m2000sp v7 Ops Manual [PDF]

Citation preview

Operations Manual List No. 9K20-07



© 2013 Abbott Laboratories



Abbott Molecular Inc. 1300 E. Touhy Ave. Des Plaines, IL 60018 200681-107—July 2013



NOTES



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Revision Status



Document Control Number(s)



Revision Date



Section(s) Revised



Software Version



200681-101



10/05



Original Issue



Version 1.0



200681-102



11/06



All Sections



Version 2.0



200681-103



09/07



All Sections



Version 3.0



200681-104



09/09



All Sections



Version 4.0



200681-105



10/11



All Sections, except Section 6 and the Glossary



Version 5.0



200681-106



10/12



Sections 1, 4, 5, 7-10, and the Appendix



Version 6.0



200681-107



7/13



Sections 1, 2, 5, 9, and 10



Version 7.0



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NOTES



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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 were added to the manual. 5. Record the date that the revised section was incorporated in the fifth column. Document Control Number



m2000sp Operations Manual



200681-107—July 2013



Revision Date



Software Version (If applicable)



Revision Incorporated by



Date Incorporate d



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Foreword Congratulations on the purchase of the ABBOTT® m2000sp System. The m2000sp is an automated system designed to perform nucleic acid sample preparation through the utilization of general purpose reagents and an automated liquid handling platform. The m2000sp 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 Abbott Representative. The following information can be found in this introduction: •



Proprietary Statement on page –vii Describes conditions for use of the information, documents, and graphics in this manual.



•



Pictorial Disclaimer on page –viii Explains that printouts, graphics, displays, screens, etc., used in this manual are for illustration and informational use only.



•



Master Table of Contents/Index Disclaimer on page –viii Cautions that manual updates may cause changes in page numbering.



•



Intended Use, page –viii Explains the intended use of the m2000 System



•



Abbott Instrument Warranty on page –ix Presents m2000sp System warranty information.



•



Licensing and Copyright Summary on page –xi Summarizes licensing and copyright details.



•



Instrument Labeling on page –xiv Gives symbols used on instrument labeling.



•



Responsible Parties on page –xxi Lists the parties responsible for the m2000sp instrument.



•



Trademark Statements, page –xxii Summarizes m2000sp System trademark details.



If you have any questions, please contact your Area Abbott Customer Representative.



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Proprietary Statement The ABBOTT® m2000sp 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



•



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. ABBOTT LABORATORIES HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT, OR OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NON-INFRINGEMENT. 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 PROFIT) 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.



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Pictorial Disclaimer All illustrations (printouts, graphics, photographs, screens, etc.) are for information and illustration purposes only, and not to be used for clinical or maintenance evaluations. Screens and other images intended for illustration purposes might not always reflect current software or instrument configurations. Further, 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 through illustrations. The screens and other images used in this manual are not intended to illustrate assay-specific scenarios. Always refer to the assay-specific package insert for assay-related details. The photographs and illustrations of the m2000sp instrument used in this manual are representative of conditions and equipment common to both instrument models. In the few areas where functional differences exist, those differences are specifically addressed. Optional features shown are not available in all areas.



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



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.



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•



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 m2000sp 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. This 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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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 NONINFRINGEMENT. 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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Licensing and Copyright Summary Parts of this software Copyright © 2004-2006 Enterprise Distributed Technologies Ltd. All rights reserved. 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 (http://www.apache.org/). 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 nonassignable. 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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(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 Used on Instrument Labeling The symbols in the following table are used on the instrument’s labeling. Table 0.1: Symbol



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Symbols Used on Instrument Labeling



Definition



Symbol



Definition



Catalog number



Caution



Serial number



Caution, risk of electric shock



Batch code/ Lot number



Caution, hot surface



Unit



Biological Risks



Item



Warning, laser beam



Quantity



Use by



Size



Alternating current



Date of manufacture



Manufacturer



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Symbol



Definition



Symbol



Definition



OFF (power)



ON (power)



Authorized Representative in the European Community



Waste Electrical and Electronic Equipment (WEEE)



In vitro diagnostic medical device



Mobile transmitter forbidden (Avoid cell phone use)



Global Trade Item Number



GTIN



Warning: Do not tighten the DiTi cones as part of Daily Maintenance



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.



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•



Do not treat electrical and electronic equipment as unsorted municipal waste.



•



Collect waste electrical and electronic equipment separately.



xv



Typical Instrument Labeling Nomenclature Table 0.2:



Key to Typical Instrument Labeling Nomenclature



Typical Nomenclature



Definition



Fuse



Indicates the replacement fuse rating. Fuse should be replaced only by an Abbott Service Representative.



U, f



Indicates the voltage frequency range.



P



Indicates the power rating of the instrument.



Symbols used in this Manual Table 0.3:



Symbol



Key to Symbols Used in this Manual



Definition NOTE. This precedes additional information that could be helpful to the operator.



!



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IMPORTANT. This precedes information or instruction that is critical to the operator.



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Safety and Electromagnetic Compatibility (EMC) Standards This section addresses the safety and EMC compliance of the following: •



the m2000sp G-series Model



•



the m2000sp E-series Model



•



the m2000sp System Control Center



G-series Model 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.



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 61010-2-101, “Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular Requirements for In-Vitro Diagnostic (IVD) Medical Equipment.” 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 A), “Electrical Equipment for Measurement, Control and Laboratory Use – EMC Requirements.”



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E-series Model 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.



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/IEC 61010-1:2001, “Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use, Part 1: General Requirements” and EN/IEC 61010-2-101, “Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular Requirements for InVitro Diagnostic (IVD) Medical Equipment.” 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 61326-1 (Group 1, Class A), “Electrical Equipment for Measurement, Control and Laboratory Use – EMC Requirements.”



System Control Center Safety The SCC has been evaluated in accordance with Low Voltage Directive 2006/95/EC. EMC Compliance The SCC has been evaluated in accordance with EMC Directive 2004/108/EC.



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IVDD 98/79/EC The Abbott m2000sp is designed and built in accordance with the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical device (IVD Directive). This Operations Manual serves as the instructions for Use as required by the IVD Directive essential requirements (Annex I). If the following label is on the instrument, the instrument is CE marked for IVD Directive. Figure 0.1: Instrument Labels



E-series label



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G-series label



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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 [email protected].



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Responsible Parties Table 0.3:



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Parties Responsible for the Instrument



In Vitro Diagnostic Directive



98/79/EC



Authorized Representative in the European Community



ABBOTT MAX-PLANCK-RING 2 65205 WIESBADEN GERMANY +49-6122-580



Manufacturer



ABBOTT MOLECULAR 1300 E. TOUHY AVE. DES PLAINES, IL 60018 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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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



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Master Table of Contents-1



NOTES



Master Table of Contents-2



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Section 1



Section 1: Use or Function



Use or Function



Use or Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1



Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 m2000sp Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 m2000sp Cabinet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 System Control Center . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 Instrument Hood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 System Control Center and Software . . . . . . . . . . . . . . . . . 1-14 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14 Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23 Toolbar Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26 Software Column Sorting . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28 Information Icons; Messages . . . . . . . . . . . . . . . . . . . . . . . 1-29 Tooltip Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30



Instrument Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31 Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32 Positive ID Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . 1-33 Liquid Handling System . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-34 System Liquid Flow Direction . . . . . . . . . . . . . . . . . . . 1-34 Dilutors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35 Liquid Handling Arm . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36 Disposable Tip Eject . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38 Fast Wash Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39 Waste System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40 1 mL Subsystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43 Robotic Manipulator Arm (RoMa) . . . . . . . . . . . . . . . . . . . 1-45 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-47 Door Lock Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-47



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Table of Contents-1



Use or Function



Section 1



Liquid Waste Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . System Liquid Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . Solid Waste Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . Worktable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reagent Vessel Carriers . . . . . . . . . . . . . . . . . . . . . . . . . DiTi Rack Carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disposable Tip Shelves . . . . . . . . . . . . . . . . . . . . . . . . . DiTi Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DiTi Reuse Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Output Deck . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Guide Pins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cabinet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Solid Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . Liquid Waste Container . . . . . . . . . . . . . . . . . . . . . . . . System Liquid Container . . . . . . . . . . . . . . . . . . . . . . .



1-48 1-48 1-49 1-50 1-51 1-52 1-53 1-54 1-54 1-55 1-56 1-57 1-58 1-59 1-59 1-60 1-61



Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-63 Required Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample Preparation Reagents . . . . . . . . . . . . . . . . . . . . 200 mL Reagent Vessels . . . . . . . . . . . . . . . . . . . . . . . . 5 mL Reaction Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . Disposable Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Deep Well Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . ABBOTT® 96-Well Optical Reaction Plate . . . . . . . . . . ABBOTT Optical Adhesive Covers . . . . . . . . . . . . . . . . ABBOTT Adhesive Seal Applicator . . . . . . . . . . . . . . . . ABBOTT Splash Free Support Base . . . . . . . . . . . . . . . . Master Mix Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DiTi Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disposable Biohazard Bags (Optional) . . . . . . . . . . . . .



Table of Contents-2



1-63 1-64 1-64 1-64 1-64 1-65 1-65 1-65 1-65 1-65 1-65 1-66 1-66



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Section 1



Use or Function



Section 1: Use or Function



Use or Function The m2000sp Instrument (09K14-01) is described in this chapter as the G-series. The m2000sp Instrument E-series (09K14-02) is described in this chapter as the E-series. All text and descriptions apply to both instruments unless specifically designated as G-series or E-series. All E-series specific information will be shown in a blue-shaded box.



Overview This section describes the structure and function of the ABBOTT® m2000sp. The following topics are included: •



Structure, page 1–3 Identifies the primary components of the system control center (SCC), instrument, and cabinet.



•



System Control Center and Software, page 1–14 Describes the operation of the SCC and the system software menu structure.



•



Instrument Overview, page 1–31 Identifies the following instrument components and the sample preparation activities performed by the instrument:



•



–



bar code reader (PosID)



–



liquid handling arm (LiHa)



–



1 mL Subsystem



–



robotic manipulator arm (RoMa)



–



sensors



–



worktable



–



Output Deck



Consumables, page 1–63 Describes the consumables required to perform the protocols on the m2000sp.



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Use or Function Section 1



Overview



NOTES



1-2



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Structure System Overview The ABBOTT® m2000sp is an automated system for performing sample preparation for nucleic acid testing. The operator controls the system through the System Control Center (SCC), using Abbott m2000sp software. At the end of the Sample Extraction procedure, the user may select a Master Mix Addition protocol to automatically distribute the assay reagents and extracted nucleic acid samples into an ABBOTT 96-Well Optical Reaction plate. This plate can be used on the Abbott m2000rt (Real-Time PCR instrument) for nucleic acid detection.



