6.21:A1 Plate Well

A1 position

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200680-106—October 2012
Calibration Procedures
Background Calibration Section 6

13. Close the tray drawer.


NOTE: When closing the tray drawer, apply
pressure, at an angle, at the circular depression in
the drawer on the right side of the tray’s front
edge.
Figure 6.22:Close the Tray Drawer

14. Select <Start> to begin the run. The <Instrument


Status> screen displays <Background> and is shown to
be <RUNNING>.
15. When the calibration process has completed, a message
displays alerting the user if the calibration has passed or
failed.
16. The <System Calibration Status> screen is updated to
reflect the new Background calibration.
17. If the Background calibration fails, an alert message
displays and these results occur:
• The instrument status changes to <STOPPED>.
• The <System Calibration Status> list is not
updated.
• If an active Background exists, its Background
calibration status remains unchanged.
NOTE: Perform the Fluorescence Contamination
Check on page 9–13 of Section 9, Service and
Maintenance, Contamination Check.
NOTE: Refer to Section 10, Troubleshooting
and Diagnostics.

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200680-106—October 2012
Calibration Procedures
Section 6 Background Calibration

18. Press the tray to open the tray drawer.


19. Remove the Background plate from the m2000rt
instrument.
20. Place the Background plate inside its packaging sleeve, and
return the repackaged plate to the ABBOTT® Optical
Calibration Kit. Be sure to write the date opened on the
packaging sleeve.
NOTE: Do not discard the calibration plate.
If stored in its packaging sleeve at -10°C or colder,
the plate can be used for a specific time after initial
use as indicated by the calibration plate label or
until the expiration date on the package,
whichever comes first. Maximum number of uses
is ten (10).

m2000rt Operations Manual 6-27


200680-106—October 2012
Calibration Procedures
Background Calibration Section 6

Creating a Background Plate


If a Background plate from the Optical Calibration Kit is not
available, a Background plate can be created by following the
procedure detailed below.
NOTE: This plate should be used for only one
Background calibration. Do not store this plate for
future use.

Materials Required
• ABBOTT® 96-well Optical Reaction Plate
• ABBOTT Optical Adhesive Cover
• ABBOTT Optical Adhesive Cover Applicator
• Pipettor, 200 μl (with pipet tips)
• Deionized water
• Powder-free gloves
• ABBOTT Splash Free Support Base

NOTE: The Splash Free Support Base should be


cleaned after each use. For cleaning procedure,
refer to Clean the Splash Free Support Base on
page 9–35 of Section 9, Service and
Maintenance.

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200680-106—October 2012
Calibration Procedures
Section 6 Background Calibration

Procedure
1. Place the optical reaction plate in the ABBOTT Splash Free
Support Base.
2. Aliquot 50 μl of deionized water to each well of the
reaction plate.
Figure 6.23:Pipette into Each Plate Well

NOTE: For detailed instructions about plate


preparation, refer to Prepare the ABBOTT® 96-Well
Optical Reaction Plate on page 5–26 of Section 5,
Operating Instructions.

m2000rt Operations Manual 6-29


200680-106—October 2012
Calibration Procedures
Background Calibration Section 6

3. Seal the plate using an ABBOTT® Optical Adhesive Cover


by doing the following:
• Grasp the Optical Adhesive Cover by its tab edge and
carefully remove it from the box.
Figure 6.24:Carefully Remove the Optical Adhesive
Cover from the Box

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200680-106—October 2012
Calibration Procedures
Section 6 Background Calibration

• Place it directly on the plate, so that the seal remains


clean.
Figure 6.25:Place the Optical Adhesive Cover on the
Plate

NOTE: If the Optical Adhesive Cover is not


correctly placed on the plate the first time, discard
it, and use a new Optical Adhesive Cover.

m2000rt Operations Manual 6-31


200680-106—October 2012
Calibration Procedures
Background Calibration Section 6

• Using the Optical Adhesive Cover Applicator,


thoroughly seal the cover to the plate.
Figure 6.26:Use the Applicator to Seal the Center of
the Cover and the Edges

NOTE: When using a manually prepared


Background plate, enter the expiration date as the
current date and all zeros “0000000” for the lot
number.

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200680-106—October 2012
Calibration Procedures
Section 6 Uniformity Calibration

Uniformity Calibration
Data collected from the Uniformity calibration are used to
compensate for the small differences in fluorescent response
across the 96 well locations.

When to Perform Uniformity Calibration


Perform Uniformity calibration at these times:
• during m2000rt System installation
• after lamp replacement
• prior to Pure Dye calibration
• as part of regular system maintenance

NOTE: To run this, or any, calibration, the instrument


must first be in the <READY> state.

Assemble Required Materials


Assemble the following materials necessary for performing the
calibration:
• Centrifuge with plate adapter
NOTE: Centrifuge parameters:
• Time = 1 minute
• 1200 - 1500 x g
• ROI calibration plate from the Optical Calibration Kit
NOTE: The ROI calibration plate is used for the
Uniformity calibration.
• Powder-free gloves
• ABBOTT Splash Free Support Base
NOTE: The Splash Free Support Base should be
cleaned after each use. For cleaning procedure,
refer to Clean the Splash Free Support Base on
page 9–35 of Section 9, Service and
Maintenance.

Getting Started
NOTE: Uniformity calibration requires approximately
8 minutes to complete.

m2000rt Operations Manual 6-33


200680-106—October 2012
Calibration Procedures
Uniformity Calibration Section 6

To perform the calibration:


• obtain the tools and materials required for installation,
listed above in Assemble Required Materials.
• begin the calibration as explained below in Conduct the
Uniformity Calibration.

Conduct the Uniformity Calibration


NOTE: Wear powder-free gloves when handling the
ROI calibration plate. Handle the plate by the edges to
prevent fluids and other contaminants from adhering
to the bottom of the plate.
NOTE: Do not remove the ROI calibration plate
from its packaging until it is time to run the
calibration. The fluorescent dye contained in the
wells of the plate is photosensitive. Prolonged exposure
to light can diminish the fluorescent signal strength of
the plate.

1. Retrieve the ABBOTT® Optical Calibration Kit from


storage, and remove the prepared ROI calibration plate.
2. Return the Optical Calibration Kit to storage.
3. Allow the ROI calibration plate to warm to room
temperature (at least 5 minutes).

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200680-106—October 2012
Calibration Procedures
Section 6 Uniformity Calibration

4. Remove the ROI calibration plate from its packaging.


NOTE: Do not discard the calibration plate.
If stored in its packaging sleeve at -10°C or colder,
the plate can be used for up to six months after
initial use or until the expiration date, whichever
comes first. Maximum number of uses is ten (10).
• Carefully remove the ROI calibration plate from its
package, but do not discard the packaging. The plate
can be used up to ten (10) times if it is stored in the
freezer in its original packaging sleeve.
• Be sure to write the date opened on the packaging
sleeve label.
• Visually check that the plate is thawed prior to
centrifuging.

NOTE: Always keep the plate clean by


placing it in its Splash Free Support Base
when it is outside of its packaging or the
instrument. Fluids and other contaminants that
adhere to the bottom of the plate can contaminate
the sample block and cause an abnormally high
background signal.
Figure 6.27:Set Plate in Splash Free Support Base

m2000rt Operations Manual 6-35


200680-106—October 2012
Calibration Procedures
Uniformity Calibration Section 6

5. Centrifuge with Splash Free Support Base.


NOTE: Centrifuge parameters:
• Time = 1 minute
• 1200 - 1500 x g

6. From the m2000rt menu, select <System>, then <System


Calibration>.
7. Verify that the ROI calibration dye in each well of the ROI
plate is positioned at the bottom of the well and that no
bubbles are present. To detect bubbles, carefully examine
the plate from all angles.
If necessary, re-centrifuge the plate for a longer period of
time.
Figure 6.28:Correct Position of Dye in Plate Well

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200680-106—October 2012
Calibration Procedures
Section 6 Uniformity Calibration

8. From the <Calibration Tasks> menu, select <Run


Uniformity>.
NOTE: The instrument should be in the
<READY> state.
Figure 6.29:<Calibration Tasks> Menu

The <Calibrate Uniformity: Plate Information>


screen displays.
Figure 6.30:<Calibrate Uniformity: Plate Information>
Display

9. Enter the lot number and expiration date of the ROI


calibration plate. Select <Next>.

m2000rt Operations Manual 6-37


200680-106—October 2012
Calibration Procedures
Uniformity Calibration Section 6

10. The <Calibrate Uniformity: Calibration Start>


screen displays.
Figure 6.31:<Calibrate Uniformity: Calibration Start>

11. Press the release to open the tray drawer.


Figure 6.32:Open the Tray Drawer

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200680-106—October 2012
Calibration Procedures
Section 6 Uniformity Calibration

12. Carefully load the ROI calibration plate into the plate
holder so as not to cause splashing within the wells.
NOTE: The A1 position is at the top left side of the
plate. If the plate is put into the drawer backwards,
the drawer will not close. DO NOT FORCE the
tray drawer to close.
Figure 6.33:A1 Plate Well

A1 position

13. Close the tray drawer.


NOTE: When closing the tray drawer, apply
pressure, at an angle, at the circular depression in
the drawer on the right side of the tray’s front
edge.
Figure 6.34:Close the Tray Drawer

m2000rt Operations Manual 6-39


200680-106—October 2012
Calibration Procedures
Uniformity Calibration Section 6

14. Select <Start> to begin the run. The <Instrument


Status> screen displays <Uniformity> and is shown to
be <RUNNING>.
15. When the calibration process has completed, a message
displays alerting the user if the calibration has passed or
failed.
16. The <System Calibration Status> screen is updated to
reflect the new Uniformity Calibration.
17. If the Uniformity calibration fails, an alert message
displays and these results occur:
• The instrument status changes to <STOPPED>.
• The <System Calibration Status> list is not
updated.
• If an active Uniformity calibration exists, its
Uniformity calibration status remains unchanged.
NOTE: Refer to Section 10, Troubleshooting
and Diagnostics.
18. Remove the ROI calibration plate from the m2000rt
instrument.
19. Place the ROI calibration plate inside its packaging sleeve,
and return the repackaged plate to the ABBOTT® Optical
Calibration Kit.
NOTE: Do not discard the ROI calibration plate. If
stored in its packaging sleeve at -10°C or colder,
the plate can be used for a specific time after initial
use as indicated by the calibration plate label or
until the expiration date on the package,
whichever comes first. Maximum number of uses
is ten (10).

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200680-106—October 2012
Calibration Procedures
Section 6 Pure Dye Calibration

Pure Dye Calibration


Before operating the m2000rt instrument, generate pure
spectra data by performing a Pure Dye calibration.
A Pure Dye calibration consists of a run during which the
m2000rt software collects optical data from a Pure Dye plate.
The m2000rt instrument uses the data obtained from the Pure
Dye calibration to distinguish the individual contribution of
each dye in the collective fluorescence gathered by the
instrument during a run.
The following Pure Dyes can be calibrated on the m2000rt
instrument:
• FAM™ • ROX™ • SYBR® Green
• JOE™ • TAMRA™ • Cy™5
• NED™ • VIC®

In addition, up to five user-defined dyes can be calibrated for


laboratory-defined applications. Refer to Section 3,
Calibration Procedures, of the m2000rt
Laboratory-Defined Applications Guide. Contact your
Abbott representative for more information on
laboratory-defined functionality.

NOTE: After recalibration of the Optical Pure Dye, an


assay recalibration might be necessary. Refer to the
assay-specific package insert for further instructions.

m2000rt Operations Manual 6-41


200680-106—October 2012
Calibration Procedures
Pure Dye Calibration Section 6

When to Perform Pure Dye Calibration


Perform Pure Dye calibration at these times:
• during m2000rt system installation
• after lamp replacement
• when a new assay is installed requiring a new dye
• after Uniformity calibration
• as part of regular system maintenance

NOTE: ROI, Background, and Uniformity calibrations


must be performed successfully before running Pure
Dye calibrations.
NOTE: Background calibration should be performed
prior to, and on the same day as, a Pure Dye calibration.

NOTE: To run this, or any, calibration, the instrument


must first be in the <READY> state.

Assemble Required Materials


Assemble the following materials necessary for performing the
calibration:
• Centrifuge with plate adapter
NOTE: Centrifuge parameters:
• Time = 1 minute
• 1200 - 1500 x g
• Pure Dye plates from the ABBOTT® Optical Calibration Kit
• Powder-free gloves
• ABBOTT Splash Free Support Base
NOTE: The Splash Free Support Base should be
cleaned after each use. For cleaning procedure,
refer to Clean the Splash Free Support Base on
page 9–35 of Section 9, Service and
Maintenance.

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200680-106—October 2012
Calibration Procedures
Section 6 Pure Dye Calibration

Getting Started
NOTE: Pure Dye calibration requires approximately 9
minutes per dye to complete.
To perform the calibration:
• obtain the tools and materials required for installation,
listed above in Assemble Required Materials.
• begin the calibration, as explained below in Conduct the
Pure Dye Calibration.

Conduct the Pure Dye Calibration


NOTE: Wear powder-free gloves when handling Pure
Dye plates. Handle the plate by the edges to prevent
fluid and other contaminants from adhering to the
bottom of the plate.

1. Retrieve the ABBOTT® Optical Calibration Kit from


storage, and remove the Pure Dye calibration plates to be
calibrated.
NOTE: Do not remove the Pure Dye plates
from their packaging until it is time to run
the calibration. The fluorescent dye contained
in the wells of the plates is photosensitive.
Prolonged exposure to light can diminish the
fluorescent signal strength of the plates.
2. Return the Optical Calibration Kit to storage.
3. Allow the Pure Dye calibration plates to thaw to room
temperature (at least 5 minutes).
4. Remove the Pure Dye plate from its packaging.
• Carefully open the Pure Dye plate packaging, but do
not discard the packaging. The plate can be used up to
ten (10) times if it is stored properly in its original
packaging sleeve.
• Be sure to write the date opened on the packaging
sleeve label.
• Visually check that the plate is thawed prior to
centrifuging.

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200680-106—October 2012
Calibration Procedures
Pure Dye Calibration Section 6

NOTE: Always keep each plate clean by


placing it in a Splash Free Support Base
when it is outside of its packaging or the
instrument. Fluids and other contaminants that
adhere to the bottom of the plate can contaminate
the sample block and cause an abnormally high
background signal.
Figure 6.35:Set Plate in Splash Free Support Base

NOTE: Do not discard the calibration plate.


If stored in its packaging sleeve at -10°C or colder,
the plate can be used for a specific time after initial
use as indicated by the calibration plate label or
until the expiration date, whichever comes first.
Maximum number of uses is ten (10).

5. Centrifuge with Splash Free Support Base.


NOTE: Centrifuge parameters:
• Time = 1 minute
• 1200 - 1500 x g

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200680-106—October 2012
Calibration Procedures
Section 6 Pure Dye Calibration

6. Verify that the Pure Dye in each well of the Pure Dye plate
is positioned at the bottom of the well and that no bubbles
are present. To detect bubbles, carefully examine the plate
from all angles. If necessary, re-centrifuge the plate for a
longer period of time.
Figure 6.36:Correct Position of Pure Dye in Plate Well

7. From the m2000rt menu, select <System>, and then


<System Calibration>.
NOTE: The instrument should be in the
<READY> state.

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200680-106—October 2012
Calibration Procedures
Pure Dye Calibration Section 6

8. From the <Calibration Tasks> menu, select <Run


Pure Dye>. The <Calibrate Pure Dye: Dye
Information> screen displays.
Figure 6.37:<Calibration Tasks> Menu

9. From the dropdown menu, select the pure dye to be


calibrated. Enter the lot number and expiration date of the
Pure Dye plate.
Figure 6.38:Select the Pure Dye

Dropdown

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200680-106—October 2012
Calibration Procedures
Section 6 Pure Dye Calibration

The <Calibrate Pure Dye: Calibration Start> screen


displays.
Figure 6.39:<Calibrate Pure Dye: Calibration Start>
Display

10. Press the release to open the tray drawer.


Figure 6.40:Open the Tray Drawer

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200680-106—October 2012
Calibration Procedures
Pure Dye Calibration Section 6

11. Carefully load the Pure Dye plate into the plate holder so
as not to cause splashing within the wells.
NOTE: The A1 position is at the top left side of the
plate. If the plate is put into the drawer backwards,
the drawer will not close. DO NOT FORCE the
tray drawer to close.
Figure 6.41:A1 Well Position

A1 position

12. Close the tray drawer.


NOTE: When closing the tray drawer, apply
pressure, at an angle, at the circular depression in
the drawer on the right side of the tray’s front
edge.
Figure 6.42:Close the Tray Drawer

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200680-106—October 2012
Calibration Procedures
Section 6 Pure Dye Calibration

13. Select <Start> to begin the run. The <Instrument


Status> screen displays <Pure Dye> and is shown to be
<RUNNING>.
14. When the calibration process has completed, a message
displays alerting the user if the calibration has passed or
failed.
15. The <System Calibration Status> screen is updated to
reflect the new Pure Dye plate calibration.
16. If the Pure Dye plate calibration fails, an alert message
displays and these results occur:
• The instrument status changes to <STOPPED>.
• The <System Calibration Status> list is not
updated.
• If an active Pure Dye calibration exists, its calibration
remains unchanged.
NOTE: Refer to Section 10, Troubleshooting
and Diagnostics.
17. Press the tray to open the tray drawer.
18. Remove the Pure Dye plate from the m2000rt instrument.
19. Place the Pure Dye plate inside its packaging sleeve, and
return the repackaged plate to the ABBOTT® Optical
Calibration Kit.
NOTE: Do not discard the Pure Dye
calibration plate. If stored in its packaging
sleeve at -10°C or colder, the plate can be used for
a specific time after initial use as indicated by the
calibration plate label or until the expiration date,
whichever comes first. Maximum number of uses
is ten (10).
20. Repeat the steps above for the other Pure Dye plates that
need to be calibrated.

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200680-106—October 2012
Calibration Procedures
Pure Dye Calibration Section 6

NOTES

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200680-106—October 2012
Section 7

Section 7: Operational Precautions and Limitations

Operational Precautions and


Limitations

Section 7 Table of Contents


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Short-Term Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Long-Term Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Assemble Required Materials . . . . . . . . . . . . . . . . . . . . . 7-6
Prepare the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Packing and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Disposal of Packing Material . . . . . . . . . . . . . . . . . . . . 7-12
European Electronic Equipment/Battery Disposal
Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Disposal of Operating Material . . . . . . . . . . . . . . . . . . . 7-13
Disposal of the Instrument . . . . . . . . . . . . . . . . . . . . . . 7-14
Points of Disposal, Authorities . . . . . . . . . . . . . . . . . . . 7-14

m2000rt Operations Manual Table of Contents-1


200680-106—October 2012
Operational Precautions and Limitations Section 7

NOTES

Table of Contents-2 m2000rt Operations Manual


200680-106—October 2012
Section 7 Operational Precautions and Limitations

Section 7: Operational Precautions and Limitations

Operational Precautions and


Limitations

Overview
This section explains how to shut down the m2000rt, how to
pack it for storage or transport, and how to store and ship it.
The section also explains how to prepare the m2000rt and how
to separate it into different material groups for proper and
lawful disposal.
The following topics are included:
• Short-Term Shutdown on page 7–3
Provides instruction for a short-term shutdown.
• Long-Term Shutdown on page 7–7
Provides instruction for a long-term shutdown.
• Packing and Transport on page 7–12
Provides packing requirements for the system.
• Storage on page 7–13
Provides storage requirements for the instrument.
• Disposal on page 7–14
Provides guidelines for disposal of packing, operating,
and instrument material.

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200680-106—October 2012
Operational Precautions and Limitations
Overview Section 7

NOTES

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200680-106—October 2012
Operational Precautions and Limitations
Section 7 Short-Term Shutdown

Short-Term Shutdown
If the instrument will be used within seven days, perform the
short-term shutdown procedure.
NOTE: Refer to Maintenance on page 9–3 of Section
9, Service and Maintenance, before performing
Short-Term Shutdown.

1. Open the tray drawer.


NOTE: It is important to distinguish between the
On/Off switch, and the control for opening the
m2000rt’s tray drawer, which is located adjacent to the
On/Off switch.
Figure 7.1: Open the Tray Drawer

Power switch

Tray drawer control

2. If the tray drawer contains a plate, remove it.


Figure 7.2: Remove the Plate

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200680-106—October 2012
Operational Precautions and Limitations
Short-Term Shutdown Section 7

3. Close the tray drawer.


NOTE: When closing the tray drawer, apply
pressure, at an angle, at the circular depression in
the drawer on the right side of the tray’s front
edge.
Figure 7.3: Close the Tray Drawer

4. Power OFF the instrument.


Figure 7.4: Power Switch and Tray Drawer Control

Power switch

Tray drawer control

NOTE: It is important to distinguish between the


On/Off switch, and the control for opening the
m2000rt’s tray drawer, which is located adjacent to
the On/Off switch.

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200680-106—October 2012
Operational Precautions and Limitations
Section 7 Short-Term Shutdown

5. Shut down the system control center (SCC) computer and


power off the monitor by doing the following.
a. From <Overview>, select <System Shutdown>.
Figure 7.5: <Overview> Menu; <System Shutdown>
Option

b. A message displays, asking the operator to confirm the


intention to shutdown. Select <Yes>.
Figure 7.6: Select <Yes> to Exit the Application

Select <Yes>
to exit the
application

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200680-106—October 2012
Operational Precautions and Limitations
Short-Term Shutdown Section 7

c. Power OFF the monitor.


Figure 7.7: Shut Down the SCC

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200680-106—October 2012
Operational Precautions and Limitations
Section 7 Long-Term Shutdown

Long-Term Shutdown
Prior to long-term shutdown, thoroughly decontaminate all
relevant parts. Refer to Maintenance on page 9–3 of Section 9,
Service and Maintenance, for decontamination
instructions and precautionary measures to take while
performing decontamination activities. Contact the local
Abbott Representative for more information.
To take the instrument out of service for storage or shipping
(i.e., if the instrument is shut down for more than 7 days)
proceed as follows.

Assemble Required Materials


• Shipping plate
• Packaging

Prepare the Instrument


1. Open the tray drawer.
NOTE: It is important to distinguish between the
On/Off switch, and the control for opening the
m2000rt’s tray drawer, which is located adjacent to
the On/Off switch.
Figure 7.8: Open the Tray Drawer

Tray drawer control

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200680-106—October 2012
Operational Precautions and Limitations
Long-Term Shutdown Section 7

2. If the tray contains a plate, remove it.


Figure 7.9: Remove the Plate

3. Load the shipping plate into the tray.


NOTE: The shipping plate protects the m2000rt
optics block by supporting it during storage. If the
shipping plate is not available, it is important to
substitute an unused reaction plate to provide the
necessary support.
Figure 7.10:Load the Shipping Plate

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200680-106—October 2012
Operational Precautions and Limitations
Section 7 Long-Term Shutdown

4. Close the tray drawer.


NOTE: When closing the tray drawer, apply
pressure, at an angle, at the circular depression in
the drawer on the right side of the tray’s front
edge.
Figure 7.11:Close the Tray Drawer

5. Power OFF the m2000rt.


Figure 7.12:Shut Down the m2000rt

Power switch

Tray drawer control

6. Shut down the SCC computer and monitor by doing the


following:

m2000rt Operations Manual 7-9


200680-106—October 2012
Operational Precautions and Limitations
Long-Term Shutdown Section 7

a. From <Overview>, select <System Shutdown>.


Figure 7.13:<Overview> Menu; <System Shutdown>
Option

b. Select <Yes>.
Figure 7.14:Message: Confirm Exit Intention

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200680-106—October 2012
Operational Precautions and Limitations
Section 7 Long-Term Shutdown

c. Power OFF the monitor.


Figure 7.15:Shut Down the SCC

m2000rt Operations Manual 7-11


200680-106—October 2012
Operational Precautions and Limitations
Packing and Transport Section 7

Packing and Transport


General
The instrument must be decontaminated prior to packaging.
Refer to Maintenance on page 9–3 of Section 9, Service and
Maintenance.
Always keep the instrument in its original packaging. Do not
stack other goods on the cardboard box of the m2000rt.

!! IMPORTANT: Only an Abbott Representative may


move the m2000rt. Contact the Abbott Customer
Support for assistance.

For Shipping
The m2000rt must be prepared and packed for shipping by an
Abbott Representative.

!! IMPORTANT: All Abbott Laboratories guarantees are


void if the instrument is not correctly packed by an
Abbott Representative for shipping. Contact the Abbott
Customer Support for assistance.

Transport
The Abbott Representative determines the transport method
depending on the shipping distance and other criteria.

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200680-106—October 2012
Operational Precautions and Limitations
Section 7 Storage

Storage
Proper Storage
Follow the instructions below to ensure that the instrument is
not damaged during storage:
NOTE: To prevent damage due to oxidation, all parts
must be dry before storage.

1. Protect the m2000rt against dust and humidity with a


plastic cover.
2. Store the instrument in its original packaging.
3. Keep and store the following documents together with the
instrument:
• All manuals
• A completed decontamination form (available from
the Abbott Representative)

Storage Conditions
The environmental conditions for storage are listed in
Environmental Conditions on page 4–6 in Section 4,
Performance Characteristics and Specifications.

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200680-106—October 2012
Operational Precautions and Limitations
Disposal Section 7

Disposal
Responsibility
According to EC Directive 2008/98/EC, the owner is
responsible for proper disposal of the instrument in keeping
with the relevant regulations.
Outside the European Union, comparable statutory
regulations are binding.
The owner must provide the instrument or its parts to either a
licensed private or public disposal company, or recycle the
instrument, or dispose of it in accordance with the pertinent
regulations.

Disposal of Packing Material


The packaging consists of wood, cardboard and polyethylene
film. This material can be disposed of or recycled, in
accordance with local, state, or federal requirements.

European Electronic Equipment/Battery Disposal Directives

Figure 7.16:EU Symbol warning against disposal of


electrical equipment

Waste Electrical and Electronic Equipment


The European Commission has released the Directive on
Waste Electrical and Electronic Equipment (WEEE;
2002/96/EC). Since August 2005, producers have been
responsible for taking back and recycling electrical and
electronic equipment.

Batteries
The European Battery Directive requires separate collection of
spent batteries, aiming to facilitate recycling and to protect the
environment.

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200680-106—October 2012
Operational Precautions and Limitations
Section 7 Disposal

This device contains batteries that are not intended to be


serviced or removed by the user. The batteries in this product
should be removed at the end of the life of the device by an
Abbott Service Technician or a qualified individual, and
disposed in accordance with local regulations for separate
collection of spend batteries. Your local Abbott product
support office may be contacted for additional information.

Disposal of Operating Material


It is the responsibility of each facility to characterize its waste
stream to ensure the waste is disposed of in accordance with
applicable waste regulations. Decontaminate and dispose of all
specimens, reagents, reaction plates and other potentially
contaminated materials in accordance with local, state and
federal regulations.
All used and contaminated materials should be handled and
disposed of in a manner that minimizes the chance of
potential RNA/DNA contamination of the work area.
NOTE: Autoclaving the sealed Reaction Plate will not
degrade the amplified product and may contribute to
the release of the amplified product by opening the
sealed plate. The laboratory area can become
contaminated with amplified product if the waste
materials are not carefully handled and contained.
NOTE: Be sure to place used PCR plates in a sealed
plastic bag before disposal.

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200680-106—October 2012
Operational Precautions and Limitations
Disposal Section 7

Disposal of the Instrument


Decontaminate the instrument prior to disposal. Refer to
Maintenance on page 9–3 of Section 9, Service and
Maintenance.

Material groups
The m2000rt should be taken apart and separated into
appropriate material groups. It mainly comprises the following
material groups:
• Light metals (aluminum, magnesium and their alloys)
• Ferrous materials (gray cast iron, steel)
• Copper materials (brass parts, spools)
• Zinc alloys (zinc die-cast parts)
• Different plastics
• PVC cable insulation, tubes
• Electric components (e.g., motors, relays, terminals etc.)
• Electronic circuits
When the m2000rt is separated into these material groups the
parts can be supplied to the respective collecting points.

Points of Disposal, Authorities

Where to Dispose of Waste


Inquire about the appropriate collecting points in your
country, state, or region.
Dispose of the parts of the m2000rt in accordance with local,
state, and federal regulations.

Return of Instrument
Contact your local Abbott Representative for information
concerning return or disposal of the m2000rt.

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200680-106—October 2012
Section 8

Section 8: Hazards

Hazards

Section 8 Table of Contents


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Operator Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Emergency Shutdown Procedure . . . . . . . . . . . . . . . . . . . . . 8-4
Safety Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Biological Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Spill Cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Waste Handling and Disposal . . . . . . . . . . . . . . . . . . . . . . 8-12
Decontamination Procedure Requirements . . . . . . . . . . . . 8-13
Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
Physical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17

m2000rt Operations Manual Table of Contents-1


200680-106—October 2012
Hazards Section 8

NOTES

Table of Contents-2 m2000rt Operations Manual


200680-106—October 2012
Hazards
Section 8 Overview

Section 8: Hazards

Hazards

Overview
This section describes the types and locations of potential
hazards that could cause physical harm to an operator or
damage to the laboratory environment, or where failure to
follow instructions may result in instrument failure or
generation of erroneous patient results.

Safety topics and hazards discussed in this section include:


• Operator Responsibility on page 8–3
Provides guidance on using the m2000rt instrument as
designed.
• Emergency Shutdown Procedure on page 8–4
Provides instructions on the proper shutdown procedure
for the m2000rt instrument.
• Safety Icons on page 8–6
Provides an illustration of each safety symbol and sample
text associated with each symbol.
• Biological Hazards on page 8–8
Provides an overview of the biological hazards the
operator may be exposed to, and the precautions the
operator should take to minimize exposure.
• Chemical Hazards on page 8–10
Provides an overview of the chemical hazards the
operator may be exposed to, and the precautions the
operator should take to minimize exposure.
• Spill Cleanup on page 8–11
Provides guidelines for cleaning spills in accordance with
established biosafety practices.
• Waste Handling and Disposal on page 8–12
Identifies the responsibilities for appropriate waste
disposal.

m2000rt Operations Manual 8-1


200680-106—October 2012
Hazards
Overview Section 8

• Decontamination Procedure Requirements on page 8–13


Provides a link to information on decontaminating an
m2000rt instrument.
• Electrical Hazards on page 8–14
Provides an overview of precautions the operator should
take to avoid personal injury or damage to the system
from the electrical components.
• Mechanical Hazards on page 8–15
Provides an overview of the precautions the operator
should take to avoid personal injury or damage to the
system from the mechanical components.
• Physical Hazards on page 8–17
Provides an overview of the precautions the operator
should take to avoid physical injury when operating or
moving the system.

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200680-106—October 2012
Section 8 Hazards

Operator Responsibility
Operators of the ABBOTT® m2000rt instrument are responsible
for using the instrument only as designed. Operators must be
trained before being allowed to operate the m2000rt
instrument. Failure to follow safe use instructions could cause
• injury to the operator
• damage to the system
• adverse effect on assay results

NOTE: Refer to Section 7, Operational Precautions


and Limitations, for information about actions or
conditions that could impact the m2000rt instrument
or assay performance.

m2000rt Operations Manual 8-3


200680-106—October 2012
Hazards
Emergency Shutdown Procedure Section 8

Emergency Shutdown Procedure


In the event of an emergency, immediately power OFF the
m2000rt instrument.

m2000rt Instrument
1. Power OFF the m2000rt instrument by pressing the power
switch at the lower right front of the instrument.
Figure 8.1: m2000rt Power Switch

Power switch

NOTE: Be sure to distinguish between the power


switch and the adjacent button for opening the
tray drawer.

2. Disconnect the main power cord at its receptacle.

8-4 m2000rt Operations Manual


200680-106—October 2012
Section 8 Hazards

m2000rt System Control Center (SCC)


1. Power OFF the m2000rt SCC by pressing the power switch.
Figure 8.2: SCC Power Switch

NOTE: Powering OFF the instrument or the SCC


could cause a loss of sample information currently
in progress.

2. Disconnect the main power cord at its receptacle.

m2000rt Operations Manual 8-5


200680-106—October 2012
Hazards
Safety Icons Section 8

Safety Icons
Safety icons in the manual and on the m2000rt instrument
identify potentially dangerous conditions. Operators must
recognize the icons and understand the type and degree of the
potential hazard.

Safety Icons and Descriptions


Table 8.1: Safety Icons and Descriptions
Icon Description
Biological Risks
Identifies an activity or area where
operators may be exposed to potentially
infectious material. For more
information, see Biological Hazards on
page 8–8.
Caution, risk of electric shock
Indicates the possibility of electrical
shock if procedural or engineering
controls are not observed. For more
information, see Electrical Hazards on
page 8–14.
Caution, hot surface
Identifies an activity or area where the
operator may be exposed to hot
surfaces. For more information, see
Physical Hazards on page 8–17.

Caution
Identifies an activity that may present a
! safety-related hazard, and advises the
operator to consult caution or warning
instructions.

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200680-106—October 2012
Hazards
Section 8 Safety Icons

Figure 8.3: Caution Labels, Heated Cover

Label: Caution,
hot surface
Label: Caution

Label: Biological Risks

Figure 8.4: Caution Labels, Halogen Lamp

Label: Caution

Label: Caution,
hot surface

m2000rt Operations Manual 8-7


200680-106—October 2012
Hazards
Biological Hazards Section 8

Biological Hazards
When performing the following activities, the operator may be
exposed to potentially infectious materials:
• handling samples, reagents, calibrators, and controls
• cleaning spills
• handling and disposing of waste
• moving the system
• performing maintenance procedures
• performing a run
• performing cleaning/decontamination procedures
• performing component replacement procedures
The following information is presented to help minimize the
impact of this exposure.

Precautions
Consider all clinical specimens, reagents, controls, calibrators,
and used PCR plates that contain human-sourced material and
instrument surfaces of components that have come into
contact with human-sourced material or other potentially
infectious materials as potentially infectious.
No known test method can offer complete assurance that
products derived from human-sourced material or instrument
component contaminated with these materials will not
transmit infection. Therefore, all products derived from
human-sourced materials and contaminated instruments
should be considered potentially infectious.
It is recommended that all potentially infectious materials be
handled in accordance with the OSHA Standard on
Bloodborne Pathogens.1 Biosafety Level 22 or other
appropriate biosafety practices3,4 should be used for materials
that contain, or are suspected of containing, infectious agents.
Precautions include, but are not limited to, the following:
• Wear powder-free gloves, lab coats, and protective
eyewear when handling human-sourced material or
contaminated instrument components.
• Do not pipet by mouth.

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200680-106—October 2012
Hazards
Section 8 Biological Hazards

• Do not eat, drink, smoke, apply cosmetics, or handle


contact lenses when handling human-sourced material or
contaminated instrument components.
• Clean spills of potentially infectious materials and
contaminated instrument components with a detergent
followed by an appropriate disinfectant, such as 1%
sodium hypochlorite solution or other suitable
disinfectant.
Operators exposed to biohazardous or potentially infectious
materials should seek medical attention immediately and take
the following steps to cleanse the affected area:

Table 8.2: First Aid Following Exposure


Eyes Rinse with water for 15 minutes
Mouth Rinse with water
Skin Wash the affected area with soap and
water
Puncture wound • Allow wound to bleed freely
• Wash the affected area with soap and
water

References
1. US Department of Labor, Occupational Safety and Health
Administration, 29 CFR Part 1910.1030, Occupational Exposure to
Bloodborne Pathogens.
2. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories, Fourth Edition. Washington,
D.C.: US Government Printing Office, May 1999.
3. World Health Organization. Laboratory Biosafety Manual. Geneva:
World Health Organization, 2004.
4. National Committee for Clinical Laboratory Standards. Protection of
Laboratory Workers from Occupationally Acquired Infections: Approved
Guideline -- Second Edition. NCCLS Document M29-A2. Wayne, PA:
NCCLS, 2001.

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200680-106—October 2012
Hazards
Chemical Hazards Section 8

Chemical Hazards
Operators may be exposed to hazardous chemicals when
handling reagents, calibrators, controls, or liquid
consumables. Operator exposure to hazardous chemicals is
minimized by following instructions provided in the assay
package inserts and Material Safety Data Sheets (MSDS).
Exposure levels are further reduced by the design features of
the instrument when it is used properly.

Precautions
In general, observe the following precautions when handling
chemicals:
• Consult MSDS for safe use instructions and precautions.
• Avoid contact with skin and eyes. If contact with material
is anticipated, wear impervious gloves and protective eye
wear and clothing.
• Always maintain good housekeeping. Do not eat, drink, or
store food and beverages in areas where chemicals are
used.
• If irritation or signs of toxicity occur after exposure, seek
medical attention.

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200680-106—October 2012
Hazards
Section 8 Spill Cleanup

Spill Cleanup
Clean spills in accordance with established biosafety practices
and follow instructions provided in the MSDS. In general, safe
work practices for cleaning spills include:
1. Wear appropriate personal protective equipment, such as
gloves, eyewear, and lab coats.
2. Absorb the spill with absorbent material.
3. Wipe the spill area with detergent solution.
4. Wipe the area with an appropriate disinfectant such as
1% sodium hypochlorite solution.

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Hazards
Waste Handling and Disposal Section 8

Waste Handling and Disposal


It is the responsibility of each facility to characterize its waste
stream to ensure the waste is disposed of in accordance with
applicable waste regulations. Decontaminate and dispose of all
specimens, reagents, reaction plates and other potentially
contaminated materials in accordance with local, state and
federal regulations.
All used and contaminated materials should be handled and
disposed of in a manner that minimizes the chance of
potential RNA/DNA contamination of the work area.

NOTE: Autoclaving the sealed Reaction Plate will not


degrade the amplified product and may contribute to
the release of the amplified product by opening the
sealed plate. The laboratory area can become
contaminated with amplified product if the waste
materials are not carefully handled and contained.

NOTE: Be sure to place used PCR plates in a sealed


plastic bag before disposal.

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Hazards
Section 8 Decontamination Procedure Requirements

Decontamination Procedure Requirements


Always wear appropriate personal protective equipment such
as gloves, eyewear, and lab coat while performing the
decontamination activities necessary prior to servicing or
transporting the instrument.
Refer to Maintenance on page 9–3 of Section 9, Service and
Maintenance, for instructions and requirements.

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Hazards
Electrical Hazards Section 8

Electrical Hazards
The m2000rt instrument does not pose uncommon electrical
hazards to operations if it is installed correctly and connected
to a power source that meets required specifications.
For details, refer to Supply, Interfaces, Connections on page
4–4 of Section 4, Performance Characteristics and
Specifications.
Basic electrical hazard awareness is essential to the safe
operation of any system. It is recommended that a ground
fault circuit interrupter be used when working in a wet
environment. Only qualified personnel should perform
electrical servicing. Elements of electrical safety include, but
are not limited to, the following:
• Periodically inspect electrical cabling for signs of wear and
damage.
• Turn the m2000rt instrument OFF before disconnecting
the power cord, and before servicing any electrical or
internal components.
• Keep liquids away from all connectors of electrical or
communication components. Unplug the instrument
before cleaning up major liquid spills.
• Before touching any switches or outlets, make sure hands
are dry.
• Keep the surface where the m2000rt instrument stands dry
and clean, both under and around the instrument.
• To protect against electrical shock, use only approved
power cords and electrical accessories, such as those
supplied with the m2000rt instrument.
• Connect power cords only to correctly grounded outlets.

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Hazards
Section 8 Mechanical Hazards

Mechanical Hazards
The m2000rt instrument is an automated system that operates
under computer control. As with most automated equipment,
there is potential for injury and bodily harm from moving
mechanical components whenever the instrument is
operating. The m2000rt instrument minimizes mechanical
hazards by providing a door to protect against accidental
contact with moving components.
It is never acceptable to reach into the instrument’s working
area when the instrument is operating. If operator
intervention is necessary during a run, the run should be
stopped by selecting <Stop> from the <Instrument Tasks>
menu.
Figure 8.5: Instrument Tasks Menu

Operators of the m2000rt instrument are potentially exposed


to the following moving mechanical component:
• Thermal block
Injury may result from instrument malfunction, or from an
unexpected sequence of movements of the mechanical
components. Basic elements of mechanical equipment safety
include, but are not limited to, the following:
• Never bypass or override a safety device.
• Never operate the m2000rt instrument without protective
covers in place.
• Never use the surfaces of the m2000rt instrument as work
areas for setting objects, or for performing manual tasks.
• Do not wear clothing or accessories that could get caught
on the m2000rt instrument.
• Keep pockets empty of items that could fall into the
m2000rt instrument.

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Hazards
Mechanical Hazards Section 8

• Do not perform maintenance, cleaning, adjustments, or


repair on the m2000rt instrument, without specific
training.
• Use caution when loading PCR plates into, or removing
from, the m2000rt instrument.

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200680-106—October 2012
Hazards
Section 8 Physical Hazards

Physical Hazards
To avoid potential injury, observe safe practices while working
with the following physical hazards.

Heavy Objects
The m2000rt instrument is heavy. Obtain adequate help before
attempting to move the system.

Hot Objects
The thermal block and the halogen lamp within the m2000rt
instrument may be hot. Allow surfaces to cool before touching
and handling. Use temperature-resistant gloves when
necessary.

Trip Hazard
The m2000rt instrument is equipped with a power cord and
computer connectors. To avoid a tripping hazard, ensure that
cords and other trip hazards in high foot-traffic areas are
properly stored.

Pinch Hazard
Take care to avoid pinching hands or fingers when placing the
plate in the tray or pushing the tray door closed.

