715002407 REV. G Performance Maintenance Protocol ACQUITY UPLC® H-Class/H-Class Bio/I-Class Sample Manager – Flow Through Needle (SM-FTN) and ACQUITY® Advanced Polymer Chromatography™ (APC) System Sample Manager – Flow Through Needle (SM-pFTN) Serial Number/ Firmware Version: Date: Performer: © 2014 WATERS CORPORATION. ALL R IGHTS RESERVED. *715002407* *Rev.G* 715002407 REV. G Performance maintenance Goal This 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. Schedule Waters 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 considerations Caution: Always observe Good Laboratory Practice and, when handling Waters Critical Clean™ parts, refer to the Controlling Contamination in UPLC/MS and HPLC/MS Systems, P/N 715001307. Warning: To prevent personal contamination with biologically hazardous or toxic materials, carefully dispose of the replaced component in the appropriate waste container. Warning: When performing maintenance to components of an ACQUITY UPLC system, remove power to the unit by powering down and disconnecting the power cord. Warning: Always use proper static protection when handling any printed circuit boards. Warning: Dispose of components in accordance with local or customer regulations. If the component comes with a Waters Corporation return sheet, follow its instructions. Warning: Avoid contact with solvents by wearing suitable gloves and safety glasses. Some 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 Parts Waters designs and manufactures Waters Quality Parts® to the same strict regulatory standards as your high-performance Waters systems. Waters recommends using Waters Quality Parts for all ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 2 OF 14 715002407 REV. G maintenance activities. Failure to use Waters Quality Parts may compromise laboratory results and reliability. Customer education Waters 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 services Waters 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 Compliance Services, please visit the Waters web site. General tasks Use 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 need only testing and 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. Such 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 Guides located on www.waters.com. ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 3 OF 14 715002407 REV. G Inspect Maintenance tasks Post-performance maintenance checks Firmware version1 Side panel air filter Initialization diagnostics Fan Syringe, 100 µL Prime SM-FTN/SM-pFTN Waste management FTN needle and needle guide Calibrations and characterizations Tubing & fittings Vespel seat Readiness and leak tests Error logs Inject valve cartridge assembly Reset injection counter Inject/wash station Pump outlet tubing2 Wash needle3 Seat port assembly Create log entry 1 Firmware upgrades, if required, should 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. 2 Pump outlet tubing not replaced in the ACQUITY Advanced Polymer Chromatography System SM-pFTN. 3 Perform only if the needle and inject/wash station were cleaned. ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 4 OF 14 715002407 REV. G Inspect Firmware version Confirm what firmware versions are installed. Update if required. NOTE: Refer to Software Downloads section under the Services & Support tab on the waters.com home page for the latest firmware and driver pack release notes. These release notes detail software and data system requirements, and installation notes. From the ACQUITY Console: 1. Click Sample Manager-FTN in the systems tree. 2. From the menu bar, click Configure > View module information. 3. Check the firmware version and note it on the cover page. Firmware check complete. Yes No N/A Comments: Fan To inspect the fan: 1. Observe the fan on the rear of the Sample Manager-FTN. 2. Ensure that the fan grate is clear of debris and dust. The fan should be blowing outward. 3. Clean if necessary. Fan inspection complete. Yes No N/A Comments: ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 5 OF 14 715002407 REV. G Waste management Inspect the waste management system for leaks and proper routing of waste tubing. Ensure that there are no loops or kinks in the tubing that could result in the back up of solvent. Waste management inspection complete. Yes No N/A Comments: Tubing and fittings Check tubing and fittings for leaks. Tubing and fittings check complete. Yes No N/A Comments: Error logs To inspect the error logs: 1. From the Run Samples window in Empower, click the ACQUITY Console icon in the Sample Manager control editor. 