Open-Mode Functionality The m2000sp and m2000rt instruments are capable of performing open-mode (user-validated) protocols. The m2000sp instrument is capable of performing Sample Extractions for open-mode protocols. Reagent addition activities can be performed either manually or by the m2000sp. The m2000rt instrument is capable of PCR (polymerase chain reaction) thermal cycling and real time reading for Laboratory-Defined Applications (open-mode protocols). Any special requirements or system restrictions for specific open-mode protocols will be communicated upon installation of the protocol. Please contact your Area Abbott Customer Service for additional information.



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Use or Function Section 1



System Description



System Description There are two separate m2000sp instrument models: •



the G-series



•



the E-series



For the purposes of this manual, the term “instrument” refers to both models. From functional and operational standpoints, the two models perform similarly and will produce similar results. The instructions given in this manual apply to both models equally. In the few areas where differences exist, those differences are specifically addressed. NOTE: To determine whether a specific instrument is a G-series or an E-series, refer to Hardware Configuration on page 2–25 of Section 2, Installation Procedures and User Configuration, of this manual. The figures below illustrates the three main components of the m2000sp System, which are: •



the instrument



•



the cabinet



•



the SCC



Figure 1.1: m2000sp System: E-series and G-series System control center (SCC)



m2000sp E-series



System control center (SCC)



m2000sp G-series



Cabinet Cabinet



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System Description



m2000sp Instrument The figure below illustrates the main components of the m2000sp instrument: Figure 1.2: m2000sp Instrument Liquid Robotic manipulator handling Arm arm (RoMa) (LiHa) Positive ID (PosID) bar code reader 1 mL Subsystem Safety Door



Disposable tip (DiTi)



Output Deck



Worktable Chiller



Door lock sensors



Component Description



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•



The robotic manipulator arm (RoMa) is equipped with eccentric gripper fingers which move the 1 mL Subsystem carrier and disposable tip racks to different positions on the worktable



•



The Output Deck is the site of the chiller, amplification reagent packs, master mix tubes, and PCR and deep well plates used during instrument operation



•



The liquid handling arm (LiHa) pipettes, dilutes, and mixes samples and reagents, and dispenses liquid through eight different channels, using disposable tips (DiTis)



•



The positive ID (PosID) bar code reader is an optical device which reads information from the reagent vessels, carrier and rack labels, and specimen labels



•



The 1 mL Subsystem is a subassembly which performs magnetic separation and heating steps during the extraction



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Use or Function Section 1



System Description



•



The disposable tip racks hold the disposable tips (DiTis) used by the LiHa to aspirate and dispense specimens, controls, calibrators and reagents during instrument operation



•



The worktable is configured to process 96 samples, including required calibrators and controls, for the isolation of nucleic acids



•



The two door lock sensors indicate whether the safety door is locked, as necessary during instrument operation NOTE: All E-series models and some G-series models also have hoods as part of their basic setup. Refer to Instrument Hood on page 1–11.



The figures below show front and back views of the Edgeport™ USB Converter. The Edgeport is connected by a serial cable to the chiller located on the Output Deck, to the hood (if applicable), and to the SCC by a USB cable. Figure 1.3: Edgeport™ USB Converter, Front



Figure 1.4: Edgeport™ USB Converter, Cabling at Back



Serial cable



USB cable



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Use or Function



Figure 1.5: Optional LIS connection at Port3 (COM5)



9-pin connection from the in-house LIS



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Use or Function Section 1



System Description



m2000sp Cabinet The following figure illustrates the storage area and the waste tray within the m2000sp cabinet located below the instrument’s work surface: •



The storage area in the cabinet provides shelf space for supplies and materials necessary to instrument function



•



The waste tray holds –



the solid waste container, which collects used disposable tips ejected through a chute leading from the instrument’s work surface



–



the liquid waste container, which collects waste fluids



–



the system liquid container, containing liquid used as wash fluid (distilled or deionized water)



Figure 1.6: m2000sp Cabinet, Inside



Lid used for transport



Waste container



Storage area



Waste tray



There are three volume-capacity sensors located in the instrument cabinet. They are for:



1-8



•



the liquid waste container



•



the solid waste container



•



the system liquid container



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System Description



The sensors monitor volume capacity of the waste containers and the system liquid sufficiency. The sensors signal the instrument when critical values are reached prior to initiating a run. Figure 1.7: Sensors for Liquid Waste and System Liquid Liquid waste sensor



System liquid sensor



Figure 1.8: Sensor for Solid Waste Container Volume Capacity



Sensor, solid waste



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Use or Function Section 1



System Description



System Control Center The figure below illustrates the m2000sp SCC, which is made up of these primary components: •



monitor



•



keyboard



•



mouse



•



CD 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, the bar code scanner and keyboard cannot be configured in the same language, so it is recommended that the bar code scanner not be used unless both 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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System Description



Figure 1.9: m2000sp SCC Monitor



Computer (CPU) with CD drive Keyboard



Mouse



Instrument Hood All E-series models and some G-series models include hoods covering the worktable as part of their basic setup. Figure 1.10:Instrument with hood



NOTE: Hoods are not standard equipment and are, therefore, not available in all regions.



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Use or Function Section 1



System Description



Signal Tower Each hood includes a signal tower with a red, a yellow, and a green light. Figure 1.11:Signal Tower



The signal tower functions can be enabled or disabled by an Abbott Representative at installation or after. Refer to Hardware Configuration on page 2–25 of Section 2, Installation and User Configuration, to learn how users can view the current status of this function. Administrators can change the signal tower configuration (i.e., what color signifies what meaning) through the menu. Refer to Signal Tower on page 2–41 of Section 2, Installation and User Configuration.



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System Description



Fluorescent Lamp To illuminate the worktable, a fluorescent lamp is provided within the hood. It can be turned on or off by the toggle switch located in the upper corner of the right side panel. Figure 1.12:Florescent Lamp On/Off Toggle Switch



NOTE: The hood and the lamp are powered by the instrument. If the instrument is powered off, the lamp will not turn on.



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Use or Function Section 1



System Control Center and Software



System Control Center and Software Introduction The SCC uses system software to operate the m2000sp. The system software provides a user interface navigated by the mouse (pointing device) and/or keyboard. The following functions can be performed:



1-14



•



create Test Orders



•



view results



•



export results



•



manually enter patient, calibrator, and control information



•



perform instrument maintenance procedures



•



install and delete Application Specifications



•



manage user accounts



•



configure the system



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System Control Center and Software



Software Overview The figure below illustrates options of the system software with their connections. Figure 1.13:Software Overview



Overview



Orders



Instrument Status



Sample Extraction



Logon



Master Mix Addition



Results



View By Deep Well Plate View By PCR Plate



Logoff View LIS Test Order System Shutdown



Inventory



Disposable Tip Status



Reagent Packs



System



System Logs System Calibration Application Specifications



Available Reagent Packs



Maintenance Procedures



Reagent Pack Search



Settings



Help



About



On-line Documentation



Message History Log Process Log



User Accounts Reagent Pack History Database Management Run Completion



Change Password Account Management



Network Data Store Mngmt Printer Queue



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Use or Function Section 1



System Control Center and Software



Menu The menu offers the following options: Table 1.1:



Menu



Permits the operator to view the current status of the instrument and current process



Permits the operator with appropriate user access to log on to the system



Logs off the current user. A new user must log on prior to initiating any tasks



Permits the operator to shut down the m2000sp application and turn off the computer



Menu The menu offers the following options: Table 1.2:



1-16



Menu



Permits the operator to select a specific Sample Extraction protocol for execution (see below for further detail)



Permits the operator to select a specific Master Mix Addition protocol for a previously run Sample Extraction (see below for further detail)



Permits the operator to delete or reuse specific Test Orders that have been downloaded from the host LIS, and provides a means for the operator to print a list of all Test Orders in the database. Refer to LIS Test Order Management on page 5–257 for details.



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System Control Center and Software



The Sample Extraction function performs the nucleic acid extraction procedure. The nucleic acid target is isolated from its native biological source (for example, human blood or plasma), making the target available for amplification. The eluate is then dispensed into the 96 deep well plate.



Selection of this menu option triggers the master mix step. Master Mix can be created/distributed in two ways, depending on the assay-protocol. In the first way, the system combines Abbott assay-specific reagents into the master mix tube. This master mix is dispensed into the ABBOTT® 96-Well Optical Reaction Plate (PCR plate). The eluate is then transferred from the deep well plate to the PCR plate. In the second way, the instrument distributes user-prepared master mix and eluate to the PCR plate.



Menu The menu offers two options for viewing sample results: by deep well plate or by PCR plate. Table 1.3:



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Menu



Permits the operator to view status of a specific deep well plate processed by Sample Extraction



Permits the operator to view status of a specific PCR plate processed by Master Mix Addition and to export processed plate data to a CD for further processing on the m2000rt.



1-17



Use or Function Section 1



System Control Center and Software



Menu The menu offers two options for management of disposable tips and Master Mix reagents. Table 1.4:



Menu



Permits the operator to view and upgrade the system’s understanding of the current inventory of DiTis on the shelves



Refer to Disposable Tip Status on page 5–272 of Section 5, Operating Instructions.



1-18



Offers the operator the following four options: • allows the operator to search for available amplification reagent packs for use with a specific application specification. • allows the operator to determine the status of a specific pack by either scanning the pack’s bar code or entering the bar code data via the keyboard. • allows the operator to identify packs that are no longer usable on the system. • indicates pack status and which packs and Master Mix vials should be discarded after the run. Refer to Amplification Reagent Pack Inventory Management on page 5–277 of Section 5, Operating Instructions.



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System Control Center and Software



Menu The menu offers the following options to the operator: Table 1.5:



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Menu



Permits the operator to view logs of messages and processes carried out on the m2000sp System for each procedure performed • lists all messages accumulated on the system, starting with the most recent message • lists all the steps performed on the system, starting with the most recent process



Permits the operator to view the status of LiHa and RoMa calibrations and print LiHa/RoMa calibration reports.



Permits the operator with Administrator access to install/delete assay applications onto the system



Permits the operator to perform daily maintenance and flush procedures (refer to Section 9, Service and Maintenance)



1-19



Use or Function Section 1



System Control Center and Software



1-20



• Abbott Representative can set the instrument’s serial number, model type, and external devices, and view computer information. • Operator can configure audible alerts for errors, warnings, and information. • Operator can configure some or all LIS settings depending on their level of access. • Administrator can configure current system date, time zone, and/or time. • Administrator can configure sample bar code parameters. • Operator can view the currently configured sample rack sizes and custom sample tube parameters. • Administrator can configure the checks that will be performed prior to starting a run. • Administrators can change the default signal tower configuration (i.e., what color signifies what state). This option is only available on hooded systems that have had the signal tower activated under .



