ACQUITY UPLC System Operator’s Guide - Waters

1 ACQUITY uplc System Quick Start Guide 71500082503/ Revision CCopyright Waters Corporation rights reserved. Copyright notice 2004 06 Waters CORPORATION. PRINTED IN THE UNITED STATES OF AMERICA AND IRELAND. ALL RIGHTS RESERVED. THIS DOCUMENT OR PARTS THEREOF MAY NOT BE REPRODUCED IN ANY FORM WITHOUT THE WRITTEN PERMISSION OF THE information in this document is subject to change without notice and should not be construed as a commitment by Waters Corporation. Waters Corporation assumes no responsibility for any errors that may appear in this document. This document is believed to be complete and accurate at the time of publication.

2 In no event shall Waters Corporation be liable for incidental or consequential damages in connection with, or arising from, its Corporation34 Maple StreetMilford, MA 01757 USAT rademarksMillennium and Waters are registered trademarks, and ACQUITY uplc , eCord, Empower, MassLynx, and nanoACQUITY uplc are trademarks of Waters is a registered trademark of Saint-Gobain Ceramics & Plastics, is a registered trademark of Microsoft trademarks or registered trademarks are the sole property of their respective commentsWaters Technical Communications department invites you to tell us of any errors you encounter in this document or to suggest ideas for otherwise improving it.

3 Please help us better understand what you expect from our documentation so that we can continuously improve its accuracy and seriously consider every customer comment we receive. You can reach us at Corporation34 Maple StreetMilford, MA 01757 USAivSafety considerationsSome reagents and samples used with Waters instruments can pose chemical, biological, and radiological hazards. Be sure you are aware of the potentially hazardous effects of all substances you work with. Always observe Good Laboratory Practice (GLP) guidelines, published by the Food and Drug Administration, and consult your organization s safety representative for you develop methods, follow the Protocol for the Adoption of Analytical Methods in the Clinical Chemistry Laboratory, American Journal of Medical Technology, 44, 1, pages 30 37 (1978).

4 This protocol addresses good operating procedures and the techniques necessary to validate System and method advisoriesConsult Appendix A in the ACQUITY uplc System operator s Guide for a comprehensive list of warning and caution the ACQUITY uplc systemWhen operating the ACQUITY uplc System , follow standard quality control procedures and the guidelines presented in this useThe Waters ACQUITY uplc System is intended for analyzing compounds and introducing separated samples into a mass you develop methods, follow the Protocol for the Adoption of Analytical Methods in the Clinical Chemistry Laboratory, American Journal of Medical Technology, 44, 1, pages 30 37 (1978).

5 This protocol covers good operating procedures and techniques necessary to validate System and method calibrate uplc systems, follow acceptable calibration methods using at least five standards to generate a standard curve. The concentration range for SymbolDefinitionAuthorized Representative of the European CE symbol serves as confirma-tion of the conformity of a product with all European Community direc-tives applicable to that in vitro diagnostic ACQUITY uplc System is CE-marked according to the European Union in vitro Diagnostic Device Directive 98/79 : The ACQUITY uplc System is to be used for in vitro diagnostic use only by trained, qualified laboratory personnel.

6 EC REP IVD vistandards should cover the entire range of quality-control samples, typical specimens, and atypical calibrate mass spectrometers, consult the calibration section of the operator s Guide of the instrument you are controlRoutinely run three quality-control samples that represent subnormal, normal, and above-normal levels of a compound. Ensure that quality-control sample results fall within an acceptable range, and evaluate precision from day to day and run to run. Data collected when quality control samples are out of range might not be valid. Do not report these data until you are certain that the instrument performs analyzing samples from a complex matrix such as soil, tissue, serum/plasma, whole blood, etc.

7 , note that the matrix components can adversely affect LC/MS results, enhancing or suppressing ionization. To minimize these matrix effects, Waters recommends you adopt the following measures: Prior to the instrumental analysis, use appropriate sample pretreatment such as protein precipitation, liquid/liquid extraction (LLE), or solid phase extraction (SPE) to remove matrix interferences. Whenever possible, verify method accuracy and precision using matrix-matched calibrators and QC samples. Use one or more internal standard compounds, preferably isotopically-labeled authorized representative informationIVD authorized representativeWaters Corporation (Micromass UK Limited) is registered in the United Kingdom with the Medicines and Healthcare Products Regulatory Agency (MHRA) at Market Towers, 1 Nine Elms Lane, London, SW8 5NQ.

8 The reference number is Corporation (Micromass UK Ltd.)Floats RoadWythenshaweManchester M23 9 LZUnited KingdomTelephone:+44-161-946-2400 Fax:+44-161-946-2480 Contact:Quality managerviiiTable of ContentsixSafety considerations .. iv Safety advisories .. ivOperating the ACQUITY uplc System .. iv Symbols .. v Intended v Calibration .. v Quality control .. viIVD authorized representative information .. vii IVD authorized representative .. vii1 System Overview .. 1-1 Instruments, components, and data systems .. 1-2 Binary solvent manager .. 1-4 How the binary solvent manager works.

9 1-5 Sample manager .. 1-6 How sample flows .. 1-6 Column heater .. 1-7 Optional sample organizer .. 1-8 Optical detectors .. 1-9 TUV detector .. 1-9 PDA detector .. 1-9 ELS 1-9 Median baseline filter .. 1-10 Data systems .. 1-10 Empower software .. 1-10 MassLynx software .. 1-10 Columns .. 1-11 eCord column chip .. 1-11 Table of ContentsxTable of ContentsFlexCart .. 1-12 For more information .. 1-122 Preparing System Hardware .. 2-1 Powering-on the System .. 2-2 Monitoring startup tests .. 2-2 Monitoring System instrument LEDs.

10 2-3 Power LED .. 2-3 Status LEDs .. 2-3 Preparing the binary solvent manager .. 2-5 Performing a seal wash prime .. 2-5 Priming the binary solvent manager .. 2-8 Priming a dry binary solvent 2-8 Priming a wetted binary solvent manager .. 2-10 Preparing the sample manager .. 2-14 Selecting weak wash and strong wash 2-14 Priming the sample manager .. 2-16 Washing the sample manager needle .. 2-18 Characterizing the needle 2-20 Characterizing the needle and sample loop 2-21 Loading sample plates in the sample 2-22 Selecting the optimum sample injection 2-23 Installing the sample manager shade.