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Hazards
Physical Hazards Section 8

NOTES

8-18 m2000rt Operations Manual


200680-106—October 2012
Section 9

Section 9:

Service and Maintenance

Section 9 Table of Contents


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Monthly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Biannual Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
As-Needed Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Maintenance Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Instrument Decontamination . . . . . . . . . . . . . . . . . . . . . . 9-11
Decontamination Form . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Fluorescence Contamination Check . . . . . . . . . . . . . . . . . 9-13
Clean the Thermal Block . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
Prior to Cleaning the Thermal Block . . . . . . . . . . . . . . 9-20
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
Decontaminate the Thermal Block . . . . . . . . . . . . . . . . . . 9-25
Assemble Required Materials . . . . . . . . . . . . . . . . . . . . 9-25
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-26
Clean the Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32
Clean the Plate Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-33
Clean the Splash Free Support Base . . . . . . . . . . . . . . . . . . 9-35
Amplicon (Nucleic Acid) Decontamination . . . . . . . . . . . . 9-36
Assemble Required Materials . . . . . . . . . . . . . . . . . . . . 9-37
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-37
Replace the Halogen Lamp . . . . . . . . . . . . . . . . . . . . . . . . . 9-39
Determine Lamp Status . . . . . . . . . . . . . . . . . . . . . . . . 9-39
Replace Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-41
Lamp Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-46
Database Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-49
<Backup> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51
<Restore> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-54

m2000rt Operations Manual Table of Contents-1


200680-106—October 2012
Section 9

NOTES

Table of Contents-2 m2000rt Operations Manual


200680-106—October 2012
Section 9 Service and Maintenance

Section 9: Service and Maintenance

Service and Maintenance

Overview
Proper service and maintenance of the ABBOTT® m2000rt
System is one of the most important aspects of a complete
quality assurance program. A thorough service and
maintenance program:
• minimizes downtime
• maintains records for inspection and accreditation
• maintains optimal system operation to provide optimal
test results

Service and maintenance topics include:


• Maintenance on page 9–3
Provides a description of all maintenance procedures, the
software screens and windows associated with
maintenance activities, associated graphics for some
maintenance procedures, and step-by-step instructions
for performing related procedures.
• Instrument Decontamination on page 9–11
Provides a general description of decontamination
procedures.
• Fluorescence Contamination Check on page 9–13
Explains the procedure for checking which wells require
cleaning after a Background calibration failure, and
provides active feedback when cleaning.
• Clean the Thermal Block on page 9–20
Explains how to clean the thermal block.
• Decontaminate the Thermal Block on page 9–25
Explains how to eliminate contaminants from the
thermal block.
• Clean the Plate on page 9–32
Explains how to eliminate contaminants from the plate
itself.

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Service and Maintenance
Overview Section 9

• Clean the Plate Holder on page 9–33


Explains how to eliminate contaminants from the plate
holder.
• Clean the Splash Free Support Base on page 9–35
Explains how to eliminate contaminants from the splash
free support base.
• Amplicon (Nucleic Acid) Decontamination on page 9–36
Explains how to decontaminate the instrument from
amplicon contaminants.
• Replace the Halogen Lamp on page 9–39
Gives safe techniques for replacing the lamp.
• Database Management on page 9–49
Explains how to back up and restore system calibration
and configuration files.

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200680-106—October 2012
Service and Maintenance
Section 9 Maintenance

Maintenance
Weekly Maintenance
Each week wipe instrument surfaces with a lint-free cloth.

Monthly Maintenance
Each month perform the Background Calibration, discussed
on page 6–17 of Section 6, Calibration Procedures.
NOTE: Background calibration is only valid for one
month.

Biannual Maintenance
NOTE: Preventive maintenance (PM) scheduling for
biannual maintenance does not indicate exact time
frames of 6 months, but rather a targeted time frame for
completion.
Twice a year, perform the following tasks:
• Region of Interest (ROI) Calibration on page 6–7
• Background Calibration on page 6–17
• Uniformity Calibration on page 6–33
• Pure Dye Calibration on page 6–41

As-Needed Maintenance
Perform the following tasks, as needed, to resolve problems as
they arise:
• Clean the Splash Free Support Base on page 9–35
• Clean the Plate Holder on page 9–33
• Amplicon (Nucleic Acid) Decontamination on page 9–36
• Thermal block
– Clean the Thermal Block on page 9–20
– Decontaminate the Thermal Block on page 9–25
• Halogen lamp
– Replace the Halogen Lamp on page 9–39
• Calibrations
– Region of Interest (ROI) Calibration on page 6–7

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200680-106—October 2012
Service and Maintenance
Maintenance Section 9

– Background Calibration on page 6–17


– Uniformity Calibration on page 6–33
– Pure Dye Calibration on page 6–41
Refer to Section 6, Calibration Procedures, for
instructions.
• Perform System <Backup> on page 9–51

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200680-106—October 2012
Service and Maintenance
Section 9 Maintenance Logs

Maintenance Logs
The m2000rt Maintenance Log is designed for the user’s
convenience in documenting routine weekly and monthly
maintenance of the m2000rt. Additional copies of this Log can
be made as necessary.
The following tables are provided as templates for your
m2000rt System maintenance.
• Weekly, Monthly, and As-Needed Maintenance Log sheets
• m2000rt System Problem Record

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200680-106—October 2012
Service and Maintenance
Maintenance Logs Section 9

NOTES

9-6 m2000rt Operations Manual


200680-106—October 2012
m2000rt Maintenance Log
Maintenance Logs

9-7
Service and Maintenance

Month_____ Year_____ Serial No._________________


WEEKLY Week 1 Week 2 Week 3 Week 4 Week 5 MONTHLY Date
Clean instrument surfaces (Do not use organic Perform Background Calibration
solvents)
Technologist Technologist Technologist Technologist Technologist Technologist
SEMI-ANNUALLY Date Technologist AS NEEDED Date Technologist
Perform ROI Calibration Clean the thermal block
Perform Background Calibration Decontaminate the thermal block
Perform Uniformity Calibration Replace the halogen lamp
Perform Pure Dye Calibrations Clean the Plate Holder
Clean the Splash Free Support Base
•FAM™ Calibration Perform System Backup
•JOE™ Calibration
•NED™ Calibration

200680-106—October 2012
•ROX™ Calibration
•SYBR® Calibration

m2000rt Operations Manual


•TAMRA™ Calibration
•VIC® Calibration
Section 9

•Cy™5 Calibration
Service and Maintenance
Maintenance Logs Section 9

NOTES

9-8 m2000rt Operations Manual


200680-106—October 2012
m2000rt Problem Record
Maintenance Logs

9-9
Service and Maintenance

Month_____ Year_____ Serial No._________________


Date Description of Problem Corrective Action Taken Technologist

200680-106—October 2012
m2000rt Operations Manual
Section 9
Service and Maintenance
Maintenance Logs Section 9

NOTES

9-10 m2000rt Operations Manual


200680-106—October 2012
Service and Maintenance
Section 9 Instrument Decontamination

Instrument Decontamination
Decontaminate parts having direct contact with chemical or
biological material.
BIOLOGICAL RISKS: Always wear appropriate
personal protective equipment such as gloves, eyewear,
and lab coat while performing the decontamination
activities necessary prior to servicing or transporting
the instrument.

Prior to servicing, transporting, relocating, or disposing of the


m2000rt, the following activities must be completed:
Table 9.1: Decontamination
Exterior Surfaces • Wipe exterior surfaces with a
detergent solution.
• Then wipe exterior surfaces with an
appropriate disinfectant, such as 0.1%
sodium hypochlorite solution.
NOTE: If sodium hypochlorite is
not recommended or is otherwise
prohibited at your site, a
germicidal disinfectant, such as
quaternary ammonium
surfactant, may be used.
Decontaminate the Refer to Decontaminate the Thermal
Thermal Block Block on page 9–25.
Clean the Plate Refer to Clean the Plate Holder on page
Holder 9–33.
Amplicon Refer to Amplicon (Nucleic Acid)
(Nucleic Acid) Decontamination on page 9–36.
Decontamination

NOTE: If you must ship the m2000rt to a new location,


contact your Abbott Area Customer Service for
assistance. The Abbott Representative will prepare the
decontaminated system for shipment and install it at
the new destination.

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200680-106—October 2012
Service and Maintenance
Instrument Decontamination Section 9

Decontamination Form
Before an Abbott Representative performs any work on the
instrument, or before the instrument is returned to Abbott, the
owner of the instrument must complete a decontamination
form for the m2000rt, and keep it with the instrument. A
decontamination form can be obtained from the local Abbott
Representative.

NOTE: Abbott Laboratories reserves the right to reject


any instrument or component if the decontamination
form or Repair Order is not completed and duly signed.

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200680-106—October 2012
Service and Maintenance
Section 9 Fluorescence Contamination Check

Fluorescence Contamination Check


The Contamination Check is performed when the Background
or other system calibration fails. During this procedure the
instrument assesses each well in the thermal block and flags
any wells that are experiencing any unknown fluorescence or
when contamination is suspected. This fluorescence can be
attributed to a dirty thermal block or could represent true
biological contamination of the wells.
It is recommended that a Contamination Check be performed
prior to:
• performing an ROI calibration
• replacing the halogen lamp

BIOLOGICAL RISKS: Instrument parts could be


contaminated with potentially infectious materials.
• Observe basic biohazard precautions.
• Wear appropriate personal protective equipment
such as gloves, lab coats, and protective eye wear.

To perform the Contamination Check:


1. Select <System>, then <System Calibration>.
Figure 9.1: <System> Menu, <System Calibration>
Option

The <System Calibration Status> screen displays.

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200680-106—October 2012
Service and Maintenance
Fluorescence Contamination Check Section 9

2. From the <Maintenance Tasks> menu, select


<Contamination Check>.
Figure 9.2: <Maintenance Tasks> Menu,
<Contamination Check> Option

Figure 9.3: <Contamination Check Preparation>

3. Open the tray drawer and remove the PCR plate, if


present. Then remove the plate holder.
Figure 9.4: Remove the Plate and the Plate Holder

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200680-106—October 2012
Service and Maintenance
Section 9 Fluorescence Contamination Check

4. Close the tray drawer.


Figure 9.5: Close the Tray Drawer

5. Select <Start> to initiate the contamination check


procedure.

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200680-106—October 2012
Service and Maintenance
Fluorescence Contamination Check Section 9

The screen displays <Initiating Contamination


Check, please wait.>. Then, the Contamination Check
screen displays a status of <RUNNING>.
Figure 9.6: <Contamination Check> Status:
<RUNNING>

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200680-106—October 2012
Service and Maintenance
Section 9 Fluorescence Contamination Check

When the check has completed, a message displays.


Figure 9.7: Message: <No contamination was
detected.>

If contamination was detected, an alert message will


display indicating the level of contamination.
Figure 9.8: Message: <A high level of contamination
was detected.>

The Contamination Check screen displays <Status:> and


the contaminated well is highlighted in red. The operator
is able to point the mouse over the highlighted location
and the well location is displayed.
NOTE: <Status:> can be Normal or High
Contamination.

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200680-106—October 2012
Service and Maintenance
Fluorescence Contamination Check Section 9

Figure 9.9: <Status: High Contamination>

The operator is then instructed to clean the thermal


block.

6. Select <Next> to proceed to the thermal block cleaning.


The <Clean Thermal Block> screen displays
instructions for cleaning the thermal block:
Figure 9.10:<Clean Thermal Block> Display

<1. Power off the m2000rt instrument.> -- Power


the instrument OFF
<2. Open the access door to the m2000rt
instrument.> -- Open the access door

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200680-106—October 2012
Service and Maintenance
Section 9 Fluorescence Contamination Check

<3. Move the heated cover to the back position.>


-- Push the heated cover to the back position
<4. Clean the contaminated wells of the Thermal
block.> -- Clean the contaminated wells. Refer to Clean
the Thermal Block on page 9–20 in this section.
<5. Move the heated cover to the front position.>
-- Pull the heated cover all the way to the front position
<6. Close the access door.> -- Close the access door
<7. Power on the instrument.> -- Power the
instrument ON
<8. Wait approximately 1 minute for the system
to establish a connection.> -- Wait approximately one
minute for the system to establish a connection
<9. Select Next to execute the Contamination
Check.> -- Select <Next> to start the Contamination
Check

NOTE: For complete instructions on cleaning the


thermal block, refer to Clean the Thermal Block on
page 9–20.
If the Contamination Check fails again, repeat the Clean
the Thermal Block procedure with 95% EtOH solution.
Perform another Contamination Check and if the check
continues to fail, Decontaminate the Thermal Block on
page 9–25.
If the Contamination Check passes, select <Finish>,
replace the plate holder, and perform the Background
Calibration, discussed on page 6–17 of Section 6,
Calibration Procedures.

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200680-106—October 2012
Service and Maintenance
Clean the Thermal Block Section 9

Clean the Thermal Block


CAUTION: Do not remove the instrument casing.
! There are no components inside the m2000rt System
that you can safely service yourself. If you suspect a
problem, contact an Abbott Service Representative.
NOTE: Do not use compressed air to clean the thermal
block.

BIOLOGICAL RISKS: Instrument parts could be


contaminated with potentially infectious materials.
• Observe basic biohazard precautions.
• Wear appropriate protective equipment such as
gloves, lab coats, and protective eye wear.

This procedure explains how to eliminate environmental


contaminants (e.g., dirt and dust) from the thermal block of
the m2000rt System. If biological contamination (e.g., spilled
patient samples, etc.) is known or suspected, Decontaminate
the Thermal Block on page 9–25 instead.

Prior to Cleaning the Thermal Block


If you have not already done so, perform the Fluorescence
Contamination Check on page 9–13 to identify contaminated
wells. Then, check the Message History Log for recent error
messages referencing failed wells. Compare these with the
wells identified during the Contamination Check and then
proceed. (Refer to Message History Log on page 10–9 of
Section 10, Troubleshooting and Diagnostics, for more
information.)

Assemble Required Materials


• Pipet
• 95% EtOH solution
• Cotton or nylon swabs (individually packaged, if
available) and lint-free cloths
• Deionized water
• Powder-free gloves
• Thin screwdriver

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200680-106—October 2012
Service and Maintenance
Section 9 Clean the Thermal Block

Procedure
NOTE: Wear powder-free gloves when you handle the
thermal block.

1. Power OFF and unplug the m2000rt System. Allow it to


cool for 15 minutes.
CAUTION: Hot Surface. During instrument
operation, the thermal block can be heated as high as
100°C. Before performing the following procedure, be
sure to wait until the thermal block reaches room
temperature.

2. Open the access door to the m2000rt System by inserting


a thin screwdriver into the keyhole located on the edge of
the access door, and pressing carefully until you hear the
door latch release.
Figure 9.11:Unlatch the Instrument Access Door

Latch keyhole

3. Open the tray drawer and remove the plate holder if


present, and then close the tray drawer.

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200680-106—October 2012
Service and Maintenance
Clean the Thermal Block Section 9

4. Move the heated cover to the back of the instrument.


Figure 9.12:Move the Heated Cover

5. Clean the contaminated wells of the thermal block using


deionized water as follows:
a. Pipet deionized water into the contaminated well,
ensuring that it is completely filled. Be sure to use
long, thin tips and clean each contaminated well
separately.
Figure 9.13:Pipet into Contaminated Well

b. Pipet the water up and down several times to rinse the


well.
c. Pipet the water to a waste beaker. Discard the tip.
d. Using a new tip and clean deionized water each time,
repeat steps a. through c. three times.

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200680-106—October 2012
Service and Maintenance
Section 9 Clean the Thermal Block

e. Using a new tip and clean deionized water, pipet a


small amount of deionized water into the
contaminated well.
f. Using a cotton or nylon swab, scrub (or clean) inside
the contaminated well.
Figure 9.14:Clean the Contaminated Well

g. Wrap a lint-free cloth around the wooden end of a


cotton or nylon swab, insert it into the contaminated
well, and absorb the excess water.
Figure 9.15:Dry the Cleaned Well

h. Repeat the above steps for each contaminated well.

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200680-106—October 2012
Service and Maintenance
Clean the Thermal Block Section 9

6. Pull the heated cover to the front of the instrument and


close the access door.
NOTE: Ensure the heated cover is pulled all the
way to the front of the instrument.
Figure 9.16:Move the Heated Cover

7. Plug in and power ON the m2000rt System


Figure 9.17:Power ON

Power switch

8. Perform the Fluorescence Contamination Check on page


9–13 to verify the identified wells have been cleaned.
• If the check passes, perform the Background
Calibration on page 6–17 of Section 6, Calibration
Procedures.
• If the Contamination Check fails, repeat the entire
procedure (starting with step 1) using 95% EtOH
solution.
• If the Contamination Check continues to fail,
perform the Decontaminate the Thermal Block
procedure on page 9–25.

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200680-106—October 2012
Section 9 Service and Maintenance

Decontaminate the Thermal Block


CAUTION: Do not remove the instrument casing.
! There are no components inside the m2000rt system
that you can safely service yourself. If you suspect a
problem, contact an Abbott Laboratories Service
Representative.

NOTE: Do not use compressed air to clean the thermal


block.

BIOLOGICAL RISKS: Instrument parts could be


contaminated with potentially infectious materials.
• Observe basic biological precautions.
• Wear appropriate personal protective equipment
such as gloves, lab coats, and protective eye wear.

This procedure should be performed:


• to eliminate biohazardous contaminants (e.g., spilled
patient samples, etc.) from the thermal block. To
eliminate simple environmental contaminants (e.g., dirt
and dust), it is typically only necessary to Clean the
Thermal Block on page 9–20.
• when the Clean the Thermal Block procedure has been
unsuccessful.
• as part of general decontamination procedures (refer to
Instrument Decontamination on page 9–11 for more
information).

Assemble Required Materials


• Pipet
• 95% EtOH solution
• 0.1% sodium hypochlorite solution
NOTE: If sodium hypochlorite is not
recommended or is otherwise prohibited at your
site, a germicidal disinfectant, such as a quaternary
ammonium surfactant, may be used.
• Cotton or nylon swabs and lint-free cloths

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200680-106—October 2012
Service and Maintenance
Decontaminate the Thermal Block Section 9

• Deionized water
• Powder-free gloves
• Thin screwdriver

Procedure
NOTE: Wear powder-free gloves when you handle the
thermal block.

1. Power OFF and unplug the m2000rt System. Allow it to


cool for 15 minutes.

CAUTION: Hot Surface. During instrument


operation, the thermal block can be heated as high as
100°C. Before performing the following procedure, be
sure to wait until the thermal block reaches room
temperature.

2. Open the access door to the m2000rt System by inserting


a thin screwdriver into the keyhole located on the edge of
the access door, and pressing carefully until you hear the
door latch release.
Figure 9.18:Unlatch the Instrument Access Door

Latch keyhole

3. Open the tray drawer and remove the plate holder if


present, and then close the tray drawer.

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200680-106—October 2012
Service and Maintenance
Section 9 Decontaminate the Thermal Block

4. Move the heated cover to the back of the instrument.


Figure 9.19:Move the Heated Cover

m2000rt Operations Manual 9-27


200680-106—October 2012
Service and Maintenance
Decontaminate the Thermal Block Section 9

5. Clean the wells of the thermal block using 0.1% sodium


hypochlorite solution, and following the steps below:
NOTE: If performing this procedure after the
Clean the Thermal Block procedure failed, it is
only necessary to decontaminate the specific wells
identified by the original error message and the
Contamination Check.
NOTE: If performing this procedure to remove
biohazardous contamination, it is only necessary
to decontaminate the wells, and areas between the
wells, that were identified as biohazardous.
a. Pipet enough 0.1% sodium hypochlorite solution into
each well and the areas between each well to nearly
fill them.
NOTE: If sodium hypochlorite is not
recommended or is otherwise prohibited at your
site, a germicidal disinfectant, such as a quaternary
ammonium surfactant, may be used.
Figure 9.20:Pipet into Each Well

b. Pipet the solution up and down several times to rinse


the wells and surroundings.
c. Remove the solution and dispose of it in a waste
beaker.

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Service and Maintenance
Section 9 Decontaminate the Thermal Block

d. Using a cotton or nylon swab, scrub (or clean) inside


and outside each well, including the flat areas around
the tops and in between the wells.
Figure 9.21:Clean Each Well

e. Using a lint-free cloth or tissue wrapped around a


swab, absorb the excess sodium hypochlorite solution.
Figure 9.22:Dry Each Clean Well

6. Repeat Step 5 using deionized water and follow with 95%


EtOH solution.
NOTE: Ensure all of the residue has been removed
from the wells.

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Service and Maintenance
Decontaminate the Thermal Block Section 9

7. Pull the heated cover to the front of the instrument and


close the instrument’s access door.
NOTE: Ensure the heated cover is pulled all the
way to the front of the instrument.
Figure 9.23:Move the Heated Cover

8. If needed, open the tray drawer, replace the plate holder,


and close the drawer.
9. Plug in and power ON the m2000rt instrument.
NOTE: It is important to distinguish between the
On/Off switch, and the control for opening the
tray drawer, which is located adjacent to the
On/Off switch.
Figure 9.24:Power ON

Tray drawer
control

Power switch

If this procedure was performed after an unsuccessful Clean


the Thermal Block procedure, perform the Fluorescence
Contamination Check on page 9–13.

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200680-106—October 2012
Service and Maintenance
Section 9 Decontaminate the Thermal Block

• If the Contamination Check passes, perform the


Background Calibration on page 6–17 of Section 6,
Calibration Procedures.
• If the Contamination Check continues to fail, contact
your Area Abbott Customer Service.

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Service and Maintenance
Clean the Plate Section 9

Clean the Plate


Instrument parts could be contaminated with
potentially infectious materials.
• Observe basic biohazard precautions.
• Wear appropriate personal protective equipment
such as gloves, lab coats, and protective eyewear.
NOTE: Do not use alcohol to clean the plate.

Purpose
This procedure is used to do the following:
• Remove visible contamination (dust, dirt, hair, etc.) from
the plate.
• Eliminate invisible contamination that might be present
in wells identified either by error messages or during the
Contamination Check.
NOTE: It is not necessary to clean wells that were not
identified by error messages or during the
Contamination Check.

Procedure
1. Dip a lint-free cloth or wipe in distilled water, and use it to
lightly scrub the top of the contaminated well location or
to remove any visible contamination from the plate.
Discard cloth/wipe.
2. Use a clean, lint-free cloth or wipe dipped in distilled water
to scrub the bottom and around the sides of the
contaminated well location or to remove any visible
contamination. Discard cloth/wipe.
3. Use a clean, lint-free cloth or wipe to dry the previously
cleaned area of the plate. Ensure you use a clean section of
the wipe (or two different wipes) to avoid any cross
contamination.
4. Recentrifuge the plate and inspect the plate for any air
bubbles. If bubbles remain, recentrifuge until they are
gone.

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Section 9 Service and Maintenance

Clean the Plate Holder

Instrument parts could be contaminated with


potentially infectious materials.
• Observe basic biohazard precautions.
• Wear appropriate personal protective equipment
such as gloves, lab coats, and protective eye wear.

1. Remove the plate holder from the m2000rt instrument.


Figure 9.25:Remove the Plate Holder

2. Wipe the plate holder with 0.1% sodium hypochlorite


solution.
NOTE: If sodium hypochlorite is not
recommended or is otherwise prohibited at your
site, a germicidal disinfectant, such as a quaternary
ammonium surfactant, may be used.
3. Rinse the plate holder with water. Ensure all sodium
hypochlorite residue has been removed.
4. Air dry the plate holder.

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Service and Maintenance
Clean the Plate Holder Section 9

5. Reinstall the plate holder on the m2000rt instrument.


Figure 9.26:Reinstall the Cleaned Plate Holder

NOTE: The plate holder is keyed on the top left


corner (position A1) and will fit in the tray drawer
only one way.

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Section 9 Service and Maintenance

Clean the Splash Free Support Base

Instrument parts could be contaminated with


potentially infectious materials.
• Observe basic biohazard precautions.
• Wear appropriate personal protective equipment
such as gloves, lab coats, and protective eye wear.

NOTE: The Splash Free Support Base should be cleaned


after every protocol run.

The Splash Free Support Base can come into contact with
reagents, specimens, and controls, which must be removed.
Perform the following procedure to clean the support base.
Figure 9.27:Splash Free Support Base

1. Soak the Splash Free Support Base in 0.5% sodium


hypochlorite solution (10% bleach solution) for
approximately ten minutes.
NOTE: If sodium hypochlorite is not
recommended or is otherwise prohibited at your
site, a germicidal disinfectant, such as a quaternary
ammonium surfactant, may be used.
2. Rinse the Splash Free Support Base completely with water.
Ensure all residue has been removed.
3. Air dry the Splash Free Support Base thoroughly.

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200680-106—October 2012
Service and Maintenance
Amplicon (Nucleic Acid) Decontamination Section 9

Amplicon (Nucleic Acid) Decontamination


The m2000rt System amplifies targets by PCR, which increases
the number of amplicons by many orders of magnitude. If the
PCR plate integrity is compromised during or after
amplification, the amplicon may contaminate the instrument
and/or the surrounding area. This contamination may indicate
false positive results or give artificially high results for positive
samples.
The amplicon decontamination procedure should be
performed in order to eliminate the amplicon contamination
from the m2000rt. Amplicon decontamination should be
performed in the following situations:
• Physical damage to a PCR plate is observed or suspected
when the PCR plate is being loaded or undergoing
amplification.
• Physical damage to the PCR plate seal is observed or
suspected when the PCR plate is being loaded or
undergoing amplification.
• Negative controls indicate positive results.
• As part of the instrument decontamination procedure
prior to the instrument being serviced.

NOTE: Amplicon decontamination is not necessary to


eliminate environmental contaminants (e.g., dirt and
dust); see Clean the Thermal Block on page 9–20 to
remove environmental contaminants.
NOTE: If a biological contamination (e.g., spilled
patient sample, etc.) is present or suspected, utilize the
procedure to Decontaminate the Thermal Block on
page 9–25.
CAUTION: Do not remove the instrument casing.
! There are no components inside the m2000rt System
that you can safely service yourself. If you suspect a
problem, contact an Abbott Service Representative.
NOTE: Do not use compressed air to clean the thermal
block.

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Section 9 Service and Maintenance

BIOLOGICAL RISKS: Instrument parts could be


contaminated with potentially infectious materials.
• Observe basic biohazard precautions.
• Wear appropriate protective equipment such as
gloves, lab coats, and protective eye wear.

Assemble Required Materials


• Pipet
• Cotton or nylon swabs and lint-free cloths
• Deionized water
• Powder-free gloves
• Thin screwdriver
• 95% EtOH solution
• 0.1% sodium hypochlorite solution
NOTE: If sodium hypochlorite is not
recommended or is otherwise prohibited at your
site, one of several commercially available
products for decomposing nucleic acids may be
used. Examples include:
• NucleoClean™ Decontamination Wipes,
Chemicon (Millipore), Catalogue number 3097
• DNAZap™, Applied Biosystems, part
number AM9890
NOTE: Abbot does not guarantee the performance
of the above products. It is the responsibility of
the customer to verify their performance. Follow
the procedures and safety instructions provided
with the product used.

Procedure
NOTE: Wear powder-free gloves when you handle the
thermal block.
1. Wipe the exterior surfaces of the instrument with an
appropriate disinfectant solution.
2. Perform the Decontaminate the Thermal Block on page
9–25 procedure.
3. Perform the Clean the Plate Holder on page 9–33
procedure.

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Service and Maintenance
Amplicon (Nucleic Acid) Decontamination Section 9

4. Verify that the decontamination of the thermal block and


plate holder have been cleaned by performing a
Fluorescence Contamination Check on page 9–13.

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200680-106—October 2012
Service and Maintenance
Section 9 Replace the Halogen Lamp

Replace the Halogen Lamp


CAUTION: Hot Surface. The m2000rt System and
halogen lamp are hot! The lamp can become very hot
while in use. Allow sufficient time for the lamp to cool,
and put on protective, powder-free gloves before
handling it.

NOTE: The halogen lamp should be replaced after


approximately 1,000 hours of life.

CAUTION: Replacing the lamp will invalidate all


! system calibrations. Ensure you have sufficient time to
perform all system calibrations.

CAUTION: Before starting procedure, ensure you have


! a replacement lamp available.

Determine Lamp Status


Proper function of the halogen lamp is essential to the
m2000rt System. The table below details categories of lamp
status.

Table 9.2: Categories of Lamp Status


Lamp Status Description
Usage hours <1,000 hours
<Normal>
Lamp current within specification
Usage hours <1,000 hours
<Replace soon> Lamp current less than 50% of the
nominal installed current
<Expired> Usage hours >1,000 hours
Lamp current out of specification or
<Failed>
lamp burned out
Instrument powered off
<[blank]>
Lamp status unknown

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200680-106—October 2012
Service and Maintenance
Replace the Halogen Lamp Section 9

Lamp <Status>, and hours of lamp <Usage> can be


monitored by checking the <Lamp Information> section of
the <Instrument Status> display.
Figure 9.28:Lamp <Status> Categories

Status: Normal

Status: Replace Soon

Status: Expired

Status: Failed

Check lamp <Status> to determine whether the lamp has


degraded or needs replacement.

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200680-106—October 2012
Service and Maintenance
Section 9 Replace the Halogen Lamp

Replace Lamp
NOTE: User access of administrator is necessary for
carrying out this procedure.

CAUTION: Replacing the lamp will invalidate all


! system calibrations. Before initiating the lamp
replacement procedure, ensure that you have sufficient
time, and materials required, to perform all system
calibrations.

Assemble Required Materials


• Halogen lamp
• Screwdriver, small
• Powder-free gloves

CAUTION: Before starting procedure, ensure you have


! a replacement lamp available.

Procedure
To perform lamp replacement:
1. First perform the Fluorescence Contamination Check on
page 9–13 to determine whether contamination is present.
If contamination is found, note the affected wells and
then Clean the Thermal Block on page 9–20.
2. Select <System>, then <System Calibration>.
Figure 9.29:<System> Menu, <System Calibration>
Option

The <System Calibration Status> screen displays.

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200680-106—October 2012
Service and Maintenance
Replace the Halogen Lamp Section 9

3. From the <Maintenance Tasks> menu, select


<Replace Lamp>.
Figure 9.30:<Replace Lamp> Menu Option

The <Calibrate Lamp: Lamp Information> screen


displays.
Figure 9.31:<Calibrate Lamp: Lamp Information>
Display

4. Turn off the instrument only.


When the system detects the m2000rt as no longer
communicating, the instrument status changes to
<OFFLINE>.

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200680-106—October 2012
Service and Maintenance
Section 9 Replace the Halogen Lamp

5. Wait 15 minutes for the lamp bulb to cool.


CAUTION: Hot Surface. The m2000rt System and
halogen lamp are hot! The lamp can become very hot
while in use. Allow sufficient time for the lamp to cool,
and put on protective, powder-free gloves before
handling it.

6. Open the access door to the m2000rt System by inserting


a thin screwdriver into the keyhole located on the edge of
the access door, and pressing carefully until you hear the
door latch release.
Figure 9.32:Unlatch the Instrument Access Door

Latch keyhole

7. Remove the halogen lamp from the instrument by doing


the following:
CAUTION: Do not touch the halogen lamp
! without powder-free gloves. Fingerprints shorten
the lamp life.

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200680-106—October 2012
Service and Maintenance
Replace the Halogen Lamp Section 9

a. Slide the lamp release lever toward the front of the


instrument and downward. (This moves the halogen
bulb upward for removal.)
b. Firmly grasp the halogen lamp and lift it up and out
of the slotted mount.
Figure 9.33:Remove the Used Halogen Lamp

c. Slide the lamp release lever upward to its initial


position.

d. Firmly grasp the new halogen lamp, place it into the


slotted mount, and then carefully slide the lamp
downward into place.
Figure 9.34:Insert the New Halogen Lamp

8. Close the access door.

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200680-106—October 2012
Service and Maintenance
Section 9 Replace the Halogen Lamp

When the system detects the m2000rt instrument is


OFFLINE, the <Next> button will be activated
Figure 9.35:<Calibrate Lamp: Lamp Information>
Display

<Next>

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200680-106—October 2012
Service and Maintenance
Replace the Halogen Lamp Section 9

9. Select <Next>. The <Calibrate Lamp: Start


Calibration> screen displays and explains that to
complete the lamp bulb replacement operation, the
system must calibrate the lamp.
Figure 9.36:<Calibrate Lamp: Start Calibration>
Display

Lamp Calibration
1. Power ON the instrument
Figure 9.37:Power On the Instrument

Power switch

The system will attempt to re-establish a connection to


the m2000rt instrument. This will take approximately one
minute.

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200680-106—October 2012
Service and Maintenance
Section 9 Replace the Halogen Lamp

When the system detects the m2000rt instrument is


STOPPED, the <Start> button will be activated.
Figure 9.38:<Calibrate Lamp: Start Calibration>
Display

<Start>

2. Select <Start>. The instrument performs a lamp


calibration in which it does the following:
• lamp warm-up (approximately 15 minutes)
• reads new lamp current settings
• resets the lamp <Usage> hours to <0 hours>
• sets lamp <Status> to <Normal>
• invalidates all system calibrations

When the calibration is complete, the screen should


display lamp <Usage> as 0.
Figure 9.39:Lamp <Usage: 0 Hours>

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200680-106—October 2012
Service and Maintenance
Replace the Halogen Lamp Section 9

3. Perform all system calibrations:


• Region of Interest (ROI) Calibration on page 6–7 of
Section 6, Calibration Procedures
• Background Calibration on page 6–17
• Uniformity Calibration on page 6–33
• Pure Dye Calibration on page 6–41

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Service and Maintenance
Section 9 Database Management

Database Management

Database Management provides the user with a method of


backing up and restoring system calibration and system
database files. Users with General User access are able to
perform a backup. Only an Abbott Representative is able to
access the restore files function.

To access Database Management, select <System>, and then


<Database Management>.

Figure 9.40:<System> Menu>, <Database Management>


Option

The <Database Management> screen displays.


Figure 9.41:<Database Management> Display

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200680-106—October 2012
Service and Maintenance
Database Management Section 9

There are four backup operations available to General Users:


• <Full>, which combines the system database and system
calibrations options below plus the following additional
data:
– user accounts
– language and locale settings
– product information
– LIS configuration
• <System Database>, which includes all database
information (including result information, assay
calibrations, logs, Test Orders, and Application
Specifications)
• <System Calibrations>, which includes all data related
to ROI, Background, Uniformity, Pure Dye, and lamp
calibrations
• <User Defined Pure Dyes>, which includes all data
related to user-defined pure dye calibrations.
(User-defined Pure Dyes are applicable to
laboratory-defined applications only.)

NOTE: It is the laboratory’s responsibility to


determine the frequency of backing up files.

The <Database Management Tasks> menu permits the


user to
• <Backup> (General User)
• <Restore> (Abbott Representative only)

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Service and Maintenance
Section 9 Database Management

<Backup>
The backup procedure allows the operator to transfer m2000rt
information, such as system calibrations and database files, to
a CD. Users with General User access are able to perform the
backup function. Perform this procedure in accordance with
your laboratory’s data backup schedule. Backing up system
information protects against data loss if the SCC fails. It is
recommended that a backup be performed in the following
cases:
• After system calibration
• After application specification installation
• After assay calibration
• On a regular weekly or monthly schedule

1. To back up files, select <System>, and then <Database


Management>.
Figure 9.42:<System> Menu, <Database Management>
Option

The <Database Management> screen displays.


Figure 9.43:<Database Management> Display

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200680-106—October 2012
Service and Maintenance
Database Management Section 9

2. Select the type of backup, then, from the <Database


Management Tasks> menu, select <Backup>. The
<Perform System Backup> screen displays.
Figure 9.44:<Perform System Backup> Display

3. Enter the following information:


• <Backup Name> (required) -- Backup name for the
file
• <Comment> -- Comments regarding this backup
(optional)

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Service and Maintenance
Section 9 Database Management

4. Insert a new CD into the CD drive, and select <Start>. A


message displays stating the <Backup> is in progress.
Figure 9.45:Message: <Backup . . . in progress>

When the backup has completed, a message displays


reporting that the backup was successful.
Figure 9.46:Message: <Backup . . . completed
successfully>

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200680-106—October 2012
Service and Maintenance
Database Management Section 9

5. Select <Close> to close the alert message.


6. Remove the CD and store it in a secure location.

NOTE: If the backup was not successful, refer to


Section 10, Troubleshooting and Diagnostics for
more information.

<Restore>
Restoring files is performed after a hard disk or software
failure. Only an Abbott Representative is able to access the
<Restore> file function.
Contact your Area Abbott Customer Service if data needs to be
restored.

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200680-106—October 2012
Section 10

Section 10:

Troubleshooting and Diagnostics

Section 10 Table of Contents


Troubleshooting and Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Approach to Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 10-3
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Event Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Error Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Message History Log . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Process Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
<Delete> Process Log . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Error Light Displays . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Lamp Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Determine Lamp Status . . . . . . . . . . . . . . . . . . . . . . . 10-12

Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15

m2000rt Operations Manual Table of Contents-1


200680-106—October 2012
Section 10

NOTES

Table of Contents-2 m2000rt Operations Manual


200680-106—October 2012
Section 10 Troubleshooting and Diagnostics

Section 10: Troubleshooting and Diagnostics

Troubleshooting and Diagnostics

Overview
Observed problems with the m2000rt are characterized by
symptoms. Troubleshooting tools, references, and suggested
techniques are provided to help the operator diagnosis the
symptom(s) to one or more root causes. With this
information, the operator can perform corrective actions
necessary to resolve the problem.
The tables in this section list possible m2000rt malfunctions
and errors. The operator has access rights to correct some
problems or errors. When this type of error occurs, appropriate
corrective actions are described in the Corrective Action(s)
column.
Correction of more complicated malfunctions or errors is
usually performed by the Abbott Representative. When this
type of malfunction or error occurs, contact your Abbott
Representative for assistance.

• Troubleshooting on page 10–3


– Approach to Troubleshooting on page 10–3
Provides a general model for troubleshooting the
m2000rt System.
– Observed Problems on page 10–6
Lists symptoms observed by the operator, and
provides detailed information on probable causes and
corrective actions.
– Event Descriptions on page 10–8
Lists and defines three levels of messages on the
m2000rt: Information, Warning, and Error.
– Error Light Displays on page 10–11
• Error Codes on page 10–15
Lists possible error codes and their messages, and
provides detailed information on probable causes and
corrective actions.

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200680-106—October 2012
Troubleshooting and Diagnostics
Troubleshooting and Diagnostics Section 10

Customer Support
If you have any questions, please contact your Area Abbott
Customer Service.

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200680-106—October 2012
Section 10 Troubleshooting and Diagnostics

Troubleshooting

Approach to Troubleshooting
Troubleshooting consists of implementing a practical,
systematic approach to problem solving. This approach
focuses on:
• Observing, recognizing, and categorizing symptoms
• Identifying the probable cause(s)
• Eliminating, systematically, each potential problem (from
most likely to least likely)

The troubleshooting model that follows describes a five step


approach to defining symptoms, identifying problems, and
implementing solutions. When troubleshooting the m2000rt
System, the operator should also include considerations
appropriate to the operator’s specific environment.

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200680-106—October 2012
Troubleshooting and Diagnostics
Troubleshooting Section 10

Table 10.1:Troubleshooting Model

Troubleshooting Explanation of m2000rt - Specific


Step Model Examples
1. Observe or recognize The operator must fully Observe:
the symptom. understand m2000rt • Error codes or error
operation to recognize log messages
symptoms when generated
troubleshooting issues
• A symptom (noise,
arise.
leak, trend in
controls)
2. Categorize the Variables that can affect Categorize:
symptom - variables results should be Four variables that
that can affect a identified and affect m2000rt
result. categorized. This allows performance:
similar symptoms or
• Operator
problems to be grouped
together to focus on • Instrument
steps needed to isolate a • Reagent
root cause. • Environment
Performing resolution
steps before identifying
root causes could
increase
troubleshooting time
and expense.
3. Isolate the root cause It is important to Isolate by using:
- using diagnostic determine the root • Error code message
tools. cause before repair or description
replacement procedures
• Logs - Error logs,
begin. This saves time
Maintenance logs
and money, and
prevents frustration. • m2000rt Operations
Manual instructions
• Maintenance
procedures

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Troubleshooting

Table 10.1:Troubleshooting Model (Continued)

Troubleshooting Explanation of m2000rt - Specific


Step Model Examples
4. Resolve the problem. After root cause is Resolve:
identified, resolution • Adjust (remove
procedures can be obstructions)
performed.
5. Verify the resolution The same tools used to Verify:
worked. determine the root • Use the same
cause can also be used diagnostic procedures
to verify resolution of in Step 3
the issue.
• Check control values,
if appropriate

NOTE: Review Section 8, Hazards, before


performing any corrective actions.

m2000rt Operations Manual 10-5


200680-106—October 2012
Troubleshooting and Diagnostics
Troubleshooting Section 10

Observed Problems
The following table lists observed problems and errors with
probable causes and corrective actions. If the problem still
exists after performing corrective actions, contact your Abbott
Customer Service for assistance.

Table 10.2:Troubleshooting Observed Instrument


Problems

Problem/Error Probable Cause(s) Corrective Action(s)


Instrument switched off Switch ON instrument.
Power/ Check cable plug.
communication
Status is OFFLINE interrupted
No communication 1. Power OFF instrument and PC.
2. Power instrument and PC back ON
and wait for LED to turn green.
No communication Power OFF instrument and tighten
connection.
Initialization error
Hardware failure Contact your Area Abbott Customer
Service.
Lamp current out of Replace lamp
range Refer to Replace the Halogen Lamp on
page 9–39 of Section 9, Service and
Lamp Status Failed, Maintenance.
Expired, OR
Change soon Exceeded lamp hours Replace lamp
Refer to Replace the Halogen Lamp on
page 9–39 of Section 9, Service and
Maintenance.
Status displays RUNNING • Instrument lost power Reboot computer by pressing
with no protocol Control + Alt + Delete
information
• USB cable is on the keyboard.
OR
disconnected OR
protocol data is not
updating Select Shutdown.
SCC displays out of SCC has been powered Cycle power on the SCC by performing
memory error. on for a long period of a System Shutdown.
time.