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System Control Center and Software



continued



• Permits the operator with Administrator access to configure the following to meet regional preferences: - the date and time display format - the numeric format for test results featured in reports - On-line documentation format - Keyboard language - User interface language • Abbott Representative can set the method of data transfer to the m2000rt. • Permits the operator to choose to have Test Order results exported automatically to the m2000rt.



• Permits all users to change their individual password • This is for Administrators only. Displays options including: - - -



• Allows user to create system backups of the database • Allows Abbott Customer Support and Abbott Representatives to restore saved database and system calibrations



1-21



Use or Function System Control Center and Software







1-22



Section 1



• Lists all files exported from the m2000sp to the Network Data Store until those files are either imported for an m2000rt run or deleted • Allows users with Administrator access to delete old files that are no longer needed Refer to Managing the Network Data Store on page 5–251 of Section 5, Operating Instructions • Shows current print jobs • Permits user to delete jobs



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System Control Center and Software



Menu The menu features the following options: •



, which lists the current software version on the m2000sp System



•



, which features an on-line version of this manual, including addenda, loaded on to the system by an authorized Abbott Representative



!



IMPORTANT: Any paper (hard-copy) 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 m2000sp Operations Manual addenda.



On-line Documentation Features The screen includes the tools shown in the following illustration: Figure 1.14: Screen Features



menu



bar



options



option



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Use or Function Section 1



System Control Center and Software



1. The menu has clickable links to the various sections of the document and expandable/collapsible nodes for more in-depth searching. 2. The 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 1.15: Bar Center arrows



Outside arrows



3. The options allow the user to enlarge or reduce the size of the page shown depending on the button selected. Figure 1.16: 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 (as shown in Figure 1.14) The fourth button forces the page to fit the width of the viewer space



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System Control Center and Software



4. The option features a text field that allows the user to type in a search word. When the button is clicked, the software takes you to the next page that word occurs on. Figure 1.17: Field



Clicking again, takes the user to the next occurrence after that.



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Use or Function Section 1



Toolbar Icons



Toolbar Icons Table 1.6:



Toolbar Icons



Toolbar Icon



Command



Back Navigates back to the previous screen Forward Navigates forward to the next screen Home Navigates to the screen Sample Extraction Navigates to the Test Order screen Master Mix Addition Navigates to the Test Order screen Deep Well Plates Navigates to the screen PCR Plates Navigates to the screen



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Toolbar Icons



Toolbar Icon



Command Message Log Navigates to the screen Process Log Navigates to the screen System Calibration Navigates to the screen Application Specifications Navigates to the screen Disposable Tip Status Navigates to the screen Maintenance Procedures Navigates to the screen Settings Navigates to the screen



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Use or Function Section 1



Software Column Sorting



Software Column Sorting Most of the list fields in the m2000sp 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.



!



IMPORTANT: To avoid user-input errors, the and screens cannot be sorted.



A narrow triangular icon indicates which column has been selected by the operator and in what order the listing occurs. Figure 1.18:Sort Icon Examples



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Information Icons; Messages



Information Icons; Messages During the course of normal system operation, the m2000sp System software displays messages with information icons to signal certain conditions. These messages display in front of the currently displayed screen, and require user acknowledgement. All interaction with the user interface is suspended as long as the message displays. Table 1.7: Icon



Information Icon



Explanation Informational Information for the operator Example:



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Use or Function Section 1



Information Icons; Messages



Warning Alerts the operator to a potential problem Example:



Error Alerts the operator that an error requiring corrective action has occurred on the screen or the system Example:



Tooltip Icon If any text runs beyond its border on the screen and displays ellipses (...), hold the mouse pointer over the text to display the entire text. Figure 1.19:Tooltip icon



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Information Icons; Messages



Instrument Overview The ABBOTT® m2000sp instrument performs automated sample preparation. Preparation includes:



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•



transferring sample preparation reagents, calibrators, controls, and specimens



•



reading bar codes for positive identification of samples and reagents



•



performing pipetting tasks, such as liquid transfer, washing, and mixing



•



performing magnetic separation process for wash and elution steps



•



preparing and distributing master mix



•



transferring purified nucleic acid



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Use or Function Section 1



Components



Components The m2000sp instrument is comprised of the major elements listed and explained in the table below. Table 1.8:



m2000sp Components



Positive identification Scans and reads bar codes bar code reader (PosID) Consists of all instrument components containing or directly Liquid handling system influencing liquid flow. The major components include the LiHa, which performs all pipetting tasks, and the DiTi racks 1 mL Subsystem Robotic manipulator arm (RoMa)



Sensors



Worktable



Output Deck



Cabinet



Performs magnetic separation and heating Transports DiTi racks and the 1 mL Subsystem carrier Monitor status of: • door locks • liquid waste capacity • solid waste capacity • system liquid capacity Site of: • sample input • 1 mL Subsystem • waste station • reagent carriers • DiTi carriers • Output Deck with chiller Site where: • master mix procedure is performed • eluate is transferred to deep well plate • PCR plate is prepared and chilled Provides storage of: • system fluid • all system waste • accessories required during sample preparation NOTE: All E-series models and some G-series models also have hoods as part of their basic setup. However, hoods are not standard equipment and are, therefore, not available in all regions.



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Positive ID Bar Code Reader



Positive ID Bar Code Reader The PosID reads bar codes for positive identification and positioning of carriers, racks, and sample containers by means of a scanner. By scanning through the worktable and sometimes using its gripper to pull carriers toward the rear of the instrument, the PosID: •



identifies bar codes on sample tubes, carriers, and sample preparation reagent labels



•



reads amplification reagent pack labels and all carrier IDs



Figure 1.20: PosID



Laser beam output window



Scanner head



Housing Gripper Tube sensor



Scanner head



The E-series PosID is protected by an additional housing



WARNING: Laser beam. The PosID uses a Class II laser product that contains an embedded low power visible Class II laser diode bar code scanner. Avoid direct viewing of the bar code laser beam or reflections from the beam.



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Use or Function Section 1



Liquid Handling System



Liquid Handling System The liquid handling system includes all instrument components containing or directly influencing liquid flow: •



dilutors (eight syringes with 3-way valves)



•



liquid handling arm (LiHa)



•



DiTi eject



•



fast wash (FaWa) pump



•



waste system



System Liquid Flow Direction Figure 1.21:Liquid System Principle: System Liquid Flow Direction



System liquid (deionized or distilled water) is delivered to the system from the system liquid container when aspirated and distributed by tubing, valves, syringes, and connectors. Distribution of the system liquid is affected by the movement of the syringes and is accelerated by the fast wash pump.



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Liquid Handling System



Dilutors Eight dilutors aspirate and dispense system liquid. Each dilutor consists of a 1 mL syringe and a 3-way valve. Figure 1.22:Dilutors



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Use or Function Section 1



Liquid Handling System



Liquid Handling Arm The LiHa is used for pipetting, diluting, and mixing of specimens and reagents. The LiHa aspirates and dispenses liquids through the disposable tips, from up to eight different channels. The LiHa moves in three directions: •



X—arm movement left and right



•



Y—tip movement and spacing front and rear



•



Z—range for tip movement up and down



Figure 1.23:LiHa Movement



Y Z X



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Liquid Handling System



Liquid Detection Each disposable tip is connected to an integrated liquid detector module which detects the surface of a liquid upon contact. The liquid detectors operate by monitoring the capacitance between the tip and the instrument working surface. When a tip touches the liquid surface, the integrated liquid detector module detects the change in capacitance and triggers a detection signal. A signal is produced both when moving into a liquid and when coming out, allowing detection of aspirated clots. As the tip is withdrawn from fluid, the system must detect a level-sense change after the tip exits fluid. If a change is not detected, the system assumes a clot was aspirated. Liquid detection allows for: •



minimum submerge depth of the tip



•



error messages if inadequate liquid is present or inadequate liquid is measured



•



specimen clot detection



•



constant submerge depth during aspiration and dispense



Cross-contamination Cross-contamination is controlled by the protocol and the integrity of the liquid handling system. System cross-contamination depends on several liquid handling parameters, such as types of liquid, material and geometry of the tip, temperature, etc., and how aspiration and dispense operations are performed (liquid handling parameters). NOTE: The m2000sp uses disposable tips with filters to eliminate carryover. Measurement of cross-contamination is dependent on the detection technique. The value of cross-contamination obtained with one method can be different from the value obtained with another method. To ensure appropriate instrument performance, it is essential that required maintenance be performed at prescribed intervals. See Section 9, Maintenance and Diagnostics, for more information.



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Use or Function Section 1



Liquid Handling System



Disposable Tip Eject To minimize contamination risk, the LiHa ejects disposable tips (DiTis) using the lower DiTi eject, so that ejected DiTis are closer to the waste station. Figure 1.24:DiTi Eject



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Liquid Handling System



Fast Wash Pump The fast wash (FaWa) pump accelerates aspiration and distribution of system liquid into the liquid system. The FaWa pump also accelerates the flush and wash operations, improving efficiency during the wash operations of the liquid handling system. The FaWa is equipped with a pressure-relief valve to allow proper function and ensure fluidic performance. Figure 1.25:FaWa Pump



Pressure-relief valve FaWa pump



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Use or Function Section 1



Liquid Handling System



Waste System BIOLOGICAL RISKS:: The m2000sp waste is potentially infectious. Use appropriate biohazard precautions. The waste system consists of: •



solid waste chute



•



solid waste container



•



liquid waste container



Solid Waste Chute Disposable tips are ejected by the lower DiTi eject through the solid waste chute into the solid waste container. While there is only one solid waste chute on each m2000sp, there are two models currently in use. The primary difference between the two from a user perspective is the above-deck collar on the second model. Figure 1.26:Waste Chute models



Above-deck collar



The directions for use and cleaning provided in this manual apply equally to both models. When loading the waste chute, ensure the green label is visible. A red-slash warning label will be visible when the chute has been loaded incorrectly.



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Liquid Handling System



Figure 1.27:Waste Chute Direction Indicators



Incorrect positioning



!



Correct positioning



IMPORTANT: Incorrect loading/positioning of the waste chute could result in errors.