2. In the system tree, click ACQUITY UPLC System. 3. Click on Logs to review error logs. Review error logs complete. Yes No N/A Comments: ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 6 OF 14 715002407 REV. G Inject/wash station Caution: SM-FTNs/SM-pFTNs may have visible salt precipitation on certain parts (needle and wash housing) when used with mobile phases containing non-volatile salts and buffers. Never use a squirt bottle to direct a stream of water onto the system. Some parts may be damaged by getting wet (load cell, cables, and PCBs). Caution: In severe cases where salt precipitation has migrated to the base of the inject/wash station, a Waters field service engineer may be required to properly disassemble and clean the wash station. If cleaning is necessary: 1. Reset the SM-FTN/SM-pFTN in the ACQUITY Console. This will move the needle carriage to the middle of the instrument, enabling access to the inject port. 2. Open the front door. Using a T20 Torx driver, loosen the two captive screws that secure the access panel, and then remove the panel. 3. Dampen a Kimwipe® with HPLC-grade water and use it to wipe off the inject port. Caution: Take care not to bend or scratch the needle. 4. Replace the front access panel. Needle and inject/wash station inspection complete. Yes No N/A Comments: Maintenance tasks The following procedures are routinely performed as part of the performance maintenance. Waters Quality Parts have been used to replace/rebuild all parts. Side panel air filter Syringe, 100 µL FTN needle and needle guide Vespel seat Inject valve cartridge assembly ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 7 OF 14 715002407 REV. G Pump outlet tubing (SM-FTN only) Seat port assembly Yes No N/A Comments: Post-performance maintenance checks Perform the post-performance maintenance checks only in the order listed. NOTE: Procedures not included here can be found in the ACQUITY UPLC Sample Manager – Flow Through Needle Operator’s Overview and Maintenance Information Guide, ACQUITY Advanced Polymer Chromatography Sample Manager – Flow Through Needle Overview and Maintenance Guide, or in the ACQUITY Console Online Help. Initialization diagnostics Turn on power, allow instrument to complete and pass on-board software checks. Initialization diagnostics check complete. Yes No N/A Comments: ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 8 OF 14 715002407 REV. G Prime SM-FTN/SM-pFTN Prime the SM-FTN/SM-pFTN in the following manner: Prime solvent Duration Wash 60 secs Purge 5 cycles Priming the SM-FTN/SM-pFTN complete. Yes No N/A Comments: Calibrations and characterizations Calibrate needle Z-axis Calibrate needle Z-axis complete. Yes No N/A Z offset mm Comments: Characterize needle seal NOTE: Characterizing the needle seal finds the position at which the needle achieves a seal on the wash station block. Pass/fail of the test is driven by firmware criteria. Characterize needle seal complete. Yes No N/A ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 9 OF 14 715002407 REV. G Seal constant (N/mm) Pass/Fail Pass Distance to seal (mm) Foot offset (mm) Fail Comments: Readiness and leak tests Needle seal readiness test NOTE: The needle seal readiness test determines the integrity of the needle and seal interface by monitoring pressure. Pass/fail of the test is driven by firmware criteria. 1. Attach the active pre-heater to the inlet of the column. For H-Class/H-Class Bio/I-Class, use the ACQUITY UPLC BEH C18 column (2.1 x 50 mm; 1.7 µm; P/N 186002350). For APC, use the ACQUITY APC XT 200Å column (4.6 x 150 mm; 2.5 µm; P/N 186007005). 