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Troubleshooting

Table 10.2:Troubleshooting Observed Instrument


Problems (Continued)

Problem/Error Probable Cause(s) Corrective Action(s)


SCC unable to read Test • Bad CD 1. Try a new CD.
Order on the CD • Wrong CD 2. If problem persists, contact your
• CD hard drive failure Area Abbott Customer Service.
• CD not recognized 1. Open CD drive door
• CD not seated 2. Reseat CD
SCC displays checking for correctly 3. Try a new CD
CD drive continuously • Defective CD 4. If problem persists, contact your
• Hardware failure: CD Area Abbott Customer Service
drive
SCC displays an error • CD not recognized 1. Restart the application.
when attempting to save • CD not seated 2. Retry to save or archive the
or archive to a CD-ROM correctly information.
• Defective CD 3. If problem persists, contact your
• Hardware failure: CD Area Abbott Customer Service
drive
Printer will not print • Power switch is off 1. Ensure the power switch is on.
• Printer is out of paper 2. Load the printer with paper if
• USB cable connection needed.
is not secure 3. Ensure the USB cable connection is
• USB cable is not secure and that the cable is in the
connected to the correct port.
correct port. If the 4. If it is suspected that the cable or
printer port has been port was switched, contact your
changed or the cable Area Abbott Customer Service for
switched out (or assistance.
switched from parallel
to USB), a copy of the
printer will have been
created in the system,
preventing the actual
printer from printing
• Hardware failure:
printer

m2000rt Operations Manual 10-7


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Troubleshooting and Diagnostics
Troubleshooting Section 10

Event Descriptions
Error Levels
There are three levels of codes on the m2000rt:
• Information
• Warning
• Error

Information
International alert for the operator.

Warning
Alerts the operator to a potential problem.

Error
Alerts the operator that an error has occurred on the system.
When an error occurs, the operator is prompted to take
corrective action, then has the option to resume the run. If the
event message is still generated after performing corrective
actions, contact your Area Abbott Customer Service for
assistance.

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Troubleshooting and Diagnostics
Section 10 Troubleshooting

Message History Log


Error codes can be located on the <Message History Log> by
performing the following steps.
1. From the menu, select <System>, <System Logs>, then
<Message History Log>.
2. Under the <Message History Log>, the Code, Severity,
Description, and Date/Time display.
• Code - Numeric code associated with the message
• Severity - Labels the code as information, warning,
or error
• Description - the message displayed that describes
the code
• Date and time - the date and time the message
occurred

Figure 10.1:<Message History Log> Display

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Troubleshooting and Diagnostics
Troubleshooting Section 10

Process Log
The Process Log allows the operator to view a summary of
activity from a run.
1. From the menu, select <System>, <System Logs>, then
<Process Log>.
2. Under the <Process Log>, highlight the plate Process Log
to view. The log for the selected plate displays the
following information.
• Code - Numeric code associated with the message
• Severity - Labels the codes as Information, Warning,
or Error
• Description - the message displayed that describes the
code
• Date and Time - the date and time the message
occurred

Figure 10.2:<Process Log> Display

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Troubleshooting

<Delete> Process Log


Under the <Process Log Tasks> menu the operator is able to
delete a Process Log.
To delete a Process Log, highlight the plate to delete, then
select <Delete> from the <Process Log Tasks> menu.

Error Light Displays


NOTE: Throughout a successful run, the instrument
light “IN USE” will illuminate.

Press on the access door to ensure that it is closed.


If the instrument displays a blinking green status light, then
the tray drawer is open.
Figure 10.3:Error Light Display Area

Error light
display area

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Troubleshooting and Diagnostics
Troubleshooting Section 10

Lamp Failure
CAUTION: Hot Surface. The m2000rt System and
halogen lamp are hot! The lamp can become very hot
while in use. Allow sufficient time for the lamp to cool,
and put on protective, powder-free gloves before
handling it.

NOTE: The halogen lamp should be replaced after


approximately 1000 hours of life.

CAUTION: Replacing the lamp will invalidate all


! system calibrations. Ensure you have sufficient time to
perform all system calibrations.

CAUTION: Before starting procedure, ensure you have


! a replacement lamp available.

Determine Lamp Status


Proper function of the halogen lamp is essential to the
m2000rt System. The table below details categories of lamp
status.

Table 10.3:Categories of Lamp Status


Lamp Status Description
Usage hours <1000 hours
<Normal>
Lamp current within specification
Usage hours <1000 hours
<Replace soon> Lamp current outside 50% of the
nominal installed current
<Expired> Usage hours >1000 hours
Lamp current too low or lamp burned
<Failed>
out
Instrument powered off
<[blank]>
Lamp status unknown

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Troubleshooting

Lamp <Status> and hours of lamp <Usage> can be monitored


by checking the <Lamp Information> window of the
<Instrument Status> screen.
Figure 10.4:<Lamp Information> Window

Figure 10.5:Lamp <Status> Categories

<Status: Replace Soon>

<Status: Expired>

<Status: Failed>

Check lamp <Status> to determine whether the lamp has


degraded or needs replacement.
If it is necessary to replace the lamp, refer to Replace the
Halogen Lamp on page 9–39 of Section 9, Service and
Maintenance.

m2000rt Operations Manual 10-13


200680-106—October 2012
Troubleshooting and Diagnostics
Troubleshooting Section 10

NOTES

10-14 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Error Codes

NOTE: Some of the error codes listed in the table below


feature assay-dependent messages. In those cases, the
specific messages, probable causes, and corrective
actions will be shown for each assay type separately.

Table 10.4: m2000rt Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Test Order file (0) does not • Test Order import failed 1. Verify Test Order
exist. • Test Order file does not directory location.
exist or is not accessible 2. Reinstall Test Order Files
4000 0 = File name • CD was removed in the appropriate
directory location.
3. Attempt Test Order
import again.
Test Order file (0) digital • Test Order import failed 1. Export Test Order files
signature verification failed. on signature verification again from the m2000sp.
Test Order file is corrupt, • Test Order file is corrupt, 2. Reinstall Test Order files
inaccessible or invalid. invalid, or altered in the appropriate
0 = File name directory location.
4002
3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) schema • Test Order import failed 1. Export Test Order files
validation failed (1). on schema validation again from the m2000sp.
• Test Order file is not in 2. Reinstall Test Order files
0 = File name the correct format in the appropriate
directory location.
4003 1 = Failure data
3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.

m2000rt Operations Manual 10-15


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Test Order file (0) data Test Order import failed on 1. Export Test Order files
validation failed. data validation. again from the m2000sp.
Application Id (1) version 2. Reinstall Test Order files
(2) type (3) is not installed. in the appropriate
directory location.
4004
0 = File name 3. Attempt Test Order
1 = Application ID import again.
4. If import fails again,
2 = Application version
manually create Test
3 = Application type Order.
Test Order file (0) data • Test Order import failed 1. Install the application
validation failed. on data validation specification with the
Application Id (1) version • Application ID and correct Application ID,
(2) is not installed. Application Version version and Assay ID,
specified are not present and versions.
4005
0 = File name on the system 2. Correct the Application
ID, version and Assay
1 = Application
ID(s), and version, in the
specification ID
Test Order file.
2 = Application version
Test Order file (0) data • Test Order import failed 1. Install the application
validation failed. Assay Id on data validation specification with the
(1) version (2) is not • Assay ID and Assay correct Assay ID and
installed. Version specified are not versions.
4006 present on the system 2. Correct the Assay ID(s),
0 = File name and version in the Test
Order file.
1 = Assay ID
2 = Assay version
Test Order file (0) data • Test Order import failed 1. Export Test Order files
validation failed. Invalid on data validation again from the m2000sp.
PCR plate status (1). • PCR Plate Info element 2. Reinstall Test Order files
has invalid value of Plate in the appropriate
Status attribute directory location.
4009 0 = File name
1 = Plate status ID 3. Attempt Test Order
import again.
(1 = running,
4. If import fails again,
2 = completed, 3 = failed)
manually create Test
Order.

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200680-106—October 2012
Section 10 Troubleshooting and Diagnostics

Code Message Probable Cause(s) Corrective Action(s)


Test Order file (0) data • Test Order import failed 1. Export Test Order files
validation failed. Sample on data validation again from the m2000sp.
type is (1). Control is • Required Control 2. Reinstall Test Order files
expected but not present. element not present in the appropriate
directory location.
4011
0 = File name 3. Attempt Test Order
1 = Sample type ID import again.
(1 = patient, 2 = control, 3 = 4. If import fails again,
calibrator) manually create Test
Order.
Test Order file (0) data • Test Order import failed 1. Export Test Order files
validation failed. Sample on data validation again from the m2000sp.
type is (1). Calibrator is • Required Calibrator 2. Reinstall Test Order files
expected but not present. element not present in the appropriate
directory location.
4012
0 = File name 3. Attempt Test Order
1 = Sample type ID import again.
(1 = patient, 2 = control, 3 = 4. If import fails again,
calibrator) manually create Test
Order.
Test Order file (0) is corrupt. Software error 1. Export Test Order files
Test Order element was not again from the m2000sp.
found in the file. 2. Reinstall Test Order files
in the appropriate
directory location.
4016 0 = File name
3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) is corrupt. Software error 1. Export Test Order files
Test order list element was again from the m2000sp.
not found in the file. 2. Reinstall Test Order files
in the appropriate
directory location.
4017 0 = File name
3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.

m2000rt Operations Manual 10-17


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Test Order file (0) is corrupt. Software error 1. Export Test Order files
Well count (1) is not in the again from the m2000sp.
valid range. 2. Reinstall Test Order files
in the appropriate
directory location.
4018 0 = File name
1 = Number of wells 3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) is corrupt. Software error 1. Export Test Order files
Well count (1) is not in the again from the m2000sp.
valid range. 2. Reinstall Test Order files
in the appropriate
directory location.
4019 0 = File name
1 = Number of wells 3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) is corrupt. Software error 1. Export Test Order files
Test Order list element again from the m2000sp.
count (1) is not in the valid 2. Reinstall Test Order files
range. in the appropriate
directory location.
4020
0 = File name 3. Attempt Test Order
1 = Number of elements import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) is corrupt. Software error 1. Export Test Order files
Test Order element count again from the m2000sp.
(1) is not in the valid range. 2. Reinstall Test Order files
in the appropriate
directory location.
4021 0 = File name
1 = Number of Test Orders 3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


No Test Order data exists in Database Access Error 1. Export Test Order files
the database. again from the m2000sp.
2. Reinstall Test Order files
in the appropriate
directory location.
4029
3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) import • Test Order import failed 1. Utilize Test Order file
failed. PCR plate (1) already on data validation currently in the pending
exists in the pending test • Test Order with the list,
order list. specified PCR Plate is OR
4030
already present in the 2. Delete current Test Order
0 = File name pending list file from the pending list
1 = PCR Plate ID and import the desired
Test Order file.
Test Order file (0) data Incorrect Test Order format 1. Export Test Order files
validation failed. System again from the m2000sp.
type (1) is not valid. 2. Reinstall Test Order files
in the appropriate
directory location.
4031 0 = Test Order
1 = Test Order file type 3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) data Test Order file is corrupted 1. Export Test Order files
validation failed. Sample Id or unreadable. again from the m2000sp.
(1) is not a valid value. 2. Reinstall Test Order files
in the appropriate
directory location.
4032 0 = File name
1 = Sample ID 3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.

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200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Test Order file (0) is corrupt Test Order file is corrupted 1. Export Test Order files
or unreadable. or unreadable. again from the m2000sp.
2. Reinstall Test Order files
0 = File name in the appropriate
directory location.
4033
3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) data Software error 1. Export Test Order files
validation failed. Duplicate again from the m2000sp.
well Id (1) is present. 2. Reinstall Test Order files
in the appropriate
directory location.
4038 0 = File name
1 = Well number 3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) is corrupt. Software error 1. Export Test Order files
Well Id (1) does not have a again from the m2000sp.
valid value. 2. Reinstall Test Order files
in the appropriate
directory location.
4039 0 = File name
1 = Well number 3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Test Order file (0) data Software error 1. Export Test Order files
validation failed. Null or again from the m2000sp.
empty PCR Plate Id (1). 2. Reinstall Test Order files
in the appropriate
directory location.
4040 0 = File name
1 = Plate ID 3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Test Order file (0) data Software error 1. Export Test Order files
validation failed. Sample again from the m2000sp.
type (1) is not a valid value. 2. Reinstall Test Order files
in the appropriate
directory location.
4041 0 = File name
1 = Sample type 3. Attempt Test Order
(1 = patient, 2 = control, 3 = import again.
calibrator) 4. If import fails again,
manually create Test
Order.
Test Order file (0) data Software error 1. Export Test Order files
validation failed. Duplicate again from the m2000sp.
Assay Id (1) Version (2) is 2. Reinstall Test Order files
present for the sample at in the appropriate
location (3). directory location.
4042 3. Attempt Test Order
0 = File name import again.
1 = Assay ID 4. If import fails again,
manually create Test
2 = Version number
Order.
3 = Sample location
Unable to open (0) port for Hardware failure. Cable • Verify RS232 cable is
LIS. from LIS to SCC (COM1) connected to SCC and
has a poor connection or host system.
failed. • Verify the correct cable is
0 = Serial port (COM1)
being used (refer to
4100
m2000 Standard
Interface Guide).
• If error persists, contact
your Area Abbott
Customer Service.

m2000rt Operations Manual 10-21


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


LIS port disabled. The communication port is 1. Verify the host system is
disabled due to multiple functional.
failures while attempting to 2. Re-enable host
establish communication communications.
with the remote system. 3. Cycle power to the SCC.
• Host is busy or not 4. Reconfigure the host
responding baud rate.
• Incorrect baud rate on 5. Re-enable the
host port Bidirectional host
4103 • Message response is option, after correcting
incorrectly defined for the baud rate.
the host 6. Refer to the m2000
Abbott Standard
Hardware failure. Cable Interface Guide for
from LIS to SCC (COM1) information about the
has a poor connection or ASTM protocol.
failed. 7. If problem persists,
contact your Area Abbott
Customer Service.
Received (NAK) for Incorrectly formatted Refer to the m2000
outgoing frame from LIS. record or message received Abbott Standard
4104 from the host. Interface Guide.
NAK = Negative
acknowledgement

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Maximum retries exceeded Unable to send frame to the 1. Refer to the m2000
for outgoing frame sent to remote system because the Abbott Standard
LIS. remote system sends a Interface Guide.
negative acknowledgement 2. Contact your Area
(NAK) for the frame Abbott Customer
received. Service.
• Incorrectly formatted
record or message
4105 received from the host
• Checksum is invalid
• Frame is not received in
sequence

Hardware failure. Cable


from LIS to SCC (COM1)
has a poor connection or
failed.
Time out on frame sent to System timed out waiting 1. Verify that the host
LIS. for confirmation that the system is functional.
remote system received a 2. Re-enable the host
frame. The connection is communication.
terminated by the system. 3. Cycle power to the SCC.
4106 • Host is busy or not 4. Refer to the m2000
responding Abbott Standard
• Message response is Interface Guide.
incorrectly defined for 5. Contact your Area
the host Abbott Customer
Service.
LIS connection cannot be • Host is busy or not 1. Verify the host system is
established, no response responding functional.
was received from the LIS. • Incorrect baud rate on 2. Re-enable host
host port. Reconfigure communications.
the host baud rate 3. Cycle power to the SCC.
4107 • Message response is 4. Refer to the m2000
incorrectly defined for Abbott Standard
the host Interface Guide.
5. Contact your Area
Abbott Customer
Service.

m2000rt Operations Manual 10-23


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


LIS connection cannot be System attempted to Wait for host system to
established, LIS is busy. connect with the remote become available.
system, but the remote
system was busy and
responded with a NAK.
4108
NAK = Negative
acknowledgement

• Host is busy.
LIS connection cannot be Both systems request a Refer to the m2000
established because of connection at the same Abbott Standard
contention. time by sending an ENQ Interface Guide.
4109 and this creates contention.

ENQ = Enquiry
The maximum number of Multiple failures while 1. Verify that the host
connection attempts has attempting to establish system is functional.
been reached for LIS. communication with the 2. Re-enable host
remote system. communications.
• Host is busy or not 3. Cycle power to the SCC.
responding 4. Refer to the m2000
• Incorrect baud rate on Abbott Standard
host port. Reconfigure Interface Guide.
4110 the host baud rate 5. Contact your Area
• Message response is Abbott Customer
incorrectly defined for Service.
the host

Hardware failure. Cable


from LIS to SCC (COM1)
has a poor connection or
failed.
Invalid checksum received • Frame received did not Refer to the m2000
in incoming frame from terminate in a carriage Abbott Standard
LIS. (NAK) has been sent. return Interface Guide.
4111
• Incorrectly formatted
NAK = Negative record or message
acknowledgement received from the host

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Incoming frame from LIS is • Frame received exceeds Refer to the m2000
too long. (NAK) has been ASTM length limit Abbott Standard
sent. • Incorrectly formatted Interface Guide.
4112
record or message
NAK = Negative received from the host
acknowledgement
Restricted character in Incorrectly formatted Refer to the m2000
message text from LIS. record or message received Abbott Standard
(NAK) has been sent. from the host. Interface Guide.
4113

NAK = Negative
acknowledgement
Invalid frame number • Record received did not Refer to the m2000
received from LIS. (NAK) contain the frame in Abbott Standard
has been sent. sequence Interface Guide.
4114
• Incorrectly formatted
NAK = Negative record or message
acknowledgement received from the host

No terminating (CR) in • Frame received did not Refer to the m2000


received frame from LIS. terminate in a carriage Abbott Standard
(NAK) has been sent. return Interface Guide.
4115 • Incorrectly formatted
CR = Carriage return record or message
received from the host
NAK = Negative
acknowledgement
No terminating (LF) in • Frame received did not Refer to the m2000
received frame from LIS. contain a terminating Abbott Standard
(NAK) has been sent. line feed Interface Guide.
4116 • Incorrectly formatted
LF = Line feed record or message
received from the host
NAK = Negative
acknowledgement

m2000rt Operations Manual 10-25


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Time out on incoming System timed out waiting 1. Verify that the host
frame from LIS. to receive a frame. The system is functional.
connection is terminated 2. Re-enable host
by the system. communications.
• Host is busy or not 3. Cycle power to the SCC.
responding 4. Refer to the m2000
• Message response is Abbott Standard
4117
incorrectly defined for Interface Guide.
the host 5. Contact your Area
Abbott Customer
Hardware failure. Cable Service.
from LIS to SCC (COM1)
has a poor connection or
failed.
Incoming connection from System can only transmit Refer to the m2000
LIS has been rejected, the results to the host. No Abbott Standard
4118
system does not support records can be received by Interface Guide.
test order download. the system.
Field (0) received from LIS • Data field in a record Refer to the m2000
is not repeatable. received contains an Abbott Standard
illegal repeat delimiter Interface Guide.
4119
0 = ASTM Field Number • Incorrectly formatted
record or message
received from the host
Required field (0) was not • Mandatory ASTM field Refer to the m2000
populated by LIS. was blank in the message Abbott Standard
received. The remainder Interface Guide.
of the message is ignored
4120 0 = ASTM Field Number by the system
• Incorrectly formatted
record or message
received from the host
Record (0) received from LIS • Incorrectly formatted 1. Refer to the m2000
did not terminate in a record or message was Abbott Standard
4121 carriage return. received from the host Interface Guide.
• Cabling was not properly 2. Use shorter or shielded
0 = ASTM Field Number shielded or was too long cable.

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Error detected when • An error was detected Refer to the m2000
parsing record (0) from LIS. when parsing an ASTM Abbott Standard
record received. The Interface Guide.
record may not utilize the
4122 0 = Record contents delimiters correctly
• Incorrectly formatted
record or message
received from the host
Data field (0) received from • Incorrectly formatted Refer to the m2000
LIS must be a numeric record or message Abbott Standard
value. received from the host Interface Guide.
4123
• Field can only contain
0 = Contents of field characters 0 - 9
containing the error
Data field (0) must be a • Incorrectly formatted Refer to the m2000
printable string. record or message Abbott Standard
received from the host Interface Guide.
4124
0 = Contents of field • Field can only contain
containing the error ASCII characters 32 - 126
and 128 - 254
Data field (0) must be a Incorrectly formatted Refer to the m2000
valid date. record or message received Abbott Standard
4125 from the host. Interface Guide.
0 = Contents of field
containing the error.
Message received from LIS • Host is busy or not 1. Verify the host system is
did not end with a responding functional.
terminator record. • Incorrectly formatted 2. Re-enable host
record or message communications.
received from the host 3. Cycle power to the SCC.
4126 • Hardware failure. Cable 4. Refer to the m2000
from LIS to SCC (COM1) Abbott Standard
has a poor connection or Interface Guide.
failed 5. Contact your Area
Abbott Customer
Service.

m2000rt Operations Manual 10-27


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Record (0) was received in • Message received without Refer to the m2000
message from LIS prior to a the Header record as the Abbott Standard
required header record. first record of the Interface Guide.
4127 message
0 = Record contents • Incorrectly formatted
record or message
received from the host
LIS sent illegal record type • Record received is an Refer to the m2000
(0). The remainder of the invalid record type not Abbott Standard
message will be ignored. defined by the ASTM Interface Guide.
4128 E1392 Standard
0 = Record type • Incorrectly formatted
record or message
received from the host
LIS sent an unsupported • Record received was valid Refer to the m2000
record type (0). The record ASTM format but is not Abbott Standard
will be ignored. supported by the system Interface Guide.
4129
• Unsupported record or
0 = Record type message received from
the host
LIS sent record (0) which • Message received Refer to the m2000
contained an incorrect contained a record which Abbott Standard
sequence number. was out of sequence Interface Guide.
4130
• Incorrectly formatted
0 = Record type record or message
received from the host
LIS sent record (0) which • Message received Refer to the m2000
contained an improper contained a record which Abbott Standard
level transition. caused an improper Interface Guide.
message hierarchy level
4131 transition
0 = Record type
• Incorrectly formatted
record or message
received from the host
Record received from LIS Incorrectly formatted Refer to the m2000
contained an invalid field record or message received Abbott Standard
4132 (0). from the host Interface Guide.

0 = Field type

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


LIS sent record (0) for a Record received from the Refer to the m2000
negative query response. host contains an invalid Abbott Standard
4133 query response Interface Guide.
0 = Record type
Invalid LIS2-A record (0) in Test Order message received Refer to the m2000
test order message. from the host contains an Abbott Standard
unacceptable ASTM record. Interface Guide.
Acceptable records in a Test
4134 0 = Record type
Order message: Header,
Patient, Test Order,
Comment, and Terminator
records.
Required data (0) is missing • The system received a 1. Install the requested
from message received from Test Order from the host application specification.
LIS. requesting an assay that Refer to Application
is not installed Management on page
• The assay number is 5–15 of Section 5,
4135 0 = Data type
incorrectly defined in the Operating
host Instructions.
2. Correct the assay
number in the host
system.
Length of data (0) received Incorrectly formatted Refer to the m2000
from LIS exceeded specified record or message received Abbott Standard
4136 maximum length. from the host Interface Guide.

0 = Data type
Data field (0) received from Incorrectly formatted Refer to the m2000
LIS must be an alpha value. record or message received Abbott Standard
4137 from the host Interface Guide.
0 = Data type
Data field (0) must be an Incorrectly formatted Refer to the m2000
alphanumeric value. record or message received Abbott Standard
4138 from the host Interface Guide.
0 = Data type

m2000rt Operations Manual 10-29


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Negative query response for • The Sample ID returned 1. Increase the host query
Sample ID (0), did not from the host did not timeout value.
match the Sample ID sent match the Sample ID 2. Refer to the m2000
to the host. queried for by the system Abbott Standard
• The host is responding to Interface Guide.
4139 0 = Sample ID a previous query, which
has timed out on the
system
• The host sent an order
not requested by the
system
Negative query response for • Negative query response 1. Increase the host query
Sample ID (0) received after message contained a timeout value.
a host query timeout. Sample ID which was 2. Refer to the m2000
different than the one Abbott Standard
contained in the earlier Interface Guide.
0 = Sample ID
issued query message
4140
• The host is responding to
a previous query, which
has timed out on the
system
• A query message was
never issued to the host
Orders received for Sample The Sample ID returned 1. Increase the host query
ID (0) did not match the from the host did not timeout value.
Sample ID sent to the LIS. match the Sample ID 2. Refer to the m2000
queried for by the system Abbott Standard
because: Interface Guide.
0 = Sample ID
• The host is responding to
4141
a previous query, which
has timed out on the
system
• The host sent an order
not requested by the
system
Invalid message sent by LIS. Incorrectly formatted Refer to the m2000
4142 record or message received Abbott Standard
from the host. Interface Guide.

10-30 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Result for Sample ID (0), • Communication failure. Refer to the m2000
Assay Id (1) could not be Retransmit the result Abbott Standard
transmitted to the LIS. • Host is not configured for Interface Guide.
4143 the expected result
0 = Sample ID format
1 = Assay ID
LIS results transmission User cancelled result No action required.
4144
canceled by the user. transmission to the host.
Unsupported character sent Record received from the 1. Refer to the m2000
to the LIS in a record. host containing a character Abbott Standard
Original: (0), Translated: not supported in the ASI Interface Guide.
4145 (1). Code page. This character is 2. Acceptable characters are
translated as the copyright defined in the ASI Code
symbol (© or code 0169). page.
0 = Original record
1 = Translated record
The system set the The system sets the code No action required.
character code page to (0) page for LIS interface.
4146 for the LIS interface. Currently two code pages
are supported: Windows
1252 and DOS 850.
0 = Code page
Assay (0) Calibration failed, User manually failed a valid No action required.
user manually failed the calibration.
4300 calibration.

0 = Assay name
Unable to fail calibration User tried to manually fail a No action required.
for Assay (0), calibration calibration, which was
4301 status is not valid. already in the failed state.

0 = Assay name
Unable to fail calibration User tried to manually fail a Wait until the run has
for Assay (0), an instrument calibration while an completed.
4302 is running. instrument was running.

0 = Assay name

m2000rt Operations Manual 10-31


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


File (0) does not exist. Software error Contact your Area Abbott
4400 Customer Service.
0 = File name
Unable to load XML result Software error Contact your Area Abbott
data set (0). Customer Service.
4401

0 = Data set name


CSV file is missing required Software error Contact your Area Abbott
4402
headers. Customer Service.
CSV file is missing required Software error Contact your Area Abbott
4403
fields. Customer Service.
CSV file is missing the Software error Contact your Area Abbott
4404
required Well column. Customer Service.
CSV file is missing the Software error Contact your Area Abbott
4405
required Dye column. Customer Service.
CSV record on line (0) had Software error Contact your Area Abbott
(2) fields but expected (1) Customer Service.
fields.

4406
0 = Line number
1 = Number of fields found
2 = Number of fields
expected
Unable to load CSV result Software error Contact your Area Abbott
data set (0). Customer Service.
4407

0 = Data set name


Unable to process results, Communication error or Reprocess and then repeat
4408 no read data available. user stopped the run before the run.
it had completed

10-32 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Unable to process results, Communication error Reprocess and then repeat
invalid number of reads (1). the run.
Expected reads (0).
4409
0 = Number of reads found
1 = Number of reads
expected
Unable to process results, Software error Contact your Area Abbott
unknown assay type (0). Customer Service.
4410

0 = Assay type
Unable to process results. Software error Contact your Area Abbott
4411
Customer Service.
Unable to process result, no Software error Contact your Area Abbott
4413 read data available for this Customer Service.
location.
Unable to process result, no Communication error Reprocess and then repeat
read data available for the the run.
detector dye (0) for this
4414 location.

0 = Dye name
Cutoff calibrator is out of • Sample preparation error 1. Repeat the run.
range. • Calibrator degradation 2. Ensure the calibrator is
4417 • Reagent degradation within date.
3. Check that the reagents
are within date.
Insufficient number of Insufficient number of Repeat the run with correct
Cutoff calibrator replicates replicates run on the plate number of Cutoff calibrator
4418
available. or one or more of the replicates.
replicates failed.
Insufficient number of The run is missing one or Repeat the run with correct
4419 Cutoff calibrator levels more defined Cutoff number of Cutoff calibrator
available. calibrator levels. levels.

m2000rt Operations Manual 10-33


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unable to process result, no Cutoff control was not Repeat the run with cutoff
Cutoff calibration available valid or was not found in controls.
4420 for reagent lot (0). the run.

0 = Reagent lot number


Insufficient number of The run is missing one or Add the correct number of
4421 control levels available. more defined control levels. control levels. Refer to the
assay package insert.
Insufficient number of One or more control Add the correct number of
4422 control replicates available. replicates were not found or control replicates. Refer to
were not valid. the assay package insert.
Negative control is reactive. • Sample contaminated 1. Ensure the negative
• Wrong sample was loaded control was identified
correctly.
2. For manual plate
preparation, ensure assay
controls were pipetted
into the proper wells.
3. Check for
4423 contamination. Refer to
the Fluorescence
Contamination Check
on page 9–13.
4. Refer to the appropriate
assay package insert for
further instructions on
precautions to avoid
contamination.

10-34 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Positive control is • Inhibition has occurred 1. Ensure the positive
non-reactive. • Wrong sample was loaded control identified
correctly.
2. For manual plate
preparation, ensure the
assay controls were
4424 pipetted into the proper
wells.
3. Refer to the appropriate
assay package insert for
further instructions on
precautions to avoid
inhibition.
Invalid result. Cycle • Sample contaminated 1. Rerun the sample.
4425 number is out of range. • Data abnormality 2. Check for
contamination.
Invalid result. Delta cycle Software error Contact your Area Abbott
4426
number is out of range. Customer Service.
Internal control cycle • Too much internal 1. Ensure correct amount
number is too low. Valid control added to lysis of internal control was
range is [(0), (1)]. • Internal control used.
amplicon contamination 2. Ensure the internal
4427 has occurred control is within date.
0 = Minimum internal
control range 3. Rerun the sample.
1 = Maximum internal
control range

m2000rt Operations Manual 10-35


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Internal control cycle • Sample preparation Verify the following, make
number is too high. Valid operator error: any necessary adjustments,
range is [(0), (1)]. insufficient internal and then rerun the plate:
control (IC) added to lysis
1. Verify the correct
buffer amount of IC is in the
0 = Minimum internal
control range • Sample preparation lysis.
instrument error: 2. Ensure the sample
1 = Maximum internal
control range – Reagent carryover preparation instrument
is functioning properly.
– Liquid handling errors,
If problems (e.g.,
such as too little, too
bubbles, liquid handling
much, or no liquid
errors, etc.) are observed,
detected (these errors
perform the
can be observed on
recommended daily
random wells)
maintenance.
• Sample-specific error 3. Refer to the assay
(inhibition) package insert to ensure
• Insufficient or incorrect • the specimen type is
assay reagent. (If errors acceptable
4428
appear in the last column • the sample handling
and/or in the bottom process (including
rows, it is likely the tube type, centrifuge
reagents are not parameters, sample
completely thawed.) volume, etc.) meets
the requirements.
4. Verify assay reagents are
thawed completely and
positioned correctly.
5. For manual master mix
preparation, ensure the
correct assay reagents
and calibrated pipettes
are used.

If the problem persists after


the plate is rerun, contact
your Area Abbott Customer
Service.

10-36 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Sample (0) is not a defined Wrong Sample ID entered. Ensure the correct
Qualitative assay calibrator. calibrator is being used
4429 and/or has been identified.
0 = Sample ID
Sample (0) is not a defined Wrong Sample ID entered. Ensure the correct control is
Qualitative assay control. being used and/or has been
4430 identified.
0 = Sample ID
Insufficient number of One or more calibrator 1. Ensure the correct
calibrator replicates replicates were not found or number of calibrator
available. were not valid. replicates were run.
4433 2. If one or more of the
calibrators was invalid
the calibration will need
to be repeated.
Insufficient number of The run is missing one or Ensure the correct number
4434 calibrator levels available. more defined calibrator of calibrator levels were
levels. run.
Unable to process result, no A calibration curve was not 1. Calibrate the assay.
calibration curve available available for the reagent lot 2. Rerun the samples.
4435 for reagent lot (0). in the run.

0 = Reagent lot number


Insufficient number of The run is missing one or Ensure the correct number
4436
control levels available. more defined control levels. of control levels were run.
Insufficient number of One or more control Ensure the correct number
4437 control replicates available. replicates were not found or of control replicates were
were not valid. run.

m2000rt Operations Manual 10-37


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Negative control is reactive. • Sample contamination 1. Ensure the negative
• Wrong sample loaded control was identified
correctly.
• Environmental
contamination, such as 2. For manual plate
what can occur when preparation, ensure assay
completed PCR plates are controls were pipetted
autoclaved instead of into the proper wells.
incinerated 3. Try new lot number of
controls.
4. Check for environmental
contamination as
4438 instructed in the assay
package insert. If
contamination occurred,
decontaminate the lab
and rerun the plate.
NOTE: To avoid
environmental
contamination,
always incinerate
completed PCR
plates. Never
autoclave them.
Positive control is • Wrong sample loaded 1. Ensure the positive
non-reactive. • Inhibition has occurred control was identified
correctly.
2. For manual plate
preparation, ensure assay
controls were pipetted
4439
into the proper wells.
3. Refer to the appropriate
assay package insert for
further instructions on
precautions to avoid
inhibition.

10-38 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Positive control • Wrong sample loaded 1. Ensure the positive
concentration is out of • Incorrect concentration control was correctly
range. was entered identified.
• Sample contamination 2. Ensure the correct
concentrations were
entered.
3. Perform the Fluorescence
Contamination Check
4440
on page 9–13 of Section
9, Service and
Maintenance.
4. Refer to the appropriate
assay package insert for
further instructions on
precautions to avoid
contamination.
Internal control cycle • Internal control 1. Perform the Fluorescence
number is too low. Valid amplicon contamination Contamination Check
range is [(0), (1)]. has occurred on page 9–13 of Section
• Incorrect amount of 9, Service and
internal control added to Maintenance.
4441
lysis 2. Ensure the correct
amount of internal
control was added to the
lysis.
3. Rerun the sample.

m2000rt Operations Manual 10-39


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Internal control cycle • Sample preparation Verify the following, make
number is too high. Valid operator error: any necessary adjustments,
range is [(0), (1)]. insufficient internal and then rerun the plate:
control (IC) added to lysis
1. Verify the correct
buffer amount of IC is in the
0 = Minimum internal
control range • Sample preparation lysis.
instrument error: 2. Ensure the sample
1 = Maximum internal
control range – Reagent carryover preparation instrument
is functioning properly.
– Liquid handling errors,
If problems (e.g.,
such as too little, too
bubbles, liquid handling
much, or no liquid
errors, etc.) are observed,
detected (these errors
perform the
can be observed on
recommended daily
random wells)
maintenance.
• Sample-specific error 3. Refer to the assay
(inhibition) package insert to ensure
• Insufficient or incorrect • the specimen type is
assay reagent. (If errors acceptable
4442
appear in the last column • the sample handling
and/or in the bottom process (including
rows, it is likely the tube type, centrifuge
reagents are not parameters, sample
completely thawed.) volume, etc.) meets
the requirements
4. Verify assay reagents are
thawed completely and
positioned correctly.
5. For manual master mix
preparation, ensure the
correct assay reagents
and calibrated pipettes
are used.

If the problem persists after


the plate is rerun, contact
your Area Abbott Customer
Service.

10-40 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Sample (0) is not a defined The sample ID is not Ensure the assay calibrator
Quantitative assay defined as a calibrator in is identified correctly.
4443 calibrator. the application
specification
0 = Sample ID
Sample (0) is not a defined The sample ID is not Ensure the assay control is
Quantitative assay control. defined as a control in the identified correctly.
4444 application specification
0 = Sample ID
Calibration curve validity • Calibrators misidentified Recalibrate assay
check failed. Slope is out of • Calibrator concentration confirming calibrator
4445 range. identification and
entered incorrectly
concentrations are correct.
• Sample preparation error
Calibration curve validity • Calibrators misidentified Recalibrate assay
check failed. Offset is out of • Calibrator concentration confirming calibrator
4446 range. identification and
entered incorrectly
concentrations are correct.
• Sample preparation error

m2000rt Operations Manual 10-41


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Insufficient level of (0) • Sample preparation error 1. Ensure the manually
reference dye. (manually entered Test entered Test Order
Order does not match the matches the actual
pipetted order) conditions on the
0 = Assay
• Insufficient or incorrect pipetted plate. When
assay reagent. (If errors running a new plate,
appear in the last column always ensure the correct
and/or in the bottom Test Order was created.
rows, it is likely the Do not include empty
reagents are not wells.
completely thawed.) 2. Verify assay reagents are
• Pipetting error in master thawed completely and
4447 mix preparation or plate positioned correctly.
preparation 3. Ensure the sample
preparation instrument
is functioning properly.
If problems (e.g.,
bubbles, liquid handling
errors, etc.) are observed,
perform the
recommended daily
maintenance.
4. If the problem persists,
contact your Area Abbott
Customer Service.
Excessive noise was • Bubbles in the well(s) 1. If present in only a few
detected in the (0) reference • Lamp instability or wells, rerun the sample.
signal. failure 2. If present in most or all
• Hardware failure wells, check lamp status
0 = Assay via <Overview>,
4448 <Instrument Status>.
3. Replace the lamp if
necessary.
4. If the problem persists,
contact your Area Abbott
Customer Service.
(0) data spike detected. Bubble in well(s) Rerun the sample.

4449
0 = Assay or internal
control

10-42 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Normalized fluorescence • Sample preparation Verify the following, make
too low instrument error: any necessary adjustments,
– Reagent carryover and then rerun the plate:
1. Ensure the sample
– Liquid handling errors,
preparation instrument
such as too little, too
is functioning properly.
much, or no liquid
If problems (e.g.,
detected (these errors
bubbles, liquid handling
can be observed on
errors, etc.) are observed,
random wells)
perform the
• Instrument error (well recommended daily
contamination in maintenance.
thermal block or PCR 2. Perform the Fluorescence
plate) Contamination Check
• Sample-specific error on page 9–13 of Section
(inhibition) 9, Service and
• Insufficient or incorrect Maintenance.
assay reagent. (If errors 3. If the Contamination
appear in the last column Check fails, perform the
4450 and/or in the bottom Clean the Thermal Block
rows, it is likely the procedure on page 9–20
reagents are not of Section 9.
completely thawed.) 4. Refer to the assay
package insert to ensure
• the specimen type is
acceptable
• the sample handling
process (including
tube type, centrifuge
parameters, sample
volume, etc.) meets
the requirements
5. Verify assay reagents are
thawed completely and
positioned correctly.
6. If the problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-43


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Filter exposure saturation Possible well 1. Perform the Fluorescence
detected for (0). contamination Contamination Check
on page 9–13 of Section
9, Service and
0 = Assay or internal
Maintenance.
control
4451 2. If the Contamination
Check fails, perform the
Clean the Thermal Block
procedure on page 9–20
of Section 9.
3. Rerun the sample.
Signal response exceeds • Possible well 1. Perform the Fluorescence
maximum ratio for (0). contamination Contamination Check
0 = Assay or internal • Baselining error on page 9–13 of Section
control 9, Service and
• Pure Dye calibration error
Maintenance.
2. If the Contamination
Check fails, perform the
Clean the Thermal Block
4452
procedure on page 9–20
of Section 9.
3. Perform the Pure Dye
Calibration on page 6–41
of Section 6,
Calibration
Procedures.
4. Rerun the sample.
Maximum cycle difference • Possible sample Rerun the sample.
between Ct and adjusted inhibition
FCN was exceeded for (0). • Possible pipetting error
4453
• Baselining error
0 = Assay or internal
control

10-44 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Half maximum ratio width • Sample-specific error Verify the following, make
to the peak FCN is out of (inhibition) any necessary adjustments,
range for (0). • Possible pipetting error and then rerun the plate:
• m2000sp instrument 1. Refer to the assay
0 = Assay or internal error (optical system package insert to ensure
control calibration problem) • the specimen type is
acceptable
• the sample handling
process (including
tube type, centrifuge
parameters, sample
volume, etc.) meets
4454
the requirements.
2. For manual plate
preparation, ensure the
correct volumes of
sample and master mix
were pipetted.
3. Recalibrate the Optical
Pure Dye with a new
Optical Calibration kit.
4. If the problem persists,
contact your Area Abbott
Customer Service.
Unable to process result, Abnormal response 1. Check plate wells to
instrument response is ensure all samples and
invalid. master mix were
dispensed.
4455
2. Repeat affected sample.
3. If problem persists,
contact your Area Abbott
Customer Service.
Unable to report result, Software error Contact your Area Abbott
4456 final concentration is Customer Service.
invalid.

m2000rt Operations Manual 10-45


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Internal control failed. • Sample preparation Verify or do the following,
instrument error: and then rerun the plate:
– Reagent carryover 1. Ensure the sample
preparation instrument
– Liquid handling errors,
is functioning properly.
such as too little, too
If problems (e.g.,
much, or no liquid
bubbles, liquid handling
detected (these errors
errors, etc.) are observed,
can be observed on
perform the
random wells)
recommended daily
• Sample-specific error maintenance.
(inhibition) 2. Refer to the assay
• Sample preparation package insert to ensure
operator error: the sample handling
insufficient internal process (including tube
control (IC) added to lysis type, centrifuge
buffer parameters, sample
• Insufficient or incorrect volume, etc.) meets the
assay reagent. (If errors requirements.
appear in the last column 3. Verify the correct
and/or in the bottom amount of IC is in the
4457 lysis.
rows, it is likely the
reagents are not 4. Verify assay reagents are
completely thawed.) thawed completely and
• Bubbles present in positioned correctly.
manually prepared PCR 5. For manual master mix
plates. preparation, ensure the
• Lamp failure correct assay reagents
and calibrated pipettes
are used.
6. For manually prepared
PCR plates, centrifuge as
directed by the assay
package insert.
7. If the error is present for
a significant number of
wells, and other
solutions have failed,
replace the lamp.
8. If the problem persists,
contact your Area Abbott
Customer Service.

10-46 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Internal control failed. • Sample preparation Verify the following, make
instrument error: any necessary adjustments,
– Reagent carryover and then rerun the plate:
1. Ensure the sample
– Liquid handling errors,
preparation instrument
such as too little, too
is functioning properly.
much, or no liquid
If problems (e.g.,
detected (these errors
bubbles, liquid handling
can be observed on
errors, etc.) are observed,
random wells)
perform the
• Sample-specific error recommended daily
(inhibition) maintenance.
• Sample preparation 2. Refer to the assay
operator error: package insert to ensure
insufficient internal the sample handling
control (IC) added to lysis process (including tube
buffer type, centrifuge
• Insufficient or incorrect parameters, sample
assay reagent. (If errors volume, etc.) meets the
4458 requirements.
appear in the last column
and/or in the bottom 3. Verify the correct
rows, it is likely the amount of IC is in the
reagents are not lysis.
completely thawed.) 4. Verify assay reagents are
• Bubbles present in thawed completely and
manually prepared PCR positioned correctly.
plates. 5. For manual master mix
preparation, ensure the
correct assay reagents
and calibrated pipettes
are used.
6. For manually prepared
PCR plates, centrifuge as
directed by the assay
package insert.
7. If the problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-47


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


(0) normalized fluorescence • Possible well 1. Perform the Fluorescence
too high. contamination Contamination Check
• Extraneous sample on page 9–13 of Section
fluorescence 9, Service and
0 = Assay or internal
Maintenance.
control
4459 2. If the Contamination
Check fails, perform the
Clean the Thermal Block
procedure on page 9–20
of Section 9.
3. Rerun the sample.
Assay (0) Calibration failed, One or more calibrator Rerun the sample with
insufficient number of replicates or levels failed or sufficient calibrator levels.
4460 calibrator levels available. is missing.