Solid Waste Container Figure 1.28:Waste System



Lid for solid waste container (used for transporting waste)



Solid waste container



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Liquid waste container (red label)



1-41



Use or Function Section 1



Liquid Handling System



Liquid Waste Container Liquid waste, such as flushes and unused aspirated liquid, is dispensed to the liquid waste container. The system liquid container and the liquid waste container are color-coded to match labels affixed to the drawer on which they sit: •



green label - system liquid



•



red label - liquid waste



Color coding is intended to ensure that containers are correctly placed in the waste tray. Figure 1.29:Containers for System Liquid and Liquid Waste Liquid waste (red label)



System liquid (green label)



Figure 1.30:Color Coded Labels on Waste Tray



Liquid waste (red label) System liquid (green label)



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1 mL Subsystem



1 mL Subsystem The 1 mL Subsystem, a subassembly which performs magnetic separation and heating steps, includes four zones: •



heater zone 1



•



heater zone 2



•



room temperature zone



•



magnetic zone



Figure 1.31:1 mL Subsystem with Carrier Reaction vessels in 1 mL Subsystem carrier, held in place by plastic cover



Room temperature zone



Heater zone 1



Heater zone 2



Magnetic zone



Specimens, calibrators, controls, and reagents are pipetted by the m2000sp into reaction vessels located in the 1 mL subsystem carrier. The reaction vessels are moved to various zones in the 1 mL Subsystem to allow addition of reagents, incubation, magnetic capture, and washing. When the carrier is fully lowered into magnetic low (mag low) position, magnetized particles are pulled to the side of the tube.



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Use or Function 1 mL Subsystem



Section 1



The edges of the magnetic zone have four dimpled rests which accommodate the metal feet of the subsystem carrier, permitting the carrier to sit at magnetic rest (mag rest) position. During mag rest, magnetized particles accumulate at the bottom of the reaction vessels. Each 1 mL Subsystem carrier holds up to 48 reaction vessels, which are held in place by the 1 mL Subsystem carrier cover. The 1 mL Subsystem can process up to two carriers at a time for a total of 96 samples.



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Robotic Manipulator Arm (RoMa)



Robotic Manipulator Arm (RoMa) The RoMa is equipped with eccentric gripper fingers that transport disposable tip racks and the 1 mL Subsystem carrier to different positions on the worktable. Figure 1.32:RoMa Grippers



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Use or Function Section 1



Robotic Manipulator Arm (RoMa)



The RoMa moves in five directions, illustrated by labeled arrows in the following figure: •



X—arm movement left and right



•



Y—arm movement front and rear



•



Z—arm movement up and down



•



R—gripper rotational movement



•



G—gripper horizontal direction



Figure 1.33:Five RoMa Movement Directions



Z R Y



1-46



G X



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Use or Function Section 1



Sensors



Sensors The m2000sp is equipped with sensors to monitor a number of instrument conditions. •



door lock sensors (2)



•



liquid waste sensor



•



system liquid sensor



•



solid waste sensor



Door Lock Sensors The door lock sensors detect whether the safety door is unlocked or locked. The m2000sp operates only when the door is locked. The door can only be locked if it is closed. Figure 1.34:Door Lock Sensors



Left door lock sensor



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Right door lock sensor



1-47



Use or Function Sensors



Section 1



Liquid Waste Sensor The liquid waste sensor monitors the fill state of liquid waste in the liquid waste container. If, at the start of a protocol run, the sensor detects the container is too full to handle waste from the new run, the new run will not proceed.



System Liquid Sensor The system liquid sensor monitors the fill state of system liquid in the system liquid container. If, at the start of a protocol run, the sensor detects the container lacks sufficient liquid for the run, the new run will not proceed. When the sensor detects a sufficient volume of liquid, the run will proceed. Figure 1.35:Liquid Waste Sensor and System Liquid Sensor



Liquid waste sensor



System liquid sensor



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Use or Function Section 1



Sensors



Solid Waste Sensor The solid waste sensor monitors the fill state of the solid waste container. If, at the start of a run, the sensor detects that the solid waste container lacks sufficient room for solid waste from the new run, the run will not proceed. Figure 1.36:Solid Waste Sensor



Solid waste sensor



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Use or Function Section 1



Worktable



Worktable The m2000sp worktable is configured to process 96 specimens, calibrators, and controls for the isolation of nucleic acids. The figure below identifies main components of the worktable. Figure 1.37:Worktable Layout



a k j



i b



h



c



d



e



f



g



a. Shelf for 1000 μL disposable tips



g. Reagent vessel carrier



b. Positioning pins (guide pins)



h. DiTi rack carriers



c. Sample racks



i. Disposable tip reuse rack



d. 1 mL Subsystem



j. Output Deck



e. Disposable tip rack



k. 200 ml reagent vessel



f. Waste Station



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Worktable



Sample Racks Figure 1.38:Sample rack



Standard sample racks hold up to 16 primary or secondary specimen tubes and calibrator and control vials for sample preparation. Various rack types for the following tubes are available for use on the m2000sp system: •



Transport tubes



•



13 mm tubes (rack with blue inserts)



•



16 mm tubes



The m2000sp system processes up to 96 samples per run. Tubes can be bar coded for positive identification. The sample racks are pulled toward the rear of the instrument for bar code identification and then pushed into operating position.



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Use or Function Section 1



Worktable



Reagent Vessel Carriers Two reagent vessel carriers are required to hold the sample preparation reagents used during automated sample preparation. Each reagent vessel carrier can hold up to three bar- coded, 200 ml reagent vessels. Figure 1.39:Reagent Vessels Carrier



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Worktable



DiTi Rack Carrier Two DiTi rack carriers are available on the m2000sp worktable to hold DiTi racks and DiTi reuse racks. •



The first carrier holds three DiTi racks. Two racks contain 96 x 1000 μL DiTis and one rack stores reusable DiTis.



•



The second carrier holds three DiTi racks. Two racks contain 96 x 200 μL DiTis and one rack stores reusable DiTis.



Figure 1.40:DiTi Rack Carriers 200 µL DiTi racks



1000 µL DiTi racks



Deep well plate below a reuse rack



Empty reuse rack



DiTi Rack Carrier 1



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DiTi Rack Carrier 2



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Use or Function Section 1



Worktable



Disposable Tip Shelves Seven shelf positions are available on the m2000sp to hold fully loaded 1000 μL DiTi racks. As needed, DiTi racks are stored on the DiTi shelves and moved by the RoMa to the worktable. NOTE: Do not load a DiTi rack onto shelf position 1. (See the Figure below.) This shelf position is used for an empty DiTi Rack transferred from the worktable to the shelf. Figure 1.41:DiTi Shelf, Numbered Slots Position 1



DiTi Shelf, Numbered Slots



DiTi Racks DiTi racks hold the disposable tips used by the LiHa to aspirate and dispense samples and reagents. DiTi racks are available to hold both the 1000 μL and 200 μL DiTis.



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Worktable



DiTi Reuse Rack The DiTi reuse rack is a metal holder that holds an empty white plastic tray (DiTi tray) for the storage of used DiTis. These DiTis are used again later in the same protocol run for the same samples. The deep well plate isolates each tip and catches any liquid that drips from the DiTis. Figure 1.42:DiTi Racks and Reuse Racks 1000 µL DiTi racks DiTi tray on reuse rack



200 µL DiTi racks



Empty DiTi reuse rack



Deep well plate



NOTE: The above picture is the proper setup for 48 sample or less. For more than 48 samples, a second DiTi tray and deep well plate would be required in the empty reuse rack shown above.



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Use or Function Section 1



Output Deck



Output Deck The Output Deck provides positions for the 96 Deep Well plate, ABBOTT® 96-Well Optical Reaction (PCR) plate, Abbott Reagent packs, and master mix tube. The 96-Well Optical Reaction plate is maintained at a temperature of between 5 and 30° C, depending on the protocol. Figure 1.43:Output Deck, Top View



Assay reagent pack holders



Master mix tube holder 96 deep well plate



Chilled PCR plate holder



Foam insulator



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Use or Function Section 1



Output Deck



Labels Racks and carriers on the worktable are bar coded for identification by the m2000sp. The bar codes are scanned by the PosID to identify their presence and position on the worktable. Table 1.9:



Bar Code Labels Description



Bar Code ID



Sample rack 13 mm



013



Sample rack 16 mm



016



200 mL reagent vessel carrier



510



Waste station



502



1 mL Subsystem



501



DiTi rack carrier



505



Output Deck



511



Abbott reagent pack



512



Pierceable cap rack



513



Custom 1: User-defined sample rack 13 mm



713



Custom 2: User-defined sample rack 13 mm



613



LRV (low residual volume) sample rack 13 mm



813



Custom 4: User-defined sample rack 13 mm



913



User-defined sample rack 16 mm



716



In addition to worktable grid numbers for the sample racks, reagent vessel carriers, and DiTi rack carriers, the worktable deck is labeled to ensure correct placement for operation.



!



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IMPORTANT: Some racks are assay-specific. Refer to the assay package insert to determine if a specific rack is required.



1-57



Use or Function Section 1



Output Deck



Guide Pins The guide pins on the worktable hold carriers and racks in position, and serve as a reference for hardware alignment. Table 1.10: Guide Pins



Lock pin



Reference lock pin



Guide pin



Reference guide pin



Stop pin



1-58



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Use or Function Section 1



Cabinet



Cabinet The cabinet provides a base for the m2000sp instrument and additional accessories required during sample preparation. The cabinet is configured to allow the solid waste to pass from the waste station to the solid waste container. Figure 1.44:Cabinet Interior



The liquid waste and system liquid containers are behind the solid waste container and transport lid shown in the foreground



Solid Waste Container Used DiTis are ejected over the waste station and pass through the solid waste chute into the solid waste container. The operator has the option to discard DiTis directly into the solid waste container or add a disposable biohazard bag to the solid waste container. The solid waste container is monitored at the start of a protocol run and notifies the operator if the container lacks capacity for waste expected to be generated in the new run. If capacity is insufficient, the run is not initiated. BIOLOGICAL RISKS: The waste is potentially infectious. Use appropriate biohazard precautions. BIOLOGICAL RISKS: The DiTis can potentially puncture a disposable biohazard bag. Double-bagging the DiTis is recommended.



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Use or Function Section 1



Cabinet



Liquid Waste Container All liquid waste enters the waste container through the waste station. System liquid flushed through the LiHa is placed in the liquid waste container, as well. A sensor monitors the liquid waste container at the start of a protocol and notifies the operator if the container lacks capacity for waste expected to be generated in the new run. If capacity is insufficient, the run is not initiated. BIOLOGICAL RISKS:The waste is potentially infectious. Use appropriate biohazard precautions.



