Performance Maintenance

715003445 REV. APerformance Maintenance Pro- tocol Xevo® TQDSerial Number Date Performer ©2012 WATERS CORPORATION. ALL RIGHTS RESERVED. Title: (logolockup.K.eps) Creator: Adobe Acrobat 7.0 Preview: This EPS picture was not saved with a preview included in it. Comment: This EPS picture will print to a PostScript printer, but not to other types of printers. 715003445 REV. APerformance maintenanceGoalThis performance maintenance protocol is a guide to performing maintenance tasks on your system. Packaged as part of the performance maintenance kit, it is intended to ensure optimum performance and an uninterrupted period of trouble-free operation.ScheduleWaters recommends that performance maintenance visits be performed once a year. Systems under heavy use or using aggressive solvents will need more frequent maintenance. For detailed maintenance schedules, refer to the appropriate operator’s guide(s) located on the Waters web site. Failure to follow the maintenance schedules as described in the operator’s guides may result in unreliable operation and inaccurate laboratory results. For some protocols, optional tests can be performed by Waters field service engineers for added confidence and reliability.Safety considerationsSome protocols may involve removing instrument covers, exposing the performer to high voltages, high currents, and moving parts. This presents risks of electric shock and/or damage to the instrument. To reduce these risks, Waters recommends that these protocols be conducted by certified Waters field service engineers, who have access to the latest information on Waters products. Waters does not advise and is not responsible for an unqualified performer initiating actions that they do not understand. If there is any doubt on the part of the performer, a Waters certified field service engineer should conduct the performance maintenance activity.Waters Quality PartsWaters designs and manufactures Waters Quality Parts® to the same strict regulatory standards (ISO 9001:2008) as your high-performance Waters systems. Waters recommends using Waters Quality Parts for all maintenance activities. Failure to use Waters Quality Parts may compromise laboratory results and reliability. Customer educationWaters offers several operation and maintenance courses for ACQUITY® UPLC®, Alliance® HPLC and MS systems as well as courses designed to help you maintain professional competency and further your knowledge in Chromatography, UPLC, Informatics and Mass Spectrometry. For more information on available training courses from Waters Educational Services please visit the Waters web site.Compliance servicesWaters Compliance Services help you achieve and maintain the regulatory compliance of your LC and MS instruments and software with a combination of expertise, compliant-ready systems and software, and a portfolio of services to ensure that you have quality data, consistently. To learn more about these services, please visit the Waters web site.® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 2 OF 17 715003445 REV. AGeneral tasksUse the following guidelines when conducting performance maintenance visits. This information is intended to be a guide only; for example:  If a particular module has been recently serviced, it may only need testing and the replacement of fewer parts.  Not all procedures apply to all instruments (specify NA in the Comments section if the procedure does not apply).  If the instrument fails to perform adequately during pre-performance maintenance checks, further service may be required beyond the scope of this protocol; in such cases, the extra service may incur additional parts and labor charges. The following table lists the general tasks to be performed during a performance maintenance visit. Perform and confirm the steps listed for each procedure and record any comments that you have about the results at the end of each section. For detailed instructions and a list of the necessary tools, refer to the Operator’s Guide located on the Waters website – www.waters.com/.Pre-performance Post-performance Maintenance tasks maintenance checks maintenance checksVacuum Vent, power-off, inspect VacuumHeaters Source HeatersMass scale and resolution Mass scale and resolution ESI probe check setupPMT voltage Vacuum system Fast cross talk testFast cross talk test Fan filters CalibrationPower-up Target Registry back-upGas supplies and exhaustSource optionsSource interlocksNOTE: Firmware upgrades, if required, must be performed by a Waters field service engineer prior to beginning performance maintenance. Firmware upgrades may require re-qualification of the upgraded instrument if it is in a regulated environment.® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 3 OF 17 715003445 REV. AIQ/OQ or GLP considerationsBefore starting work, determine what (if any) IQ/OQ or GLP policies are in operation on the specific instrument and ensure that the necessary paperwork is available to record the actions.Waters Quality Parts Xevo TQD / SQD 2 PM Kit (Rotary Pump) 176002780  Xevo TQD / SQD 2 PM Kit (Scroll Pump) 176002781Additional Waters service kit(s) may be required:  APCI IonSABRE II Probe Service Kit 700005744  Outer APPI Source Service Kit 700004730  NanoLockSpray Reference Probe Service Kit 700004677  TRIZAIC Service Kit (Quad) 700008959  APGC Service Kit 700004842NOTE: Chemical kits are included in the Performance Maintenance Kits (p/n 176002780 and 176002781), the following lists the individual chemical kit part numbers should additional supplies be required.Additional Waters chemical kit(s) (if required):  API calibration solution 700001593  Setup solution QP 700003105® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 4 OF 17 715003445 REV. ASoftwareConfirm what software versions are installed. Software is checked.Yes No N/ASoftware type DetailsMassLynx software version Service Pack (SP) or SCN MassLynx application manager MassLynx application manager MassLynx application manager MassLynx application manager MassLynx application manager Comments: CalibrationThe instrument must be uncalibrated throughout this PM protocol.Current calibration file name and conditions recorded and removed.Yes No N/ACalibration file name RemovedYes NoComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 5 OF 17 715003445 REV. APre-performance maintenance checksIf the instrument fails to perform adequately during initial checks, it may need service work beyond the scope of this performance maintenance protocol; in such cases, the extra service work may incur additional parts and labor charges. Perform and confirm the steps listed for each procedure and record any comments that you have about the results at the end of each section. Record values for each item in the following tables:VacuumInstrument vacuum has been checked.Yes No N/AGauge Reading (mbar)Analyser Pirani Collision Cell Pirani Comments: HeatersSource and desolvation heaters checked.Yes No N/AHeater Reading (ºC) ResultSource heater Pass FailDesolvation heater Pass FailComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 6 OF 17 715003445 REV. AMass scale and resolutionMass scale setup and resolution across the mass range are assessed.Yes No N/A m/z m/z m/z m/z MS1 tests 59.05 455.27 1080.80 2034.64Gain Peak width at FWHM (Da) Measured mass (Da) m/z m/z m/z m/z MS2 tests 59.05 455.27 1080.80 2034.64Gain Peak width at FWHM (Da) Measured mass (Da) Instrument Mass position Current DC Current FWHH 0.4 to 0.6 Da performance checks ±0.5 Da Balance Ion Energy Result Mass scale ResultMS1 Pass Fail Pass FailMS2 Pass Fail Pass FailComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 7 OF 17 715003445 REV. APMT voltageMultiplier voltage readback in both Positive and Negative Ion mode is recorded.Yes No N/AIon mode Multiplier voltage readbackPositive ion mode Negative ion mode Comments: Fast cross talk testFast Cross Talk Test is performed.Yes No N/ASpecification ResultThe peak height of the m/z 455 to 165 is between 1E7 and 6E7 Pass FailThe ratio of the average peak area for m/z 1000 to 165 and m/z 455 Pass Fail to 165 is ≤0.02%The ratio of the average peak area for m/z 1500 to 165 and m/z 455 Pass Fail to 165 is ≤0.01%Comments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 8 OF 17 715003445 REV. AMaintenance tasksThe following routine procedures are performed as part of performance maintenance. Any additional maintenance requirements identified in the previous section are beyond the scope of this document. For more information on these procedures, refer to the Xevo TQD Operator's Overview and Maintenance Guide (p/n 715002944). Perform and confirm the steps listed for each procedure and record any comments at the end of each section.Vent, power-off, inspectInstrument vented through MassLynx.Yes No