0 = Assay name
Assay (0) cutoff calculation Insufficient valid cutoff Rerun the sample with
failed. calibrators to process cutoff sufficient cutoff controls.
4461 calculation.
0 = Assay name
Assay (0) Calibration failed, • Calibrators misidentified Rerun with a new lot of
slope is out of range. • Calibrator concentration calibrator material.
4462
entered incorrectly
0 = Assay name • Sample preparation error
Assay (0) Calibration failed, • Calibrators misidentified Rerun with a new lot of
offset is out of range. • Calibrator concentration calibrator material.
4463
entered incorrectly
0 = Assay name • Sample preparation error
Invalid Cutoff calibrator • Wrong sample was 1. Check to ensure the
result, target not detected. processed cutoff calibrator was
4464
• Sample processing error identified correctly.
2. Repeat the run.
Invalid calibrator result, • Wrong sample was 1. Ensure the cutoff
target not detected. processed calibrator was identified
4465
• Sample processing error correctly.
2. Recalibrate the assay.

10-48 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Median calibrator internal • Possible internal control 1. Ensure the correct
control cycle number (0) is amplicon contamination amount of internal
4466 too low. • Incorrect amount of control was added to the
internal control added to lysis.
0 = Cycle number lysis 2. Recalibrate the assay.

Median calibrator internal • Sample preparation 1. Ensure the correct


control cycle number (0) is related inhibition amount of internal
4467 too high. • Insufficient or no internal control was added to the
control added to lysis lysis.
0 = Cycle number 2. Recalibrate the assay.

Single ratio maximum • Contamination by 1. Decontaminate the


above threshold at cycle 1 amplified product instrument and lab.
for (0). • Improper sample type 2. Use sample types as
4468 specified in package
0 = Assay or Internal inserts.
Control
Cycle number is out of • Contamination by 1. Decontaminate the
range for (0). amplified product instrument and lab.
4469 • Improper sample type 2. Use sample types as
0 = Assay or Internal specified in package
Control inserts.

Unable to process results, m2000rt application is Contact your Area Abbott


could not load result data configured for Data Customer Service.
4470 file (0). Reduction simulation mode

0 = Data file
Reagent configuration is Software error Contact your Area Abbott
4471
undefined for the well. Customer Service.
Reagent configuration (0) is Software error Contact your Area Abbott
undefined for the Customer Service.
4472 application specification.

0 = Reagent configuration
Assay is not defined for the Software error Contact your Area Abbott
4473
Application specification. Customer Service.

m2000rt Operations Manual 10-49


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Assay (0)/(1) is not Software error Contact your Area Abbott
compatible with reagent Customer Service.
configuration (2).
4474
0 = Assay name
1 = Version
2 = Reagent configuration
Sample (0) is not a defined Software error Contact your Area Abbott
Open assay calibrator. Customer Service.
4475

0 = Sample
Sample (0) is not a defined Software error Contact your Area Abbott
Open assay control. Customer Service.
4476

0 = Sample name
Genotype data error (0). Software error Contact your Area Abbott
4477 Customer Service.
0 = Data error
Sample (0) is not a defined Software error Contact your Area Abbott
Genotype control. Customer Service.
4478

0 = Sample name
Internal control failed, Positive or negative Repeat the run.
insufficient valid replicates controls have insufficient
available (0) to compute number of valid internal
4479 median. controls.

0 = Number of available
valid replicates

10-50 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Internal control failed, • Sample preparation error 1. Check sample integrity;
cycle number is out of • Possible sample centrifuge sample if
range [(0), (1)]. inhibition particulates are observed.
• Incorrect amount of 2. Check sample collection
0 = Low end of range internal control added to tube type. Refer to assay
lysis package insert for
1 = High end of range
4480 acceptable collection
tube types.
3. Ensure the correct
amount of internal
control was added to the
lysis.
4. Rerun the sample.
Internal control is • Sample preparation error 1. Check sample integrity;
non-reactive. • Possible sample centrifuge sample if
inhibition particulates are observed.
• No internal control 2. Check sample collection
added to lysis tube type. Refer to assay
package insert for
4481 acceptable collection
tube types.
3. Ensure the correct
amount of internal
control was added to the
lysis.
4. Rerun the sample.
Internal control failed. • Sample preparation error 1. Ensure the correct
• Possible sample amount of internal
4482 inhibition control was added to the
lysis.
• No or incorrect internal
control added to lysis 2. Rerun the sample.

Internal control failed. • Sample preparation error 1. Ensure the correct


• Possible sample amount of internal
4483 inhibition control was added to the
lysis.
• No internal control
added to lysis 2. Rerun the sample.

m2000rt Operations Manual 10-51


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Genotype (0) is reactive. • Contamination 1. Decontaminate
• Misidentified sample instrument and lab.
2. Use sample types as
4484 0 = Genotype name
specified in package
inserts.
3. Repeat the run.
Unable to process result, Negative control(s) not Repeat the run.
4485 negative control was not present on plate
found.
Insufficient number of • Negative control(s) not Repeat the run.
4486 negative control replicates present on plate
available. • Negative control(s) failed
Negative control failed. • Sample preparation error 1. Decontaminate the
• Misidentified negative instrument and lab.
control 2. Make sure to correctly
4487
• Contamination present identify negative
control.
3. Repeat the run.
Unable to process result, Positive control(s) not Repeat the run.
4488 positive control was not present on plate
found.
Insufficient number of • Positive control(s) not Repeat the run.
4489 positive control replicates present on plate
available. • Positive control(s) failed
Positive control failed. • Sample preparation error 1. Make sure to correctly
• Possible sample identify positive control.
inhibition 2. Ensure correct amount
4490
• Misidentified positive of internal control added
control to lysis.
3. Repeat the run.
Genotype (0) is reactive. • Contamination 1. Decontaminate the
• Misidentified positive instrument and lab.
4491 0 = Genotype name control 2. Make sure to correctly
identify positive control.
3. Repeat the run.

10-52 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Genotype (0) is • Sample preparation error 1. Make sure to correctly
non-reactive. • Misidentified positive identify positive control.
4492
control 2. Repeat the run.
0 = Genotype name • Sample inhibition
Genotype (0) is • Contamination 1. Decontaminate the
non-reactive and Genotype • Misidentified positive instrument and lab.
(1) is reactive. control 2. Make sure to correctly
identify positive control.
4493
0 = Non-reactive Genotype 3. Repeat the run.
name
1 = Reactive Genotype
name
Genotype control (0) cycle • All signals are out of 1. Decontaminate the
number is out of range [(1), range instrument and lab.
(2)]. • Sample inhibition 2. Make sure to correctly
4494 • Misidentified positive identify positive control.
0 = Control name control 3. Repeat the run.
1 = Low end of range • Contamination
2 = High end of range
Genotype control (0) is
• All signals are 1. Make sure to correctly
non-reactive. non-reactive identify positive control.
4495 • Sample inhibition 2. Repeat the run.
0 = Genotype control name • Misidentified positive
control
Internal control failed. • Sample preparation error 1. Check sample integrity;
• Possible sample centrifuge sample if
inhibition particulates are observed.
• No or incorrect internal 2. Check sample collection
control added to lysis tube type. Refer to assay
package insert for
4496 acceptable collection
tube types.
3. Ensure the correct
amount of internal
control was added to the
lysis.
4. Rerun the sample.

m2000rt Operations Manual 10-53


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unable to process results, Software error Contact your Area Abbott
unknown derived assay Customer Service.
4497 type (0).

0 = Assay type
Invalid Quantitative assay Software error Contact your Area Abbott
4498 calibrator, concentration is Customer Service.
undefined.
Internal control failed, • Sample preparation error 1. Ensure the correct
insufficient valid control IC • Possible sample amount of internal
4499 values (0). inhibition control was added to the
lysis.
• No or incorrect internal
0 = Number of IC values control added to lysis 2. Repeat the run.

(0) calibration failed on This message is issued on 1. Shutdown software in a


instrument (1) due to an startup when the software normal fashion and then
abnormal system was shutdown Restart software.
shutdown. unexpectedly, or the SCC 2. Rerun the system
4500 was turned off while a calibration.
system calibration was
0 = Calibration name
running.
1 = Instrument serial
number
(0) calibration failed. The instrument was not in 1. Initialize the instrument.
Instrument (1) is not ready. the READY state when user 2. Verify that the
tried to initiate the instrument is in the
4501 calibration. READY state.
0 = Calibration name
1 = Instrument serial 3. Initiate calibration.
number
(0) calibration failed. The instrument was either 1. Initialize the instrument.
Instrument (1) is not stopped or lost 2. Verify that the
running. communication after user instrument is in the
4502 initiated a system READY state.
calibration. 3. Initiate calibration.
0 = Calibration name
1 = Instrument serial
number

10-54 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Instrument (0) is already An attempt was made to Either STOP or WAIT for the
executing a process. run an instrument that was process currently running
4503 already running another before initiating another
process. process.
0 = Instrument serial
number
(0) calibration failed. Dependent calibrations are Perform required
Required (1) calibration is missing. calibrations and then
not available. perform the calibration in
question. Refer to
Section 6, Calibration
0 = Calibration name
Procedures.
1 = Calibration name
• Region of Interest (ROI)
4504 Calibration on page 6–7
• Background Calibration
on page 6–17
• Uniformity Calibration
on page 6–33
• Pure Dye Calibration on
page 6–41
(0) calibration failed. The instrument was not in 1. Initialize the instrument.
Instrument (1) is not the STOPPED or READY 2. Start the calibration
Stopped or Ready. state when a calibration procedure.
4505 was initiated.
0 = Calibration name
1 = Instrument serial
number
Lamp calibration failed. The instrument did not 1. Cycle the instrument
complete the initialization power.
and therefore failed the 2. Reinitialize the
system calibration. instrument.
4506
3. Start the Lamp
Calibration on page 9–46
of Section 9, Service
and Maintenance.
Lamp calibration Lamp was successfully No action required.
4507
successful. calibrated.

m2000rt Operations Manual 10-55


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


(0) assay run failed. • Tray drawer was opened 1. Review the Message
Instrument (1) is not • User selected Stop History Log for
running. associated failure
• Hardware failure
4600 messages.
• Communication error
0 = Assay name 2. Initialize the instrument.
1 = Instrument serial 3. Discard the PCR plate.
number 4. Run the assay again.

PCR Run failed. Instrument The instrument was not in 1. Initialize the instrument.
(0) is not ready. READY state when user 2. Verify that the
4601 tried to initiate calibration. instrument is in the
0 = Instrument serial READY state.
number 3. Initiate calibration.
(0) instrument is not The instrument is not Calibrate instrument. Refer
calibrated. calibrated. to Section 6, Calibration
Procedures.
0 = Instrument serial • Region of Interest (ROI)
number Calibration on page 6–7
4602 • Background Calibration
on page 6–17
• Uniformity Calibration
on page 6–33
• Pure Dye Calibration on
page 6–41
Instrument (1) dye (0) is Dye required by the assay Calibrate required dye
not calibrated. has not been calibrated. before initiating assay. Refer
to the assay package insert
for specific dye to calibrate,
4603 0 = Dye name
and refer to Pure Dye
1 = Instrument serial Calibration on page 6–41 of
number Section 6, Calibration
Procedures.
Instrument (0) is already The instrument is running Either stop the current
executing a process. another process. process or wait for it to
4604 finish before proceeding
with another process.
0 = Instrument serial
number

10-56 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Instrument (0) is already The instrument is running Either stop the current
executing a process. another process. process or wait for it to
4605 finish before proceeding
with another process.
0 = Instrument serial
number
Application with ID (0) and Specified application is not Install the required
version (1) is not found. installed. application specification.

4606
0 = Application
specification
1 = Application version
Test Order ID (0) is not Software error 1. Export Test Order files
found. again from the m2000sp.
2. Reinstall Test Order files
0 = Test Order ID in the appropriate
directory location.
4607
3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Failed to create result Software error 1. Export Test Order files
records from a test order id again from the m2000sp.
(0). 2. Reinstall Test Order files
in the appropriate
directory location.
4608 0 = Test Order ID
3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
Contamination check Contamination Check was Be sure the instrument is in
failed. Instrument (0) is not initiated and the system the READY or STOPPED
4609 Ready or Stopped. was not in the READY or state before initiating the
STOPPED state. Contamination Check.
0 = Instrument status

m2000rt Operations Manual 10-57


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Contamination check User attempted to start a 1. Calibrate instrument.
failed. Instrument (0) Contamination Check and Refer to Section 6,
Region of Interest is not the Region of Interest (ROI) Calibration
calibrated. calibration is not active. Procedures.
• Region of Interest
0 = Instrument Region of (ROI) Calibration on
Interest status page 6–7
• Background
Calibration on page
6–17
4610
• Uniformity
Calibration on page
6–33
• Pure Dye Calibration
on page 6–41
2. Run the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
Unable to process result, • Possible sample Rerun the sample.
signal response is inhibition
4900 abnormal.
• Non-specific
amplification
Negative control failed. • Sample preparation error Repeat the run.
• Misidentified negative
4901
control
• Contamination present
Unable to process result, Negative control(s) not Repeat the run.
4902 negative control was not present on plate
found.
Positive control failed. • Sample preparation error Repeat the run.
• Possible sample
4903 inhibition
• No internal control
added to lysis

10-58 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Unable to process result, Positive control(s) not Repeat the run.
4904 positive control was not present on plate
found.
Unable to process result, 1. Insufficient or no master 1. Verify the correct
response dye intensity is mix added to the well. amount of master mix is
too low. 2. The parameter is set too present in the well.
high. 2. Assess normal
3. Sample preparation error background fluorescence
4905 (e.g., lysis carryover). levels and set the
parameter low enough to
flag normal responses.
3. Ensure sample
preparation is performed
correctly.
Unable to process result, 1. Insufficient or no master 1. Verify the correct
reference dye intensity is mix added to the well. amount of master mix is
too low. 2. The parameter is set too present in the well.
high. 2. Assess normal
3. Sample preparation error background fluorescence
4906 (e.g., lysis carryover). levels and set the
parameter low enough to
flag normal responses.
3. Ensure sample
preparation is performed
correctly.
Unable to process result, 1. Inhibition has occurred. 1. Verify sample integrity
Log Signal to Noise ratio is 2. The signal to noise and ensure sample
too low. parameter is set too preparation is performed
high. correctly.
4907 2. Assess normal positive
LogSN levels and set the
parameter low enough to
not flag normal
responses.
Unable to process result, Software error Contact your Area Abbott
required parameter (0) is Customer Service.
4908 not defined.

0 = Undefined parameter

m2000rt Operations Manual 10-59


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unable to process results, Software error Contact your Area Abbott
error occurred (0) during Customer Service.
4909 response processing.

0 = Specific error message


Unable to process results, Software error Contact your Area Abbott
script error occurred (0) Customer Service.
4910 during response processing.

0 = Script error
Unable to process results, Software error Contact your Area Abbott
script error occurred (0) Customer Service.
4911 during assay processing.

0 = Script error
Unable to process results, Software error Contact your Area Abbott
error occurred (0) during Customer Service.
4912 assay processing.

0 = Specific error message


Script error (0) code (1) is Software error Contact your Area Abbott
outside the supported error Customer Service.
range.
4913
0 = Script error
1 = Code
Undefined script error Software error Contact your Area Abbott
4914
occurred. Customer Service.
Unable to report result, An error occurred in data Review alternate unit
outcome was not defined. reduction. Result is outside formula. Verify whether the
4915
boundaries. generated calibration curve
is valid.
Result excluded from User selected the result in Status message.
calculation by user. the <PCR Plate Analysis> If the well needs to be
4916 screen and manually reanalyzed, highlight the
excluded it. well and select <Include>.

10-60 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Unable to process result, 1. Bubbles in the well or 1. Centrifuge the plate.
Baseline standard deviation droplets on the adhesive 2. Adjust baselining
is too high. cover causing parameters.
discontinuities. (This 3. If the problem persists,
4917 would occur in certain the instrument might
wells only.) require service. Contact
2. Misbaselining might your Area Abbott
have occurred. Customer Service.
3. Hardware problem.
Unable to process results, User deleted the assay Status message.
4918
assay has been deleted. associated with the result.
Expression evaluation error This is an assay-specific Refer to the assay package
occurred: (0) error. insert for information.
4920

0 = Error
Negative Control is • Sample contamination 1. Ensure the negative
reactive. • Wrong sample loaded control was identified
correctly.
• Environmental
contamination, such as 2. For manual plate
what can occur when preparation, ensure assay
completed PCR plates are controls were pipetted
autoclaved instead of into the proper wells.
incinerated 3. Try new lot number of
controls.
4. Check for environmental
contamination as
4921 instructed in the assay
package insert. If
contamination occurred,
decontaminate the lab
and rerun the plate.
NOTE: To avoid
environmental
contamination,
always incinerate
completed PCR
plates. Never
autoclave them.

m2000rt Operations Manual 10-61


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Positive Control is out of • Wrong sample loaded 1. Ensure the positive
range (0), (1). • Incorrect concentration control was correctly
was entered identified.
0 = Start of range • Sample contamination 2. Ensure the correct
concentrations were
1 = End of range
entered.
3. Perform the Fluorescence
Contamination Check
4922
on page 9–13 of Section
9, Service and
Maintenance.
4. Refer to the appropriate
assay package insert for
further instructions on
precautions to avoid
contamination.
Positive Control is • Wrong sample loaded 1. Ensure the positive
non-reactive. • Inhibition has occurred control was identified
correctly.
2. For manual plate
preparation, ensure assay
controls were pipetted
4923
into the proper wells.
3. Refer to the appropriate
assay package insert for
further instructions on
precautions to avoid
inhibition.
Positive Control is reactive. • Positive control was out 1. Ensure the positive
of range control was identified
• Wrong sample loaded correctly.
• Inhibition has occurred 2. For manual plate
preparation, ensure assay
• Sample contaminated
controls were pipetted
4924
into the proper wells.
3. Refer to the appropriate
assay package insert for
further instructions on
precautions to avoid
inhibition.

10-62 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Median calibrator internal m2000rt instrument error 1. Recalibrate the Optical
control cycle number (optical system calibration Pure Dye with a new
difference (0) is out of range problem) Optical Calibration Kit.
[(1), (2)]. Refer to Pure Dye
Calibration on page 6–41
4925 0 = Cycle number of Section 6,
Calibration
difference
Procedures.
1 = Beginning of range
2. If the problem persists,
2 = End of range contact your Area Abbott
Customer Service.
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4626 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4927 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4928 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4929 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4930 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4931 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4932 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4933 error. insert for information.
0 = Error

m2000rt Operations Manual 10-63


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Assay-specific error: (0) This is an assay-specific Refer to the assay package
4934 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4935 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4936 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4937 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4938 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4939 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4940 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4941 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4942 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4943 error. insert for information.
0 = Error
Assay-specific error: (0) This is an assay-specific Refer to the assay package
4944 error. insert for information.
0 = Error

10-64 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Assay-specific error: (0) This is an assay-specific Refer to the assay package
4945 error. insert for information.
0 = Error
Negative control failed. • Sample contamination 1. Ensure the negative
• Wrong sample loaded control was identified
correctly.
• Environmental
contamination, such as 2. For manual plate
what can occur when preparation, ensure assay
completed PCR plates are controls were pipetted
autoclaved instead of into the proper wells.
incinerated 3. Try new lot number of
controls.
4. Check for environmental
contamination as
4946 instructed in the assay
package insert. If
contamination occurred,
decontaminate the lab
and rerun the plate.
NOTE: To avoid
environmental
contamination,
always incinerate
completed PCR
plates. Never
autoclave them.
Unable to process result, Negative control was not Repeat the run with
4947 negative control was not found in the run. negative controls.
found.
Unable to process result, • Sample preparation error Repeat the run.
negative control internal • Possible sample
4948 control failed. inhibition
• No internal control
added to lysis
Positive control failed. • Sample preparation error Repeat the run.
• Possible sample
4949 inhibition
• No internal control
added to lysis

m2000rt Operations Manual 10-65


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Quantitative Message: Calibration curve failed or a • Reanalyze calibration
Unable to process result, no curve did not exist at the data if available.
calibration curve available time the plate was • Repeat the run with
for reagent lot (0). processed. calibrators.

4950
0 = Reagent lot number
Qualitative Message: The positive control needed Repeat the run with the
Unable to process results, to generate the assay cutoff required number of positive
no Positive Control was was not found on the plate. controls
found on the plate.
Internal control is • Sample preparation error 1. Check sample integrity;
non-reactive. • Possible sample centrifuge sample if
inhibition particulates are observed.
4951 • No internal control 2. Ensure the correct
added amount of internal
control was added.
3. Rerun the sample.
Internal control failed, • Sample preparation error 1. Check sample integrity;
Cycle Number is out of • Possible sample centrifuge sample if
range [(0), (1)]. inhibition particulates are observed.
• Incorrect amount of 2. Ensure the correct
4952
0 = Low end of range internal control added to amount of internal
lysis control was added to the
1 = High end of range
lysis.
3. Rerun the sample.
Quantitative Message: The run is missing one or Ensure the correct number
Insufficient number of more defined calibrator of calibrator levels were
calibrator levels available. levels. run.

Cycle Number or • Inhibition has occurred 1. Ensure the positive


Qualitative Message: • Wrong sample was loaded control was identified
4953 correctly.
Positive control is
non-reactive. 2. For manual plate
preparation, ensure assay
controls were pipetted
into the proper wells.
3. Repeat the run.

10-66 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Quantitative Message: • Inhibition has occurred 1. Ensure the calibrator was
Calibrator is non-reactive. • Wrong sample was loaded identified correctly.
2. For manual plate
preparation, ensure assay
controls were pipetted
into the proper wells.
3. Repeat the run.
4954 Cycle Number or • Sample preparation error 1. Repeat the run.
Qualitative Message: • Calibrator degradation 2. Ensure the calibrator is
Positive control failed, • Reagent degradation within date.
Cycle Number is out of 3. Check that the reagents
range [(0), (1)]. are within date.

0 = Low end of range


1 = High end of range
Quantitative Message: • Sample contaminated 1. Rerun the sample.
Calibrator failed, Cycle • Data abnormality 2. Check for
Number is out of range [(0), contamination.
(1)].

0 = Low end of range


1 = High end of range
4955
Cycle Number or • Positive control(s) not Repeat the run.
Qualitative Message: present on plate
Positive control failed, • Positive control(s) failed
insufficient number of valid
replicates (0).

0 = Number of replicates

m2000rt Operations Manual 10-67


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Quantitative Message: One or more calibrator 1. Ensure the correct
Insufficient number of replicates were not found or number of calibrator
valid calibrator level were not valid. replicates were run.
replicates (0). 2. If one or more of the
calibrators was invalid
the calibration will need
0 = Number of replicates
4956 to be repeated.
Cycle Number or • Sample preparation error 1. Make sure to correctly
Qualitative Message: • Possible sample identify positive control.
Positive control failed. inhibition 2. Ensure correct amount
• Misidentified positive of internal control added
control to lysis.
3. Repeat the run.

10-68 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Quantitative Message: One or more calibrator 1. Ensure the correct
Insufficient number of replicates were not found or number of calibrator
valid calibrator level (0) were not valid. replicates were run.
replicates (1). 2. If one or more of the
calibrators was invalid
the calibration will need
0 = Calibrator level
to be repeated.
1 = Number of replicates
Cycle Number or • Sample contamination 1. Ensure the negative
Qualitative Message: • Wrong sample loaded control was identified
Negative control is reactive. • Environmental correctly.
contamination, such as 2. For manual plate
what can occur when preparation, ensure assay
completed PCR plates are controls were pipetted
4957 autoclaved instead of into the proper wells.
incinerated 3. Try new lot number of
controls.
4. Check for environmental
contamination. If
contamination occurred,
decontaminate the lab
and rerun the plate.
NOTE: To avoid
environmental
contamination,
always incinerate
completed PCR
plates. Never
autoclave them.
Quantitative Message: Software error Contact your Area Abbott
Computed Calibrator Customer Service.
concentration is invalid.
Cycle Number or • Negative control(s) not Repeat the run.
Qualitative Message: present on plate
4958 Negative control failed, • Negative control(s) failed
insufficient number of valid
replicates (0).

0 = Number of valid
replicates

m2000rt Operations Manual 10-69


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Quantitative Message: • Calibrators misidentified Recalibrate assay
Calibrator Log • Calibrator concentration confirming calibrator
concentration difference (0) entered incorrectly identification and
from Target Log concentrations are correct.
• Sample preparation error
concentration exceeds
maximum.

4959 0 = Concentration
difference
Cycle Number or • Sample preparation error 1. Decontaminate the
Qualitative Message: • Misidentified negative instrument and lab.
Negative control failed. control 2. Make sure to correctly
• Contamination present identify negative
control.
3. Repeat the run.
Quantitative Message: Software error Contact your Area Abbott
Unable to calculate linear Customer Service.
calibration model.
Cycle Number or • Sample contaminated 1. Rerun the sample.
Qualitative Message: • Data abnormality 2. Check for
4960
Target Cycle Number is out contamination.
of range [(0), (1)].

0 = Low end of range


1 = High end of range

10-70 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Quantitative Message: • Calibrators misidentified Recalibrate assay
Invalid calibration model, • Calibrator concentration confirming calibrator
slope (0) is out of range [(1), entered incorrectly identification and
(2)]. concentrations are correct.
• Sample preparation error

0 = Slope
1 = Low end of range
4961 2 = High end of range
Qualitative Message: Software error Contact your Area Abbott
DC value is invalid. Customer Service.

Cycle Number Message: • Sample preparation error Repeat the run.


Negative control failed, • Possible sample
cycle number is below inhibition
negative control cycle limit. • No internal control
added to lysis
Invalid calibration model, • Calibrators misidentified Recalibrate assay
intercept (0) is out of range • Calibrator concentration confirming calibrator
[(1), (2)]. entered incorrectly identification and
concentrations are correct.
4962 • Sample preparation error
0 = Intercept
1 = Low end of range
2 = High end of range

m2000rt Operations Manual 10-71


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


General Message: • Sample contamination 1. Ensure the negative
Negative control is reactive. • Wrong sample loaded control was identified
correctly.
• Environmental
contamination, such as 2. For manual plate
what can occur when preparation, ensure assay
completed PCR plates are controls were pipetted
autoclaved instead of into the proper wells.
incinerated 3. Try new lot number of
controls.
4. Check for environmental
contamination. If
contamination occurred,
decontaminate the lab
4963 and rerun the plate.
NOTE: To avoid
environmental
contamination,
always incinerate
completed PCR
plates. Never
autoclave them.
Assay-Specific Message: Incomplete or incorrect Ensure the three PCR
Three contiguous replicates manual sample setup or replicates for each sample
are required for each m2000rt test order setup. are pipetted, or Test Order
aliquot. setup, in replicates of three
in adjacent wells across the
plate.
Negative control failed, • Negative control(s) not Repeat the run.
insufficient number of valid present on plate
replicates (0). • Negative control(s) failed
4964

0 = Number of valid
replicates
Negative control failed. • Sample preparation error 1. Decontaminate the
• Misidentified negative instrument and lab.
control 2. Make sure to correctly
4965
• Contamination present identify negative
control.
3. Repeat the run.

10-72 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Target Cycle Number is out • Sample contaminated 1. Rerun the sample.
of range [(0), (1)]. • Data abnormality 2. Check for
4966 contamination.
0 = Low end of range
1 = High end of range
Computed concentration is • Invalid calibration model • Add/check calibration
invalid. leading to computed validity parameters
concentration < 0 or (slope/offset).
Infinity • Constrain calibration
• Reported result does not model with ULQ/LOD.
fit in database field (> 100 • Check for division by
characters); it is outside zero.
4967 of support range
• If issue persists, contact
• Invalid unit conversion your Area Abbott
formula leading to Customer Service.
invalid floating point
value
• Unknown error leading
to invalid floating point
value.
Positive control is • Inhibition has occurred 1. Ensure the positive
non-reactive. • Wrong sample was loaded control was identified
correctly.
2. For manual plate
4968
preparation, ensure assay
controls were pipetted
into the proper wells.
3. Repeat the run.
Positive control failed, • Wrong sample loaded 1. Ensure the positive
concentration is out of • Incorrect concentration control was correctly
range [(0), (1)]. was entered identified.
• Sample contamination 2. Perform the
4969 0 = Low end of range Contamination Check
in Section 9, Service
1 = High end of range
and Maintenance, of
the m2000rt
Operations Manual

m2000rt Operations Manual 10-73


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Positive control failed, • Positive control(s) not Repeat the run.
insufficient number of valid present on plate
replicates (0). • Positive control(s) failed
4970

0 = Number of valid
replicates
Positive control failed. • Sample preparation error 1. Make sure to correctly
• Possible sample identify positive control.
inhibition 2. Ensure correct amount
4971
• Misidentified positive of internal control added
control to lysis.
3. Repeat the run.
Positive control failed, Positive control(s) not Repeat the run.
insufficient number of valid present on plate
4972 levels (0).

0 = Number of valid levels


Invalid calibration model, • Calibrators misidentified Recalibrate assay
measure of fit (0) is less • Calibrator concentration confirming calibrator
than minimum required entered incorrectly identification and
4973 (1). • Sample preparation error
concentrations are correct.

0 = Current measure of fit


1 = Required measure of fit
Unable to process result, Positive control was not Repeat the run with
4990 positive control was not valid or was not found in positive controls.
found. the run.
Unable to process result, • Sample preparation error Repeat the run.
positive control internal • Possible sample
4991 control failed. inhibition
• No internal control
added to lysis

10-74 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Positive Control Cycle • Wrong sample loaded 1. Ensure the positive
Number ({0}) outside of • Incorrect concentration control was correctly
valid range ({1}, {2}) was entered identified.
• Sample contamination 2. Ensure the correct
0 = Positive Control Cycle concentrations were
Number entered.
1 = Start of range 3. Perform the Fluorescence
Contamination Check
4992 2 = End of range
on page 9–13 of Section
9, Service and
Maintenance.
4. Refer to the appropriate
assay package insert for
further instructions on
precautions to avoid
contamination.
Assay-specific error: {0} This is an assay-specific Refer to the assay package
4993 error. insert for information.
0 = Error
Assay-specific error: {0} This is an assay-specific Refer to the assay package
4994 error. insert for information.
0 = Error
Assay-specific error: {0} This is an assay-specific Refer to the assay package
4995 error. insert for information.
0 = Error
Assay-specific error: {0} This is an assay-specific Refer to the assay package
4996 error. insert for information.
0 = Error
Assay-specific error: {0} This is an assay-specific Refer to the assay package
4997 error. insert for information.
0 = Error

m2000rt Operations Manual 10-75


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unable to perform a The instrument is in one of Allow the instrument to
shutdown. Instrument is the following states: come to the STOPPED,
not in an idle state. INITIALIZING, RUN READY, or OFFLINE state
INITIALIZATION, or before exiting the
5000 RUNNING. The system application.
does not allow exit from
the application while the
instrument is in one of
these states.
Unable to communicate Communication error 1. Cycle power on the SCC.
5001 with the m2000rt server. 2. Retry process.
System is shutting down.
User (0) logged off. User logged off the system. No action required.
5002
0 = User ID
The m2000rt application FSE accessed the MTSS No action required.
5003 will now shutdown and software
launch MTSS.
MTSS application (0) does Software error Contact your Area Abbott
not exist. Customer Service.
5004

0 = MTSS application
Unable to import test order, The maximum number of 1. Check pending Test
the maximum number of Test Orders in the pending Order list for Test
test orders has been list has been attained. Order(s) still to be run.
5101 reached. Delete some
2. Delete Test Orders that
pending test orders and will be unused.
then try the import again. 3. Import new Test Order.
Unable to import test order. NEXT was selected after the 1. Check that the correct
The directory does not CD was removed or before directory was selected.
5102
exist. the CD was placed in the 2. Import Test Order from
drive. correct directory.

10-76 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Unable to read Test Order Directory or file not found. 1. Export Test Order files
files from the selected again from the m2000sp.
directory. 2. Reinstall Test Order files
in the appropriate
directory location.
5103
3. Attempt Test Order
import again.
4. If import fails again,
manually create Test
Order.
The test order file selected The user has imported an Data required for the Open
for import does not contain Open Mode Test Order from Mode Test Order must be
5104 all required information. the m2000sp to the m2000rt supplied by the user in the
Please provide the missing system. following screens.
information.
Unable to edit the test The user was attempting to Manually create a Test
order. A Test Order of type edit a Test Order imported Order.
(0) exported from m2000sp from the m2000sp on the
5107 cannot be edited on the m2000rt system.
m2000rt system.

0 = Test Order type


PCR Plate Name (0) entered A Test Order with the same Enter a unique plate name
already exists in the PCR plate name exists in or delete the pending order.
5108 pending test orders list. the pending list.

0 = Invalid PCR Plate Name


Unable to run the test The instrument is not in Initialize the instrument to
5109 order, the instrument is not the READY state. bring it to the READY state.
in the Ready state.
Unable to create test order, The pending Test Order list 1. Delete some Test Orders
maximum number of test has reached its maximum from the pending list.
orders has been reached. capacity. 2. Try creating the Test
5113
Delete some pending test Order again.
orders, then try the create
again.

m2000rt Operations Manual 10-77


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unable to import the test Test order was deleted from Return to the m2000sp and
order. The file does not the Network Data Store on re-export the Test Order,
5114 exist. another system when the then try to import the Test
test order was being Order on to the m2000rt
imported. again.
The m2000rt instrument is The instrument is not in Power OFF the instrument.
not in the Offline state. the OFFLINE state,
Please turn off the preventing the user from
5200
instrument. proceeding to the lamp
calibration initiation
screen.
The m2000rt instrument is The instrument is not in Power ON the instrument.
not in the Stopped state. the STOPPED state,
5201 Please turn on the preventing the user from
instrument. proceeding to the lamp
calibration screen.
Invalid concentration Invalid concentration value Enter the correct
format for (0). entered. concentration value for the
5302 identified calibrator or
control level. Refer to the
0 = Calibrator or control
assay package insert.
Invalid concentration Invalid value in the Test Enter the correct value into
format for (0). Only two Order data the Test Order.
places allowed after decimal
5303 point.

0 = Calibrator or controls
Invalid Sample Volume. The sample volume entered Enter a volume that is
Sample Volume is out of is out of range. within the specified range.
range [(0), (1)].
5304
0 = Low end of range
1 = High end of range
Invalid Sample Id. Sample Sample ID has leading or Enter the Sample ID
Id for well (0) has leading or trailing space characters. without using any leading
5305 trailing white spaces. or trailing spaces.

0 = Well number

10-78 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Invalid PCR Plate Name. PCR Plate ID has leading or Enter PCR Plate ID without
PCR Plate Name must not trailing space characters. using any leading or
5306
contain leading or trailing trailing spaces.
white spaces.
Invalid PCR Assay Reagent Spaces were found in Assay Enter PCR Assay Lot
Lot Number. PCR Assay Lot Number. Number without using any
5307 Reagent Lot Number has leading or trailing spaces.
leading or trailing white
spaces.
The number of assays More than 6 assays were Select up to 6 assays for the
selected is more than selected. Test Order.
allowed (0).
5308

0 = Number of allowable
assays
An invalid date (0) was An invalid date was Enter the correct date.
entered. entered.
5311

0 = Date entered
The Actual Concentration The concentration value Enter a correct
value for (0) is blank. was not entered. concentration value within
Concentration value ranges the specified range. Refer to
from (1) to (2) inclusive. the calibrator or control kit
card.
5312
0 = Level name
1 = Concentration value
lower range
2 = Concentration value
upper range

m2000rt Operations Manual 10-79


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


The Actual Concentration The concentration value Enter the correct
value for (0) is out of range. entered was invalid or concentration value. Refer
Concentration value ranges incorrect format. to the calibrator or control
from (1) to (2) inclusive. kit card.

5313
0 = Level name
1 = Concentration value
lower range
2 = Concentration value
upper range
Maximum number of test The pending Test Order list 1. Delete some Test Orders
orders has been reached. has reached its maximum. from the pending list.
Revert to original PCR Plate 2. Try creating the Test
5314
Name or delete some Order again.
pending test orders and try
again.
The PCR Plate Id has been PCR plate ID was changed. No action required.
5317 changed. A new test order
will be created.
The specified expiration Invalid or expired date Enter a valid date, if entered
5318 date for the kit lot has entered. incorrectly, or use a kit lot
elapsed. that has not expired
Insufficient test count to There are no remaining test Order more test counts as
execute the Laboratory counts to run instructed in License
defined application. laboratory-defined Configuration found in
5320
applications. Section 1 of the m2000rt
Laboratory-Defined
Applications Guide.
The current license is The system does not have If laboratory-defined
insufficient to execute the the correct license to application functions are
5321 Laboratory defined perform the selected needed, contact your Area
application. laboratory-defined Abbott Customer Service.
application.
License for the Laboratory A valid license was not Order a new license as
defined application was not found. instructed in License
found. Configuration found in
5322
Section 1 of the m2000rt
Laboratory-Defined
Applications Guide.

10-80 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


The license to execute The license to execute Order a new license as
Laboratory defined laboratory-defined instructed in License
applications is expired. applications has expired. Configuration found in
5323
Section 1 of the m2000rt
Laboratory-Defined
Applications Guide.
The license to execute The license is about to Verify expiration date on
Laboratory defined expire. the <License
applications is near Configuration> screen.
expiration. Order a new license as
5324 instructed in License
Configuration found in
Section 1 of the m2000rt
Laboratory-Defined
Applications Guide.
There is no Stored Curve for User imported a closed- If multiple m2000rts are in
(0) (1) and insufficient mode Test Order, but the the lab, locate the system
calibrator replicates on the plate had no or insufficient with the stored curve for
5325 plate. calibrators and there is no the assay lot. Then, import
stored curve for the assay and run the Test Order
lot. No results will be there.
0 = Assay name
generated.
1 = Assay reagent lot
The Actual value for Entered value for control is Enter the correct
parameter (0) for control Id out of range. concentration value. Refer
(1) is out of range. Valid to the assay kit card.
value ranges from (2) to (3)
inclusive.
5326
0 = Parameter name
1 = Control
2 = Start of range
3 = End of range
A value must be supplied No value was entered for a Enter a correct
for parameter (0). required field. concentration value within
5327 the specified range. Refer to
the assay kit card.
0 = Parameter name

m2000rt Operations Manual 10-81


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


The number of wells ({0}) There is an insufficient Contact your Area Abbott
on the plate is more than number of test counts Customer Service.
the tests remaining ({1}) for remaining for the selected
the selected Assay Reagent Assay Reagent Lot.
Lot ({2}). Please remove
wells or return to the
5328 previous screen and add a
new lot key value.

0 = Number of wells
1 = Remaining tests
2 = Assay Reagent Lot
A high level of At least one well with high 1. Clean identified well as
contamination was contamination was directed in Clean the
detected. detected. Thermal Block on page
9–20 of Section 9,
Service and
Maintenance.
2. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
5400 Maintenance.
3. If check passes, perform
a Background
Calibration on page 6–17
of Section 6,
Calibration
Procedures.
4. If Contamination Check
continues to fail, contact
your Area Abbott
Customer Service.

10-82 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


A medium level of At least one well with 1. Clean identified well as
contamination was medium contamination directed in Clean the
detected. was detected. Thermal Block on page
9–20 of Section 9,
Service and
Maintenance.
2. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
5401 Maintenance.
3. If check passes, perform
a Background
Calibration on page 6–17
of Section 6,
Calibration
Procedures.
4. If Contamination Check
continues to fail, contact
your Area Abbott
Customer Service.
A low level of At least one well with low 1. Clean identified well as
contamination was contamination was directed in Clean the
detected. detected. Thermal Block on page
9–20 of Section 9,
Service and
Maintenance.
2. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
5402 Maintenance.
3. If check passes, perform
a Background
Calibration on page 6–17
of Section 6,
Calibration
Procedures.
4. If Contamination Check
continues to fail, contact
your Area Abbott
Customer Service.

m2000rt Operations Manual 10-83


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


No contamination was No wells with any level of No action required.
5403 detected. contamination were
detected.
The m2000rt instrument is The instrument must be in 1. Power ON the
not in the Stopped state. the STOPPED state to instrument.
5404 perform the Contamination 2. Once the instrument is
Check. in the STOPPED state,
select the BACK button.
Warning: The serial port The upper code page No action required.
will be configured to seven conversion requires serial
data bits. Some characters port to be configured as
will not be mapped eight data bits. Otherwise
5500
properly per code page some characters will not be
conversion specification. mapped properly per code
page conversion
specification.
The serial port will be LIS port parameters were Reconfigure the LIS port
turned off for reconfiguring changed. communications to ON.
port parameters. Please set
5501 the communication on
from the LIS Configure
screen to enable LIS
communication again.
An invalid date (0) was An invalid date was Enter a valid date. Be sure
entered. entered. the date is in the proper
locale format. Refer to To
Change <Locale> on page
5600 0 = Date entered
2–36 of Section 2,
Installation Procedures
and User Configuration,
if needed.
An invalid date (0) was An invalid date was Enter a valid date. Be sure
entered. entered. the date is in the proper
locale format. Refer to To
5650
Change <Locale> on page
0 = Date entered
2–36 of Section 2, if
needed.