Figure 1.45:Liquid Waste Container, Red Label



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Cabinet



System Liquid Container The m2000sp uses deionized or distilled water for system liquid. Deionized or distilled water is aspirated from the system liquid container and is distributed to the LiHa via tubing, valves, syringes, and connectors. A sensor monitors the system liquid container at the start of a protocol run and notifies the operator when there is insufficient liquid to complete the run. If the capacity is insufficient, the run will not be initiated. Figure 1.46:System Liquid Container, Green Label



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Use or Function Section 1



Cabinet



NOTES



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Use or Function Section 1



Required Consumables



Consumables Required Consumables The following consumables are required to operate the m2000sp system. •



Sample preparation reagents



•



200 mL reagent vessels



•



5 mL reaction vessels



•



DiTis: 200 μL and 1000 μL with filter



•



96 Deep Well Plates: –



For 1-48 samples, two plates are required (one for the DiTi reuse rack and one for eluate storage)



–



For 49-96 samples, three plates are required (two for the DiTi reuse racks and one for eluate storage)



•



Master mix tube



•



Clean DiTi trays from empty DiTi rack



•



ABBOTT® 96-Well Optical Reaction Plate



•



ABBOTT Optical Adhesive Cover



•



ABBOTT Adhesive Seal Applicator



•



ABBOTT Splash Free Support Base NOTE: To ensure proper function of the m2000sp, only consumables supplied by Abbott should be used.



Optional consumables include disposable biohazard bags.



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Use or Function Section 1



Required Consumables



Sample Preparation Reagents Sample preparation reagents are used on the m2000sp system to isolate nucleic acids from patient samples. These include •



cell lysis reagent



•



magnetic particle reagent (for capturing nucleic acids)



•



wash and elution reagents



•



user-supplied or assay-specific reagent



•



Proteinase K (PK) (if applicable) NOTE: Refer to assay package insert for correct type used in the protocol (DNA or RNA).



200 mL Reagent Vessels Up to six 200 mL reagent vessels hold the sample preparation reagents needed for automated sample preparation.



5 mL Reaction Vessels Reaction vessels hold the transferred samples and reagents needed for sample preparation within the 1 mL Subsystem carrier. The reaction vessels are moved about in the 1 mL Subsystem to allow addition of reagents, incubation, washing, and magnetic capture.



Disposable Tips DiTis are used by the LiHa to aspirate and dispense samples and reagents. DiTis are automatically picked up from DiTi racks holding 96 1000-μL tips or 96 200-μL tips. After use, DiTis are either released into the solid waste chute and collected in the solid waste container in the instrument’s cabinet or deposited into the reuse rack for use later in the protocol. DiTis are supplied with filters in 200 μL and 1000 μL types.



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Use or Function Section 1



Required Consumables



96 Deep Well Plate The deep well plate has 96 wells. This plate is positioned under each DiTi reuse rack held by the DiTi rack carrier to prevent reuse tips from touching and to collect drips. Another 96 deep well plate is also used on the Output Deck for holding the purified nucleic acid (i.e., eluate) at the completion of the Sample Extraction run.



ABBOTT® 96-Well Optical Reaction Plate The 96-Well Optical Reaction Plate (PCR plate) is positioned on the PCR tray holder of the Output Deck. Eluate and master mix reagent are automatically dispensed into the wells.



ABBOTT Optical Adhesive Covers The Optical Adhesive Cover is used by the operator to seal the filled PCR plate. It helps to prevent sample evaporation and cross-contamination.



ABBOTT Adhesive Seal Applicator The Adhesive Seal Applicator is used by the operator to uniformly laminate the Optical Adhesive Cover over the filled PCR Plate.



ABBOTT Splash Free Support Base The Splash Free Support Base is used to hold a filled PCR plate when it needs to be placed on a countertop, to help keep the well bottoms clean.



Master Mix Tube An 83 x 14-mm plastic tube used to hold the master mix solution.



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Use or Function Section 1



Required Consumables



DiTi Tray The clean plastic DiTi tray from a used DiTi rack can be saved and used for the DiTi reuse rack.



Disposable Biohazard Bags (Optional) The solid waste container holds used DiTis. The operator can either discard DiTis directly into the solid waste container or line the solid waste container with a disposable biohazard bag before disposing of the DiTis.



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Section 2



Section 2: Installation Procedures and User Configuration



Installation Procedures and User Configuration



Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 m2000sp System Installation . . . . . . . . . . . . . . . . . . . . . . . . 2-3 m2000sp Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Installation by the Abbott Representative . . . . . . . . . . . 2-4 Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 When to Affix Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 How to Add Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Worktable Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Input Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 Reagent Vessel Carrier Labels . . . . . . . . . . . . . . . . . . . . . 2-7 Disposable Tip Rack Carrier Labels . . . . . . . . . . . . . . . . . 2-8 Sample Rack Bar Code Labels . . . . . . . . . . . . . . . . . . . . . 2-9 Reagent Vessel Carrier Labels . . . . . . . . . . . . . . . . . . . . 2-10 System Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Operator Access Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13 Logon Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14



Account Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15 Create User Account . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16 Delete User Account . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 Reset Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19 Change Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21



System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23 Hardware Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25 Audible Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26 LIS Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28 Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32 To Set Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32 To Select a Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33 Sample Bar Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34 Sample Racks and Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37 Run Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38 Signal Tower . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41 Language and Locale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-43



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Table of Contents-1



Installation Procedures and User Configuration



Section 2



To Change . . . . . . . . . . . . . . . . . . . . . . . . To Change . . . . . . . . . . . . . . . . . . . To Change . . . . . . . . . . . . . . . To Change . . . . . . . . . . . . . . . . . . . . . . . . . . . Network Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . Automatic Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .



Table of Contents-2



2-44 2-45 2-46 2-46 2-49 2-51



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Section 2



Installation Procedures and User Configuration



Section 2: Installation Procedures and User Configuration



Installation The m2000sp Instrument (09K14-01) is described in this chapter as the G-series. The m2000sp Instrument E-series (09K14-02) is described in this chapter as the E-series. All text and descriptions apply to both instruments unless specifically designated as G-series or E-series. All E-series specific information will be shown in a blue-shaded box.



Overview This section describes installation of the ABBOTT® m2000sp and provides instructions for initial operation. The topics include: •



m2000sp System Installation, page 2–3 Lists the procedures that will be performed by the Abbott Representative during instrument installation



•



Labeling, page 2–5 Describes the labels that will be affixed to the instrument by the Abbott Representative during instrument installation



•



System Verification, page 2–12 Describes the installation/operation qualification procedures the Abbott Representative will perform to verify the system performance



•



Operator Access Levels, page 2–13 Describes the levels of user access and the tasks available for each access level



•



Account Management, page 2–15 Describes the account management functions:



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–



Create User Account, page 2–16



–



Delete User Account, page 2–18



–



Reset Password, page 2–19



–



Change Password, page 2–21



2-1



Installation Procedures and User Configuration Section 2



Installation



•



System Settings, page 2–23 Describes how to configure or view the settings for the following:



2-2



–



Hardware Configuration, page 2–25



–



Audible Alert, page 2–26



–



LIS Configuration, page 2–28



–



Time and Date, page 2–32



–



Sample Bar Code, page 2–34



–



Sample Racks and Tubes, page 2–37



–



Run Checks, page 2–38



–



Signal Tower on page 2–41



–



Language and Locale, page 2–43



–



Network Configuration, page 2–49



–



Automatic Export, page 2–51



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Installation Procedures and User Configuration Section 2



Installation



m2000sp System Installation CAUTION: Improper installation can damage the system. The m2000sp must be installed by an Abbott Representative. CAUTION: If it becomes necessary to move the m2000sp, contact an Abbott Representative, who will arrange for an authorized Field Service Representative (to move the instrument). The operator must not move the instrument, as physical injury to the operator and/or damage to the m2000sp can happen.



m2000sp Placement The location of the m2000sp must meet environmental and electrical requirements before the system can be installed. See Technical Data on page 4–5 of Section 4, Performance Characteristics and Specifications for additional information.



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2-3



Installation Procedures and User Configuration Section 2



Installation



Installation by the Abbott Representative The Abbott Representative installs the m2000sp hardware and system software. Installation includes the following: •



unpack the system



•



unpack the accessory kit



•



position the m2000sp and its peripherals



•



assemble the m2000sp



•



connect all cables



•



confirm proper seating and secure connections of all circuit boards, power supplies, and other hardware



•



check alignment of liquid handling arm (LiHa), robotic manipulator arm (RoMa), and bar code reader (positive ID [PosID])



•



check sensors



•



affix labels



•



install software (including network configuration, if required)



•



verify the system NOTE: If any accessories or supplies are missing or in unsatisfactory condition when unpacked, the Abbott Representative assists with damage reporting and replacement.



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Installation Procedures and User Configuration Section 2



Installation



Labeling When to Affix Labels During installation, the Abbott Representative affixes labels to the m2000sp worktable, carriers, and racks. When new carriers and racks are ordered, labels should be affixed immediately. If an original label becomes detached, it should be immediately replaced.



How to Add Labels 1. Clean the surface with alcohol and allow to dry thoroughly. 2. Affix label to surface, smoothing any wrinkles.



Worktable Labels The worktable, sample racks, reagent vessel carriers, DiTi rack carrier, and Output Deck are labeled to assist the operator with correct placement of racks and carriers during operation. The figure below shows labels correctly affixed to the worktable. Figure 2.1: Worktable Labels 7 DiTi shelf locations



Input labels



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Reagent label 1



Reagent label 2



Output labels



2-5



Installation Procedures and User Configuration Section 2



Installation



Input Labels Input labels assist with placement of sample racks in the correct position on the m2000sp worktable. Place the input label on the front of the worktable. Match the input labels with the grid locations as shown in the table below. Figure 2.2: Input Labels



Table 2.1:



2-6



Match Input Label to Grid Locations



Grid Location



Input Label



1



6



2



5



3



4



4



3



5



2



6



1



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Installation Procedures and User Configuration Section 2



Installation



Reagent Vessel Carrier Labels The reagent vessel carrier labels assist the operator in placing the reagent vessel carriers in the correct position on the m2000sp worktable. Place the labels on the front of the worktable: •



Label #1 at grids 19 and 20



•



Label #2 at grids 33 and 34



Figure 2.3: Reagent Vessel Carrier Labels



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Installation Procedures and User Configuration Section 2



Installation



Disposable Tip Rack Carrier Labels The DiTi rack carrier labels assist the operator in placing the DiTi racks and empty DiTi trays in the correct position on the DiTi rack carriers. Affix the labels to the top of the DiTi rack carriers. Figure 2.4: DiTi Rack Carrier Labels



2-8



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Installation Procedures and User Configuration Section 2



Installation



Sample Rack Bar Code Labels Sample rack bar code labels are shown in the table below: Table 2.2:



Sample Rack Bar Code Labels



Sample Rack



Bar Code ID



13mm (blue insert)



013/xxxxxx



16mm



016/xxxxxx



Pierceable cap



513/xxxxxx



Custom 1: User-defined 13 mm



713/xxxxxx



Custom 2: User-defined 13 mm



613/xxxxxx



LRV (low residual volume) 13 mm



813/xxxxxx



Custom 4: User-defined 13 mm



913/xxxxxx



User-defined 16 mm



716/xxxxxx



Figure 2.5: Bar Code Labels on Standard PoSts Unique color identification band



Stripe indicating a custom rack



Bar code label



PoSt (positive identification stick)



! m2000sp Operations Manual



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IMPORTANT: Some assays require a PoSt that differs physically from the one shown above; however, the basic elements identified in Figure 2.5 are the same for all PoSt types. Refer to the assay-specific package insert for instructions.