2. Set the flow rate. For H-Class/H-Class Bio/I-Class set to 0.6 mL/min using 90:10 water/acetonitrile mobile phase. For APC set to 0.6 mL/min using 100% stabilized THF. 3. Perform the needle seal readiness test when the pressure is stable. Needle seal readiness test complete. Yes No N/A Pass/Fail Pass Pressure difference (psi) Flow (mL/min) Fail Comments: ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 10 OF 14 715002407 REV. G Sample syringe leak test NOTE: The sample syringe leak test determines the integrity of the sample syringe by monitoring pressure. Pass/fail of the test is driven by firmware criteria. Sample syringe leak test complete. Yes Test pressure (psi) Pass/Fail Pass No N/A Compressed volume (µL) Decompressed volume (µL) Start pressure (psi) End pressure (psi) Pressure change (psi) Average pressure leak (psi/sec) Fail Comments: Dynamic leak test 1. Flush all of the solvent lines with 100% degassed, new, and clean solvent to remove all air bubbles. 2. Prime the system for at least three minutes. 3. Exercise the seals for at least 30 minutes before performing the test. 4. In the Console, select Quaternary Solvent Manager (H-Class/H-Class Bio); Binary Solvent Manager (I-Class) or Isocratic Solvent Manager (APC System) from the system tree. 5. From the menu bar, select Maintain > Leak test (H-Class/H-Class Bio/APC System) or Dynamic Leak test (I-Class). 6. In the Parameters tab, specify your typical operating pressure (9000 psi) in the Accumulator field text box. 7. In the Solvent (H-Class/H-Class Bio/APC System) or Pump (I-Class) field, select one of the lines to which a new solvent filter was attached. Place a check mark in the prime box to prime that solvent line. 8. Choose one of the following End Points for the dynamic leak test: Column (inject valve outlet including the sample manager needle and seal) – to evaluate the fluid-handling integrity of the QSM/BSM/ISM including the sample needle and seal of the Sample Manager. ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 11 OF 14 715002407 REV. G Caution: To avoid damaging the instrument, and to insure a valid result, a pin plug will be required at port 6 on the inject valve. Include a check mark in the ‘include sample needle and seal’ check box. Column (active pre-heater outlet exclude sample manager needle and seal) – to evaluate the fluid-handling integrity the QSM/BSM/Isocratic Sample Manager (ISM) excluding the sample needle and seal of the Sample Manager. Caution: To avoid damaging the instrument, and to insure a valid result, a pin plug will be required in the outlet of the pre-column heater. No check mark in the ‘include sample needle and seal’ check box. 9. Click Start to perform the test. When complete, record the results below. NOTE: When using an End Point of Column (including or excluding the sample manager needle and seal), the leak rate should be < 300 nL/min. Leak test complete. Yes No N/A End point column (choose one) Pumps Inject valve outlet Active preheater outlet Leak rate (nL/min) Accumulator Pass/Fail Pass Fail Comments: Reset injection count Reset injection count complete. Yes No N/A Comments: ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 12 OF 14 715002407 REV. G Wash needle NOTE: Perform only if the needle and inject/wash station were cleaned. 1. In the ACQUITY UPLC Console, click on Sample Manager-FTN in the system tree. 2. From the menu bar, click Control > Wash Needle. The Wash Needle dialog box appears. 3. Enter a wash time of 60 seconds. Wash needle complete. Yes No N/A Comments: Create log entry 1. In the ACQUITY UPLC Console, click on Sample Manager-FTN in the system tree. 2. From the menu bar, click Maintain > Create log entry. The Create Log Entry dialog box appears. 3. Enter the operator’s name, the date the performance maintenance was performed, and any other comments.Creation of log entry complete. Create log entries complete. Yes No N/A Comments: ACQUITY H-CLASS/H-CLASS BIO/I-CLASS/APC SYSTEM SM-FTN PERFORMANCE MAINTENANCE PROTOCOL 13 OF 14 715002407 REV. G Performance maintenance confirmation I confirm on behalf of Company Name that this performance maintenance procedure has been satisfactorily completed on: Serial No. Signed: Date: Customer Type Name I certify that the maintenance has been successfully completed. Signed: Date: Waters Engineer Type Name Comments: Waters Corporation 34 Maple Street Milford, Massachusetts 01757 USA Waters, MassLynx, The Science of What’s Possible and Waters Quality Parts are registered trademarks of Waters Corporation. All other trademarks are property of their respective owners. ©2014 Waters Corporation. Printed in the U.S.A. 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