10-84 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


(0) General error: User did not Define the missing
define one or more of the parameter(s).
following parameters:
0 = Error text
5700 • sample
• control
• calibrator
• data analysis
Parameter (0) has an error: A parameter was defined Redefine the parameter as
(1) that is invalid. described in Section 1 of
5702 the m2000rt
Laboratory-Defined
0 = Parameter name
Applications Guide.
1 = Error text
Parameters (0) have errors. The listed parameters were Modify all parameters as
invalid. described in Section 1 of
5703 the m2000rt
0 = Parameter(s)
Laboratory-Defined
Applications Guide.
Field (0) has an error: (1) An error was made in the Correct the error for the
identified non-parameter field as indicated in the
5704 field, or a required field was message.
0 = Field name
left empty.
1 = Error description
Fields (0) have errors. Errors were made in Correct the errors for the
multiple non-parameter fields as indicated in the
5705
fields prior to a save message.
0 = Field names
attempt.
(0) Software error Contact your Area Abbott
5706 Customer Service.
0 = Error text
(0) Software error Contact your Area Abbott
5707 Customer Service.
0 = Error text
Parameters (0) have error: Errors were made in Correct the errors for the
(1) multiple parameter fields fields as indicated in the
5708 prior to a save attempt. message.
0 = Parameter names
1 = Error description

m2000rt Operations Manual 10-85


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


System license is invalid for The application does not Contact your Area Abbott
Laboratory defined contain the correct license Customer Service to update
5709 application specifications. level to perform the activity the license access level.
(print, copy, edit, export). If necessary, delete the
Application Specification.
Unable to find required Software error Contact your Area Abbott
Parameter model (0). Customer Service.
5710

0 = Parameter model
Parameter model (0 / 1) is Software error Contact your Area Abbott
missing. Customer Service.
5711
0 = Parameter model
1 = Parameter model
Parameter model (0 / 1) is Software error Contact your Area Abbott
missing required Customer Service.
parameters (2).
5712
0 = Parameter model
1 = Parameter model
2 = Parameter(s)
Unable to find any Assay Software error Contact your Area Abbott
5713
Parameter models. Customer Service.
File (0) loaded. Status message. No action required.
5714
0 = File
File (0) saved. Status message. No action required.
5715
0 = File
Maximum number (0) of <Add Negative Control> No action required. No
negative control levels was selected after the user more negative controls can
defined. already defined the de defined.
5716 maximum number of Limit the assay to the
negative control levels. maximum number of
0 = Maximum number of
negative control levels controls indicated.

10-86 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Invalid number of Control User did not define any Define at least the
levels. (0) controls. minimum number of
5718 required quality controls as
specified in the message.
0 = Number of control
levels, range
Maximum number (0) of <Add Positive Control> Either run the application
positive control levels was selected after the user with the currently defined
defined. already defined the control levels, or create an
5719 maximum number of assay with control levels in
positive control levels. range.
0 = Maximum number of
positive control levels
Maximum number (0) of <Add Calibrator> was Either run the application
calibrator levels defined. selected after the user with the currently defined
5720 already defined the calibrator levels, or create
maximum number of an assay with calibrator
0 = Maximum number of
calibrator levels. levels in range.
calibrator levels
Invalid number of Insufficient number of Define at least the
Calibrator levels. (0) calibrator levels were minimum number of
5722 defined. calibrator levels as specified
in the message.
0 = Number of calibrator
levels
Master Mix (0) is referenced User tried to delete a master Edit the referenced assay to
by Assay (1). mix that is being used by an use a different master mix.
5723 assay. Then, retry deleting the
master mix.
0 = Defined master mix
1 = Assay
Maximum number (0) of User has already defined 12 Either run the application
Master Mixes defined. master mixes. with the currently defined
master mixes, or delete one
5724 of the existing defined
0 = Maximum number of
master mixes and then
master mixes
create the desired master
mix.

m2000rt Operations Manual 10-87


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Maximum number (0) of User has already defined 12 Either run the application
Assays defined. assays. with the currently defined
assays, or delete one of the
5725
existing defined assays and
0 = Maximum number of
then create the desired
assays
assay.
Master Mix (0) is already User is attempting to save a Save the new master mix
defined. master mix using an definition with a unique
5726 identifier that is already identifier.
assigned to a defined
0 = Master mix
master mix.
Minimum number (0) of User is attempting to save a Define the master mix with
dyes are required. master mix with less than at least the minimum dyes
5727 the required number of required according to the
dyes. message.
0 = Minimum dyes required
Maximum number (0) of User has selected too many Redefine the master mix.
dyes defined. dyes for a master mix.
5728

0 = Maximum dyes allowed


Sample parameter User attempted to save an The sample parameters
definition is required. assay without defining the must be defined as
sample parameters. instructed in Section 1 of
5729
the m2000rt
Laboratory-Defined
Applications Guide.
Quality Control parameter User attempted to save an The quality control
definition is required. assay without defining the parameters must be defined
quality control parameters. as instructed in Section 1
5730
of the m2000rt
Laboratory-Defined
Applications Guide.
Calibration parameter User attempted to save an For Quantitative and
definition is required. assay without defining the Qualitative assays, the
calibration parameters. calibration parameters must
5731 be defined as instructed in
Section 1 of the m2000rt
Laboratory-Defined
Applications Guide.

10-88 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Data Analysis parameter User attempted to save an The data analysis
definition is required. assay without defining the parameters must be defined
data analysis parameters. as instructed in Section 1
5732
of the m2000rt
Laboratory-Defined
Applications Guide.
Amplification parameter User attempted to save an The amplification
definition is required. Application Specification parameters must be defined
without defining the as instructed in
5733 amplification parameters. Amplification Set Up in
Section 1 of the m2000rt
Laboratory-Defined
Applications Guide.
Master Mix definition is User attempted to save an The master mix parameters
required. Application Specification must be defined as
without defining the instructed in Define the
5734 master mix parameters. Master Mix in Section 1
of the m2000rt
Laboratory-Defined
Applications Guide.
Assay definition is required. User attempted to save an The assay parameters must
Application Specification be defined as instructed in
without defining the assay Beginning Assay
5735 parameters. Creation in Section 1 of
the m2000rt
Laboratory-Defined
Applications Guide.
Target Function definition User attempted to save an The sample parameters
is required. assay without defining a must be defined as
target function within the instructed in Section 1 of
5736
data analysis parameters. the m2000rt
Laboratory-Defined
Applications Guide.
Assay definition with name User attempted to save an Save the assay with a
(0) already exists. assay using an identifier unique identifier.
5737 that has already been
assigned to another assay.
0 = Assay name

m2000rt Operations Manual 10-89


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Master Mix dyes (0) User attempted to edit the If it is necessary to delete
required by Assay (1) were master mix definition by the dye from the master
deselected. deleting dyes that are mix, the data analysis
5738 required to run a defined section of the assay
assay. requiring that dye must be
0 = Dye(s)
edited first.
1 = Assay name
Assay Type selection is User attempted to save Select an assay type in the
required. without specifying the <Type> field on the
5739
assay type. <Assay Parameters> field
before proceeding.
Master Mix selection is User attempted to save Assign a defined master mix
required. without assigning a master under <Assign a Master
5740
mix. Mix> in the <Name> field
before proceeding.
Ramp Mode is a required User attempted to save On the <Amplification
parameter. amplification and detection and Detection
parameters without Parameters> screen,
5741
specifying the ramp mode. select either <Fast> or
<Slow> in the <Ramp
Mode> field.
Maximum number (0) of User tried to add stages No action required. No
Stages defined. when the maximum more stages can de defined.
5742 0 = Maximum number of number of stages is already
stages defined.

Invalid number of Negative User tried to save quality Define a negative control
controls. (0) control information for the assay.
5743 without sufficient negative
controls.
0 = Number of negative
controls
Invalid number of Positive User tried to save quality Define at least one positive
controls. (0) control information control.
5744 without sufficient positive
controls per assay
0 = Number of positive
requirements.
controls

10-90 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Maximum number (0) of User tried to add steps No action required. No
Steps defined for this Stage. when the maximum more steps can de defined.
number of steps is already
5745 defined.
0 = Maximum number of
steps per stage

Thermal Profile must be Software error. Contact your Area Abbott


5746
defined. Customer Service.
Read Point must be defined. User has not set the read Set the read point as
point. instructed in
Amplification Set Up in
5747
Section 1 of the
Laboratory- Defined
Applications Guide.
Insufficient Cycles for Read User has set the read point Set the cycles for the read
Point. (0) in a stage with less than 15 point stage to 15 or more.
5748 cycles.
0 = Number of required
cycles
Insufficient Time for Read The read point stage must Set the time for the read
Point. (0) be no shorter than the point stage to more than
5749 minimum given in the that given in the error
error message. message.
0 = Required time
Insufficient Stages in Software error Contact your Area Abbott
Thermal Profile. (0) Customer Service.
5750

0 = Error description
Sample identifiers (0) are A calibrator and control Within an assay, calibrator
defined for Control and have the same sample and control identifiers must
5751 Calibrator levels. identifier. be unique. Change one of
the conflicting identifiers.
0 = Sample ID

m2000rt Operations Manual 10-91


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Assays (0) Sample A calibrator for one assay Calibrator/control IDs must
identifiers (1) are defined has the same ID as a control be unique across assays.
for Control and Calibrator in another assay.
5752 levels.

0 = Assays
1 = Sample IDs
Sample identifiers (0) for User created two assays, Control and calibrator IDs
Control and Calibrator each with a different master must be unique across
levels are defined for Assays mix. User then defined one assays if they do not share a
(1) with different Master or more control levels or master mix. Change the
Mixes. calibrator levels with the name of the indicated
same sample IDs for both control or calibrator to a
assays. unique identifier.
5753 0 = Sample IDs
Common sample IDs
1 = Assay names
indicate multi-constituent
samples, which is
inconsistent with master
mix definitions that
indicate the assays are not
multiplexed.
Invalid state for command • Communication error 1. Cycle power on the SCC.
6000 execution.
• Instrument is busy 2. Retry command.
Unknown instrument error Firmware error Contact your Area Abbott
(0). Customer Service.
6001

0 = Error
Thermal cycler block sensor Hardware error of the block Contact your Area Abbott
6019
failure. sensor. Customer Service.
Thermal cycler cover sensor Hardware error of the cover Contact your Area Abbott
6020
failure. sensor. Customer Service.
Thermal cycler block Hardware error of the Contact your Area Abbott
6022 runaway condition heater sensor. Customer Service.
detected.
History log battery RAM Firmware error Contact your Area Abbott
6023
initialized. Customer Service.
Value out of range. Software error Contact your Area Abbott
6027
Customer Service.

10-92 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Method battery RAM Firmware error Contact your Area Abbott
6028
initialized. Customer Service.
Preferences battery RAM Firmware error Contact your Area Abbott
6029
initialized. Customer Service.
Calibration battery RAM Firmware error Contact your Area Abbott
6030
initialized. Customer Service.
Battery RAM initialized. Firmware error Contact your Area Abbott
6031
Customer Service.
Thermal cycler cover Hardware error of the cover 1. Cycle power on the SCC
runaway condition heater. and instrument.
6032 detected. 2. If problem persists,
contact your Area Abbott
Customer Service.
Battery RAM version Firmware error Contact your Area Abbott
6037
number lost. Customer Service.
Block calibration Firmware error Contact your Area Abbott
6039
initialized. Customer Service.
Thermal cycler heat sink Hardware error of the Contact your Area Abbott
6043
too hot. heater. Customer Service.
No method was loaded into Communication error 1. Cycle power on the SCC.
the run buffer. 2. If problem persists,
6063
contact your Area Abbott
Customer Service.
Instrument busy, cannot • Instrument running 1. Cycle power on the
execute command. another method or instrument and the SCC.
service software. 2. Reinitialize the
• The user selected <Stop> instrument.
when the instrument was 3. Discard the reaction
6084 ramping up between set plate and start the
points. processing from sample
preparation.
4. If problem persists,
contact your Area Abbott
Customer Service
Electronics calibration Firmware error Contact your Area Abbott
6093
parameters lost. Customer Service.

m2000rt Operations Manual 10-93


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Power amplifier calibration Firmware error Contact your Area Abbott
6094
parameters lost. Customer Service.
Instrument serial number Firmware error Contact your Area Abbott
6095
lost. Customer Service.
Watchdog reset. Firmware error Contact your Area Abbott
6102
Customer Service.
Filter wheel home switch Hardware error of the filter 1. Reinitialize the
not engaged. wheel. instrument and then
restart the run.
6108
2. If problem persists,
contact your Area Abbott
Customer Service.
The tray is out. The tray drawer is not Push in the tray drawer.
6109 pushed in when run is
started.
Block up switch is not • Hardware error of the 1. Cycle power to the
engaged. block drive. instrument and
• Possible that user has reinitialize.
tried to open the plate 2. If error repeats, cycle
drawer during power to the instrument
6111
initialization again and reinitialize the
instrument.
3. If problem persists,
contact your Area Abbott
Customer Service.
Lamp current is out of Hardware error of the lamp. Replace the Halogen Lamp
specification. on page 9–39 of Section 9,
6114
Service and
Maintenance.

10-94 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Lamp is not powered. Hardware error of the lamp. 1. Cycle power on the
instrument.
2. Verify that lamp is
correctly installed
3. Replace the Halogen
6115 Lamp on page 9–39 of
Section 9, Service and
Maintenance.
4. If problem persists,
contact your Area Abbott
Customer Service.
Filter motor step loss. Hardware error of the filter 1. Reinitialize the
wheel. instrument and then
restart the run.
6117
2. If problem persists,
contact your Area Abbott
Customer Service.
Door open during run. • Door open Close door and initiate run.
6118 • The tray drawer was open
prior to or in the middle
of the run
Detectors are required for Wrong protocol 1. Cycle power on the
this protocol. instrument.
2. Retry protocol.
6200
3. If problem persists,
contact your Area Abbott
Customer Service.
Thermal profile validation Protocol failure 1. Cycle power on the
failure. instrument.
2. Retry protocol.
6201
3. If problem persists,
contact your Area Abbott
Customer Service.
Thermal profile extension Protocol failure 1. Cycle power on the
time is too short. instrument.
2. Retry protocol.
6202
3. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-95


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Failed to start plate run. Hardware error or user 1. Attempt plate run again.
selected stop. 2. If failure persists, cycle
6203 power, reinitialize
instrument, and attempt
the run again.
Failed to start thermal Hardware error or user 1. Cycle power and
cycler. selected stop. reinitialize instrument.
2. Attempt run again.
6204
3. If failure persists, contact
your Area Abbott
Customer Service.
Failed to acquire Hardware error of the 1. Cycle power and
temperature status from heater. reinitialize instrument.
thermal cycler. 2. Attempt run again.
6205
3. If failure persists,
Contact your Abbott
Customer Service.
Failed to stop thermal Communication error 1. Cycle power and
cycler. reinitialize instrument.
2. Attempt run again.
6207
3. If failure persists, contact
your Area Abbott
Customer Service.
Failed to download camera Communication error 1. Cycle power and
firmware. reinitialize instrument.
2. Attempt run again.
6208
3. If failure persists, contact
your Area Abbott
Customer Service.
Failed to load plate. Plate not seated correctly. 1. Cycle power and
reinitialize instrument.
2. Attempt again to load
plate.
6209
3. Check the plate seal.
4. If problem persists,
contact your Area Abbott
Customer Service.

10-96 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Failed to change lamp state. Hardware failure of the 1. Cycle power and
lamp. reinitialize instrument.
6210 2. If problem persists,
contact your Area Abbott
Customer Service.
Failed to home filter wheel. Hardware failure of the 1. Cycle power and
filter wheel. reinitialize instrument.
6211 2. If problem persists,
contact your Area Abbott
Customer Service.
Failed to get temperature Hardware failure of the 1. Cycle power and
status. heater. reinitialize instrument.
6212 2. If problem persists,
contact your Area Abbott
Customer Service.
Failed to achieve block or Hardware failure of the 1. Cycle power and
cover temperature. heater. reinitialize instrument.
6213 2. If problem persists,
contact your Area Abbott
Customer Service.
Thermal cycler firmware • User stopped a run and 1. Perform a system
version incompatible. immediately re-initialized shutdown, re-start the
the system while the SCC, and re-initialize the
6214 block was lowering. system.
• Incorrect Firmware or 2. If the problem persists,
software is loaded on the contact your Area Abbott
system. Customer Service.
Camera firmware version Incorrect software loaded. Contact your Area Abbott
6215
incompatible. Customer Service.
Intensity check failed. Software failure. Contact your Area Abbott
6216
Customer Service.

m2000rt Operations Manual 10-97


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


The heated cover is in the Heated cover not pulled 1. Check to be sure the
back position. forward. heated cover is pulled all
the way forward.
2. Check to be sure the tray
drawer is pushed in.
6217 3. Cycle power and
reinitialize the
instrument.
4. If problem persists,
contact your Area Abbott
Customer Service.
Set block idle temperature Hardware failure of the 1. Cycle power and
failure. block heater. reinitialize instrument
and try again.
6218
2. If problem persists,
contact your Area Abbott
Customer Service.
Set cover idle temperature Hardware failure of the 1. Cycle power and
failure. cover heater. reinitialize instrument
and try again.
6219
2. If problem persists,
contact your Area Abbott
Customer Service.
Lamp current failure. Lamp failure Replace the Halogen Lamp
on page 9–39 of Section 9,
6220
Service and
Maintenance.
Lamp performance has • Lamp current out of Replace the Halogen Lamp
degraded. range on page 9–39 of Section 9,
6221
• Lamp is aging Service and
Maintenance.
Block failed to achieve idle Hardware failure of the 1. Cycle power and
temperature in time. block heater. reinitialize instrument
and try again.
6222
2. If problem persists,
contact your Area Abbott
Customer Service.

10-98 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Block failed to hold idle Hardware failure of the 1. Cycle power and
temperature. block heater. reinitialize instrument
and try again.
6223
2. If problem persists,
contact your Area Abbott
Customer Service.
Cover failed to achieve idle Hardware failure of the 1. Cycle power and
temperature in time. cover heater. reinitialize instrument
and try again.
6224
2. If problem persists,
contact your Area Abbott
Customer Service.
Cover failed to hold idle Hardware failure of the 1. Cycle power and
temperature. cover heater. reinitialize instrument
and try again.
6225
2. If problem persists,
contact your Area Abbott
Customer Service.
Camera failed to acquire Communication error. 1. Cycle power and
image. reinitialize instrument
and try again.
6226 2. Verify USB connection.
3. If problem persists,
contact your Area Abbott
Customer Service.
The plate drawer is open. Plate drawer is opened. 1. Close the plate drawer.
6227 2. If problem persists,
contact your Area Abbott
Customer Service.
The access door is open. Access door is open before 1. Check to be sure the
or during run. access door is closed.
6228 2. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-99


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Error while setting • Hardware failure of the 1. Cycle power and
cover/block temperature. heater reinitialize instrument
• User selected Stop and try again.
6229
2. If problem persists,
contact your Area Abbott
Customer Service.
Error while checking lamp Lamp failure 1. Cycle power and
current. reinitialize instrument
and try again.
2. Perform the Replace the
Halogen Lamp procedure
6230 on page 9–39 of Section
9, Service and
Maintenance.
3. If problem persists,
contact your Area Abbott
Customer Service.
Failed to unload plate. • Hardware failure of the 1. Cycle power to the
plate eject instrument and
• Plate seal not applied reinitialize.
correctly 2. If error repeats, cycle
6232 power and reinitialize
again.
3. If problem persists,
contact your Area Abbott
Customer Service.

10-100 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Recalculated count Contamination 1. Perform the Fluorescence
exceeded max value during Contamination Check
optimization. on page 9–13 of Section
9, Service and
Maintenance.
2. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
6233
3. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
4. Rerun the failed
calibration.
5. If problem persists,
contact your Area Abbott
Customer Service.
Exposure time out of range Contamination 1. Perform the Fluorescence
during optimization. Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
2. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
6234
3. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
4. Rerun the failed
calibration.
5. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-101


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Well (0) standard deviation • Bubbles or droplets in the 1. Repeat the run.
exceeds maximum value. plate 2. If the problem persists,
• Condensation in plate centrifuge the plate.
6235 0 = Well ID 3. Make sure there are no
droplets or bubbles in
the plate wells.
4. Repeat the run.
Failed to acquire image. Communication error 1. Cycle power and re
initialize instrument and
try again.
6236 2. Verify USB connection.
3. If problem persists,
contact your Area Abbott
Customer Service.

10-102 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Well (0) background • Plate not loaded 1. Check whether plate was
correlation coefficient • Incorrect Plate Used used. If no plate was
exceeded maximum. used, rerun with a plate.
• Block contamination
2. Check whether the
• Plate contamination
0 = Well ID correct plate was used. If
the wrong plate was
used, rerun with the
correct plate.
3. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
4. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
6237 5. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
6. Rerun the failed
calibration.
7. If the calibration
continues to fail, create a
new plate (see Creating a
Background Plate on
page 6–28 of Section 6,
Calibration
Procedures). Then,
rerun with the new
plate.
8. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-103


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Well (0) background • Plate not loaded 1. Check whether plate was
correlation coefficient • Incorrect Plate Used used. If no plate was
below minimum. used, rerun with a plate.
• Block contamination
2. Check whether the
• Plate contamination
0 = Well ID correct plate was used. If
the wrong plate was
used, rerun with the
correct plate.
3. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
4. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
6238 5. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
6. Rerun the failed
calibration.
7. If the calibration
continues to fail, create a
new plate (see Creating a
Background Plate on
page 6–28 of Section 6,
Calibration
Procedures). Then,
rerun with the new
plate.
8. If problem persists,
contact your Area Abbott
Customer Service.

10-104 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Well (0) background slope • Plate contamination 1. Perform the Fluorescence
exceeded maximum slope. • Block contamination Contamination Check
on page 9–13 of Section
9, Service and
0 = Well ID
Maintenance.
2. If contamination exists,
perform the Clean the
Thermal Block procedure
on page 9–20 of Section
9.
3. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
6239 contamination.
4. Rerun the failed
calibration.
5. If the calibration
continues to fail, create a
new plate (see Creating a
Background Plate on
page 6–28 of Section 6,
Calibration
Procedures). Then,
rerun with the new
plate.
6. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-105


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Well (0) background slope • Plate not loaded 1. Check whether plate was
below minimum slope. • Incorrect Plate Used used. If no plate was
used, rerun with a plate.
• Block contamination
0 = Well ID 2. Check whether the
• Plate contamination
correct plate was used. If
the wrong plate was
used, rerun with the
correct plate.
3. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
4. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
6240 5. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
6. Rerun the failed
calibration.
7. If the calibration
continues to fail, create a
new plate (see Creating a
Background Plate on
page 6–28 of Section 6,
Calibration
Procedures). Then,
rerun with the new
plate.
8. If problem persists,
contact your Area Abbott
Customer Service.

10-106 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Well (0) background offset • Plate not loaded 1. Check whether plate was
exceeded maximum offset. • Incorrect Plate Used used. If no plate was
0 = Well ID used, rerun with a plate.
• Block contamination
2. Check whether the
• Plate contamination
correct plate was used. If
the wrong plate was
used, rerun with the
correct plate.
3. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
4. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
6241 5. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
6. Rerun the failed
calibration.
7. If the calibration
continues to fail, create a
new plate (see Creating a
Background Plate on
page 6–28 of Section 6,
Calibration
Procedures). Then,
rerun with the new
plate.
8. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-107


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Well (0) background offset • Plate not loaded 1. Check whether plate was
below minimum offset. • Incorrect Plate Used used. If no plate was
used, rerun with a plate.
• Block contamination
0 = Well ID 2. Check whether the
• Plate contamination
correct plate was used. If
the wrong plate was
used, rerun with the
correct plate.
3. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
4. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
6242 5. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
6. Rerun the failed
calibration.
7. If the calibration
continues to fail, create a
new plate (see Creating a
Background Plate on
page 6–28 of Section 6,
Calibration
Procedures). Then,
rerun with the new
plate.
8. If problem persists,
contact your Area Abbott
Customer Service.

10-108 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Background calibration Hardware failure 1. Select START and
initializing instrument reinitialize instrument.
failed. 2. Restart the Background
Calibration on page 6–17
of Section 6,
6243
Calibration
Procedures.
3. If problem persists,
contact your Area Abbott
Customer Service.
Prepare for running Hardware failure 1. Cycle power and
background calibration reinitialize instrument.
failed. 2. Restart the Background
Calibration on page 6–17
of Section 6,
6244
Calibration
Procedures.
3. If problem persists,
contact your Area Abbott
Customer Service.
Background calibration Hardware failure 1. Cycle power and
start run failed. reinitialize instrument.
2. Restart the Background
Calibration on page 6–17
of Section 6,
6245
Calibration
Procedures.
3. If problem persists,
contact your Area Abbott
Customer Service.
Background calibration This is a general error After the specific error code
failed. associated with specific has been identified in the
Background errors. Message History Log, see
6246 that error’s Probable
See the Message History Log
for the specific error in this Cause(s) and Corrective
case. Action(s).

m2000rt Operations Manual 10-109


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Well (0) exceeded • Incorrect plate used 1. Check whether the
maximum number of • Plate or block correct plate was used. If
saturated pixels. contamination the wrong plate was
used, rerun with the
correct plate.
0 = Well ID
2. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
3. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
4. Perform the Clean the
Plate procedure on page
6247
9–32 of Section 9 to
remove any
contamination.
5. Rerun the failed
calibration.
6. If the calibration
continues to fail, create a
new plate (see Creating a
Background Plate on
page 6–28 of Section 6,
Calibration
Procedures). Then,
rerun with the new
plate.
7. If problem persists,
contact your Area Abbott
Customer Service.

10-110 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Well intensity below • Insufficient volume in 1. Check the plate’s fluid
minimum acceptable value. one or more wells levels. If too little fluid is
• Plate or block present in even one well,
contamination rerun with a new plate.
2. If the fluid levels are
sufficient, perform the
Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
3. If contaminated wells
exist, Clean the Thermal
Block on page 9–20 of
6248 Section 9.
4. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
5. Rerun the failed
calibration.
6. If the calibration
continues to fail, repeat
Step 4 and Step 5.
7. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-111


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


ROI calibration failed. • Plate not loaded 1. Verify the correct plate
• Incorrect plate used was loaded. Repeat the
run, if not.
• Bubbles or droplets in the
plate 2. If the problem persists,
centrifuge the plate.
• Insufficient volume in
one or more wells 3. Make sure there are no
droplets or bubbles in
• Plate or block the plate wells and
contamination repeat the run.
4. Check well fluid levels. If
fluid levels are too low in
any wells, use a new
plate and redo the run.
5. If problem persists,
perform the
Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
6250 Maintenance.
6. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
7. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
8. Rerun the failed
calibration.
9. If the calibration
continues to fail, repeat
Step 7 and Step 8.
10.If problem persists,
contact your Area Abbott
Customer Service.

10-112 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


ROI wells count exceeded. • Bubbles or droplets in the 1. Repeat the run.
plate 2. If the problem persists,
• Plate contamination centrifuge the plate.
• Block contamination 3. Make sure there are no
• Hardware failure (Heated droplets or bubbles in
Cover) the plate wells.
4. Repeat the run.
5. If problem persists,
perform the
Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
6. If contaminated wells
exist, perform the Clean
6251 the Thermal Block
procedure on page 9–20
of Section 9.
7. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
8. Rerun the failed
calibration.
9. If the calibration
continues to fail, repeat
Step 7 and Step 8.
10.If problem persists,
contact your Area Abbott
Customer Service. The
issue might be a
hardware failure.

m2000rt Operations Manual 10-113


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Well (0) exceeded Potential plate/block 1. Perform the Fluorescence
maximum number of contamination. Contamination Check
pixels. on page 9–13 of Section
9, Service and
Maintenance.
0 = Well ID
2. If contaminated wells
exist, Clean the Thermal
Block on page 9–20 of
Section 9.
3. Perform the Clean the
Plate procedure on page
6252
9–32 of Section 9 to
remove any
contamination.
4. Rerun the failed
calibration.
5. If the calibration
continues to fail, repeat
Step 3 and Step 4.
6. If problem persists,
contact your Area Abbott
Customer Service.
Pure dye (0) calibration This is a general error 1. If the operator stopped
failed. associated with specific the run, restart.
Pure Dye errors, although it 2. Identify the specific error
can also be triggered when code in the Message
6253 0 = Pure dye the operator stops the run. History Log, and then
See the Message History Log refer to that error’s
for the specific error in this Probable Cause(s) and
case. Corrective Action(s).

10-114 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Well (0) intensity exceeded • Incorrect plate used 1. Check whether the
maximum acceptable value. • Plate or block correct plate was used. If
contamination the wrong plate was
used, rerun with the
0 = Well ID
correct plate.
2. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
3. If contamination exists,
Clean the Thermal Block
on page 9–20 of Section
9.
4. Perform the Clean the
Plate procedure on page
6255 9–32 of Section 9 to
remove any
contamination.
5. Rerun the failed
calibration.
6. If the calibration
continues to fail, create a
new plate (see Creating a
Background Plate on
page 6–28 of Section 6,
Calibration
Procedures). Then,
rerun with the new
plate.
7. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-115


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Error while optimizing • Plate not loaded 1. Check whether plate was
exposure time. • Incorrect plate used used. If no plate was
used, rerun with a plate.
• Insufficient volume in
one or more wells 2. Check whether the
correct plate was used. If
the wrong plate was
used, rerun with the
6256 correct plate.
3. Check well fluid levels. If
fluid levels are too low in
any wells, use a new
plate and redo the run.
4. If problem persists,
contact your Area Abbott
Customer Service.
Error while reading from Software error Contact your Area Abbott
the system calibration Customer Service.
6257
configuration file. Dye
name is empty.

10-116 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Normalized well intensity • Incorrect plate used 1. Check whether the
value out of range. • Plate or block correct plate was used. If
contamination the wrong plate was
used, rerun with the
• Hardware failure (filter)
correct plate.
2. Perform the Fluorescence
Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
3. If contamination exists,
Clean the Thermal Block
on page 9–20 of Section
6258 9.
4. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
5. Rerun the failed
calibration.
6. If the calibration
continues to fail, repeat
Step 4 and Step 5.
7. If problem persists,
contact your Area Abbott
Customer Service.
Pure dye (0) calibration Pure Dye calibration No action required.
successful. successful.
6259

0 = Dye name
Region of Interest Region of Interest No action required.
6260
calibration passed. calibration passed.
Background calibration Background calibration No action required.
6261
passed. passed.
Uniformity calibration Uniformity calibration No action required.
6263
passed. passed.

m2000rt Operations Manual 10-117


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Uniformity calibration This is a general error After the specific error code
failed. associated with specific has been identified in the
Uniformity errors. Message History Log, see
6264 that error’s Probable
See the Message History Log
for the specific error in this Cause(s) and Corrective
case. Action(s).

Not in the same hold after Hardware failure of the Contact your Area Abbott
6265
read was completed. thermal cycler. Customer Service.
Assay (0) run complete. Assay run complete. No action required.
6266
0 = Assay name
Assay (0) run failed. Assay run failed to 1. Review the Message
complete processing due to: History Log for
• Communication error associated failure
0 = Assay name
messages.
• Hardware failure
6267 2. Discard the PCR plate.
• User selected Stop
3. Run the assay again.
4. If problem persists,
contact your Area Abbott
Customer Service.

10-118 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Uniformity calibration ROI calibration plate 1. Check that the ROI
coefficients are not in contaminated. calibration plate was
range. used.
2. Check plate for bubbles,
contamination and
expiration date.
3. Use a new ROI
calibration plate.
4. If problem persists,
perform the
Fluorescence
6268 Contamination Check
on page 9–13 of Section
9, Service and
Maintenance.
5. If problem persists,
Clean the Thermal Block
on page 9–20 of Section
9, Service and
Maintenance
6. If problem persists,
contact your Area Abbott
Customer Service.
Missed PCR read point. Communication error 1. Ensure instrument is in
READY state.
2. Cycle power and
6269 reinitialize instrument.
3. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-119


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Error communicating with Communication error with 1. Check to be sure
thermal cycler. the thermal cycler. instrument is in READY
state.
2. Cycle power and
6270
reinitialize instrument.
3. If problem persists,
contact your Area Abbott
Customer Service.
Waiting for the heated Waiting for temperature to No action required.
6271
cover to reach temperature. reach target.
Thermal cycler method Thermal cycler finished No action required.
6272 finished. processing the downloaded
method.
Thermal cycler is in Thermal cycler is in 1. Check to be sure
unknown state. unknown state. instrument is in READY
state.
2. Cycle power and
6273
reinitialize instrument.
3. If problem persists,
contact your Area Abbott
Customer Service.
Finished downloading Thermal profile No action required.
6275 protocol to thermal cycler. downloaded successfully to
system.
Finished reading (0). Finished read. No action required.
6276
0 = Read number
Started reading (0). Started read. No action required.
6277
0 = Read number
Sample temperature before Sample temperature prior No action required.
read: (0). to read.
6278
0 = Sample temperature
(oC)

10-120 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Sample temperature after Temperature reading during No action required.
read: (0). a process run.
6279
0 = Sample temperature
(oC)
Interwell ROI calibration Interwell ROI calibration Refer to the Message
6280 failed. failed. History Log for error
associated with failure.
Unable to load interwell Software error 1. Cycle power on the SCC
ROI calibration bitmask. and instrument.
2. Retry process.
6281
3. If problem persists,
contact your Area Abbott
Customer Service.
Interwell ROI calibration • Plate contaminated 1. To remove any
bitmask dimensions are too • ROI calibration failed contamination, perform
large. the Clean the Plate
• Hardware failure (optical
procedure on page 9–32
system)
of Section 9.
2. Rerun the failed
calibration.
6282 3. If the calibration
continues to fail, rerun
with a new plate.
4. If problem persists, it
might indicate a
hardware failure.
Contact your Area
Abbott Customer
Service.

m2000rt Operations Manual 10-121


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Interwell ROI pixel is • Plate contaminated 1. To remove any
outside of the normal • Hardware failure (camera contamination, perform
image boundary. alignment or optical the Clean the Plate
system) procedure on page 9–32
of Section 9.
2. Rerun the failed
calibration.
3. If the calibration
6283
continues to fail, rerun
with a new plate.
4. If problem persists, it
might indicate a
hardware failure.
Contact your Area
Abbott Customer
Service.
Interwell ROI mask • Plate contaminated 1. To remove any
intersected with the ROI • Hardware failure (optical contamination, perform
mask. system) the Clean the Plate
procedure on page 9–32
of Section 9.
2. Rerun the failed
calibration.
3. If the calibration
6284
continues to fail, rerun
with a new plate.
4. If problem persists, it
might indicate a
hardware failure.
Contact your Area
Abbott Customer
Service.
6285 Assay run started. Assay run started. No action required.

Failed to reset lamp usage User cancelled out of lamp Repeat lamp calibration.
6286
statistics. calibration.
Lamp has exceeded the Lamp has exceeded the Replace the Halogen Lamp
recommended operational recommended operational procedure on page 9–39 of
6287
life. life of 1000 hours. Section 9, Service and
Maintenance.

10-122 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Cover temperature (0) has The heated cover drifted 1. Cycle power, reinitialize
drifted out of range. out of the tolerable range instrument and retry
during a system calibration run.
6288
or assay run. 2. If problem persists,
0 = Temperature (oC)
contact your Area Abbott
Customer Service.
Invalid floating point value Software error Contact your Area Abbott
6290
detected. Customer Service.
Failed to move to filter Hardware failure of the 1. Cycle power, reinitialize
position (0). filter. instrument and retry
run.
6291
0 = Filter position 2. If problem persists,
contact your Area Abbott
Customer Service.
Validation of Pure dye (0) • Fluorescence 1. Perform the Fluorescence
calibration failed. contamination in the Contamination Check
thermal block on page 9–13 of Section
• Contamination on the 9, Service and
0 = Pure Dye name
calibration plate Maintenance.
2. If contaminated wells
exist, perform the Clean
the Thermal Block
procedure on page 9–20
of Section 9.
3. Perform the Clean the
6292 Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
4. Rerun the failed
calibration.
5. If the calibration
continues to fail, repeat
Step 3 and Step 4.
6. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-123


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Well (0) pure dye • Fluorescence 1. To determine block
calibration value abnormal. contamination in the contamination:
thermal block a. Perform the
0 = Well ID • Contamination on the Fluorescence
calibration plate Contamination Check
• Bad plate on page 9–13 of
Section 9.
NOTE: If any
contaminated wells
exist and match
those identified in
the error message,
skip step b.
b. With a newly created
plate (see Creating a
Background Plate on
page 6–28), perform
the Background
Calibration on page
6–17 of Section 6.
6293
2. If contaminated wells
exist, Clean the Thermal
Block on page 9–20 of
Section 9.
3. Perform the Clean the
Plate procedure on page
9–32 of Section 9 to
remove any
contamination.
4. Rerun the failed
calibration.
5. If the calibration
continues to fail, repeat
Step 3 and Step 4.
6. If the problem still
continues, order a new
plate.
7. If problem persists,
contact your Area Abbott
Customer Service.

10-124 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Contamination check Contamination Check was No action required.
6294
successful. executed successfully.
Contamination check Contamination Check was 1. Cycle power to the SCC
failed. executed unsuccessfully. and instrument.
2. Re-initialize the
instrument.
6295 3. Retry Contamination
Check.
4. If problem persists,
contact your Area Abbott
Customer Service.
Restarting instrument Communication error 1. Wait until instrument
control process. status is STOPPED.
6296
2. If error persists, cycle
power.
Unable to retrieve run Software error Contact your Area Abbott
6297
history records. Customer Service.
Thermal cycler block Hardware failure of the 1. Cycle power on the
o
drifted more than 2 C from thermal block. instrument.
6298 a setpoint. 2. If problem persists,
contact your Area Abbott
Customer Service.
Thermal cycler failed to The thermal cycler failed to 1. Cycle power to the SCC
reach a setpoint in time. reach a setpoint in time. and instrument.
2. Reinitialize the
instrument.
6299
3. Try the process again.
4. If problem persists,
contact your Area Abbott
Customer Service.
Instrument communication Communication error 1. Cycle power to the SCC
error. and instrument.
2. Reinitialize the
instrument.
6300
3. Try the process again.
4. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-125


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unable to verify read Communication error 1. Cycle power to the SCC
occurred during hold. and instrument.
2. Reinitialize the
instrument.
6301
3. Try the process again.
4. If problem persists,
contact your Area Abbott
Customer Service.
Multicomponent analysis Software error 1. Cycle power to the SCC
failed. and instrument.
2. Reinitialize the
instrument.
6302
3. Try the process again.
4. If problem persists,
contact your Area Abbott
Customer Service.
Failed to store system • Software error, unable to 1. Cycle power to the SCC
calibration. store optical calibration and instrument.
data in the file system. 2. Reinitialize the
6303 • System calibration instrument.
download from the 3. If problem persists,
system database to the contact your Area Abbott
instrument failed Customer Service.
PCR data acquisition Status message. The process 1. Select <Stop>.
complete. Run can be is complete but the 2. Remove the plate.
6304 stopped at any time. instrument will remain in a 3. Review results.
Initiating hold. temperature hold until the
user selects <Stop>.
Failed to download Software error 1. Repeat the action.
Thermal Cycler protocol. 2. If the error continues,
6305
contact your Area Abbott
Customer Service.
Unable to delete process log The user attempted to Wait for the process to be
when it is active. delete the Process Log while completed before deleting
the system has it open. the Process Log.
7100
Process Logs that are open
by the system cannot be
deleted.

10-126 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: SampleId Customer Service.
7101 attribute is not allowed in
DerivedResultProcessing if
Type is UnknownSample.
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Only one Customer Service.
7102 DerivedResultProcessing
element allowed where
Type is UnknownSample.
Genotype Data Analysis Software error Contact your Area Abbott
Extension: SampleId Customer Service.
7103 attribute is required in
DerivedResultProcessing
element if Type is Control.
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Customer Service.
DerivedResultProcessing
7104 Control SampleId (0) is
invalid.

0 = Control name
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Customer Service.
DerivedResultProcessing
7105 element is already defined
for Control (0).

0 = Control name
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Test order Customer Service.
parameter Id is required for
7106 Constant (0).

0 = Constant

m2000rt Operations Manual 10-127


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Test order Customer Service.
parameter Id (0) referenced
by Constant (1) is not
7107 defined.

0 = Parameter
1 = Constant
Genotype Data Analysis Software error Contact your Area Abbott
Extension: An Aggregate, Customer Service.
Variable or Constant with
7108 name (0) already exists.

0 = Aggregate, Variable or
Constant
Genotype Data Analysis Software error Contact your Area Abbott
Extension: An Aggregate, Customer Service.
Variable or Constant with
name (0) has a value of
7109 NULL.

0 = Aggregate, Variable or
Constant
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Unallowed Customer Service.
characters are present in
expression (0) for (1). These
characters are not allowed
in this particular context:
(2).
7110

0 = Expression to evaluate
1 = Name of the expression
(variable name)
2 = Characters not allowed
in expression

10-128 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Boolean Customer Service.
expression (0) for (1) is too
complex. No more than
two uses of logical
7111 operators (and, or) are
allowed.

0 = Expression to evaluate
1 = Name of the expression
(variable name)
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The expression Customer Service.
(0) is expected to return a
value type of (1), but it is
7112 not currently supported.

0 = Expression to evaluate
1 = Value type
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The expression Customer Service.
7113 (0) evaluates to NULL.

0 = Expression to validate
Genotype Data Analysis Software error Contact your Area Abbott
Extension: An expression Customer Service.
evaluation error occurred
evaluating expression (0)
for (1). The error message
7114 was: (2).

0 = Expression to validate
1 = Variable name
2 = Error message

m2000rt Operations Manual 10-129


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Invalid Customer Service.
Constant, Aggregate or
Variable name (0). It is a
7115 restricted keyword or
already defined.

0 = Constant, Aggregate or
Variable
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The referenced Customer Service.
7116 Assay Id (0) is invalid.

0 = Assay name
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Assay Processing Customer Service.
stage for Assay (0) is already
7117 defined.

0 = Assay name
Genotype Data Analysis Software error Contact your Area Abbott
Extension: One or more Customer Service.
arguments supplied to the
error code (0) is invalid. The
7118 error was: (1).

0 = Error number
1 = Error event
Genotype Data Analysis Software error Contact your Area Abbott
Extension: ErrorReplicate Customer Service.
Number of (0) is invalid.
7119
Maximum allowed
ErrorReplicate Number for
Assay (1) is (2).
Genotype Data Analysis Software error Contact your Area Abbott
Extension: A Control Customer Service.
7120 sample cannot contain (0)
in TrueCondition or
FalseCondition.