2-9



Installation Procedures and User Configuration Section 2



Installation



Reagent Vessel Carrier Labels Reagent labels on the front of the reagent vessel carriers assist the operator with placing the reagent vessel carriers in the correct position on the m2000sp worktable. In addition, the reagent labels on the side of the carrier assist with placement of the correct reagent vessel on the reagent carrier. 1. Place labels 1 and 2 on the end of the carriers underneath the pull-tab 2. Place labels for mLysis (1), mLysis (2), and mMicroparticles (3) on the right side of reagent carrier 1 3. Place labels for mWash 1 (4), mWash 2 (5), and mElution Buffer (6) on the right side of reagent carrier 2 Figure 2.6: Reagent Carrier Labels



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Installation Procedures and User Configuration Section 2



Installation



4. Some assays may require the use of Proteinase K (PK). Refer to the assay-specific package insert for detailed information regarding the use of PK. If PK is used, it will be placed in reagent carrier #1 location 2. Figure 2.7: Reagent Carrier #1 with PK Label at Location 2



5. Add labels as follows:



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•



reagent vessel carrier: bar code ID 510/xxxxxx



•



Output Deck label: bar code ID 511/xxxxxx



2-11



Installation Procedures and User Configuration Installation



Section 2



System Verification After the m2000sp is positioned and connected, the Abbott Representative confirms satisfactory installation and operation by performing several tests (system verification). After the Abbott Representative completes these procedures, the m2000sp is ready for use.



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Installation Procedures and User Configuration Section 2



Installation



Operator Access Levels The operator’s logon level determines access to screens and functions. The levels of user access for the m2000sp are described in the following table. Table 2.3:



Logon Authorization and Actions Possible



Logon Authorization



General User



Administrator Additional Capabilities



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Actions Possible at Corresponding Access Level • • • • •



Update disposable tip status Run protocols Review, export, and print results Turn LIS communication on or off View logs and configuration information • Perform daily maintenance and flush procedures • Perform system backup • Configure audible alert • Install and delete Application Specifications • Delete process logs • Manage Administrator and General User accounts • Configure time and date, and language and locale format preferences • Configure sample bar code • Configure result export options • Configure all LIS options • Enable or disable run checks • Perform advanced maintenance and diagnostics procedures • Exclude/include wells in a deep well plate from further analysis



2-13



Installation Procedures and User Configuration Section 2



Installation



Logon Screen The screen displays when the m2000sp software program starts. As shown in the figure below, user logon requires the operator to enter and . Figure 2.8: Display



If an invalid and/or is entered, an error message displays. NOTE: The field is case-sensitive. For more information on error messages, see Section 10, Troubleshooting and Diagnostics.



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Installation Procedures and User Configuration Section 2



Account Management



Account Management Users with Administrator access can create and delete user accounts for Administrators and General Users, and reset passwords. To perform account management tasks, select , then , then . Figure 2.9: System User Account Dropdown Menu



The screen displays the current , their access level (Administrator or General User), and a description. Figure 2.10: Account Management Screen



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Installation Procedures and User Configuration Section 2



Account Management



From the menu, a user with Administrator access can: •



- Create user accounts



•



- Delete existing accounts



•



- Reset passwords for existing accounts



Figure 2.11: Account Management Tasks Menu



Accounts displayed in red are new accounts or accounts that have had their passwords reset.



Create User Account 1. To create a new user account, select , then , and then . Figure 2.12:, Menu



The screen displays. Select from the menu. Figure 2.13:Account Management Tasks Menu



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Account Management



The screen displays. Figure 2.14:Create User Account Screen



2. Enter the user name (1 to 20 characters). NOTE: The initial password will be set to the user name. During the first login, the user will be prompted to change this password. 3. Select the Access Level for the user: •



•



Figure 2.15:Completed Create User Account Screen



4. If desired, enter a description (this is an optional field). NOTE: The fields designated by a red asterisk (*) are required fields.



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Account Management



5. When the entries are complete, select . The screen displays with the new user added to the list. Figure 2.16:Account Management Screen with New User



The new user can now log on to the system using the user name created, with the initial password being the same as the user name. The user will immediately be asked to change the password.



Delete User Account 1. To delete a user account, select , then , and then . Figure 2.17:, Menu



2. Select the account to delete. 3. From the menu, select . Figure 2.18:Account Management Tasks Menu



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Account Management



An alert message displays, requesting the operator to confirm the intention to delete the user account. 4. Select . 5. The screen displays the updated list of current user accounts.



Reset Password 1. To reset a user password, select , , and then . Figure 2.19:, Menu



2. Select the user account password to be reset. 3. From the menu, select . Figure 2.20:Account Management Tasks Menu



An alert message displays requesting the operator to confirm the intention to reset the password for the selected user account. 4. Select to reset the password. An alert message displays, stating that the password for the user account (user name) has been reset to the user name.



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Account Management



Figure 2.21:Account Management Reset Password Alert



5. Select to close the alert message. The next time the user logs on to the m2000sp system, the system will require that the user change their password. Figure 2.22:New Password Prompt



6. The user enters the current password (same as user name). 7. 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 the password cannot contain the following characters: \ / ” [ ] : | < > + = ; , ? * @. NOTE: The password is case sensitive; the user name is not.



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Change Password A user with General User access is able to change his or her password. 1. To change a password, select , , then . Figure 2.23: Dropdown Menu



The screen displays. Only the user currently logged onto the system will be able to change their password. Figure 2.24:Change Password Screen



2. To change the password, the user enters the current password, then enters a new password, and re-enters the password as confirmation. 3. 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 the password cannot contain the following characters: \ / ” [ ] : | < > + = ; , ? * @. NOTE: The password is case sensitive; the user name is not.



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NOTES



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System Settings



System Settings To access the menu, select then . Figure 2.25: Menu



Figure 2.26: Menu



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The menu offers the following possible options to the operator: •



Hardware Configuration, described on page 2–25



•



Audible Alert, described on page 2–26



•



LIS Configuration, described on page 2–28



•



Time and Date, described on page 2–32



•



Sample Bar Code, described on page 2–34



•



Sample Racks and Tubes, described on page 2–37



•



Run Checks, described on page 2–38



•



Signal Tower, described on page 2–41



•



Language and Locale, described on page 2–43



•



Network Configuration, described on page 2–49



•



Automatic Export, described on page 2–51 NOTE: The option will appear only if that device has been enabled by the Abbott Representative on the screen.



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System Settings



Hardware Configuration Hardware configuration is performed by an Abbott Representative during installation. To view the configured settings, highlight on the screen and then, from the task menu, select . Figure 2.27: Hardware Configuration



Figure 2.28: screen



This screen includes the following configured setting categories: •



, which lists the instrument’s serial number and model type (G-series or E-series).



•



, which provides a listing of any external devices installed with that instrument, and indicates whether they have been enabled. NOTE: The signal tower listed here is part of the hood configuration. It can only be enabled if a hood has been installed on the instrument in question.



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Audible Alert Any operator (General Users and higher) may do the following: •



enable or disable the audible alert when an alert dialog is generated



•



choose a sound scheme



•



adjust the volume for operator notifications



1. To configure the audible alert, highlight on the screen and then, from the task menu, select . Figure 2.29: Audible Alerts



2. On the screen, select a sound scheme for each message type to be enabled: •



•



•



To disable a sound scheme, choose from the respective message type’s dropdown menu. Figure 2.30: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



3. Select to hear the selected sound scheme.



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4. Choose the volume level desired by using the arrows on the toggle at the top of the screen. The volume setting can be verified by clicking . Figure 2.31: Display



NOTE: The volume on the monitor may also need to be adjusted. NOTE: Contact your Abbott Representative if external speakers are desired. 5. Click when finished.



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System Settings



LIS Configuration Any operator (General Users and higher) may turn communication between the host and m2000sp on or off. Administrators can configure all other settings. To configure the LIS settings, do the following: 1. Highlight on the screen and then, from the task menu, select . Figure 2.32:System Settings screen



Figure 2.33:LIS Configuration screen



All users can turn LIS communication on or off



Only Administrators can make changes to these settings (NOTE: COM5 is the only current option for Port ID)



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System Settings



2. Configure the settings in the field. The table below describes the options available: Table 2.4:



Communication Configuration field



Option



Description



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 OFF allows you to clear all results waiting to be sent to the host.



Allows the Administrator to choose the method for Test Order deletion. Options: • Auto - The system automatically deletes patient Test Orders after they have been run (Default). • Manual - The user must manually select and delete Test Orders. NOTE: If Test Orders for controls are downloaded to the m2000sp by the host LIS, those Test Orders must be manually deleted by the operator regardless of which option is selected here. It is recommended that Test Orders for controls not be downloaded to the m2000sp. 3. Select only if all changes on this screen are complete. If changes are to be made, proceed to Step 4 below. NOTE: Select to cancel all changes and return to the screen. NOTE: When the LIS is configured , LIS will appear at the bottom of the screen. An message will also be displayed when Test Orders are pending. See Figure 2.34: on page 2–31.



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4. Configure the settings. The table below describes the options available:



!



Table 2.5:



IMPORTANT: Only the system Administrator can configure communication settings for the serial ports. Serial Port Configuration field



Option



Description



Displays the unique ID for the port. The only option is COM5.



Allows you to select the baud rate for the selected port. Options: • 1200 • 2400 • 4800 • 9600 (Default) • 19200 • 38400 • 57600 • 115200



Allows you to select from the following options: • None (Default) • Even • Odd



Allows you to select from the following options: • 7 • 8 (Default) IMPORTANT: If you select 7 bits for transmission, the use of upper code page characters (ASCII codes 128-255) will not be mapped properly during the transmission.