N/AInstrument cooling fans are working.Yes No N/ASystem powered-off and unplugged from mains supply.Yes No N/AFluidics system and liquid waste tubing inspected.Yes No N/AComments: SourceSource components cleaned and/or replaced.Yes No N/AComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 9 OF 17 715003445 REV. AESI probeESI probe dismantled and rebuilt using the relevant parts from the PM kit.Yes No N/AMaintenance tasks associated with the internal vacuum pump performed.Yes No N/AComments: Vacuum systemMaintenance tasks associated to the external vacuum pump performed.Yes No N/AComments: Fan filtersFan filter elements replaced.Yes No N/AComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 10 OF 17 715003445 REV. APower-upSystem powered-up.Yes No N/AInstrument pumped through MassLynx.Yes No N/AComments: Gas supplies and exhaustsGas supplies and exhaust systems checked.Yes No N/AComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 11 OF 17 715003445 REV. ASource and probe optionsMaintenance tasks for any of the source and probe options performed as appropriate.Yes No N/AAdditional PM kits are available for the following options as required.Yes No N/A APCI IonSABRE II Probe Service Kit 700005744  Outer APPI Source Service Kit 700004730  NanoLockSpray Reference Probe Service Kit 700004677  APGC Service Kit 700004842  TRIZAIC Service Kit (Quad) 700008959Comments: Source and probe interlocksInterlocks checked.Yes No N/A ESI/APCI source enclosure  Probe(s)  APPI source enclosure (if applicable)  NanoFlow source enclosure (if applicable)  NanoFlow adjuster (if applicable)  APGC source enclosure (if applicable)  TRIZAIC source enclosure (if applicable)Comments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 12 OF 17 715003445 REV. APost-performance maintenance checksPerform and confirm the steps listed for each procedure and record any comments that you have about the results at the end of each section. Record values for each item in the following tables:VacuumInstrument vacuum has been checked.Yes No N/AGauge Reading (mbar)Analyser Pirani Collision Cell Pirani Comments: HeatersSource and desolvation heaters checked.Yes No N/AHeater ResultSource heater Pass FailDesolvation heater Pass FailComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 13 OF 17 715003445 REV. AMass scale and resolutionMass scale setup and resolution across the mass range are assessed.Yes No N/A m/z m/z m/z m/z MS1 tests 59.05 455.27 1080.80 2034.64Gain Peak width at FWHM (Da) Measured mass (Da) m/z m/z m/z m/z MS2 tests 59.05 455.27 1080.80 2034.64Gain Peak width at FWHM (Da) Measured mass (Da) Instrument Mass position Current DC Current FWHH 0.4 to 0.6 Da performance checks ±0.5 Da Balance Ion Energy Result Mass scale ResultMS1 Pass Fail Pass FailMS2 Pass Fail Pass FailComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 14 OF 17 715003445 REV. AFast cross talk testFast Cross Talk Test is performed.Yes No N/ASpecification ResultThe peak height of the m/z 455 to 165 is between 1E7 and 6E7 Pass FailThe ratio of the average peak area for m/z 1000 to 165 and m/z 455 Pass Fail to 165 is ≤0.02%The ratio of the average peak area for m/z 1500 to 165 and m/z 455 Pass Fail to 165 is ≤0.01%Comments: CalibrationThe instrument must be uncalibrated throughout this PM protocol.Instrument setup and calibration for each of the default resolution settings performed using IntelliStart.Yes No N/AComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 15 OF 17 715003445 REV. ATarget Registry back-upTarget Registry is backed up.Yes No N/AComments: ® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 16 OF 17 715003445 REV. APerformance maintenance confirmationI confirm on behalf of Company Name that this performance maintenance procedure has been satisfactorily completed on: Serial No.Signed: Date: CustomerType NameI certify that the maintenance procedure has been successfully completed.Signed: Date: Waters EngineerType NameComments: Waters Corporation 34 Maple Street Milford, Massachusetts 01757 USAWaters, Xevo, TRIZAIC, and Waters Quality Parts are registered trademarks of Waters Corporation. MassLynx and The Science of What’s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners. ©2012 Waters Corporation. Printed in the U.S.A. – 715003445 Rev. A® XEVO TQD PERFORMANCE MAINTENANCE PROTOCOL 17 OF 17

Performance Maintenance

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