10-130 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Not all Check Customer Service.
paths guarantee a result. A
result call must be
7121 guaranteed within this
Calling Scheme. OpId ({0})

0 = OpId
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The argument Customer Service.
(0) for Aggregate (1) is
invalid. The assay does not
7122 have Internal Control
defined.

0 = Argument
1 = Aggregate
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The constituent Customer Service.
assay (0) references model
(1), which is not supported
by this extension.
7123 Supported model is: (2).

0 = Assay
1 = Unsupported model
2 = Supported model
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Attribute (0) is Customer Service.
required when attribute (1)
7124 is defined.

0 = Required attribute
1 = Defined attribute

m2000rt Operations Manual 10-131


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Attribute (0) is Customer Service.
not allowed for Negative
7125 Control validity.

0 = Disallowed attribute
Genotype Data Analysis Software error Contact your Area Abbott
Extension: IDS (0) specified Customer Service.
in error code (1) is not
7126 defined.

0 = IDS specified
1 = Error code
Genotype Data Analysis Software error Contact your Area Abbott
Extension: IDS (0) specified Customer Service.
in error code (1) is already
7127 used by another error code.

0 = IDS specified
1 = Error code
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The referenced Customer Service.
error code (0) is not
7128 defined.

0 = Error code
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The error code Customer Service.
number (0) is already
7129 defined.

0 = Error code

10-132 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Attribute Customer Service.
(AssayId) is not allowed for
element (0) in stage (1). The
AssayId of (2) is assumed
from the inherited
7130
definition.

0 = Element
1 = Stage
2 = Assay ID
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Attribute Customer Service.
(AssayId) is required for
7131 element (0) in stage (1).

0 = Element
1 = Stage
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Attribute ({0}) is Customer Service
not allowed when attribute
7132 ({1}) is defined.

0 = Attribute not allowed


1 = Defined attribute
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Duplicate Customer Service
procedure name ({0}).
7133 Procedure name must be
unique.

0 = Procedure name

m2000rt Operations Manual 10-133


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Duplicate Customer Service
parameter or variable name
({0}) in procedure ({1}). All
7134
parameters (input or
output), variables and
aggregates must be unique
within the procedure.
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Invalid Customer Service
parameter, variable or
aggregate name ({0}) in
procedure ({1}). The
message was: ({2}).
7135

0 = Parameter, variable, or
aggregate name
1 = Procedure name
2 = Message
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Incorrect Customer Service
number of Set statements in
procedure ({0}). The
number of Set statements
({1}) must match the
number of Output
parameters ({2}).
7136

0 = Number of Set
statements
1 = Number of Set
statements
2 = Number of Output
parameters

10-134 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: No Customer Service
corresponding Set
statement found for Output
Parameter ({0}) in procedure
({1}). Each Output
7137 Parameter must have a
corresponding Set
statement.

0 = Output Parameter
1 = Procedure
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The Scope of Customer Service
({0}) is invalid for variable
or aggregate ({1}) in
procedure ({2}). All
variables and aggregates in
7138 a procedure must have
Local scope.

0 = Scope
1 = Variable or aggregate
2 = Procedure
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The Procedure Customer Service
Call ({0}) references a
7139 procedure that is not
defined.

0 = Procedure Call
Genotype Data Analysis Software error Contact your Area Abbott
Extension: The Procedure Customer Service
Call ({0}) is invalid. It
cannot be called from Stage
7140 ({1}).

0 = Procedure Call
1 = Stage

m2000rt Operations Manual 10-135


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software Error Contact your Area Abbott
Extension: Incorrect Customer Service
number ({0}) of Input
parameters in Procedure
Call ({1}). The procedure
expects ({2}) Input
parameters.
7141

0 = Number of Input
parameters
1 = Procedure Call
2 = Expected Input
parameters
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Input Parameter Customer Service
({0}) was not supplied in
Procedure Call ({1}). All
7142 Input parameters must be
supplied.

0 = Input Parameter
1 = Procedure Call
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Input Parameter Customer Service
({0}) supplied in Procedure
Call ({1}) contains a value of
type ({2}). Expected value
type is ({3}).
7143

0 = Input Parameter
1 = Procedure Call
2 = Value type
3 = Value type

10-136 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Procedure Call Customer Service
to ({0}) supplies Output
Parameter ({1}), which is
7144 not defined by the
procedure.

0 = Procedure name
1 = Output Parameter
Genotype Data Analysis Software error Contact your Area Abbott
Extension: CallingScheme Customer Service
7145 cannot be empty because a
result call must be
guaranteed.
Genotype Data Analysis Software error Contact your Area Abbott
Extension: FormatString Customer Service
({0}) defined for ({1}) is not
allowed. FormatString
attribute is not allowed on
7146 expressions that do not
have ValueType of Text.

0 = Format String
1 = Variable name
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Procedure ({0}) is Customer Service
defined but never called. It
7147 must be called at least once
for it to be validated.

0 = Procedure

m2000rt Operations Manual 10-137


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Variable name Customer Service
({0}) referenced in the Set
statement is not defined.
7148 Set statement can only
reference locally declared
(Scope=Local) variables.

0 = Variable name
Genotype Data Analysis Software error Contact your Area Abbott
Extension: AssayIdRef ({0}) Customer Support
is invalid. AssayIdRef can
only contain locally
7149 defined variable and
parameter names that have
ValueType = AssayId.

0 = AssayIdRef
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Attribute Customer Service
(AssayIdRef) is not allowed
for element ({0}) in stage
({1}). The AssayId of ({2}) is
assumed from the inherited
7150
definition.

0 = Error replicate
1 = Assay processing
2 = Assay Id

10-138 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Genotype Data Analysis Software error Contact your Area Abbott
Extension: Procedure Customer Service
definition for Procedure
({0}) in invalid. The
procedure cannot suppress
errors, yet guarantee a
7151 result call. It must be
allowed to error the derived
result if a result call must be
guaranteed.

0 = Procedure
Genotype Data Analysis Software error Contact your Area Abbott
Extension: In Procedure Customer Service
Definition for Procedure
({0}), each ErrorSample
element must contain at
7152 least one ErrorReplicate
child element because the
procedure suppresses
derived result errors.

0 = Procedure
Application specification • The Application Place the CD in the drive
(0) not found. Specification is not and reinstall the
installed on the Application Specification.
7200 instrument
0 = Application
specification file name • CD was removed when
trying to install
Application specification Application Specification 1. Reinstall the Application
(0) is corrupt. file error Specification.
7201 2. If problem persists,
0 = Application contact your Area Abbott
specification file name Customer Service.

m2000rt Operations Manual 10-139


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Application specification File has been modified 1. Reinstall the Application
(0) digital signature Specification.
verification failed. 2. If problem persists,
7202 contact your Area Abbott
0 = Application Customer Service.
specification file name
Application specification File has been modified 1. Reinstall the Application
(0) schema validation failed Specification.
(1). 2. If problem persists,
7203 contact your Area Abbott
0 = Application Customer Service.
specification file name
1 = Failure information
Application specification • Referenced liquid class 1. Check to be sure the
(0) installation failed. not present referenced liquid class is
• Application already installed. Verify the file
installed is not already installed.
0 = Application
7204 specification file name • Application Specification 2. Reinstall the Application
file error Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.
Application specification User cancelled the No action required.
7205
installation cancelled. installation
Application specification Pending Test Order exists Process or delete
deletion cancelled. There outstanding Test Orders
7206 are outstanding test orders before attempting to delete
pending. the application
specification.
Could not install Incorrect instrument state Wait until the instrument
Application specification, to install has completed processing,
7207
an instrument is running. then install the Application
Specification.

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Maximum number of The maximum number of 1. Delete old Application
allowed Application Application Specifications Specifications that are no
specification installations allowed on the system has longer in use.
7208 exceeded (0). been reached. 2. Install new Application
Specification.
0 = Maximum application
count
Component (0) schema Software error 1. Delete the Application
validation failed (1). Specification.
2. Reinstall the Application
7209 0 = Component name Specification.
1 = Failure information 3. If problem persists,
contact your Area Abbott
Customer Service.
Application specification Attempted to install an Reinstall the Application
type (0) is not compatible m2000sp application on an Specification on the correct
with the System type (1). m2000rt system, or an instrument.
m2000rt on an m2000sp
system.
0 = Application Application/Instrument:
specification name m2000: m2000sp/m2000rt
1 = System type m2000sp: m2000sp
7210
m2000rt: m2000rt
Liquid class: m2000sp
m2000sp MnD: m2000sp
m2000rt MnD: m2000rt

MnD = Maintenance and


Diagnostics
Application specification The system does not have Reinstall a different version
requires software version the required system of the application. Refer to
(0). Current system version software version to support the assay application CD
is (1). the Application package insert.
7211 Specification.
0 = Required software
version
1 = Current software
version

m2000rt Operations Manual 10-141


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


A newer version (0) of the An attempt has been made No action required.
Application specification to install an older version of Use the most current
(1) already exists on the an Application version of the Application
system. Specification that currently Specification.
7212 is installed on the system.
0 = New application
specification version
1 = Old application
specification version
An Application An attempt has been made 1. Use the currently
specification with the same to load an Application installed Application
Id (0) already exists on the Specification that already Specification.
system. exists on the system. 2. When installing
Application Specification
0 = Application (i.e., upgrading to a
specification name newer version), the
earlier version of the
Application Specification
currently installed on
the system must be
7213
deleted prior to
installing the new
version. Refer to
Application
Management <Delete>
on page 5–20 of Section
5, Operating
Instructions.
3. If problem persists,
contact your Area Abbott
Customer Service.
Invalid number (0) of Software error 1. Delete the Application
Component (1) instances. Specification.
Expected a minimum of (2). 2. Reinstall the Application
Specification.
7215 3. If problem persists,
0 = Number of components
1 = Component type contact your Area Abbott
Customer Service.
2 = Minimum number of
components

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200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Invalid number (0) of Software error 1. Delete the Application
Component (1) instances. Specification.
Expected a maximum of 2. Reinstall the Application
(2). Specification.
7216 0 = Number of components
3. If problem persists,
1 = Component type contact your Area Abbott
2 = Maximum number of Customer Service.
components
Invalid Component (0) Software error 1. Delete the Application
reference. Specification.
2. Reinstall the Application
7217 0 = Component type Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.
Referenced Component Liquid reference class does 1. Install the referenced
type (0) with identity not exist. liquid class.
(1)/(2) does not exist. 2. Reinstall the Application
7218 Specification.
0 = Component type 3. If problem persists,
1 = Component name contact your Area Abbott
Customer Service.
2 = Component version
Component with identity Application already 1. Delete any conflicting
(1)/(2) already exists. installed or an application Application
with a different version Specifications.
number is already installed 2. If liquid class application
1 = Component ID
is deleted, delete all
2 = Component version
m2000 applications,
7219 then reinstall the liquid
class.
3. Reinstall the Application
Specification.
4. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-143


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Requested Component type Software error 1. Delete the Application
(0) does not exist in Specification.
Application specification 2. Reinstall the Application
(1). Specification.
7220
3. If problem persists,
0 = Component type contact your Area Abbott
1 = Application Customer Service.
specification
Component type (0) has an Software error 1. Delete the Application
invalid read stage (1) and Specification.
read step (2) for the 2. Reinstall the Application
Thermal profile. Specification.
7222 3. If problem persists,
0 = Component type contact your Area Abbott
1 = Read stage Customer Service.
2 = Read step
Component type (0) has an Software error 1. Delete the Application
invalid Target dye name (1). Specification.
2. Reinstall the Application
7223 0 = Component name Specification.
1 = Dye name 3. If problem persists,
contact your Area Abbott
Customer Service.
Component type (0) has an Software error 1. Delete the Application
invalid Control dye name Specification.
(1). 2. Reinstall the Application
7224 Specification.
0 = Component name 3. If problem persists,
1 = Dye name contact your Area Abbott
Customer Service.
Component type (0) has an Software error 1. Delete the Application
invalid Reference dye name Specification.
(1). 2. Reinstall the Application
7225 Specification.
0 = Component name 3. If problem persists,
1 = Dye name contact your Area Abbott
Customer Service.

10-144 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Component type (0) has a Software error 1. Delete the Application
duplicate dye name (1). Specification.
2. Reinstall the Application
7226 0 = Component name Specification.
1 = Dye name 3. If problem persists,
contact your Area Abbott
Customer Service.
Component type (0) has an Software error 1. Delete the Application
unsupported dye name (1). Specification.
2. Reinstall the Application
7228 0 = Component name Specification.
1 = Dye name 3. If problem persists,
contact your Area Abbott
Customer Service.
Could not delete An attempt was made to Wait until instrument has
Application specification, delete an Application completed the run, then
7229
an instrument is running. Specification while delete the Application
instrument was running. Specification.
Missing required liquid Software error 1. Delete the Application
class references for Specification.
component (0) 2. Install the correct liquid
7230
class references.
0 = Component name 3. Install the Application
specification.
Missing liquid class or Software error 1. Delete the Application
liquid class reference (1) in Specification.
component (0) 2. Install the correct liquid
7231 class references.
0 = Component name 3. Install the Application
1 = Liquid class specification.

Missing liquid classes or Software error 1. Delete the Application


liquid class references (1) in Specification.
component (0) 2. Install the correct liquid
7232 class references.
0 = Component name 3. Install the Application
1 = Liquid class name specification.

m2000rt Operations Manual 10-145


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Missing (2) Command for Software error 1. Delete the Application
timer(s) with id(s)=(1) in Specification.
component (0) 2. Reinstall the Application
7234 Specification.
0 = Component name 3. If problem persists,
1 = Timer ID contact your Area Abbott
Customer Service.
2 = Timer type
The specifications for Software error 1. Delete the Application
timer(s) with id(s)=(1) are Specification.
invalid in component (0). 2. Reinstall the Application
7235 Specification.
0 = Component name 3. If problem persists,
1 = Timer ID contact your Area Abbott
Customer Service.
Invalid cycle difference Software error 1. Delete the Application
range [(0), (1)]. Specification.
2. Reinstall the Application
7238 0 = Minimum cycle number Specification.
1 = Maximum cycle 3. If problem persists,
number contact your Area Abbott
Customer Service.
Invalid ratio range [(0), (1)]. Software error 1. Delete the Application
Specification.
0 = Minimum ratio 2. Reinstall the Application
7239 Specification.
1 = Maximum ratio
3. If problem persists,
contact your Area Abbott
Customer Service.
Invalid ratio width range Software error 1. Delete the Application
[(0), (1)]. Specification.
2. Reinstall the Application
7240 0 = Minimum ratio width Specification.
1 = Maximum ratio width 3. If problem persists,
contact your Area Abbott
Customer Service.

10-146 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


maxRatio (0) must be Software error 1. Delete the Application
greater than the threshold Specification.
after the transition cycle 2. Reinstall the Application
7241 (1). Specification.
3. If problem persists,
0 = Maximum ratio contact your Area Abbott
1 = Cycle number Customer Service.

Threshold (0) for Ct Software error 1. Delete the Application


analysis must be greater Specification.
than 0. 2. Reinstall the Application
7242 Specification.
0 = Threshold 3. If problem persists,
contact your Area Abbott
Customer Service.
Invalid concentration range Software error 1. Delete the Application
[(0), (1)]. Specification.
2. Reinstall the Application
7243 0 = Minimum Specification.
concentration 3. If problem persists,
1 = Maximum contact your Area Abbott
concentration Customer Service.

Invalid internal control Software error 1. Delete the Application


cycle limits [(0), (1)]. Specification.
2. Reinstall the Application
7244 0 = Minimum cycle number Specification.
1 = Maximum cycle 3. If problem persists,
number contact your Area Abbott
Customer Service.
Invalid calibration model Software error 1. Delete the Application
slope range [(0), (1)]. Specification.
2. Reinstall the Application
7245 0 = Minimum slope Specification.
1 = Maximum slope 3. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-147


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Invalid calibration model Software error 1. Delete the Application
intercept range [(0), (1)]. Specification.
2. Reinstall the Application
7246 0 = Minimum intercept Specification.
1 = Maximum intercept 3. If problem persists,
contact your Area Abbott
Customer Service.
Duplicate quantitative Software error 1. Delete the Application
control level name Specification.
definition (0). 2. Reinstall the Application
7247 Specification.
0 = Level name 3. If problem persists,
contact your Area Abbott
Customer Service.
Duplicate quantitative Software error 1. Delete the Application
calibrator level name Specification.
definition (0). 2. Reinstall the Application
7248 Specification.
0 = Level name 3. If problem persists,
contact your Area Abbott
Customer Service.
Duplicate qualitative Software error 1. Delete the Application
control level name Specification.
definition (0). 2. Reinstall the Application
7249 Specification.
0 = Level name 3. If problem persists,
contact your Area Abbott
Customer Service.
Missing qualitative Software error 1. Delete the Application
calibrator level cutoff Specification.
definition. 2. Reinstall the Application
7250 Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.

10-148 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Invalid qualitative sample Software error 1. Delete the Application
internal control cycle limits Specification.
[(0), (1)]. 2. Reinstall the Application
7251 Specification.
0 = Minimum cycle number 3. If problem persists,
1 = Maximum cycle contact your Area Abbott
number Customer Service.

Invalid qualitative control Software error 1. Delete the Application


internal control cycle limits Specification.
[(0), (1)]. 2. Reinstall the Application
7252 Specification.
0 = Minimum cycle number 3. If problem persists,
1 = Maximum cycle contact your Area Abbott
number Customer Service.

Duplicate overlapping Software error 1. Delete the Application


timers (1) are defined in Specification.
component (0) 2. Reinstall the Application
7254 Specification.
0 = Component name 3. If problem persists,
1 = Timer name contact your Area Abbott
Customer Service.
Nested loop (id = 1) found Software error 1. Delete the Application
in component (0) Specification.
2. Reinstall the Application
7255 0 = Component name Specification.
1 = Loop ID 3. If problem persists,
contact your Area Abbott
Customer Service.
Invalid default unit Software error 1. Delete the Application
conversion (0). There are Specification.
only (1) unit conversions 2. Reinstall the Application
available. Specification.
7257
3. If problem persists,
0 = Conversion formula contact your Area Abbott
1 = Number of alternate Customer Service.
units

m2000rt Operations Manual 10-149


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Duplicate unit name Software error 1. Delete the Application
definition (0). Specification.
2. Reinstall the Application
7258 0= Result unit name Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.
Invalid unit (0) conversion Software error 1. Delete the Application
formula definition (1). Specification.
2. Reinstall the Application
7259 0 = Result unit ID Specification.
1 = Formula 3. If problem persists,
contact your Area Abbott
Customer Service.
Duplicate interpretation Software error 1. Delete the Application
name definition (0). Specification.
2. Reinstall the Application
7260 0 = Interpretation name Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.
Invalid interpretation range Software error 1. Delete the Application
[(0), (1)]. Specification.
2. Reinstall the Application
7261 0 = Minimum Specification.
concentration 3. If problem persists,
1 = Maximum contact your Area Abbott
concentration Customer Service.

Invalid inverse unit (0) Software error 1. Delete the Application


conversion formula Specification.
definition (1). 2. Reinstall the Application
7262 Specification.
0 = Unit ID 3. If problem persists,
1 = Formula contact your Area Abbott
Customer Service.

10-150 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Bar code identifier (0) is not Software error 1. Delete the Application
unique across quantitative Specification.
calibrators and controls. 2. Reinstall the Application
7263 Specification.
0 = Bar code sample ID 3. If problem persists,
contact your Area Abbott
Customer Service.
Bar code identifier (0) is not Software error 1. Delete the Application
unique across qualitative Specification.
calibrators and controls. 2. Reinstall the Application
7264 Specification.
0 = Bar code sample ID 3. If problem persists,
contact your Area Abbott
Customer Service.
Stage (0) Cycles (1) is Software error 1. Delete the Application
greater than the maximum Specification.
limit (2). A Stage with one 2. Reinstall the Application
Step may only have one Specification.
Cycle. 3. If problem persists,
7265
contact your Area Abbott
0 = Stage Customer Service.
1 = Number of cycles
2 = Cycle limit
Temperature difference Software error 1. Delete the Application
(0)°C between Stage (1) Specification.
Steps (2) is less than the 2. Reinstall the Application
minimum limit (3)°C. Specification.
3. If problem persists,
7266 0 = Temperature difference contact your Area Abbott
1 = Stage number Customer Service.
2 = Step numbers
3 = Minimum temperature
difference

m2000rt Operations Manual 10-151


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Total number of Stages and Software error 1. Delete the Application
Steps (0) is greater than the Specification.
maximum limit (1). 2. Reinstall the Application
7267 Specification.
0 = Number of steps 3. If problem persists,
1 = Stage/step limit contact your Area Abbott
Customer Service.
Invalid qualitative Software error 1. Delete the Application
calibrator internal control Specification.
cycle limits [(0), (1)]. 2. Reinstall the Application
7268 Specification.
0 = Minimum cycle limit 3. If problem persists,
1 = Maximum cycle limit contact your Area Abbott
Customer Service.
Invalid qualitative Software error 1. Delete the Application
calibrator target cycle limits Specification.
[(0), (1)]. 2. Reinstall the Application
7269 Specification.
0 = Minimum cycle limit 3. If problem persists,
1 = Maximum cycle limit contact your Area Abbott
Customer Service.
Negative quantitative Software error 1. Delete the Application
control level (0) Specification.
concentration is non-zero. 2. Reinstall the Application
7271 Specification.
0 = Level name 3. If problem persists,
contact your Area Abbott
Customer Service.
Positive quantitative Software error 1. Delete the Application
control level (0) Specification.
concentration is zero. 2. Reinstall the Application
7272 Specification.
0 = Level name 3. If problem persists,
contact your Area Abbott
Customer Service.

10-152 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Component type (0) is Software error 1. Delete the Application
missing Control parameters Specification.
required by the Detector. 2. Reinstall the Application
7273 Specification.
0 = Component name 3. If problem persists,
contact your Area Abbott
Customer Service.
Ct analysis requires cycle Software error 1. Delete the Application
difference validity check Specification.
parameters. 2. Reinstall the Application
7274 Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.
Command (1) in Software error 1. Delete the Application
component (0) cannot be Specification.
defined outside of a 2. Reinstall the Application
7275 composite command. Specification.
3. If problem persists,
0 = Component name contact your Area Abbott
1 = Command name Customer Service.

Stage (0) Step (1) Software error 1. Delete the Application


Temperature (2)°C out of Specification.
range due to invalid 2. Reinstall the Application
temperature extension Specification.
(3)°C over (4) cycles. 3. If problem persists,
7277 contact your Area Abbott
0 = Stage Customer Service.
1 = Step
2 = Temperature
3 = Temperature extension
4 = Number of cycles

m2000rt Operations Manual 10-153


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Stage (0) Step (1) Time (2) Software error 1. Delete the Application
out of range due to invalid Specification.
time extension (3) over (4) 2. Reinstall the Application
cycles. Specification.
3. If problem persists,
7278 0 = Stage contact your Area Abbott
1 = Step Customer Service.
2 = Time
3 = Time extension
4 = Number of cycles
The bar code Id (0) is Software error 1. Delete the Application
assigned to a calibrator Specification.
level and a control level. 2. Reinstall the Application
7279 Specification.
0 = Bar code ID 3. If problem persists,
contact your Area Abbott
Customer Service.
Heater commands are Software error 1. Delete the Application
invalid in component (0) Specification.
2. Reinstall the Application
7280 0 = Component name Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.
Chiller commands are Software error 1. Delete the Application
invalid in component (0) Specification.
2. Reinstall the Application
7281 0 = Component name Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.
Tip reuse commands are Software error 1. Delete the Application
invalid in component (0) Specification.
2. Reinstall the Application
7282 0 = Component name Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.

10-154 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


The reuse tip type (200 μL) Software error 1. Delete the Application
is invalid in tip reuse Specification.
commands in component 2. Reinstall the Application
7283 (0) Specification.
3. If problem persists,
0 = Component name contact your Area Abbott
Customer Service.
Duplicate liquid class Software error 1. Delete the Application
reference (1) in component Specification.
(0) 2. Reinstall the Application
7285 Specification.
0 = Component name 3. If problem persists,
1 = Liquid class reference contact your Area Abbott
Customer Service.
Duplicate liquid classes Software error 1. Delete the Application
references (1) in Specification.
component (0) 2. Reinstall the Application
7286 Specification.
0 = Component name 3. If problem persists,
1 = Liquid class reference contact your Area Abbott
Customer Service.
Invalid liquid class Software error 1. Delete the Application
reference (1) in component Specification.
(0). Components with 2. Reinstall the Application
specified versions are either Specification.
7287 invalid or not installed.
3. If problem persists,
contact your Area Abbott
0 = Component name Customer Service.
1 = Liquid class reference
Invalid liquid classes Software error 1. Delete the Application
references (1) in Specification.
component (0). 2. Reinstall the Application
Component with specified Specification.
7288 version is either invalid or 3. If problem persists,
not installed. contact your Area Abbott
Customer Service.
0 = Component name
1 = Liquid class references

m2000rt Operations Manual 10-155


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Duplicate GPR location (1) Software error 1. Delete the Application
defined in component (0) Specification.
2. Reinstall the Application
7289 0 = Component name Specification.
1 = GPR location 3. If problem persists,
contact your Area Abbott
GPR = General purpose Customer Service.
reagent
Application (0) (1) Application installed No action required.
installed.
7291
0 = Application name
1 = Application version
Application (0) (1) deleted. Application deleted No action required.

7292
0 = Application name
1 = Application version
Application specification Software error 1. Repeat action.
update cancelled. 2. If problem persists,
7293
contact your Area Abbott
Customer Service.
Unable to install Software error 1. Delete the Application
Application, application Specification.
specification name (0) 2. Reinstall the Application
7294 contains invalid characters. Specification.
3. If problem persists,
0 = Application contact your Area Abbott
specification name Customer Service.
Command (1) in Software error 1. Delete the Application
component (0) cannot be Specification.
defined inside a composite 2. Reinstall the Application
7296 (or loop) command. Specification.
3. If problem persists,
0 = Component name contact your Area Abbott
1 = Command name Customer Service.

10-156 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Component (0) has loop Software error 1. Delete the Application
commands (1) defined Specification.
which are invalid. 2. Reinstall the Application
7297 Specification.
0 = Component name 3. If problem persists,
1 = Command name contact your Area Abbott
Customer Service.
Component (0) has invalid Software error 1. Delete the Application
liquid handling commands Specification.
defined in it. 2. Reinstall the Application
7298 Specification.
0 = Component name 3. If problem persists,
contact your Area Abbott
Customer Service.
Ambiguous Component Software error 1. Delete the Application
type (0) reference. Specification.
2. Reinstall the Application
7299 0 = Component type name Specification.
3. If problem persists,
contact your Area Abbott
Customer Service.
Unable to create results for Software error 1. The plate will need to be
the plate in the database. reprocessed and rerun.
7300 2. If problem persists,
contact your Area Abbott
Customer Service.
Unable to update the plate Software error 1. The plate will need to be
status in the database. reprocessed and rerun.
7301 2. If problem persists,
contact your Area Abbott
Customer Service.
Unable to update the well Software error 1. The plate will need to be
statuses in the database. reprocessed and rerun.
7302 2. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-157


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unable to update the well Software error 1. The plate will need to be
error in the database. reprocessed and rerun.
7304 2. If problem persists,
contact your Area Abbott
Customer Service.
Unable to set intensity data Software error 1. The plate will need to be
for the plate. reprocessed and rerun.
7305 2. If problem persists,
contact your Area Abbott
Customer Service.
Unable to get intensity data Software error 1. The plate will need to be
for the plate. reprocessed and rerun.
7306 2. If problem persists,
contact your Area Abbott
Customer Service.
Unable to update Software error 1. The plate will need to be
information for the plate. reprocessed and rerun.
7307 2. If problem persists,
contact your Area Abbott
Customer Service.
Unable to get the result for Software error Contact your Area Abbott
7310 result (0) from the database. Customer Service.
0 = Result ID
Unable to update plate Software error Contact your Area Abbott
7311
comment. Customer Service.
Unable to update comment Software error Contact your Area Abbott
7312
for results. Customer Service.
Error while getting result Software error Contact your Area Abbott
for plate (0) from the Customer Service.
database. Invalid number of
7313 row count (1) in plate table

0 = Plate ID
1 = Row count

10-158 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Error while getting result Software error Contact your Area Abbott
for plate (0) from the Customer Service.
database. Invalid number of
7314 row count (1) in wells table

0 = Plate ID
1 = Row count
Error while getting result Software error Contact your Abbott
for plate (0) from the Customer Service.
database. Invalid number of
row count (1) in the results
table for well Id (2).
7315

0 = Plate ID
1 = Row count
2 = Well ID
Error while exporting Software error Contact your Area Abbott
results for plate (0). Invalid Customer Service.
sample type (1) present in
7316 the wells table

0 = Plate ID
1 = Sample type in file
Error while exporting Hardware failure: 1. Export Test Order files
results for plate (0) to file • CD-drive again from the m2000sp
(1). using a new CD-R or
• CD media
CD-RW.
0 = Plate ID 2. Reinstall Test Order files
in the appropriate
1 = File name
directory location.
7318 3. Attempt Test Order
import again.
4. If import or export fails
again, manually create
Test Order.
5. If problem persists,
contact your Area Abbott
Customer Service.

m2000rt Operations Manual 10-159


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Error when attempting to Software error 1. Shutdown computer and
send running results to restart.
7319 exceptions on startup. 2. If problem persists,
contact your Area Abbott
Customer Service.
Result not processed since • System was shutdown Reprocess the samples.
run did not complete. during a run/or while
result data was being
7320 generated
• All results that are in
process are sent to
exception with this error
Plate (0) not processed since • System was shutdown Reprocess the samples.
plate run did not complete. during a run
7321 • All plates that are not
0 = Plate ID completed are sent to
exception with this error
message
Error while exporting Hardware error. Incorrect Contact your Area Abbott
results for plate (0) to drive found. Customer Service.
specified file (1). Invalid
7322 recorder type present.

0 = Plate ID
1 = File name
Error while exporting Write failure to CD. 1. Wait until the drive is
results for plate (0) to not in use.
specified file (1). Drive is in 2. Try again when the
the middle of erasing or removable drive has
burning a CD. completed its burning or
erasing function.
7323 0 = Plate ID 3. Shutdown software and
1 = File name cycle power on the
computer.
4. Try again.
5. If problem persists,
contact your Area Abbott
Customer Service.

10-160 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Error while exporting • Incorrect CD used Retry using a new CD-R or
results for plate (0) to • CD is corrupt CD-RW.
specified file (1). The CD
drive does not contain a
7324 valid writable media.

0 = Plate ID
1 = File name
Results for plate (0) were Status message No action required.
successfully exported to
specified file (1).
7325
0 = Plate ID
1 = File name
Error while exporting Write CD to the file failed. Retry using a new CD-R or
results for plate (0) to CD-RW.
specified file (1). Burn CD
7326 thread time out occurred.

0 = Plate ID
1 = File name
Error while exporting Insufficient disc space on Try again on a CD-R or
results for plate (0) to the CD. CD-RW with more storage
specified (1). Insufficient space.
7327 space on removable media.

0 = Plate ID
1 = File name
Archive failed, the selected Software error Contact your Area Abbott
7329 plate does not exist in the Customer Service
database.
Error while exporting Failure writing to the CD 1. Retry using a new CD-R
results for plate (0). Failed or CD-RW.
7330 to create output file. 2. If problem persists,
contact your Area Abbott
0 = Plate name Customer Service.

m2000rt Operations Manual 10-161


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Error during CD export of Failure writing to the CD 1. Retry using a new CD-R
plate (0) to file (1) or CD-RW.
7331 2. If problem persists,
0 = Plate name contact your Area Abbott
Customer Service.
1 = File name
Unable to export data for All results selected for No action required.
plate (0) for selected assay export are invalid; data
(1). No valid results were cannot be evaluated
7332 found.

0 = Plate name
1 = Assay name
Failed to create output file. Software error Contact your Area Abbott
A schema validation error Customer Service
occurred during the export
7333 of plate (0).

0 = Plate name
Results for plate (0) were Status message No action is required.
automatically exported to
file (1).
7334
0 = Plate name
1 = File name
Results for plate (0) failed to Plate was completed with Verify:
export to file (1) automatic export • Cables are connected
automatically. configured to <On>; properly
however, plate data failed
• AbbottLink computer is
to transfer to the Network
0 = Plate name powered on
Data Store because of a
1 = File name communication error • Network Data Store
7335 instrument is powered on
possibly related to:
• Cabling • Router is powered on
• AbbottLink If problem persists, contact
your Area Abbott Customer
• Network Data Store
Service.
instrument turned off
• Router

10-162 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


7336 Unable to export data for Not results were found in Perform a query for the
the Quality Control the Quality Control query Quality Control results
selection. No valid results to export again, then perform the
were found. export.
Unable to delete plate while An attempt is made to Wait until the plate run is
plate is running. delete a plate that has a complete and the plate
7350 status of running. status is completed before
attempting to delete the
plate.
Unable to delete results An attempt is made to Wait until the plate run is
while plate is running. delete results that have a complete and the results
7351 status of running. status is completed before
attempting to delete the
result.
Unable to delete plate while An attempt has been made Allow plate results to
plate has results that are to delete a plate that has complete transmission
7353 pending transmission. results that have a release before attempting to delete
status of pending the plate.
transmission
Unable to delete results that An attempt has been made Allow results to complete
are pending transmission. to delete results that have a transmission before
7354
release status of pending attempting to delete them.
transmission
Plate (0) was deleted. Plate has been deleted. No action required.
7355
0 = Plate ID
Error while exporting the An attempt has been made 1. Wait for the run to
the plate results. Plate is in to export a plate that is complete and select
invalid status (either currently in running or <Close Process> before
Running or Failed) and can failed status. attempting to export the
7356 not be exported. plate.
2. If the status is failed,
reprocess and repeat the
run.
Unable to release results An attempt has been made Wait for the run to
while plate is running. to release a plate result or complete before attempting
7357
selected result that has a to release results.
status of running.

m2000rt Operations Manual 10-163


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unable to archive plate An attempt was made to Wait for the run to
7358 while the instrument is archive a plate when the complete, then perform the
running. instrument is running. archive procedure.
Result at location (0) for User deleted a result No action required.
assay (1) in plate (2) was
deleted.
7359
0 = Well location
1 = Assay name
2 = Plate name
Unable to print results Attempt was made to print Wait until the run has
details while plate is result details while the plate completed and select
7360 running. was still running. <Close Process> on the
m2000sp before attempting
to print the result details.
An unrecoverable error has Hardware error: CD drive Contact your Area Abbott
occurred while archiving to Customer Service.
7361
the CD. The system is going
to shutdown.
Plate (0) cannot be Attempt was made to Wait for the process to
exported since the process export a plate while the complete and select <Close
7362 is still running. process was still running Process> on the m2000sp,
then export the plate.
0 = Plate name
Plate (0) cannot be deleted Attempt was made to delete Wait for the process to
since the process is still a plate while the process complete and select <Close
7363 running. was still running Process> on the m2000sp,
then delete the plate.
0 = Plate name
Unable to export plate User attempted to export a Export the plate upon
7364 while the instrument is plate while the instrument completion of the run.
running. was still running.
Unable to print results list User attempted to print Wait until the plate has
7365 while plate is running. results list while the plate completed the run before
was still running. printing the result list.

10-164 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Unable to release genotype A plate/result that If Genotype results need to
result(s) for plate (0) to LIS contained Genotype results be sent to the host,
when the configuration is was manually selected for configure the Transmit to
7366 disabled. release to the LIS when the Host option by selecting
configuration to release Genotype results.
Genotype results to the
0 = Plate name
host was not checked.
Unable to release laboratory A plate/result that If laboratory-defined results
defined application result(s) contained open mode need to be sent to the host,
for plate (0) to LIS when the (laboratory-defined) results configure the Transmit to
configuration is disabled. was manually selected for Host option by selecting
7367 release to the LIS when the laboratory- defined results.
configuration to release
0 = Plate name
laboratory-defined results
to the host was not
checked.
Unable to release genotype A plate/result that If Genotype results need to
result(s) for plate (0) to LIS contained genotype results be sent to the host,
when the configuration is was automatically selected configure the Transmit to
7368 disabled. for release to the LIS when Host option by selected
the configuration to release Genotype results.
Genotype results to the
0 = Plate name
host was not checked.
Unable to release laboratory A plate/result that If laboratory-defined results
defined application result(s) contained open mode need to be sent to the host,
for plate (0) to LIS when the (laboratory-defined) results configure the Transmit to
configuration is disabled. was automatically selected Host option by selecting
7369 for release to the LIS when laboratory- defined results.
the configuration to release Otherwise, ignore the
0 = Plate name
laboratory-defined results message.
to the host was not
checked.
Number of results in the Secondary results were If results are to be printed,
report will be less than selected for assay and configure secondary result
number of results selected configured for <Display>, units to be sent to
by user. Please check the but not configured for <Report>.
7371 settings in the result units <Report>. Selected results Refer to Result Units
configuration. will not be printed. Configuration on page 2–41
of Section 2, Installation
Procedures and User
Configuration.

m2000rt Operations Manual 10-165


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Number of results to be Secondary results were If results are to be archived,
archived will be less than configured for assay and configure secondary result
number of results selected configured for <Display>, units to <Archive>.
by user. Please check the but not configured for Refer to Result Units
7372 settings in the result units <Archive>. Selected results Configuration on page 2–41
configuration. will not be printed. of Section 2, Installation
Procedures and User
Configuration.
Number of results to be Secondary results were No action required. If
released to the LIS will be configured for assay and results are to be
less than number of results configured for <Display>, transmitted, configure
selected by user. Please but not configured for secondary result units to
check the settings in the <Release to LIS>. Some of <Release to LIS>.
7373 result units configuration. the selected results will not Refer to Result Units
be transmitted. Configuration on page 2–41
of Section 2, Installation
Procedures and User
Configuration.
There is no result for Operator selected view No action required. If it is
viewing with current result details when no necessary, configure
configuration setting. results were available for secondary result units to
Please check the settings in viewing. Secondary units <Display>.
7374 the result units were configured for the Refer to Result Units
configuration. assay, but not for display, Configuration on page 2–41
and all primary results were of Section 2, Installation
deleted from the plate. Procedures and User
Configuration.
There is no result to be Operator selected archive No action required. If it is
archived with current when no results were necessary, configure
configuration setting. available for archiving. secondary result units to
Please check the settings in Secondary units were <Archive>.
7375 the result units configured for the assay, Refer to Result Units
configuration. but not archive, and only Configuration on page 2–41
secondary units are of Section 2, Installation
currently available for Procedures and User
display. Configuration.

10-166 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


There is no result on the Operator selected Print No action required. If it is
report with current Result List or Print Result necessary, configure
configuration setting. Details when no results secondary result units to
Please check the settings in were available to print. <Print>.
7376 the result units Secondary units were Refer to Result Units
configuration. configured for the assay, Configuration on page 2–41
but not for print. of Section 2, Installation
Procedures and User
Configuration.
There is no result to be Operator selected release No action required. If it is
released to LIS with current when no results were necessary, configure
configuration setting. available for release. secondary result units to
Please check the settings in Secondary units were <Release to LIS>.
7377 the result units configured for the assay, Refer to Result Units
configuration. but not for transmit to LIS. Configuration on page 2–41
of Section 2, Installation
Procedures and User
Configuration.
(0) plate(s) successfully User selected multiple Status message.
archived to CD. (1) plate(s) plates to archive Review message history if
failed to archive to CD. errors occurred during
archive. Refer to Message
7378 History Log on page 10–9.
0 = Number of plates
archived
1 = Number of plates with
errors
The selected plate data was Status message No action required.
7379
successfully written to CD.
The selected plate data The plate data was not Try again with a new CD.
failed to be written to the saved to the CD. Review message history for
7380 CD. causes of failure. Refer to
Message History Log on
page 10–9.

m2000rt Operations Manual 10-167


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Writing of the (0) (1) data The software detected one Wait a few minutes and
failed, a file with the same or more plates with the then attempt to archive the
name already exists in the same name being archived failed plate.
7381 CD. at the same time.

0 = Plate name
1 = Archive file name
One or more data reduction A function parameter is Hover over the name or
parameters has an error. invalid or out of range on error icon to determine the
7382 the <PCR Plate Analysis> cause of the error. Fix the
screen. error prior to selecting
<Recalculate> or <Save>.
The Application User deleted the Status message; plate can
Specification associated Application Specification no longer be analyzed
7383 with this plate is no longer associated with the plate.
installed. Error occurs when selecting
<Analyze>.
Analysis cannot be User selected <Analyze> Wait until the current
7384 performed while the system for a plate while the system process is finished running
is in the Running state. was running. before analyzing the plate.
Analysis cannot be Some or all of the results in Wait until all results are
performed while the plate the selected results are transmitted before
7385
has results pending pending transmission to analyzing.
transmission. LIS.
The system is not The system no longer has New license is required;
7386 sufficiently licensed to an adequate LDA license to contact your Area Abbott
analyze this plate. analyze the data. Customer Service.
Analysis cannot be Test Orders exist for the Delete or run any pending
performed while there are application that was used to Test Orders for the
7387
test orders pending for the generate the selected plate. application, then perform
associated application. plate results analysis.

10-168 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


There is no result to be User has deleted all primary If results need to be
archived with current results on the plate and has archived, navigate to
configuration setting for selected archive. The <System>, <Settings>,
plate (0). configuration for the result and <Result Unit
7388 archive is set to archive Configuration>. Refer to
only the primary unit. Result Units Configuration
0 = Plate name
on page 2–41 of Section 2,
Installation Procedures
and User Configuration.
Analysis was performed on User performed post-run Status message. No action
plate (0) and new results analysis on laboratory- required.
7389 were generated. defined application results.