!



Allows you to select from the following stop bit options: • 1 (Default) • 2 5. Select when all changes are complete.



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Figure 2.34:Example of LIS display



When LIS communication is on and Test Orders are pending, the bottom of the screen will display these status indicators



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System Settings



Time and Date Administrators can set the correct time and date, and time zone, by selecting from the menu, highlighting , and choosing from the menu. Figure 2.35: Display



Figure 2.36:



To Set Time and Date Select the desired field, and then use the toggle at the right to move the setting up or down as necessary. Click when finished. Figure 2.37: Setting Time and Date



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System Settings



NOTE: Daylight savings settings are configured by the Abbott FSE. NOTE: The date and time formats can be changed to meet regional preferences. See Language and Locale on page 2–43.



To Select a Time Zone Click on the dropdown menu arrow at the end of the field to reveal the list of choices. Figure 2.38:Setting the Time Zone



Dropdown menu arrow



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



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System Settings



Sample Bar Code Administrators are able to configure the m2000sp to read several different types of sample bar code labels. These include the following symbologies and what can be configured: Table 2.6:



Bar Code Symbologies



Symbology



Editable Parameters



Interleaved 2 of 5



• Length (2-20 characters bar code length) • Use and transmission of Checksum



Code 39



Use and transmission of Checksum



UPCA



Use and transmission of Checksum



Codabar



• Use and transmission of Checksum • Use and transmission of Start/Stop characters



Code 128



Not editable



Code 93



Not editable



1. Select from the menu. Then, highlight and choose from the menu. Figure 2.39: Menu



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The screen displays. Figure 2.40: Screen



2. Configure the length (Interleaved 2 of 5, 2 - 20 even) by editing the number in the length column. 3. Configure the Checksum by using the dropdown menu and selecting: •



Off (no Checksums)



•



On with transmit (Checksum in bar code transmitted, or sent, to SCC for display)



•



On without transmit (Checksum in bar code but not sent to SCC)



Figure 2.41:Bar Code Configuration Checksum



NOTE: If Checksum for UPCA is set to , the system will ignore this setting.



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System Settings



4. Configure the Start/Stop by using the dropdown menu and selecting: •



Off



•



On with transmit (start and stop characters used in bar code and sent to SCC for display)



•



On without transmit (start and stop characters used in bar code but not sent to SCC for display)



Figure 2.42:Bar Code Configuration Start/Stop



NOTE: Codabar start/stop characters are always on. “Off” is the same as “on without transmit.”



5. When configuration is complete, select .



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Sample Racks and Tubes Sample tube size and style configurations are performed by an Abbott Representative. However, all users may view these configurations by selecting from the menu, highlighting , and choosing from the menu. Figure 2.43: Screen



Figure 2.44: Display



Contact your Abbott Representative if custom sample tubes are to be used or if other assay-specific racks need to be enabled. To determine the minimum sample volume required for a particular custom rack, see LiHa Sample Volume Checks on page 9–99 of Section 9, Service and Maintenance.



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System Settings



Run Checks Administrators may enable or disable m2000sp run checks by selecting from the menu, highlighting , and choosing from the menu. General Users may view these settings only. Figure 2.45: Display



Figure 2.46: Display



These checks are used to verify the correct placement of racks, plates, and carriers, and the volume of sample preparation reagents prior to beginning a run.



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System Settings



Administrators can enable or disable the following Sample Extraction checks: •



Checks the minimum and/or maximum required fill volume of each reagent vessel, as configured by the application specification that is running and the number of samples being processed. If there is too little or too much volume, the fill volume must be corrected prior to continuing with the run.



•



Checks the placement of one or both 1 mL Subsystem carriers and all empty locations. Carriers must be in the correct locations prior to continuing the run (refer to the screen).



•



Checks for the presence of the deep well plate on the Output Deck. A warning is given if the check fails. The user must then manually verify the plate is in position.



•



Checks that no DiTi rack is present in shelf location 1. This shelf must be empty before the run can proceed.



Master Mix Addition check options are as follows: •



Checks for the presence of the deep well plate on the Output Deck. A warning is given if the check fails. The user must then manually verify the plate is in position.



•



Checks for the presence of the PCR plate on the Output Deck. A warning is given if the check fails. The user must then manually verify the plate is in position.



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System Settings



•



Checks that no DiTi rack is present in shelf location 1. This shelf must be empty before the run can proceed.



When checks are disabled a message is sent to the Message Log indicating such.



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System Settings



Signal Tower The screen appears as an option on the menu for hooded instruments, and only when the signal tower has been enabled by an Abbott Representative. NOTE: Refer to Hardware Configuration on page 2–25 to determine the current status of this function. The signal tower, which includes a red, a yellow, and a green lamp, is designed to light up in a unique way for each of the following five states: •



: the instrument is ready



•



: a run is in progress



•



: an instrument function was paused



•



: the run has finished



•



: the run has failed



Administrators can change the default signal tower configuration (i.e., what color signifies what state) by doing the following: 1. Select from the menu, and then select from the menu. Figure 2.47: Menu



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System Settings



Figure 2.48: Default Settings



2. The screen is divided into five grids representing each of the five states listed above. Each grid is divided into three color menus featuring the following choices: •



: that lamp color will not light up in the selected state



•



: that lamp color will light up in the selected state



•



: that lamp color will blink on and off in the selected state



To make changes, click on the choice desired for each color. 3. To see the signal tower display the new setting, click the button for that state. 4. Select after all changes have been made.



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Language and Locale Figure 2.49: screen



On the screen, Administrators can change the following to meet regional preferences:



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•



, which determines the language of the software interface, including display menus and error messages



•



, which determines what regional keyboard layout will be used with the system



•



, which determines what language the on-line documentation (e.g., the m2000sp Operations Manual) will display in when accessed through the menu



•



, which determines: –



how numeric data are presented in reports and screens



–



how the date and time is displayed and entered for expiration dates



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System Settings



To make changes, first select from the menu, highlight , and choose from the menu. Figure 2.50: menu



To Change 1. On the page, go to the field and click on the dropdown menu to select a language preference for the software interface. Figure 2.51: Field



The following languages are supported: •



German



•



English



•



Spanish



•



French



•



Italian



•



Portuguese



2. Select .



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To Change 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 page, go to the field and click on the dropdown menu to select a keyboard layout preference. Figure 2.52: Field



2. Select .



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, but be careful not to disturb the other cables. NOTE: If a handheld bar code reader is installed, plug it into the new keyboard. NOTE: Contact your Area Abbott Customer Service for a list of supported keyboards.



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To Change 1. On the page, go to the field and click on the dropdown menu to select a language preference for the on-line documentation, such as m2000sp Operations Manual. Figure 2.53: Field



2. Select .



To Change 1. On the page, go to the 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 2.54:Choose a preference



3. The section below the dropdown menu will show examples of how dates, times, and numerical data will be depicted in the m2000sp Software.



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Figure 2.55:Examples of New Formats



If these new formats are acceptable, and if all other changes have been made to the settings on this screen, select . NOTE: Changes made to the setting require a system restart to implement. It is best to make all desired changes to the other settings on the screen before selecting here. 4. A message displays explaining that the change requires a system restart. Select . After the system restarts, the date and time will be displayed in the new format. Figure 2.56:Reformatted Date and Time Display



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Section 2



The on-line documents, found under the , 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. Contact your Abbott Representative to have the desired manual loaded onto the instrument.



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System Settings



Network Configuration The m2000sp allows Test Order results to be exported for use on the m2000rt either physically, by saving the results to a CD, or directly, via a network or crossover cable connection. During installation, an Abbott Representative configures the instrument’s network settings. All users may view the settings and test applicable connections by selecting from the menu, highlighting , and choosing from the menu. Figure 2.57: menu



The screen shows the data transfer method chosen. To verify the connection is operating properly, select the button for the connection type that is configured. Figure 2.58: screen



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System Settings



This page offers four connectivity options: •



, which leaves the instrument unconnected to an m2000rt; in this case, Test Orders can only be exported via CD NOTE: Exporting Test Orders via CD is always an option regardless of what network configuration option has been selected.



•



, which allows the instrument to be connected directly to one m2000rt via a crossover cable; the exported Test Orders are stored on the connected m2000rt system



•



, which allows the instrument to be connected directly to one m2000rt with release 2.0 via a network connection; the exported Test Orders are stored on the connected m2000rt system



•



, which allows the instrument and other m2000sps to be connected to one or more m2000rts in a multi-instrument network (refer to Managing the Network Data Store on page 5–251 of Section 5, Operating Instructions); the exported Test Orders are stored on any of the connected systems in the network or on an Abbottlink computer, if available NOTE: The Network Data Store option is only available with an m2000rt system with release 2.1 software and higher.



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Automatic Export The m2000sp allows Test Order results to be exported for use on the m2000rt via a network or crossover cable connection where available. If such a connection was configured during installation (refer to Network Configuration on page 2–49), Administrators can choose to have Test Order results exported automatically on the page; General Users can view the settings only. 1. To enable or disable automatic exporting, select from the menu, highlight , and choose from the menu. Figure 2.59: menu



Figure 2.60: screen



2. On the screen, select one or all of the following export options: •



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for Sample Extraction open mode; deep well plate data will be transferred at the end of a successful open-mode Sample Extraction run



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System Settings



•



for reagent addition open mode; PCR plate data will be transferred after a successful Master Mix Addition run



•



for reagent addition closed mode; PCR plate data will be transferred after a successful Master Mix Addition run



3. When finished, select . NOTE: Results can still be manually transferred via CD at any time.



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Section 3



Section 3: Principles of Operation



Principles of Operation Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 The Abbott m2000sp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Sample Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Master Mix Addition . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6



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Table of Contents-1



Principles of Operation



Section 3



NOTES



Table of Contents-2



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Principles of Operation Section 3



Overview



Section 3: Principles of Operation



Principles of Operation The m2000sp Instrument (09K14-01) is described in this chapter as the G-series. The m2000sp Instrument E-series (09K14-02) is described in this chapter as the E-series. All text and descriptions apply to both instruments unless specifically designated as G-series or E-series. All E-series specific information will be shown in a blue-shaded box.



Overview The ABBOTT® m2000sp is an automated system for performing sample preparation for nucleic acid testing. The operator controls the system through the System Control Center (SCC), using Abbott m2000sp software. At the end of the Sample Extraction procedure, the user may select a Master Mix Addition protocol to automatically distribute the assay reagents and extracted nucleic acid samples into an ABBOTT 96-Well Optical Reaction plate. This plate can be used on the Abbott m2000rt (Real-Time PCR instrument) for nucleic acid detection. The topics include: •



The Abbott m2000sp, page 3–3 Describes the principles of automated sample preparation on the m2000sp



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Principles of Operation Section 3



Overview



NOTES



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The Abbott m2000sp



The Abbott m2000sp Sample Preparation The sample preparation process consists of the following: •



releasing the nucleic acid target from its native biological source (e.g., lysis of microorganisms)



•



binding of nucleic acids to a solid phase (i.e., magnetic particles)



•



separation of the solid phase from the residual lysis solution



•



washing to remove unwanted materials



•



elution, or separation, of nucleic acid from the solid phase



The m2000sp automates this sample preparation process through the following series of operations: 1. Magnetic particles and lysis buffer are added by the liquid handling arm (LiHa) to the reaction vessels (RVs). If required, internal control (IC) can be added to the lysis. NOTE: Refer to the assay package insert for more information regarding the internal control. Figure 3.1: Magnetic Particles and Lysis Buffer



Magnetic particles



Lysis buffer



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The Abbott m2000sp



2. Samples (specimens, calibrators, and controls) are added by the LiHa to the RVs. The RVs containing the lysis reaction mixture are moved by the Robotic Manipulator Arm (RoMa) to one of the heater zones for the lysis incubation. During incubation, the nucleic acids are released from the cells and/or microorganisms and bound to the magnetic particles in the lysis buffer. Figure 3.2: Samples Are Added to the Reaction Vessel



3. After the lysis incubation, the RoMa moves the RVs to the magnetic zone of the 1 mL Subsystem, and the magnets capture the particles. Once particle capture is complete, the unbound material is aspirated by the LiHa to waste. Figure 3.3: 1 mL Subsystem Magnets



Captured particles



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The Abbott m2000sp



4. Following waste removal, the RoMa moves the RVs to a non-magnetic zone where wash solution is added. The RVs are then moved to the magnetic zone, and the particles are captured. Once particle capture is complete, the wash supernatant is aspirated by the LiHa to waste. The wash process is repeated several times. Figure 3.4: Wash Solution Wash



Captured particles



5. After completing the wash sequence, elution buffer is added to the RVs. The RoMa moves the RVs to a heater zone for the elution incubation, where the bound nucleic acid material is separated from the particles. Figure 3.5: Elution



Elution



Captured particles



6. After elution incubation, the RoMa moves the RVs to the magnetic zone where the eluate containing nucleic acids is separated from the magnetic particles and transferred to the 96 deep-well plate for further processing.



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The Abbott m2000sp



Figure 3.6: Completion of Sample Extraction



Transfer



Captured particles



Deep Well Plate



Master Mix Addition If required by the assay protocol, the operator continues the process with the Master Mix Addition protocol stage. The Output Deck chiller setpoint is established by the assay protocol when initially selected. Master Mix Addition steps are as follows: 1. For most closed-mode assays, once the operator has placed all the necessary assay reagents on the instrument, the LiHa prepares the master mix by transferring and mixing the reagents from the Abbott Reagent Kit into the master mix tube. For some close-mode assays, as well as open-mode, the operator loads a prepared master mix. 2. The master mix is distributed to reaction wells in the PCR plate. 3. The purified nucleic acid samples (eluate) are then distributed from the 96 deep well plate to the corresponding location in the Abbott PCR plate. 4. While the PCR plate is on the chiller, the operator seals the plate with an ABBOTT® Optical Adhesive Cover using the ABBOTT Adhesive Cover Applicator. The PCR plate is now prepared for amplification/detection on the m2000rt. The plate data can be transferred from the m2000sp to the m2000rt via CD or network connection.



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Section 4



Section 4: Performance Characteristics and Specifications



Performance Characteristics and Specifications Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Instrument Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Clearances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Site Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 4-7 Uninterruptable Power Supply (UPS) . . . . . . . . . . . . . . . 4-8 Throughput . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Liquid Handling Arm (LiHa) Precision . . . . . . . . . . . . . . 4-9 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . 4-10 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12 Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12 Standard Sample Racks, Tubes, and Fill Volumes . . . . . 4-14 Custom Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17 Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19 1 mL Subsystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20 Chiller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20



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Table of Contents-1



Performance Characteristics and Specifications



Section 4



NOTES



Table of Contents-2



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Section 4



Performance Characteristics and Specifications



Section 4: Performance Characteristics and Specifications



Performance Characteristics and Specifications The m2000sp Instrument (09K14-01) is described in this chapter as the G-series. The m2000sp Instrument E-series (09K14-02) is described in this chapter as the E-series. All text and descriptions apply to both instruments unless specifically designated as G-series or E-series. All E-series specific information will be shown in a blue-shaded box.



Overview This section introduces the reader to the ABBOTT® m2000sp and its main components. It contains technical data, requirements, and performance data. The topics include: •



Instrument Overview, page 4–3 Identifies the main components of the instrument.



•



Technical Data, page 4–5 Provides the dimensions, weights, electrical specifications, performance throughput, and precision conditions.



•



Environmental Conditions, page 4–10 Provides environmental requirements for the m2000sp.



•



Requirements, page 4–12 Provides the requirements for the bar code labels, samples, software, disposables, and site.



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4-1



Performance Characteristics and Specifications Section 4



Overview



NOTES



4-2



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Performance Characteristics and Specifications Section 4



Instrument Overview



Instrument Overview The primary components of the m2000sp System are: •



the instrument



•



the SCC



•



the cabinet



Figure 4.1: m2000sp System



All E-series models and some G-series models also have hoods as part of their basic setup. However, hoods are not standard equipment and are, therefore, not available in all regions. Figure 4.2: Instrument with hood



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Performance Characteristics and Specifications Section 4



Instrument Overview



Details for product identification can be read from the identification label affixed to the back of the instrument, as shown in below. Figure 4.3: Product Identification Labels



E-series label



4-4



G-series label



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Technical Data



Technical Data Dimensions and Weights Table 4.1: Component Cabinet m2000sp instrument



G-series Dimensions and Weight



Width (cm/in)



Depth (cm/in)



142.9 cm/56.3 in



79.4 cm/31.3 in



76.8 cm/30.3 in 142.9 cm/56.3 in a (176.5 cm/69.5 in ) (124.5 cm/49.0 inb)



Computer Monitor Keyboard Table 4.2: Component



Height (cm/in) Weight (kg/lbs) 79.5 cm/31.3 ing



103.4 kg/228.0 lbs



92.0 cm/36.2 inc (138 cm/54.3 ine,f)



189.3 kg/417.3 lbsd (206 kg/454 lbse,f)



33 cm/13 in



35.6 cm/14 in



12.7 cm/5 in



10.0 kg/22 lbs



37.3 cm/14.7 in



20.6 cm/8.1 in



48.3 cm/19 in



6.8 kg/15.0 lbs



45.7 cm/18 in



17.8 cm/7 in



5.1 cm/2 in



0.9 kg/2.0 lbs



E-series Dimensions and Weight



Width (cm/in)



Depth (cm/in)



Cabinet



142.9 cm/56.3 in



79.4 cm/31.3 in



79.5 cm/31.3 ing



103.4 kg/228.0 lbs



m2000sp instrument



145 cm/57.1 in (190 cm/74.8 ina)



78 cm/30.7 in (122.4 cm/48.2 inb)



98.0 cm/38.6 in (138 cm/54.3 ine,f)



194 kg/428 lbsd (211 kg/465 lbse,f)



33 cm/13 in



35.6 cm/14 in



12.7 cm/5 in



10.0 kg/22 lbs



37.3 cm/14.7 in



20.6 cm/8.1 in



48.3 cm/19 in



6.8 kg/15.0 lbs



45.7 cm/18 in



17.8 cm/7 in



5.1 cm/2 in



0.9 kg/2.0 lbs



Computer Monitor Keyboard a b c d e f g



Height (cm/in) Weight (kg/lbs)



Side service door open Front safety panel open Robotic Manipulator Arm extended Weight includes accessories packed inside the cabinet and instrument With hood (hoods are not standard equipment) Hood measurements include the 30.48 cm/12 in signal tower With wheels



NOTE: All measurements are approximate.



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Performance Characteristics and Specifications Section 4



Technical Data



Clearances Operators must assure clearance space around the instrument system to permit ventilation, service access, cable routing, and movement. Required clearances are shown below. Table 4.3:



Required Clearances



Position



Clearance (meters/inches [m/in])



Right side



1 m/39 in



Front



1 m/39 in



Left side



1 m/39 in



Rear



0.1 m/4 in



Site Requirements Table 4.4:



Site Requirements



Loading dock



Must be available



Elevator: load capacity At least 411 kg/907 lbs



4-6



Elevator: size



See Table 4.1 and Table 4.2 for instrument dimensions



Doors, Entries: size



• Wider than 81.5 cm/32 in • Taller than 203.2 cm/80.0 in



Passageway corners



Combined total width of both passageway corners must be greater than 2.8 m/110 in



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Technical Data



Electrical Requirements m2000sp Instrument The following tables present electrical requirements for the G-series and E-series models and the Output Deck. Table 4.5: G-series Primary Instrument Electrical Specifications



Circuit breaker



15 A



Equipment, safety class I Change Frequency Grounding Power Line voltage



Electrical outlets, number



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50-60 Hz correctly grounded electrical outlet 1200 VA 100-120 VAC/ 220-240 VAC ± 10% Minimum of 4 electrical outlets: • instrument • computer (CPU) • monitor • printer



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Performance Characteristics and Specifications Section 4



Technical Data



Table 4.6:



E-series Primary Instrument Electrical Specifications



Circuit breaker



F1: 2A F2: 2A F3: 10A F4: 10A



Equipment, safety class I Change Frequency Grounding



correctly grounded electrical outlet 1200 VA



Power Line voltage



Electrical outlets, number



Table 4.7:



50-60 Hz



100-120 VAC / 220-240 VAC -15% +10% Minimum of 4 electrical outlets: • instrument • computer (CPU) • monitor • printer



Output Deck Electrical Specifications



Power Voltage



70W 12 VDC



Uninterruptable Power Supply (UPS) Abbott recommends connecting the instrument to the main power via a UPS. The use of a switched UPS is not recommended. Specifications: 1500 VA/1300 WATTS/15 AMP NOTE: Contact your Abbott Representative for additional information.



Throughput Up to 96 samples can be processed in one run.



4-8



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Technical Data



Liquid Handling Arm (LiHa) Precision Table 4.8:



LiHa Precision



Specification



200 μL Disposable Tip



1000 μL Disposable Tip



10 to 150 μL



25 to 900 μL



Precisiona



• CV