0 = Plate name
Please verify the date(s) The start date is either after Enter a valid start date.
entered. If both a Start Date or the same as the end date,
7390 and End Date are specified, or the start date is blank.
the Start Date must be prior
to the End Date.
No results were selected. No results were selected. Select at least one result.
Please modify selection
7391
criteria and Generate
Results again.
Invalid export name. Name The export name was left The export name must
cannot contain only spaces. blank. contain valid text. Enter a
7392
Please enter a valid export valid export name.
name.
Unable to export results An attempt was made to Wait until the system is in
while the instrument is export results while the the READY state and then
7393
running. instrument was in the retry exporting.
RUNNING state.
Failure to backup file: (0) Backup of the specified file 1. Retry backup with a new
during task (1) has failed. CD.
7401 2. If problem persists,
0 = Backup file name contact your Area Abbott
Customer Service.
1 = Task name

m2000rt Operations Manual 10-169


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Backup: (0) was aborted Software error 1. Perform the Backup
since the request to stop the procedure again.
server: (1) has failed. 2. If problem persists,
7402 contact your Area Abbott
0 = Backup file name Customer Service.
1 = Server name
Specified database: (0) on Software error 1. Perform the Backup
server: (1) does not exist. procedure again.
7403 2. If problem persists,
0 = Database name contact your Area Abbott
Customer Service.
1 = Server name
Backup: (0) has aborted due Software error. 1. Perform the Backup
to a failure to create the procedure again.
7404 manifest 2. If problem persists,
contact your Area Abbott
0 = Backup file name Customer Service.

Specified folder path: (0) Software error 1. Perform the Backup


does not exist. procedure again.
7405 2. If problem persists,
0 = Folder path contact your Area Abbott
Customer Service.
The (0) operation has failed Unable to perform backup 1. Wait for the
since results are pending or restore when results are transmission to
transmission to the host. pending transmission to complete. Once the
the host pending results have
completed transmission
0 = Operation name
to the host, then the
backup/restore process
can be performed.
7406
2. Cancel the transmission,
see Cancel Result
Transmission on page
2–28 of Section 2,
Installation
Procedures and User
Configuration, for
details.

10-170 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


The specified database Software error 1. Perform the Backup
server: (0) does not exist procedure again.
7407 2. If problem persists,
0 = Server name contact your Area Abbott
Customer Service.
Backup: (0) was aborted Software error 1. Perform the Backup
since the request to start procedure again.
the server: (1) has failed. 2. If problem persists,
7409 contact your Area Abbott
0 = Backup file name Customer Service.
1 = Server name
Backup: (0) has aborted due Software error 1. Perform the Backup
to a failure to create the procedure again.
7411 manifest file 2. If problem persists,
contact your Area Abbott
0 = Backup file name Customer Service.

Backup: (0) has aborted due Software error 1. Perform the Backup
to a failure to create the procedure again.
7412 temporary backup archive 2. If problem persists,
contact your Area Abbott
0 = Backup file name Customer Service.

A critical software error has Software error 1. Perform the Backup


occurred during backup: (0) procedure again.
7413 2. If problem persists,
0 = Backup file name contact your Area Abbott
Customer Service.
Unable to find the backup Software error 1. Perform the Backup
archive: (0) procedure again.
7414 2. If problem persists,
0 = Archive file name contact your Area Abbott
Customer Service.
Restore for backup: (0) has Software error 1. Perform the Backup
failed since the files in the procedure again.
backup archive could not 2. If problem persists,
7415 be extracted contact your Area Abbott
Customer Service.
0 = Backup file name

m2000rt Operations Manual 10-171


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


The database backup file for Software error 1. Perform the Backup
database: (0) on server: (1) procedure again.
does not exist. 2. If problem persists,
7416 contact your Area Abbott
0 = Database name Customer Service.
1 = Server name
Backup: (0) has been • Wrong CD type used. Perform the backup using a
aborted since CD media is • CD is full. new CD-R or CD-RW.
of an invalid recorder
7417 format.

0 = Backup file name


Backup: (0) has been The CD drive is in use by a 1. Wait for the CD drive to
aborted since the CD drive different process. complete the current
is currently busy. task, then perform the
Backup procedure.
7418 0 = Backup file name 2. Perform a system
shutdown.
3. Restart.
4. Try Backup procedure
again.
Backup: (0) has been Wrong CD type used. Perform the backup using a
aborted since the CD drive new CD-R or CD-RW.
does not contain a valid
7419 writable media.

0 = Backup file name


Backup: (0) has been There is insufficient disk Perform the backup using a
aborted since there is space on the media to new CD-R or CD-RW.
insufficient space on the perform the backup
7420 media to burn the required operation.
files to disk.

0 = Backup file name

10-172 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Backup: (0) has been Software error 1. Wait one (1) minute and
aborted since a fatal retry the Backup
exception has occurred procedure.
7421 during a write operation to 2. If problem persists,
the CD. contact your Area Abbott
Customer Service.
0 = Backup file name
Backup: (0) has been Possible CD drive failure. 1. Restart the SCC and retry
aborted since the operation the Backup procedure.
to write files to the CD 2. If problem persists,
7422 media has failed. A system contact your Area Abbott
shutdown is in progress. Customer Service.

0 = Backup file name


Database: (0) was The database was No action required.
successfully restored as part successfully restored.
of restore task: (1).
7423
0 = Database name
1 = Restore task name
Failure to restore file: (0) • CD media error 1. Retry the procedure.
from backup: (1) • Software error 2. If problem persists,
7424 contact your Area Abbott
0 = File name Customer Service.
1 = Backup file name
Failure to restore database: Software error 1. Retry the procedure.
(0) on server: (1) from 2. If problem persists,
backup: (2) contact your Area Abbott
7425 Customer Service.
0 = Database name
1 = Server name
2 = Backup file name

m2000rt Operations Manual 10-173


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Failure to backup database: • CD media error 1. Refer to the Message
(0) on server: (1) during • Software error History Log for errors.
task: (2) 2. Retry the procedure
using a new CD-R or
7426
0 = Database name CD-RW.
1 = Server name 3. If problem persists,
contact your Area Abbott
2 = Task name Customer Service.
Failure to backup directory: • CD media error 1. Retry the procedure
(0) during task: (1) • Software error using a new CD-R or
CD-RW.
7427
0 = Directory name 2. If problem persists,
contact your Area Abbott
1 = Task name
Customer Service.
Restore task: (0) has failed A version of the database Restore a new backup
since version of database: was attempted to be database that has the same
(1) is incompatible with restored that is no longer version as the current
current version of system compatible with the software version.
7428 software current software version.

0 = Restore tasks
1 = Database version
7429 Database: (0) was The database was No action required.
successfully converted as successfully restored
part of transform database
task: (1).

0 = Database name
1 = Task name
7430 Failure to convert database: Software error 1. Retry the procedure.
(0) on server: (1) from 2. If problem persists,
backup: (2) contact your Area Abbott
Customer Service.
0 = Database name
1 = Server name
2 = Backup name

10-174 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


7431 The free disk space is not There is insufficient disk Contact your Area Abbott
enough to perform space on the media to Customer Service.
database conversion for perform the Backup
database: (0) on server: (1). operation.

0 = Database name
1 = Server name
7432 The system database CD was removed 1. Reinstall the CD.
backup file: (0) was not 2. Perform the Backup
found. procedure again.
3. If problem persists,
0 = Backup file name contact your Area Abbott
Customer Service.
7433 The database conversion is Restore not supported No action required.
not supported with system
software version: (0) for
database: (1) on server: (2).

0 = Software version
1 = Database name
2 = Server name
7434 Restore task: (0) has failed A restore operation is being Locate a more current
since version of system performed with a system backup disk.
calibration: (1) is calibration that is
incompatible with current incompatible with the
version of system software. current version of system
software.
0 = Failed task
1 = System calibration
version
7435 Failure to convert system Software error 1. Retry the restore
calibration: (0) from 2. If problem persists,
backup: (1). contact your Area Abbott
Customer Service
0 = Calibration
1 = Backup file name

m2000rt Operations Manual 10-175


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


7436 The system calibration 1. The wrong file was 1. Verify that the correct
conversion is not supported selected for restore file was selected for the
with system software 2. System calibration restore. Select the correct
version: ({0}). migration is not file and perform restore
supported from the old 2. Recalibration is required.
0 = Software version software version Review System
Calibration screen for
devices requiring
calibration
The remaining test counts The test count to run LDAs Order more test counts as
to execute Laboratory has run out. instructed in License
defined applications has Configuration found in
7500
been depleted. Section 1 of the m2000rt
Laboratory-Defined
Applications Guide.
The remaining test counts The test counts to run LDAs Order more test counts as
to execute Laboratory is less than 500. instructed in License
defined applications is Configuration found in
7501
running low. Section 1 of the m2000rt
Laboratory-Defined
Applications Guide.
The key entered is not valid User attempted to activate a Locate the correct key for
for this instrument (0). key for the wrong m2000rt. the instrument. If no key is
7505 License keys for laboratory- available, contact your Area
defined applications are Abbott Customer Service.
0 = Instrument ID
instrument specific.
The key (0) activation date License keys must be used Contact your Area Abbott
has expired. within 30 days of key Customer Service for a new
7506 creation. key.
0 = Instrument ID
The system failed to User attempted to activate Contact your Area Abbott
activate the key (0). The an expired license key. Customer Service for a new
7507 license has expired. key.

0 = License key

10-176 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


The system failed to User attempted to activate a Contact your Area Abbott
activate the key (0). Key has license key that was already Customer Service for a new
7508 already been activated. used on the system. key.

0 = License key
The key (0) is invalid in The license key entered was Re-enter the key. If error
length. too long. persists, contact your Area
7509 Abbott Customer Service
for a new key.
0 = License key
The valid license is required The system does not have a Enter the license key before
to activate test count key. valid license to activate the the test count key. If no
7510 test count key. license key exists, contact
your Area Abbott Customer
Service.
The key type is invalid. Software error. Contact your Area Abbott
7511
Customer Service.
The test count is invalid in Software error. Contact your Area Abbott
7512
the key. Customer Service.
The year (0) is invalid in Software error. Contact your Area Abbott
key. Customer Service.
7513

0 = Year
The month (0) is invalid in Software error. Contact your Area Abbott
key. Customer Service.
7514

0 = Month
The day (0) is invalid in key. Software error. Contact your Area Abbott
7515 Customer Service.
0 = Day
The date format is invalid Software error. Contact your Area Abbott
7516
in key. Customer Service.
The test count key (0) User entered a test count Enter the license key first,
activation is not allowed key, but the license key is then enter the test count
7517 when license has expired. expired. key. Contact your Area
Abbott Customer Service if
a new license key is needed.
0 = Count key

m2000rt Operations Manual 10-177


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


The remaining test counts Test counts for laboratory- User needs to replenish test
to execute Laboratory defined applications have count prior to next assay
defined applications are been depleted. run. Contact your Area
depleted. The test order will Abbott Customer Service to
7518
still process. Test counts order more test counts.
must be activated prior to
next Laboratory defined
application run.
You are not authorized to Trial key activation can Contact your Area Abbott
7519 activate the trial key. only be performed by an Customer Service.
Abbott Representative.
Failed to activate the trial User entered a trial key but No action required.
key (0) since a valid license a valid license was already
7520 already exists in the system. installed.

0 = Key
An invalid trial key (0) is An invalid key was entered. Enter a valid key. Contact
detected. your Area Abbott Customer
7521 Service if a valid key is
required.
0 = Key
A valid license is required to User attempted to activate a Activate the trial license
activate the trial key (0). test count key prior to first and then enter the test
7522 activating the license key. count key.
0 = Key
The instrument must be in Instrument is running Wait until instrument is
an idle state to activate a when a key was entered. <Ready>, <Offline>, or
7540
key. <Stopped> before entering
the key.
Failed to activate key (0). A failure occurred when Review the message history
entering a key. for error details. Refer to
7541
Message History Log on
0 = License key
page 10–9.
Key (0) has been activated Status message. No action required.
successfully.
7542

0 = License key

10-178 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Unable to install Software error Contact your Area Abbott
Application, name must be Customer Service.
defined for assay
7600 component (0).

0 = Assay component
Tip handling commands Software error Contact your Area Abbott
specified in component (0) Customer Service.
are invalid for this
7601 application type.

0 = Component name
Specifying initial subsystem Software error Contact your Area Abbott
carrier location in Customer Service.
component (0) is invalid for
7602 this application type.

0 = Component name
Component (0) has invalid Software error Contact your Area Abbott
assay processing Customer Service.
7603 commands.

0 = Component name
Component (0) is invalid Software error Contact your Area Abbott
since it contains elements Customer Service.
7604 that are not instructions.

0 = Component type
Specifying timer commands Software error Contact your Area Abbott
in component type: (0), Customer Service.
name: (1) is invalid per
7605 specification.

0 = Component type
1 = Component name

m2000rt Operations Manual 10-179


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Specifying commands that Software error Contact your Area Abbott
check temperature in Customer Service.
component: (0) is invalid
7606 for this application type.

0 = Component name
Specifying a MovePlate Software error Contact your Area Abbott
command in component: Customer Service.
(0) is invalid for this
7607 application type.

0 = Component name
Specifying more than one Software error Contact your Area Abbott
command of type: Customer Service.
(Instructions) in
7608 component: (0) is invalid
for this application type.

0 = Component type
Missing at least one liquid Software error Contact your Area Abbott
class reference in Customer Service.
7610 component: (0).

0 = Component type
Invalid commands defined Software error Contact your Area Abbott
in component: (0). Customer Service.
7611

0 = Component type
Component type (0) has an Software error Contact your Area Abbott
invalid Quencher dye name Customer Service.
(1).
7612
0 = Component type
1 = Quencher dye

10-180 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Resource (0) could not be Software error Contact your Area Abbott
resolved. Customer Service.
7613

0 = Resource name
Assay type (0) is not Software error Contact your Area Abbott
allowed in Application Customer Service.
specification type (1).
7614
0 = Assay type
1 = Application
Specification
Invalid number (0) of Software error Contact your Area Abbott
Genotype assays. Expected Customer Service.
(1).
7615
0 = Number of Genotype
assays
1 = Number expected
Duplicate Open mode Software error Contact your Area Abbott
control level name Customer Service.
7616 definition (0).

0 = Duplicate definition
Duplicate Open mode Software error Contact your Area Abbott
calibrator level name Customer Service.
7617 definition (0).

0 = Duplicate definition
Bar code identifier (0) is not Software error Contact your Area Abbott
unique across Open mode Customer Service.
7618 calibrators and controls.

0 = Bar code
Open mode positive control Software error Contact your Area Abbott
level (0) concentration is Customer Service.
7619 zero.

0 = Positive control level

m2000rt Operations Manual 10-181


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Open mode negative Software error Contact your Area Abbott
control level (0) Customer Service.
7620 concentration is non-zero.

0 = Negative control level


Assay (0) is not referenced Software error Contact your Area Abbott
by the Genotype Assay Customer Service.
7621 component.

0 = Assay name
Duplicate reaction (0) Software error Contact your Area Abbott
definition. Customer Service.
7622

0 = Reaction name
Duplicate reaction name (0) Software error Contact your Area Abbott
definition. Customer Service.
7623

0 = Reaction name
Invalid control genotype Software error Contact your Area Abbott
(1) specified for reaction Customer Service.
(0). Expected control
genotype (2).
7624
0 = Reaction name
1 = Given genotype name
2 = Expected control
genotype name
Duplicate genotype (1) Software error Contact your Area Abbott
definition found in reaction Customer Service.
(0).
7625
0 = Reaction name
1 = Genotype name

10-182 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Duplicate assay (2) Software error Contact your Area Abbott
definition found in reaction Customer Service.
(0) genotype (1).
7626
0 = Reaction name
1 = Genotype name
2 = Assay name
Duplicate genotype call (2) Software error Contact your Area Abbott
definition found in reaction Customer Service.
(0) genotype (1).
7627
0 = Reaction name
1 = Genotype name
2 = Genotype call name
Assay (2) defined in Software error Contact your Area Abbott
reaction (0) genotype (1) Customer Service.
has an incompatible
reagent configuration (4).
Expected reagent
configuration (3).

7628 0 = Reaction name


1 = Genotype name
2 = Assay name
3 = Expected reagent
configuration
4 = Given reagent
configuration
Assay (2) defined in Software error Contact your Area Abbott
reaction (0) genotype (1) is Customer Service.
not referenced by the
Genotype assay.
7629
0 = Reaction name
1 = Genotype name
2 = Assay name

m2000rt Operations Manual 10-183


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Assay (2) defined in Software error Contact your Area Abbott
reaction (0) genotype (1) is Customer Service.
an invalid assay type (3).
Expected (Open) assay type.

7630 0 = Reaction name


1 = Genotype name
2 = Given assay name
3 = Assay type
Open = Given assay
Target dye of Assay (2) Software error Contact your Area Abbott
defined in reaction (0) Customer Service.
genotype (1) does not
report cycle numbers.
7631
0 = Reaction name
1 = Genotype name
2 = Assay name
Internal control dye of Software error Contact your Area Abbott
assay (2) defined in reaction Customer Service.
(0) genotype (1) does not
report cycle numbers.
7632
0 = Reaction name
1 = Genotype name
2 = Assay name
Assay (2) defined in Software error Contact your Area Abbott
reaction (0) genotype (1) Customer Service.
has a Control or Calibrator
definition.
7633
0 = Reaction name
1 = Genotype name
2 = Assay name

10-184 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Invalid reaction (0) Software error Contact your Area Abbott
specified in the Sample Customer Service.
7634 section.

0 = Reaction name
Duplicate reaction (0) Software error Contact your Area Abbott
specification in the Sample Customer Service.
7635 section.

0 = Reaction name
Invalid genotype (0) Software error Contact your Area Abbott
specified for reaction (1) in Customer Service.
the Sample section.
7636
0 = Genotype name
1 = Reaction name
Duplicate genotype (0) Software error Contact your Area Abbott
specified for reaction (1) in Customer Service.
the Sample section.
7637
0 = Genotype name
1 = Reaction name
Invalid internal control Software error Contact your Area Abbott
cycle range [(0), (1)] in the Customer Service.
Sample section. Minimum
is greater than maximum.
7638
0 = Minimum internal
control cycle range
1 = Maximum internal
control cycle range
Invalid reaction (0) Software error Contact your Area Abbott
specified in the Quality Customer Service.
7639 Control section.

0 = Reaction name

m2000rt Operations Manual 10-185


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Duplicate reaction (0) Software error Contact your Area Abbott
specification in the Quality Customer Service.
7640 Control section.

0 = Reaction name
Invalid genotype (0) Software error Contact your Area Abbott
specified for reaction (1) in Customer Service.
the Quality Control
7641 section.

0 = Genotype name
1 = Reaction name
Duplicate genotype (0) Software error Contact your Area Abbott
specified for reaction (1) in Customer Service.
the Quality Control
7642 section.

0 = Genotype name
1 = Reaction name
Invalid internal control Software error Contact your Area Abbott
cycle range [(0), (1)] in the Customer Service.
Quality Control section.
Minimum is greater than
maximum.
7643
0 = Minimum internal
control cycle range
1 = Maximum internal
control cycle range

10-186 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Invalid internal control Software error Contact your Area Abbott
cycle limits [(0), (1)] in the Customer Service.
Quality Control section.
Minimum is greater than
maximum.
7644
0 = Minimum internal
control cycle limits
1 = Maximum internal
control cycle limits
Invalid cycle limits [(0), (1)] Software error Contact your Area Abbott
in the Quality Control Customer Service.
section. Minimum is greater
than maximum.
7645
0 = Minimum internal
control cycle limits
1 = Maximum internal
control cycle limits
Duplicate Genotype control Software error Contact your Area Abbott
level name definition (0). Customer Service.
7646

0 = Control level definition


Duplicate Genotype control Software error Contact your Area Abbott
bar code identifier (0). Customer Service.
7647

0 = Bar code identifier


Control genotype (1) Software error Contact your Area Abbott
specified for reaction (0) is Customer Service.
not a defined genotype.
7648
0 = Reaction name
1 = Control genotype name

m2000rt Operations Manual 10-187


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Invalid number (0) Software error Contact your Area Abbott
referenced Open assays. Customer Service.
Expected (1).
7649
0 = Given number of assays
1 = Expected number
Assay (0) is an invalid assay Software error Contact your Area Abbott
type (1). Expected (Open) Customer Service.
assay type.
7650
0 = Assay name
1 = Assay type name
Open = Expected type
Invalid default call Software error Contact your Area Abbott
conversion (0). There are Customer Service.
only (1) calls available.
7651
0 = Call conversion name
1 = Number of available
calls
Duplicate call name Software error Contact your Area Abbott
definition (0). Customer Service.
7652

0 = Call name definition


Invalid quantitative sample Software error Contact your Area Abbott
internal control cycle limits Customer Service.
[(0),(1)].

7653
0 = Minimum internal
control cycle limits
1 = Maximum internal
control cycle limits

10-188 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Invalid quantitative control Software error Contact your Area Abbott
internal control cycle limits Customer Service.
[(0),(1)].

7654
0 = Minimum internal
control cycle limits
1 = Maximum internal
control cycle limits
Duplicate report outcome Software error Contact your Area Abbott
type (0). Customer Service.
7655

0 = Report outcome type


Qualitative sample internal Software error Contact your Area Abbott
control cycle limits must be Customer Service.
7656
defined for Fixed
evaluation mode.
Qualitative sample internal Software error Contact your Area Abbott
control cycle ranges must Customer Service.
7657
be defined for Float
evaluation mode.
Qualitative control internal Software error Contact your Area Abbott
control cycle limits must be Customer Service.
7658
defined for Fixed
evaluation mode.
Qualitative control internal Software error Contact your Area Abbott
control cycle ranges must Customer Service.
7659
be defined for Float
evaluation mode.
Duplicate reagent Software error Contact your Area Abbott
configuration (1) Customer Service.
specification found for
7660 reaction (0).

0 = Reaction name
1 = Reagent configuration

m2000rt Operations Manual 10-189


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


One or more Command Software error Contact your Area Abbott
components specify a target Customer Service.
7661 plate in component: (0)

0 = Component
Command: (0) must be Software error Contact your Area Abbott
defined in Component: (1) Customer Service.
7662
0 = Command name
1 = Component name
An invalid Command: (0) Software error Contact your Area Abbott
was found in Component: Customer Service.
(1)
7663
0 = Command name
1 = Component name
Component: (0) must be Software error Contact your Area Abbott
defined within the scope of Customer Service.
Component: (1)
7664
0 = Component name
1 = Component name
The UserDefined and Software error Contact your Area Abbott
Preprocessing Component Customer Service.
types cannot co-exist in
7666 Component: (0)

0 = Component name
DistributeMasterMix Software error Contact your Area Abbott
commands are invalid in Customer Service.
7668 Component: (0)

0 = Component name

10-190 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Missing Reagent Addition Software error Contact your Area Abbott
Components for Reagent Customer Service.
Configuration(s): (0)
7669

0 = Reagent
Configuration(s)
Invalid Reagent Software error Contact your Area Abbott
Configuration specified in Customer Service.
Reagent Addition
7670 Component(s): (0).

0 = Reagent Addition
Component(s)
All Reagent Addition Software error Contact your Area Abbott
Components must have the Customer Service.
7671
same Supported Assay
Reagent Kit Size.
Invalid number of Reagent Software error Contact your Area Abbott
Addition Components: (0) Customer Service.
for Reagent Configuration:
(1) found in Application.
7672
0 = Reagent Addition
Components
1 = Reagent Configuration
All Reagent Addition Software Error Contact your Area Abbott
Components must have the Customer Service.
same value for the Disable
parameter in the ASR
7673 Configuration Component.

ASR = Assay Specific


Reagents
Quantitative sample Software error Contact your Area Abbott
internal control cycle limits Customer Service.
7674
must be defined for Fixed
evaluation mode.

m2000rt Operations Manual 10-191


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Quantitative sample Software error Contact your Area Abbott
internal control cycle Customer Service.
7675
ranges must be defined for
Float evaluation mode.
Quantitative control Software error Contact your Area Abbott
internal control cycle limits Customer Service.
7676
must be defined for Fixed
evaluation mode.
Quantitative control Software error Contact your Area Abbott
internal control cycle Customer Service.
7677
ranges must be defined for
Float evaluation mode.
Qualitative calibrator Software error Contact your Area Abbott
internal control cycle Customer Service.
7678
ranges must be defined for
Float evaluation mode.
Invalid ratio threshold (0), Software error Contact your Area Abbott
format does not meet Customer Service.
7679 specification.

0 = Ratio threshold
Invalid ratio threshold (0), Software error Contact your Area Abbott
total number of points (1) Customer Service.
outside the supported range
7680 [2, 10].

0 = Ratio threshold
1 = Number of points
Invalid ratio threshold (0), Software error Contact your Area Abbott
7681 cycle numbers must be Customer Service.
monotonically increasing.
Invalid validity criteria, Software error Contact your Area Abbott
7682 validity type and threshold Customer Service.
must be defined.
Invalid ratio threshold, first Software error Contact your Area Abbott
7683
cycle number must be 1. Customer Service.

10-192 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Invalid validity criteria, Software error Contact your Area Abbott
7684 validity type is defined as Customer Service.
Fluorescence.
Invalid validity criteria, Software error Contact your Area Abbott
7685 cycle type is not defined as Customer Service.
Ct.
Mastermix Creation Software error Contact your Area Abbott
Component invalid in Customer Service.
Reagent Addition
7688 Component: (0).

0 = Reagent Addition
Component
Mastermix Addition Software error Contact your Area Abbott
Component invalid in Customer Service.
Reagent Addition
7689 Component: (0).

0 = Reagent Addition
Component
Component with internal Software error Contact your Area Abbott
identity (0) does not exist. Customer Service.
7690
0 = Component internal
identity
Well Volume is not Software error Contact your Area Abbott
specified in the Component Customer Service
(0) of type (1).
7691
0 = Component name
1 = Type name
Minimum Eluate Volume is Software error Contact your Area Abbott
not specified in the Customer Service
Component (0) of type (1).
7692
0 = Component name
1 = Type name

m2000rt Operations Manual 10-193


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Mastermix Volume is not Software error Contact your Area Abbott
specified in the Component Customer Service
(0) of type (1).
7693
0 = Component name
1 = Type name
Reagent configuration Software error during 1. Retry installing the
name (0) is greater then 20 Application Specification Application Specification
characters. file installation 2. If the problem persists,
7694 contact your Area Abbott
0 = Reagent configuration Customer Service
name
Initial location for (0) must Software error Contact your Area Abbott
be specified in one of the Customer Service
first two commands of
7695 Component (1)

0 = 1mL Subsystem
1 = Component
Duplicate initial subsystem Software error Contact your Area Abbott
carrier locations (0) Customer Service
specified in Component (1)
7696
0 = Plate locations
1 = Component
Extraneous initial Software error Contact your Area Abbott
subsystem carrier location Customer Service
definitions (0). Expected
7697 (1).

0 = Definition
1 = Expected definition

10-194 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Timer (1) in component (0) Software error Contact your Area Abbott
must define either a Customer Service
duration or duration
7698 formula.

0 = Component
1 = Timer
Timer (1) with duration Software error Contact your Area Abbott
formula (2) in Component Customer Service
(0) failed evaluation with
variables (3), (4).

7699 0 = Component
1 = Timer
2 = Formula
3 = Variable
4 = Variable
The run times in the Software error Contact your Area Abbott
component (0) must be Customer Service
7702 monotonically increasing.

0 = Component
Duplicate sample count (2) Software error Contact your Area Abbott
defined at GPR location (1) Customer Service
defined in component (0).
7703
0 = Component
1 = Location
2 = Sample count

m2000rt Operations Manual 10-195


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Maximum expected is less Software error Contact your Area Abbott
than minimum expected Customer Service
volume for sample count
(2) defined at GPR location
(1) defined in component
7704 (0).

0 = Component
1 = Location
2 = Sample count
Invalid fluid transfer loop Software error Contact your Area Abbott
(0), source (1) and Customer Service
destination (2) are
incompatible.
7705
0 = Invalid loop
1 = Source
2 = Destination
The ASR Configuration Software error Contact your Area Abbott
component is missing the Customer Service
7706
supported kit size data
definition.
Component (0) defines Software error Contact your Area Abbott
z-margin at an invalid Customer Service
7707 source location.

0 = Component
Multiple Reagent Addition Software error Contact your Area Abbott
Components are present Customer Service
7708 and each does not have a
required Master Mix
Distribution Component.
Duplicate Parameter Software error Contact your Area Abbott
identifier found (0). Customer Service
7709

0 = Parameter ID

10-196 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Duplicate Script identifier Software error Contact your Area Abbott
found (0). Customer Service
7710

0 = Script ID
Duplicate String identifier Software error Contact your Area Abbott
found (0). Customer Service
7711

0 = String ID
Parameter (0) string Software error Contact your Area Abbott
resource (1) not found. Customer Service
7712
0 = Parameter
1 = String resource
String resource (0) is Software error Contact your Area Abbott
missing an English Customer Service
7713 translation.

0 = String resource
Script (0) syntax error (1) Software error Contact your Area Abbott
for text (2) at line (3) Customer Service
column (4).

7714 0 = Script
1 = Syntax error
2 = Text
3 = Line
4 = Column
Script (0) syntax error. Software error Contact your Area Abbott
7715 Customer Service
0 = Script

m2000rt Operations Manual 10-197


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Parameter (0) constraint Software error Contact your Area Abbott
syntax error (1) for text (2). Customer Service

7716
0 = Parameter
1 = Syntax error
2 = Text
Parameter (0) constraint Software error Contact your Area Abbott
syntax error (1). Customer Service
7717
0 = Parameter
1 = Syntax error
Parameter (0) has an Software error Contact your Area Abbott
unknown constraint (1). Customer Service
7718
0 = Parameter
1 = Constraint
Parameter (0) is missing a Software error Contact your Area Abbott
required constraint (1). Customer Service
7719
0 = Parameter
1 = Constraint
Parameter (0) data type (1) Software error Contact your Area Abbott
has an invalid constraint Customer Service
(2).
7720
0 = Parameter
1 = Data type
2 = Constraint
Parameter (0) data type (1) Software error Contact your Area Abbott
has an invalid constraint Customer Service
(2=3).

7721 0 = Parameter
1 = Data type
2 = Constraint range 1
3 = Constraint range 2

10-198 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Parameter (0) constraint Software error Contact your Area Abbott
(1=2) is out of range (3, 4). Customer Service

0 = Parameter
7722
1 = Constraint range 1
2 = Constraint range 2
3 = Range
4 = Range
Parameter (0) constraint (1) Software error Contact your Area Abbott
list cardinality is invalid. Customer Service
Expected (2) Actual (3).

7723 0 = Parameter
1 = Constraint
2 = Expected list cardinality
3 = Actual list cardinality
Parameter (0) constraint (1) Software error Contact your Area Abbott
list item type (2) is invalid. Customer Service

7724
0 = Parameter
1 = Constraint
2 = List item type
Parameter (0) constraint (1) Software error Contact your Area Abbott
is not a list type. Customer Service
7725
0 = Parameter
1 = Constraint
Parameter (0) constraint (1) Software error Contact your Area Abbott
regular expression (2) is Customer Service
invalid (3).

7726 0 = Parameter
1 = Constraint
2 = Regular expression
3 = Error text

m2000rt Operations Manual 10-199


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Parameter definition (0) Software error Contact your Area Abbott
references an unknown Customer Service
definition (1).
7727
0 = Parameter definition
1 = Unknown definition
Parameter definition (0) is Software error Contact your Area Abbott
invalid. It references a Customer Service
definition (1) and also
defines individual
7728 parameters.

0 = Parameter definition
1 = Definition
Parameter model (0) digital Software error Contact your Area Abbott
signature verification failed. Customer Service
7730

0 = Parameter model
Parameter model (0) Software error Contact your Area Abbott
schema validation failed Customer Service
(1).
7731
0 = Parameter model
1 = Error description
Parameter model (0) is Software error Contact your Area Abbott
corrupt. Customer Service
7732

0 = Parameter model
Parameter model (0) not Software error Contact your Area Abbott
found. Customer Service
7733

0 = Parameter model

10-200 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Parameter (0) value syntax Software error Contact your Area Abbott
error (1) for text (2). Customer Service

7734
0 = Parameter
1 = Syntax error
2 = Text
Parameter (0) value syntax Software error Contact your Area Abbott
error (1). Customer Service
7735
0 = Parameter
1 = Syntax error
Parameter model (0) defines Software error Contact your Area Abbott
a model reference (1). Customer Service
7736
0 = Parameter model
1 = Model reference
Parameter model reference Software error Contact your Area Abbott
(0) defines Parameters, Customer Service
Scripts or Resources.
7737

0 = Parameter model
reference
Parameter model does not Software error Contact your Area Abbott
7738
define a unique Id. Customer Service
Parameter model (0) does Software error Contact your Area Abbott
not define any Parameters, Customer Service
7739 Scripts or Resources.

0 = Parameter model
An Application User is attempting to save Save the new Application
Specification with Name (0) an Application Specification with a unique
is already defined in the Specification using an identifier.
7740 system. identifier that is already
assigned to another
Application Specification.
0 = Name

m2000rt Operations Manual 10-201


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


An Assay with Name (0) is User is attempting to save Save the new assay with a
already defined in the an assay using an identifier unique identifier.
7741 system. that is already assigned to a
defined assay.
0 = Name
Required script file (0) not Software error Contact your Area Abbott
found. Customer Service
7742

0 = Script file
Script (0) references an Software error Contact your Area Abbott
unknown Script (1). Customer Service
7743
0 = Script
1 = Unknown script
Model (0 / 1) is missing a Software error Contact your Area Abbott
required parameter (2). Customer Service

7744
0 = Model name
1 = Version
2 = Parameter
Invalid default secondary Software error Contact your Area Abbott
unit conversion (0). There Customer Service
are only (1) unit
conversions available.
7745
0 = Default secondary unit
conversion
1 = The number of available
unit conversions
Default unit and secondary Software error Contact your Area Abbott
are set to the same unit Customer Service
7746 conversion (0).

0 = Unit conversion

10-202 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Parameter Model (0) was Software error Contact your Area Abbott
not found. Customer Service
7747

0 = Parameter model
Stage (0) Step (1) Infinite Software error Contact your Area Abbott
hold definition is invalid. Customer Service
7748
0 = Stage
1 = Step
The eluate splitting Software error Contact your Area Abbott
replicate count in the Customer Service
component (0) must be
7749 between 1 and 12.

0 = Component
Test failed. Unable to • Network cable not 1. Verify cable connections
establish connection with connected at the 2. Retry
the network data store. - router 3. If problem persists,
- SCC contact your Area Abbott
- Data Store Customer Service
7750 • Network down
• Network Data Store
computer turned off
• No power to router
• Network configuration of
data store is incorrect

m2000rt Operations Manual 10-203


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Test failed. Unable to • Network cable not 1. Verify cable connections
upload a file to the network connected at 2. Retry
data store. - router 3. If problem persists,
- SCC contact your Area Abbott
- Data Store Customer Service
7751 • Network down
• Network Data Store
computer turned off
• No power to router
• Network configuration of
data store is incorrect
Test failed. Unable to • Network cable not 1. Verify cable connections
download a file from the connected at 2. Retry
network data store. - router 3. If problem persists,
- SCC contact your Area Abbott
- Data Store Customer Service
7752 • Network down
• Network Data Store
computer turned off
• No power to router
• Network configuration of
data store is incorrect
Test failed. Unable to delete • Network cable not 1. Verify cable connections
a file at the network data connected at 2. Retry
store. - router 3. If problem persists,
- SCC contact your Area Abbott
- Data Store Customer Service
7753 • Network down
• Network Data Store
computer turned off
• No power to router
• Network configuration of
data store is incorrect

10-204 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Rack type 513 is specified as Software error Contact your Area Abbott
a ValidCarriers entry in Customer Service.
combination with other
7760 rack types within the
Application Specification.
Please correct the
Application Specification.
A PrePierce command is Software error Contact your Area Abbott
present in the protocol, but Customer Service.
7761 a corresponding
ValidCarriers entry for rack
type 513 is missing.
A ValidCarriers entry for a Software error Contact your Area Abbott
Pierceable rack type is Customer Service.
7762 present, but no PrePierce
command is present in the
Sample Extraction section.
The maximum combined Software error Contact your Area Abbott
eluate splitting replicate Customer Service.
count from components (0)
in an application
7763 specification must not
exceed 12.

0 = Components
When Plate Fill is defined Software error Contact your Area Abbott
in the Reagent Customer Service.
Configuration, there must
7765 be a GPR Configuration
component in the Reagent
Addition Component of
the application.
Missing PlateFill element Software error Contact your Area Abbott
when GPR Configuration is Customer Service.
7766
defined in Reagent
Addition.
Cannot defined Plate Fill Software error Contact your Area Abbott
Component in Reagent Customer Service.
7767
Addition without PlateFill
element.

m2000rt Operations Manual 10-205


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


When Plate Fill is defined Software error Contact your Area Abbott
in the Reagent Customer Service.
Configuration, there must
7768 be a Plate Fill component in
the Reagent Addition
Component of the
application.
The eluate splitting feature Software error Contact your Area Abbott
is only supported in Customer Service.
component (0) of genotype
7769 application specification.

0 = Component
The application Software error Contact your Area Abbott
specification contains plate Customer Service.
fill components, but
7770 reagent addition
component (0) does not.

0 = Component
All plate fill column Software error Contact your Area Abbott
7771
numbers must be identical. Customer Service.
All GPRs associated with Software error Contact your Area Abbott
the Plate Fill feature must Customer Service.
7772
define identical sample
preparation reagent setups.
The number of high level Software error Contact your Area Abbott
commands components in Customer Service.
plate fill component (0)
located in reagents addition
component (1) does not
7773 match the expected
number.

0 = Plate fill component


1 = Reagent addition
component

10-206 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


The commands defined in Software error Contact your Area Abbott
high level command (0), in Customer Service.
plate fill component (1), in
reagent addition
component (2) do not
match the commands
defined in the other reagent
7774
addition component(s).

0 = High level command


1 = Plate fill component
2 = Reagent addition
component
Duplicate call Software error Contact your Area Abbott
interpretation name Customer Service.
definition (0).
7775

0 = Interpretation
definition
Invalid call interpretation Software error Contact your Area Abbott
total (0). There are (1) call Customer Service.
interpretations available.
7776
0 = Total interpretations
1 = Number of
interpretations available
The call interpretation final Software error Contact your Area Abbott
result definition (0) is Customer Service.
7777 invalid.

0 = Result definition
The call interpretation Software error Contact your Area Abbott
name or evaluation Customer Service.
operand definition (0) is
7778 invalid.

0 = Operand definition

m2000rt Operations Manual 10-207


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


The call interpretation final Software error Contact your Area Abbott
result definition (0) is not Customer Service.
in ascending sort order or
7779 consists of redundant
delimiters.

0 = Result definition
The call interpretation final Software error Contact your Area Abbott
result or name definition Customer Service.
(0) consists of duplicated
7780 call.

0 = Call interpretation final


result or name definition
Equivalent call Software error Contact your Area Abbott
interpretation name (0) Customer Service.
7781 already exists.

0 = Interpretation name
The call interpretation Software error Contact your Area Abbott
name definition (0) consists Customer Service.
7782 of redundant delimiters.

0 = Definition
There is a mismatch in the Software error Contact your Area Abbott
defined replicate counts for Customer Service.
reagent configuration id
7783 (0).

0 = Configuration
identification
Invalid normalization Software error Contact your Area Abbott
7784 mode with reference dye Customer Service.
configuration.
The normalization mode Software error Contact your Area Abbott
parameter is required for no Customer Service.
7785
reference dye
configuration.

10-208 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


The evaluation condition Software error Contact your Area Abbott
definition (0) is invalid. Customer Service.
7786

0 = Definition
Genotype test order Software error Contact your Area Abbott
parameter id (0) must be Customer Service.
7787 unique.

0 = Parameter identification
Genotype Data Analysis Software error Contact your Area Abbott
Extension: Parameter (0) Customer Service.
7788 must be of type Numeric.

0 = Parameter
Genotype test order Software error Contact your Area Abbott
parameter id (0) referenced Customer Service.
by validity for control (1) is
7789 not defined.

0 = Parameter identification
1 = Control
A CoC, QP3, QP4, QP5, and Software error Contact your Area Abbott
QP7 must be defined for Customer Service.
qualitative assays specifying
7790 a floating cut-off calibration
method. MinLevels for
calibrators must be
non-zero.
A fixed cut off value must Software error Contact your Area Abbott
be defined when specifying Customer Service.
7791
a fixed cut-off calibration
method.
A CoC, QP3, QP4, QP5, and Software error Contact your Area Abbott
QP7 cannot be defined for Customer Service.
qualitative assays specifying
7792
a fixed cut-off calibration
method. MinLevels for
calibrators must be zero.

m2000rt Operations Manual 10-209


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


The reported result units for Software error Contact your Area Abbott
7793 the controls and samples do Customer Service.
not match.
Qualitative assays cannot Software error Contact your Area Abbott
7794 define more than one result Customer Service.
specification unit.
The reported result units for Software error Contact your Area Abbott
the samples (1) and the Customer Service.
result unit specification (2)
do not match for assay id
(0).
7795

0 = Assay name
1 = Sample(s)
2 = Result unit specification
The test order parameter (0) Software error Contact your Area Abbott
defines a minimum value Customer Service.
(1) that is greater than or
equal to the maximum (2).
7796
0 = Parameter
1 = Minimum value
2 = Maximum value
Invalid calibrator internal Software error Contact your Area Abbott
control cycle difference Customer Service.
limits [(0), (1)].
7797
0 = Lower limit
1 = Upper limit
DistributeSystemFluid Software error Contact your Area Abbott
commands are invalid in Customer Service
7798 Component: ({0})

0 = Component

10-210 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


FillUnusedWells commands Software error Contact your Area Abbott
are invalid in Component: Customer Service
7799 ({0})

0 = Component
The selected (0)(1) data was Archive or export operation No action required.
successfully written to CD. completed successfully.

7800 0 = Plate name


or
1 = Application
Specification file name
Unable to write the (0) (1) The CD drive is busy Wait for the CD drive to
data, the CD drive is busy. writing or erasing. become available, then
perform the Archive
procedure.
7801 0 = Plate name
or
1 = Application
Specification file name
Unable to write the (0) (1) There is no CD in the CD Insert a writable CD-R or
data, the CD drive does not drive or the CD is either CD-RW into the CD drive
contain a writable CD. faulty or not writable. and repeat the process.

7802
0 = Plate name
or
1 = Application
Specification file name
Unable to write the (0) (1) There is not enough free Insert a new writable CD-R
data, there is not enough space left on the CD. or CD-RW into the CD
free space left on the CD. drive and repeat the
process.
7803
0 = Plate name
or
1 = Application
Specification file name

m2000rt Operations Manual 10-211


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Writing of the (0) (1) data Software error 1. Insert a new writable
failed due to an unknown CD-R or CD-RW into the
error. CD drive and repeat the
process.
7804 2. If problem persists,
0 = Plate name
contact your Area Abbott
or
Customer Service.
1 = Application
Specification file name
Writing of the (0) (1) data An existing file is in the Select another CD-R or
failed, a file with the same target directory with the CD-RW for archiving and
name already exists in the same name as the file being repeat the process.
CD. archived
7805
0 = Plate name
or
1 = Application
Specification file name
A data integrity issue was Possible manual Contact your Area Abbott
7850 detected. interference with the Customer Service.
database.
The key is not valid for The entered reagent Verify that the reagent
reagent configuration ID security removal key is not selected for the security
({0}). for the selected reagent. removal key matches the
7851 reagent for the key.
0 = Reagent configuration
ID
The key is not valid for this The key does not match the Verify that the Instrument
7852 instrument. system on which it was ID from the key matches
entered. that of the instrument.
The key has expired. The expiration date and • For a reagent lot key, the
grace period encoded in the reagent has also expired.
key has elapsed. Use new reagents and the
new corresponding
7853 reagent lot key.
• For a reagent security
removal key, contact your
Area Abbott Customer
Service.

10-212 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


The length of this key does The key was entered Re-enter the entire key.
7854 not match the incorrectly.
specification.
The key has already been The key has already been If more test counts are
used. entered on the system. needed, contact your Area
7855
Abbott Customer Service
for a new key.
Database integrity issue • Database with a pending 1. Edit the pending test
encountered. test order(s) associated order.
with an activated reagent 2. On the <Edit Test
was restored, and the Order: Assay Details>
pending test order(s) was screen, ensure the
attempted to be run. desired PCR Assay
• Possible manual Reagents Lot Number is
interference with the selected, or enter a new
database. Lot Key.
7859 3. Select <Next> to
continue to the next
screen, then select
<Finish> when the edits
are complete.
4. Re-run the pending test
order.
5. If necessary, contact your
Area Abbott Customer
Service.
({0}) tests reclaimed on the Tests were successfully No action required.
instrument. Please provide removed from a reagent lot.
the key ({1}) to your Abbott
7860 representative.

0 = Number of tests
1 = Key

m2000rt Operations Manual 10-213


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


There are insufficient tests The number of tests on the Generate a key for the
remaining on this system system is less than the correct amount of test
for lot ({0}) to reclaim ({1}) number of tests the user is counts and re-attempt the
tests. attempting to remove. key entry.
7861
0 = Lot number
1 = Number of tests
attempting to reclaim
Lot ({0}) does not exist on The lot which the user Verify that the key is being
this system. attempted to reclaim test used on the correct SCC. If
counts from is not on the the SCC is correct, contact
7862 system. Possibly the key your Area Abbott Customer
0 = Lot number
was entered onto a system Service.
for which it was not
generated.
Lot ({0}) has expired and The reagent lot key has Use a new reagent lot and
can no longer be used. expired. its associated reagent lot
7863 key.
0 = Lot number
A user access level of (FSE) An unauthorized user Log in as an authorized user
7864 is required to perform this attempted to enter a test and re-enter the key.
action. count removal key.
Reagent identification A user attempted to remove Delete the pending test
status change for reagent test counts or identification orders for the lot, then
({0}) cancelled. There are while there were test orders re-enter the key.
7865 outstanding test orders pending for the lot.
pending.

0 =Reagent
({0}) tests activated for A reagent lot key was added No action required.
reagent lot ({1}) for reagent for the specified number of
configuration id ({2}). tests.

7866
0 = Number of tests
1 = Reagent lot
2 = Reagent configuration
id

10-214 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Log file successfully created. A log was successfully No action required.
7867 created for the secured
reagent key information.
The key is invalid for this The key was entered in the • Reagent lot keys and
operation. wrong location for the reagent test removal keys
secured assays. are entered in the Test
7868 Order process.
• Security removal keys are
entered in the Reagent
Configuration screen.
Reagent configuration id An attempt was made to No action required.
({0}) is already activated. activate a reagent that was
7875 already on the active list.
0 = Reagent configuration
id
The valid range for A reagent ID of greater than Contact your Area Abbott
activated reagents is 0-994. 994 was entered. Customer Service for the
7876
correct reagent IDs to
activate.
The instrument must be in The user attempted to Wait until the process is
an idle state to configure activate the reagent IDs complete and the
7877 reagent identification. while the instrument was instrument is Ready or
running or initializing. Offline before activating
reagents.
The system failed to Unable to print a report. 1. Try reprinting the report.
generate the requested 2. Try selecting individual
report: (0). results to print.
7900
3. If problem persists,
0 = Report name contact your Area Abbott
Customer Service
7950 Invalid qualitative positive Software error Contact your Area Abbott
control target cycle limits Customer Service
[{0}, {1}].

0 = Minimum cycle limit


1 = Maximum cycle limit

m2000rt Operations Manual 10-215


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


7951 Master Mix Creation Software error Contact your Area Abbott
component in a User Customer Service
Created Master Mix
Reagent Addition is not
allowed.
7952 Master Mix Addition Software error Contact your Area Abbott
component in a User Customer Service
Created Master Mix
Reagent Addition is not
allowed.
7953 All Reagent Addition Software error Contact your Area Abbott
components must be same Customer Service
type (User Created, Reagent
Reuse, or Automated).
7955 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: Row End ({0}) Customer Service
must not be less than Row
Begin ({1}).

0 = Row End
1 = Row Begin
7956 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: Column End Customer Service
({0}) must not be less than
Column Begin ({1}).

0 = Column End
1 = Column Begin
7957 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: CellsInGroup Customer Service
({0}) must evenly divide the
number of available
columns ({1}).

0 = CellsInGroup
1 = Columns

10-216 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


7958 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: Number of Customer Service
Well Reactions ({0}) defined
must match the number of
cells in a group ({1}).

0 = Number of Well
Reactions
1 = Number of cells in a
group
7959 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: The Customer Service
referenced Reaction Id ({0})
is invalid for this
application.

0 = Reaction Id
7960 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: Allowed Customer Service
Sample Type ({0}) is invalid
for this application.

0 = Sample Type
7961 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: Allowed Customer Service
Sample Type ({0}) is already
listed.

0 = Sample Type
7962 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: Multiple Customer Service
layout definitions detected
for Well in Row ({0}),
Column ({1}).

0 = Row
1 = Column

m2000rt Operations Manual 10-217


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


7963 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: Reaction ({0}) Customer Service
is listed more times ({1})
than allowed ({2}).

0 = Reaction
1 = Number of times listed
2 = Number of times
allowed
7964 The m2000rt Fixed Test Software error Contact your Area Abbott
Order Layout: Repeated Customer Service
Reaction ({0}) must be listed
together.

0 = Reaction
7965 The ASR Configuration Software error Contact your Area Abbott
section is required when Customer Service
the sample preparation
process includes kit packs.
7966 The ASR Configuration Software error Contact your Area Abbott
section is not needed when Customer Service
the sample preparation
process utilizes user created
mastermix.
7967 Genotype Data Analysis Software error Contact your Area Abbott
Extension: A Procedure Call Customer Service
that guarantees a result is
defined. Therefore, the
Calling Scheme must be
empty at OpId ({0}).

0 = OpId

10-218 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


7968 Genotype Data Analysis Software error Contact your Area Abbott
Extension: A previous Customer Service.
Check already guarantees a
result. Therefore, Check
(OpId ({0}) Expression ({1}))
has no effect.

0 = OpId
1 = Expression
7969 Genotype Data Analysis Software error Contact your Area Abbott
Extension: The nested Customer Service.
Check depth ({0}) is greater
than the limit ({1}). OpId
({2}).

0 = Depth
1 = Limit of depth
2 = OpId
7970 Genotype Data Analysis Software error Contact your Area Abbott
Extension: The OpId Customer Service.
attribute is required on
element ({0}).

0 = Element
7971 Genotype Data Analysis Software error Contact your Area Abbott
Extension: The OpDescr Customer Service.
attribute is required on
element ({0}), OpId ({1}).

0 = Element
1 = OpId
7972 Genotype Data Analysis Software error Contact your Area Abbott
Extension: The OpId ({0}) is Customer Service.
already in use. All OpIds
must be unique within the
application.

0 = OpId

m2000rt Operations Manual 10-219


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


7973 Reagent configuration Software error Contact your Area Abbott
component in assay ({0}) Customer Service.
requires a name when the
associated reagent addition
component is designated as
utilizing user created master
mix, or reagent reuse
processing.

0 = Assay
7974 Reagent reuse and user Software error Contact your Area Abbott
created master mix are Customer Service.
incompatible features.
7975 Reagent reuse cannot be Software error Contact your Area Abbott
utilized in an open mode or Customer Service.
maintenance procedure.
7976 Reagent reuse requires the Software error Contact your Area Abbott
pack distribution feature. Customer Service.
7977 Reagent reuse requires the Software error Contact your Area Abbott
transfer master mix Customer Service.
command be defined in the
master mix addition
component.
7978 The source or destination Software error Contact your Area Abbott
bottle (0) is not defined as Customer Service.
present in reagent addition
component (1).

0 = Bottle name/ID
1 = Reagent addition
component name
7979 The destination bottle in Software error Contact your Area Abbott
reagent addition Customer Service.
component (0) cannot be
'none'.

0 = Reagent addition
component option

10-220 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


7980 The source and destination Software error Contact your Area Abbott
bottles cannot be the same Customer Service.
in reagent addition
component (0).

0 = Reagent addition
component option
7981 Reagent Bottle (0) is defined Software error Contact your Area Abbott
as present but is not used in Customer Service.
reagent addition processing
component (1).

0 = Bottle name/ID
1 = Reagent addition
component name
7982 Reagent Bottle (0) is used in Software error Contact your Area Abbott
reagent addition Customer Service.
processing(1), but is not
defined as present.

0 = Bottle name/ID
1 = Reagent addition
component name
7983 MasterMixVolume must be Software error Contact your Area Abbott
specified in reagent Customer Service.
configuration for (0) when
reagent reuse is defined.

0 = Component ID/name
7984 MasterMixVolume must Software error Contact your Area Abbott
match the (0) Command Customer Service.
VolumePerTest in
Component (1)

0 = Transfer Master Mix or


Distribute Master Mix
1 = Component ID/name

m2000rt Operations Manual 10-221


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


7985 (0) commands are invalid Software error Contact your Area Abbott
in Component: (1) Customer Service.

0 = Commands
1 = Component
7986 When performing pack Software error Contact your Area Abbott
distribution, the dispense Customer Service.
fluid command cannot
target the source bottle and
the aspirate fluid command
cannot target the
destination bottle.
7987 Component (0) must define Software error Contact your Area Abbott
reagent reuse in order to Customer Service.
make use of the transfer
master mix command.

0 = Component name
7988 In a reagent reuse protocol Software error Contact your Area Abbott
the source location for the Customer Service.
master mix distribution
command must be master
mix sources.
7989 The reagent reuse status of Software error Contact your Area Abbott
all reagent addition Customer Service.
components must be the
same.
7990 Invalid custom result Software error Contact your Area Abbott
evaluations (0). There are Customer Service.
(1) custom result
evaluations defined.

0 = Custom result
evaluation number
1 = The number of custom
result evaluations

10-222 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


7991 Duplicate customized Software error Contact your Area Abbott
reported result label Customer Service.
definition (0).

0 = Label name
7992 The custom label definition Software error Contact your Area Abbott
(0) is invalid. Customer Service.

0 = Custom label definition


User (0) login succeeded. A new user logged on No action required.
8000
0 = User name
Invalid User name and/or User name and password do Enter your correct user
Password. Please try again. not match entries in the name and password
8001
system (passwords are case
sensitive).
Account disabled. Please try Software error Contact your Area Abbott
8002
again. Customer Service.
Account locked. Please try Software error Contact your Area Abbott
8003
again. Customer Service.
Password change required. Password was reset or new Create a new password.
8004 Please select a new account was created.
password for this account.
Account restricted. Software error Contact your Area Abbott
8005
Customer Service.
Unable to perform a The instrument is in one of Wait until the instrument is
shutdown. The instrument the following states: in the STOPPED or READY
8006 is not in correct state. INITIALIZING, PAUSED, state before performing
RUN INITIALIZATION, shutdown.
RUNNING, or SCANNING.
The workgroup name User either left the field Enter a valid workgroup
8050 cannot be empty or all empty or filled it with name.
blanks. blanks.
The IP Address for the User either left the field Enter a valid IP address for
8051 network connection cannot empty or filled it with the network connection.
be empty or all blanks. blanks.

m2000rt Operations Manual 10-223


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


The IP Address for the User either left the field Enter a valid IP Address.
8052 network data store cannot empty or filled it with
be empty or all blanks. blanks.
The connection to the User test was successful. No action required.
8053 network data store tested
OK.
The connection to the User test was successful. No action required.
8054
m2000rt SCC tested OK.
Test failed. Unable to • Crossover cable not 1. Verify cable connections
establish connection with connected at the 2. Retry
the m2000rt SCC. - SCC (m2000sp or 3. If problem persists,
m2000rt) contact your Area Abbott
• Cable(s) not connected at Customer Service
8055 the router
• m2000rt computer turned
off
• No power to router
• Wrong type of cable
connected
Unable to establish • Wrong cable connected 1. Verify cable connections
connection with the • Network cable not 2. Verify power to the
Network Data Store connected at the Network Data Store SCC
- router 3. Plug in the router
- SCC 4. Retry
- Data Store 5. If problem persists,
8056 contact your Area Abbott
• Network down
Customer Service
• Network Data Store
computer turned off
• No power to router
• Network configuration of
data store is incorrect

10-224 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Unable to delete the • Wrong cable connected 1. Verify cable connections
requested files from the • Network cable not 2. Verify power to the
Network Data Store. connected at the Network Data Store SCC
- router 3. Plug in the router
- SCC 4. Retry
- Data Store 5. If problem persists,
8057 contact your Area Abbott
• Network down
Customer Service
• Network Data Store
computer turned off
• No power to router
• Network configuration of
data store is incorrect
Network configuration is User selected the • No action required if the
not configured for Network <Network Data Store Network Data Store is not
Data Store Management> screen, but configured
8058 the system is not • Contact your Area Abbott
configured to use the Customer Service if the
Network Data Store Network Data Store is
required.
The volume is not a valid The user has attempted to Set the volume within the 0
8100 number from 0 to 10. set the volume outside the to 10 range.
range of 0 to 10.
The sound, (0) is not The user has attempted to Select another sound.
currently available. select a sound that is not If custom sounds are
8102 currently available. required, contact your Area
0 = Sound Abbott Customer Service.

Exception caught during Exception caught during Contact your Area Abbott
reading files from directory reading files from directory Customer Service.
8200 (0).

0 = Directory
Unable to edit assay unit The user has attempted to Wait until the instrument is
specification. The edit assay unit in the OFFLINE, STOPPED,
8201 instrument is not in idle specifications in a state or READY state before
state. other than OFFLINE, editing assay units.
STOPPED, or READY.

m2000rt Operations Manual 10-225


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Error received while Software error Contact your Area Abbott
8202 building the application Customer Service.
specification dataset.
Unable to edit, copy or Editing of assay Wait until the instrument is
create Laboratory defined specifications can only be in one of the allowed states,
8203 application. The done if the instrument is before attempting to edit
instrument is not in idle OFFLINE, STOPPED, or the assay.
state. READY.
Maximum number of The system already If a new Application
allowed Application contains 50 Application Specification is required, an
specifications (0) exceeded. Specifications, which is the existing application will
8204 maximum number allowed. have to be deleted first.
0 = Number of allowed
Application Specifications
Maximum number of The system already If a new laboratory-defined
allowed Laboratory defined contains 50 Application Specification is
applications (0) exceeded. laboratory-defined required, an existing
8205 Application Specifications, application will have to be
which is the maximum deleted first.
0 = Number of allowed
number allowed.
laboratory-defined
applications
Unable to edit Laboratory Editing is disallowed when Delete or run any pending
defined application. There pending test orders exist. Test Orders for the
8206
is a pending test order. application, then edit the
Application Specification.
An unrecoverable error has The system encountered an 1. Restart the system.
occurred while exporting to unrecoverable error while 2. Retry export.
8207 the CD. The system is going writing the file to the CD. 3. If error continues,
to shutdown. contact your Area Abbott
Customer Service.
The primary unit and User set the same result Change one of the two unit
8208 secondary unit can not be unit for both the primary settings so that they are not
the same. and secondary units. the same.
Current license is User selected an Abbott- Contact your Area Abbott
insufficient to access the supplied Application Customer Service if
Laboratory defined Specification for edit, copy, information is required for
8209
application. export, or view, but the this Abbott-supplied
application does not Application Specification.
support these actions.

10-226 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Unable to print the report. An exception occurred 1. Restart the system.
during report generation. 2. Retry print.
8210 3. If error continues,
contact your Area Abbott
Customer Service.
Unable to print the report. Application license level is Contact your Area Abbott
Current license is higher than system license Customer Service for
8211 insufficient to access the level. licensing information.
Laboratory defined
application.
Unable to delete the user User tried to delete their User account cannot be
account (0), user is own account. deleted if user is currently
8400 currently logged in. logged into the system.

0 = User name
Unable to delete the user User tried to delete a default User cannot delete a default
account (0), it is a default (pre-configured) user account.
8401 account. account.

0 = User name
User account (0) deleted. A user account was deleted. No action required.
8402
0 = User name
New user account created. A new user account was No action required.
8403
created.
Unable to continue, one or The user did not input all Enter the required
8404 more required fields are required information. information.
empty.
Unable to create account, The user name entered is Enter a valid user name. Do
the user name entered is not valid. not use the following
invalid. User name must characters:
not consist entirely of \ / “ [ ] : | < > + = ; , ? * @.
8405 periods and/or spaces, end
with period, or contain
these characters: (0)

0=\/“[]:|<>+=;,?*@

m2000rt Operations Manual 10-227


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unable to create account, a A user with the selected Create the account using a
user with the name (0) name already exists in the user name that does not
8406 already exists in the system. system. currently exist.

0 = User name
Unable to change password, The user entered an Enter the correct password.
8407 the current password incorrect password.
entered is incorrect.
Unable to change password, The new password and the Re-enter the new password.
the re-entered password did re-entered password did not
8408
not match the new match.
password.
Unable to change the A default user tried to No action required.
password for this user change their account
8409
account, this is a default password.
account.
Account password changed The user changed their No action required.
for user (0). account password.
8410

0 = User name
Unable to reset the User tried to reset the Default accounts cannot be
password for user account password for a default reset.
8411 (0), it is a default account. (pre-configured) user
account.
0 = User name
Unable to reset the User tried to reset their own 1. Have user log out of the
password for user account password. system and use new user
(0), user is currently logged log on.
in. 2. Perform password reset
procedure. Refer to Reset
8412
0 = User name Password on page 2–14
of Section 2,
Installation
Procedures and User
Configuration.

10-228 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Password for the user Password for a user account No action required.
account (0) was reset to the was reset to be same as the
8413 user name. user name.

0 = User name
Unable to create account, The number of user 1. Remove any old or
the number of accounts of accounts of this access level unused user accounts of
this access level type has on the system has reached this access level.
reached maximum its maximum capacity. 2. Perform the create
capacity. account procedure. Refer
8414
to Create User Account
on page 2–11 of Section
2, Installation
Procedures and User
Configuration.
User (0) login succeeded. User login was successful. No action required.
8415
0 = User name
Unable to change password, The new password selected Select a different password.
the new password selected is the same as the current
is same as the current password. The new
8416
password. Please select a password should be
different password and try different from the old
again. password.
Unable to create account, The user name should not Re-create user name using
user name must not contain leading or trailing no leading or trailing white
8417
contain leading or trailing white spaces. spaces.
white spaces.
Windows error (0) setting Software error 1. Re-enter time.
the system time. 2. Perform a system
8500
shutdown.
0 = Windows error
An invalid date (0) was An invalid date was Re-enter the date using a
entered. entered. valid date.
8501

0 = Date entered

m2000rt Operations Manual 10-229


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


The instrument must be in The instrument must be in 1. Be sure the instrument is
an idle state to change the an idle state to change the in the READY state.
8502 time or date. time or date. 2. Change the time and
date.
The system time zone (0) The user updated the No action required.
was updated. Please wait system time zone.
8503 while the system restarts.

0 = Time zone
Windows error (0) setting An error occurred while the Retry setting the time zone.
the system time zone. user was setting the system
8504 time zone.
0 = Windows error
The system time zone (0) The FSE updated the system Restart the system after all
was updated. Please restart time zone and the system system setting adjustments
the system prior to did not force a reboot for are made.
8505 executing any processes. convenience.

0 = Time zone
Serial number entered is The serial number entered Enter the valid serial
invalid. Serial number must is not valid. number.
8600
not consist entirely of
spaces.
Serial number must not The serial number should Re-enter the serial number
8601 contain leading or trailing not contain leading or without any leading or
white spaces. trailing white spaces. trailing white spaces.
The instrument must be in The instrument must be in 1. Be sure the instrument is
an idle state to change the an idle state to change the in the READY state.
8602 serial number. serial number. 2. Change the serial
number.
Operator: (0) is not The operator requesting a Only users with Field
authorized to perform this database restore is not Service or CSC access are
database management authorized to perform the able to perform the restore
8700 operation. operation. process.

0 = Operator name

10-230 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


The current instrument The instrument must be in 1. Be sure the instrument is
state is invalid to perform the idle state to perform a in the READY state.
8701 the required operation. backup or restore 2. Perform the backup or
operation. The current state restore process.
is not an idle state.
Invalid backup name. The backup name consisted Re-enter the backup name
Name cannot contain only of leading or trailing space using valid text.
8702
spaces. Please enter a valid characters.
backup name.
(0) Backup: (1) has The backup operation has No action required.
completed successfully. completed successfully.

8703 0 = Backup type (Full,


System Database, or
Calibration)
1 = Backup name
No manifest files were Software error 1. Retry the action.
found on drive: (0). 2. If problem persists,
8704
contact your Area Abbott
0 = Drive location Customer Service.

No data files were found on There are no data files 1. Retry the action.
drive: (0). found on the specified 2. If problem persists,
8705 drive. contact your Area Abbott
0 = Drive location Customer Service.

Scanning drives for backups Software error Contact your Area Abbott
8706 has encountered a fatal Customer Service.
error.
(0) Backup: (1) has failed. • The backup operation has 1. Refer to the Message
See log for errors. failed. History Log for
• CD media failure associated errors.
8708 0 = Backup type (Full, 2. Try a new CD-R or
System Database, or CD-RW.
Calibration) 3. Retry the backup
1 = Backup file name procedure.

m2000rt Operations Manual 10-231


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Restore of (0) backup: (1) • The restore operation has 1. Refer to the Message
has failed. See log for errors. failed. History Log for
• CD media failure associated errors.
8709 0 = Backup type (Full, 2. Retry the restore
System Database, or procedure.
Calibration)
1 = Backup file name
8710 Database conversion of • Corrupted database 1. Refer to the Message
backup: (0) has failed. See backup History Log for
log for errors. • Restore procedure associated errors.
interrupted 2. Retry the Restore
0 = Backup file name • CD media failure procedure.

8711 Database conversion of Status message No action is required; the


backup: (0) has completed system will restart
successfully. The system automatically.
will be restarted when the
restore task is complete.

0 = Backup file name


8712 System calibration Status message No action is required.
conversion of backup: (0)
has completed successfully.

0 = Backup file name


8713 System calibration Software error • Review the Message
conversion of backup: (0) History Log; refer to
has failed. See log for errors. Message History Log on
page 10–9
0 = Backup file name • Retry the restore
• If problem persists,
contact your Area Abbott
Customer Service

10-232 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


8714 Restore of (0) backup: (1) User restored a system No action required; restart
has completed successfully. backup will occur automatically
Please wait while the
system restarts.

0 = Backup type (Full,


System Database, or
Calibration)
1 = Backup
8715 System calibration User restored a system No action required; restart
conversion of backup: (0) backup that required a will occur automatically
has completed successfully. migration of the system
Please wait while the calibration
system restarts.

0 = Backup file name


8716 Database conversion of User restored a system No action required; restart
backup: (0) has completed backup that required a will occur automatically
successfully. Please wait migration of the system
while the system restarts. database

0 = Backup file name


Application (0) failed to Software error Contact your Area Abbott
start. Customer Service.
8800
0 = Application
Specification name
Application (0) terminated Software error Contact your Area Abbott
abnormally. Customer Service.
8801
0 = Application
Specification name
Invalid password. Please try The user name and Re-enter using a valid user
8802 again. password do not match any name and password.
saved in the system.

m2000rt Operations Manual 10-233


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

Code Message Probable Cause(s) Corrective Action(s)


Unhandled exception: (0) Software error Contact your Area Abbott
8803 Customer Service.
0 = Exception name
Application (0) is already Software error If problem persists, contact
running. your Area Abbott Customer
8804 Service.
0 = Application
Specification name
Application (0) is already Software installation error If problem persists, contact
being started. your Area Abbott Customer
8805 Service.
0 = Application
Specification name
The instrument must be in System is currently in the Wait until the system is
an idle state to change the <INITIALIZING>, processing/initialization is
8900
language or locale <RUNNING>, or complete before
configuration. <PAUSED> state configuring
The system language (0) User changed language or No further action required;
and locale (1) have been locale parameter system will reboot
updated. Please wait while automatically
8901 the system restarts.

0 = Language to be used
1 = Locale to be used
The system document User changed the language No action required.
language (0) has been settings for on-line
8902 updated. documentation

0 = Language
The system input language User changed the language No action required.
(0) has been updated. settings for the keyboard
8903

0 = Language

10-234 m2000rt Operations Manual


200680-106—October 2012
Troubleshooting and Diagnostics
Section 10 Error Codes

Code Message Probable Cause(s) Corrective Action(s)


Failed to update the system Software error Repeat the action; if the
input language (0). problem persists, contact
8904 your Area Abbott Customer
Service
0 = Language
Failed to initialize PDF Software error Contact your Area Abbott
8911
renderer. Customer Service
Failed to execute PDF • The page was not 1. Open the file again and
document operation. displayed properly retry the operation
8912 • Software error 2. If the problem persists,
contact your Area Abbott
Customer Service
Failed to load document • Software error Contact your Area Abbott
(0). • An incorrect document Customer Service
8913
exists on the system
0 = The document
The search text (0) was not The entered search term Verify the spelling of the
found in the document. was not detected in the search term and retry
8914 document
0 = Text entered by user
Insufficient user access level The document that was Select a document that is
to view this document. selected is only available to available for the current
8915
users of a higher access user
level
No online documentation No on-line documentation If you wish to have on-line
is available has been loaded onto the documents loaded, contact
8916
system your Area Abbott Customer
Service
Document is password The on-line document is Contact your Area Abbott
8917 protected. password protected. Customer Service to have
the document reloaded.
An unexpected error has SCC shutdown due to an 1. Restart the SCC.
occurred: (0) error. 2. If problem persists,
9000 contact your Area Abbott
0 = Software error Customer Service.

m2000rt Operations Manual 10-235


200680-106—October 2012
Troubleshooting and Diagnostics
Error Codes Section 10

NOTES

10-236 m2000rt Operations Manual


200680-106—October 2012
Glossary

Glossary

Automatic Scaling Automatic scaling sets the axis to display the entire single
curve.

Baseline The initial cycles of PCR in which there is little change in


fluorescence signal.

Calibrator A sample of known quantity used to construct a calibrator


curve.

Control A liquid containing a known concentration of the substance


which is to be tested. Used to determine (high/low/cutoff)
limits and/or as reference for quality control. The properties
of the control are well known and stable.

Control Baselined Displays the amplification curve for the Internal Control.

Closed-mode assay Abbott-validated assay that generates final result values.

Cycle Number The fractional cycle number at which the fluorescence passes
the threshold.

Delta Rn (ΔRn) The magnitude of the signal generated by the specified set of
PCR conditions.
(ΔRn = Rn - baseline)

Fixed Scaling Fixed scaling fixes the y-axis to include all results on a plate
for easier result-to-result comparison.

Normalized Reporter (Rn) A ratio of the fluorescence emission intensity of the reporter
target or internal control dye to the fluorescence emission
intensity of the passive reference dye.

Nucleic acid target (also Nucleotide sequence to be detected or quantified.


called “template”)

Open-mode assay User-validated assay that generates only fluorescence values.

m2000rt Operations Manual Glossary-1


200680-106—October 2012
Glossary

Passive Reference A dye that provides an internal fluorescence reference to


which the reporter (target or internal control) can be
normalized during data analysis. Normalization is necessary
to correct for fluorescence fluctuations caused by changes in
concentration or in volume.

Qualitative Assay Assay that determines the presence or absence of an analyte


in a sample.

Quantitative Assay Assay that determines the amount of an analyte in a sample.

Reporter Dye The target dye.

Target Displays the amplification curve for the assay analyte (target).

Threshold A level of delta Rn — automatically determined by the


m2000rt software — used for CT determination in real-time
assays. The level is set to be above the baseline and
sufficiently low to be within the exponential growth region of
the amplification curve. The threshold is the line whose
intersection with the Amplification plot defines the CT.

Glossary-2 m2000rt Operations Manual


200680-106—October 2012
Appendix Components

Section 2. Components

Appendix

Overview
This Appendix lists disposables, spare parts, and accessories,
and provides ordering information.

• m2000rt System, page A–2


Lists product names and part numbers that are necessary
for ordering this system.
• Required User-Supplied Materials, page A–3
Provides list of Abbott materials necessary for use of this
product.

Ordering Spare Parts


Order spare parts from Abbott Laboratories. When ordering
parts, always state the product name and list number.

NOTE: This section lists only spare parts that are


orderable by the customer. If spare parts other than
those listed in this section are needed, contact Abbott
Customer Service.

m2000rt Operations Manual Appendix A-1


200680-106—October 2012
Components Appendix

Customer Support
For answers to questions, please contact the local Abbott
Representative.
United States:
1-800-553-7042
International:
Call your local Abbott Customer Support
Representative

m2000rt System
Refer to the following table for the product name and list
number.

List
Product Name Label Name
Number

m2000rt Instrument m2000rt Instrument 9K15

Appendix A-2 m2000rt Operations Manual


200680-106—October 2012
Appendix Components

Required User-Supplied Materials

Item List Number

ABBOTT® 96-Well Optical Reaction 4J71-70


Plate
ABBOTT Optical Adhesive Cover 4J71-75
ABBOTT Splash Free Support Base 9K31
ABBOTT Adhesive Cover Applicator 9K32
ABBOTT m2000rt Halogen Lamp, 9K33
Replacement
ABBOTT m2000rt Plate Holder 9K34
Replacement
m-Systems Wrench 01N71-01
ABBOTT Optical Calibration Kit 4J71-93
Centrifuge with adapter for 96-well Local purchase
plates
Gloves Local purchase

m2000rt Operations Manual Appendix A-3


200680-106—October 2012
Components Appendix

NOTES

Appendix A-4 m2000rt Operations Manual


200680-106—October 2012
Index

Numerics Durations 6-5


96-Well Optical Reaction Plate 5-26 Fail 5-125
Prepare 5-26 m2000rt Optical Calibration Kit 6-6
Prepare using the m2000sp 5-26 Overview 6-1
Seal 5-27–5-31 Procedures 6-1
A Pure Dye 6-41
Abbott Instrument Warranty -xii Pure Dye Plate 2-7
Access Levels Region of Interest (ROI) 2-6, 6-7
Menu 5-7 Status 6-4
Operator 5-7 System 6-3
Accessories 1-25 Uniformity 2-7, 6-33
Account Management 2-9 Calibration Details, View 5-121
Alert Chemical Hazards 8-10
Dialog 2-5 Spill Clean-up 8-11
Altitude 4-6 Waste Handling and Disposal 8-12
Application Management 5-15 Chemical Waste Safety 7-16
Delete Application 5-20 Clean
Details 5-15 Plate Holder 9-33
Install 5-18 Splash Free Support Base 9-35
Tasks 5-17 Thermal Block
Article 33, EU Reach -xxiii Materials Required 9-20
As-Needed Maintenance 9-3 Procedure 9-21
Assay Calibrations, View 5-120 Clearance 4-4
Audible Alert On All Sides 4-4
Configuration 2-19 Vertical 4-4
B Column Sorting 1-23
Background Calibration 6-17 Components Appendix A-1
Conduct 6-19–6-27 Communication Cable Appendix A-2
Create Plate 6-28 Customer Support Appendix A-2
Fluorescence Sources 2-7 Ordering Appendix A-1
Materials Required 6-18 Required User-Supplied Materials Appendix
System Setup 2-6 A-3
When to Perform 6-17 Create
Biological Hazards 8-8 User Account 2-11
C CT Calculation 3-7
Calibration Customer Support -ix, 10-2
Background 2-6, 6-17

m2000rt Operations Manual Index-1


200680-106—October 2012
D EU Reach -xxiii
Decontaminate Thermal Block 9-13, 9-25 Event Descriptions 10-8
Materials Required 9-25 F
Procedure 9-26–9-31 Failure
Decontamination Form 9-12 Lamp 10-12
Decontamination Procedure 8-13 G
Decontamination Procedure Requirements Guidelines
Decontamination Form 9-12 Chemical Waste Safety 7-16
Exterior Surfaces 9-11 H
Definitions Glossary-1 Halogen Lamp 4-5
Delete (Illus.) 1-27
Application 5-20 Replace 9-39
User Account 2-13 Status 9-39
Description Hardware Installation 2-3
Application Management Details 5-15 Hazards 8-1
Instrument Status Details 5-12 Biological 8-8
Instrument Status Display 5-11 Chemical 8-10
Result Details Screen 5-95 Decontamination Procedure 8-13
Dimensions 4-3 Decontamination Procedure Requirements
Disclaimer Decontamination Form 9-12
License -xv Exterior Surfaces 9-11
Master Table of Contents/Index -x Electrical 8-14
Pictorial -x Emergency Shutdown Procedure 8-4
Disposal 7-14 Mechanical 8-15
Instrument 7-16 Overview 8-1
Operating Material 7-15 Physical 8-17
Packing Material 7-14 Safety Icons 8-6
Points, Authorities 7-16 Waste Handling and Disposal 8-12
Statutory Basis 7-14 Help menu 1-17
E I
Electrical Icons
Hazards 8-14 Information 1-22
Specifications 4-5 Safety 8-6
Emergency Shutdown Procedure 8-4 Toolbar Buttons 1-21
Environmental Conditions 4-6 Illustration
Altitude 4-6 96-Well Optical Reaction Plate and Splash
Pollution 4-6 Free Support Base 1-26
Temperature and Humidity Requirements 4- Halogen Lamp (12V, 75W) 1-27
6 Instrument, Back 1-5
Error Codes 10-15 Instrument, Behind Access Door 1-6
Error Levels 10-8 Instrument, Front 1-4
Error Light Displays 10-11 Optical Adhesive Cover 1-26

Index-2 m2000rt Operations Manual


200680-106—October 2012
Optical Adhesive Cover Applicator 1-27 Symbols Used -xix
Optical Adhesive Cover for Plate Wells 5-28 Lamp Failure 10-12
Plate Holder 1-28 LIS
Power Switch 8-4 Configuration 2-21
Power Switch, Tray Drawer Release 5-4, 5-6 Log
SCC Power Switch 5-4, 8-5 Maintenance 9-7
System Control Center (SCC) 1-11 Message History 10-9
Information Icons 1-22 Problem Record 9-9
Installation Process 10-10
Hardware 2-3 Logon 2-4
Instrument Verification 2-8 Authorization Levels 2-5
Overview 2-1 User 5-8
Procedures 2-1 Long-Term Shutdown 7-7
Software 2-4 Materials Required 7-7
System 2-3 M
Where to Place 2-3 m2000rt
Instrument Back 1-5
Accessories 1-25 Behind Access Door 1-6
Back 1-5 Front 1-4
Behind Access Door 1-6 Optical Calibration Kit 6-6
Consumables 1-25 The System 1-7
Decontamination Procedures of m2000sp Instrument
Exterior Surfaces 9-11 Decontamination Procedures of
Front 1-4 Decontamination Form 9-12
Functions 1-25 Maintenance 9-3
Initialization 5-14 As-Needed 9-3
Labels -xix Logs 9-5–9-9
Overview 1-3, 1-25 Monthly 9-3
Placement 2-3 Semi-Annual 9-3
Responsible Parties -xxiv Weekly 9-3
SCC Components 1-10 Mechanical Hazards 8-15
Serial Number 4-3 Menus
Start-up 5-10 Help 1-17
Symbols Used -xix Orders 1-14
Terms Glossary-1 Overview 1-13
The System 1-7 Results 1-14
Verification of Installation 2-8 System 1-15
L Message History Log 10-9
Labels Monthly Maintenance 9-3
Caution, Halogen Lamp 8-7 O
Caution, Heated Cover 8-7 Observed Problems 10-6
Instrument -xix Operational Precautions and Limitations 7-1

m2000rt Operations Manual Index-3


200680-106—October 2012
Operator Product Identification 4-3
Access Levels 2-5 Proprietary Statement -ix
Responsibility 8-3 Pure Dye Calibration 6-41
Ordering Spare Parts Appendix A-1 Conduct 6-43–6-49
Orders menu 1-14 Materials Required 6-42
Overall Dimensions 4-3 When to Perform 6-42
Overview Pure Dye Plate Calibrations
Calibration Procedures 6-1 Setup 2-7
Components Appendix A-1 R
Hazards 8-1 Real-Time PCR
Installation Procedures and Special Require- Advantages 3-12
ments 2-1 Assay Testing 3-13
Instrument 1-25 PCR Theory 3-3–3-5
Menu 1-13 Run Phases 3-4
Operating Instructions 5-1 Region of Interest (ROI) Calibration 6-7
Operational Precautions and Limitations 7-1 Conduct 6-9–6-16
Performance Specifications and Characteris- Materials Required 6-8
tics 4-1 System Setup 2-6
Principles of Operation 3-1 When to Perform 6-7
Service and Maintenance 9-1 Required User-Supplied Materials Appendix A-3
Software 1-12 Responsible Parties -xxiv
System 1-3 Results
Troubleshooting and Diagnostics 10-1 Archive Result Tasks Menu 5-114
Use or Function 1-1 Plate Tasks Menu 5-85
Overview menu 1-13 View By Plate 5-81
P Results Management 5-81–5-94
Packing 7-12 Selected Plates 5-82
Password Results menu 1-14
Change 2-17 Run
Reset 2-14 Import and Set Up 5-61
Physical Hazards 8-17 S
Heavy Objects 8-17 Safety
Hot Objects 8-17 Icons 8-6
Pinch Hazard 8-17 Instructions 5-3
Trip Hazard 8-17 SCC
Pictorial Disclaimer -x Application Management 5-15
Pollution 4-6 Logon 5-8
Power Menu Access Levels 5-7
Off 5-5 SCC Power Switch (illus.) 8-5
On 5-4 Semi-Annual Maintenance 9-3
Power Line Regulator 4-5 Serial Number 4-3
Process Log 10-10 Configuration 2-29

Index-4 m2000rt Operations Manual


200680-106—October 2012
Service and Maintenance 9-1 System
Settings About 1-7
Time and Date Calibration 6-3
Time Zone 2-31 Disposal 7-14
Setup, System 2-6 Electrical Requirements 4-4
Shutdown Installation 2-3
Emergency 8-4 Overview 1-3
Long-Term 7-7 Packing 7-12
Short-Term 7-3 Power Off 5-5
Software Power On 5-4
Installation 2-4 Setup 2-6
Overview 1-12 Storage 7-13
System 1-15 System Control Center 1-9, 1-10
Software Column Sorting 1-23 (Illus.) 1-11
Sorting System menu 1-15
By column 1-23 System Settings 2-18
Specifications Audible Alert 2-19
Clearance 4-4 LIS Configuration 2-21
Dimensions and Weights 4-3 Serial Number 2-29
Electrical 4-5 Time and Date 2-29
Environmental Conditions 4-6 Time Zone 2-31
Supply, Interfaces, Connections 4-4 T
System Electrical Requirements 4-4 Technical Data 4-3
Temperature and Humidity Requirements 4- Clearance 4-4
6 Dimensions and Weights 4-3
Ventilation 4-6 Electrical Specifications 4-5
Standards Environmental Conditions 4-6
Canadian EMC -xxii Halogen Lamp 4-5
EMC -xxii Overall Dimensions 4-3
European Safety and EMC -xxii Supply, Interfaces, Connections 4-4
IVDD 98/79/EC -xxiii System Electrical Requirements 4-4
U.S. and Canadian Safety -xxii Ventilation Requirements 4-6
Start-up 5-10 Temperature and Humidity Requirements 4-6
Statement Test Order
Licensing and Copyright -xvi Import Order 5-52
Proprietary -ix New Order 5-35
Trademark -xxv Test Orders 5-32–??, 5-32
Warranty -xii Create Tasks 5-35
Storage 7-13 Delete Order 5-78
Supply, Interfaces, Connections 4-4 Edit Order 5-77
Symbols Order Management Tasks 5-73
Instrument Labeling -xix Plate Details 5-75

m2000rt Operations Manual Index-5


200680-106—October 2012
Run Tasks 5-57
Tasks 5-33
View Order Details 5-73
Time and Date
Configuration 2-29
Time Zone 2-31
Toolbar Buttons 1-21
Tooltip Icon 1-23
Trademark Statements -xxv
Troubleshooting and Diagnostics 10-1
Error Codes 10-15
Event Descriptions 10-8
Observed Instrument Problems 10-6
Troubleshooting Model 10-4
U
Uniformity Calibration 6-33
Conduct 6-34–6-40
Materials Required 6-33
Setup 2-7
When to Perform 6-33
User Account
Create 2-11
Delete 2-13
V
Ventilation Requirements 4-6
Venting Hot-Air-Only Exhaust 4-6
Vertical Clearance 4-4
View
Assay Calibrations 5-120
Calibration Details 5-121
W
Warranty Statement -xii
Weekly Maintenance 9-3

Index-6 m2000rt Operations Manual


200680-106—October 2012

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