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Waters ACQUITY UPLC I-Class System Manual

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ACQUITY UPLC
I-Class / Xevo TQ-S
micro IVD
System Guide
715004986IVD/Revision A
Copyright © Waters Corporation 2015
All rights reserved

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Summary of Contents for Waters ACQUITY UPLC I-Class

  • Page 1 ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System Guide 715004986IVD/Revision A Copyright © Waters Corporation 2015 All rights reserved...
  • Page 2 October 15, 2015, 715004986IVD Rev. A Page ii...
  • Page 3 Other registered trademarks or trademarks are the sole property of their owners. Contacting Waters Contact Waters with technical questions regarding the use, transportation, removal, or disposal of any Waters product. You can reach us via the Internet, telephone, or conventional mail. Waters contact information...
  • Page 4 Warning: To avoid injury, if the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System must be relocated, disconnect the power cord and all cables. Warning:...
  • Page 5 Operating the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System When operating this system, follow standard quality-control (QC) procedures and the guidelines presented in this section. Applicable symbols Symbol Definition Manufacturer Date of manufacture Authorized representative of the European Community...
  • Page 6 Audience and purpose This guide is intended only for professionally trained and qualified laboratory personnel who install, operate, and maintain ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System modules. It gives an overview of the system’s technology and operation.
  • Page 7 Use one or more internal standard compounds, preferably isotopically labeled analytes. • To ensure data integrity, Waters recommends you run QC samples before and after test samples within a single analysis. Additionally, you can periodically run known or PT/EQA samples as unknowns to verify assay results for a single analysis.
  • Page 8 Canada spectrum management emissions notice This class A digital product apparatus complies with Canadian ICES-001. Cet appareil numérique de la classe A est conforme à la norme NMB-001. EC authorized representative Waters Corporation Stamford Avenue Altrincham Road Wilmslow SK9 4AX UK...
  • Page 9 Electrical power safety notice............. iv Equipment misuse notice ..............iv Safety advisories ................iv Operating the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System ....v Applicable symbols................v Audience and purpose ..............vi Intended use of the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System...................
  • Page 10 For additional information ................18 2 Optimizing Performance ............21 General guidelines ..................21 Carryover ....................22 Contamination ..................23 Pressure limits ..................23 Temperature limits ..................23 Cycle time (between injections) ..............23 Preventing leaks ..................24 Sample preparation ................... 24 2.8.1 Particulates..................
  • Page 11 Specific warnings ................46 Notices ....................48 Bottles Prohibited symbol ................48 Required protection .................. 49 Warnings that apply to all Waters instruments and devices ......49 Warnings that address the replacing of fuses ..........52 Electrical and handling symbols ..............54 A.7.1 Electrical symbols................
  • Page 12 Recommended additives/modifiers............. 75 D.2.4 Recommended cleaning agents ............75 System recommendations ................. 76 D.3.1 ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System recommendations 76 D.3.2 Binary solvent manager recommendations.......... 76 D.3.3 Sample manager recommendations ........... 76 October 15, 2015, 715004986IVD Rev. A...
  • Page 13 Solvent viscosity ..................77 E FlexCart Assembly ..............79 Assembling the optional FlexCart ..............79 Adjusting the FlexCart’s height ..............81 Attaching the system drainage ..............81 Locking the FlexCart in place ..............82 Moving the assembled FlexCart ..............82 October 15, 2015, 715004986IVD Rev.
  • Page 14 October 15, 2015, 715004986IVD Rev. A Page xiv...
  • Page 15 ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System The ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System is a general purpose, in vitro diagnostic, tool for quantifying compounds in biological sample matrices. The system is intended to be used by only qualified operators.
  • Page 16 Maintenance Guide (part number 715003739IVD) for more details. 1.1.3 Sample manager-flow through needle (IVD) The ACQUITY UPLC I-Class IVD Sample Manager - Flow Through Needle (SM - FTN) incorporates a flow-through-needle mechanism. The mechanism aspirates a sample from plates and vials and holds it in the sample needle in preparation for injecting the sample onto the column.
  • Page 17 Establish column lifetime as part of method validation, and ensure the validated lifetime is not exceeded. Waters ACQUITY UPLC IVD columns are equipped with eCord technology, allowing you to monitor column usage history.
  • Page 18 Waters technical service team. 1.1.7 Optional columns The standard column used with the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System is the ACQUITY UPLC BEH C column, 1.7 µm, 2.1 × 50 mm, IVD. The following additional columns may be used: •...
  • Page 19 ACQUITY UPLC I-Class IVD Binary Solvent Manager Overview and Maintenance Guide (part number 715003739IVD) • ACQUITY UPLC I-Class IVD Sample Manager - Flow Through Needle Overview and Maintenance Guide (part number 715003737IVD) • ACQUITY UPLC I-Class IVD Column Heater Overview and Maintenance Guide (part number 715003738IVD) •...
  • Page 20 October 15, 2015, 715004986IVD Rev. A Page 20...
  • Page 21 ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System. 2.1 General guidelines ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System guidelines differ from those governing standard HPLC practices primarily because a chromatography that uses small (less than 2 μm) particles places certain constraints on the system.
  • Page 22 Do not block the degasser vent line. Trim the tubing, if necessary. • Do not submerge the waste or degasser vent lines in liquid. See also: For details about how to route the tubing, see the ACQUITY UPLC I-Class IVD Binary Solvent Manager Overview and Maintenance Guide (part number 715003739IVD.) •...
  • Page 23 Systems (part number 715001307). 2.4 Pressure limits Waters recommends that you set a high pressure limit and a low pressure limit when configuring a method, to more easily detect LC problems such as exhausting the supply of solvents and the occurrence of leaks or blockages. Always ensure that pressure limits are set in accordance with the specified analysis method and the expected pressure extremes of the specified gradient conditions.
  • Page 24 The Load Ahead and Loop Offline options of the ACQUITY UPLC I-Class IVD SM-FTN help decrease cycle time. See the ACQUITY UPLC Console online Help for details on how to use these features. Notice: To prevent the loss of sample, note that the Load Ahead option does not operate for the first injection of a sample set or for injection sets whose methods differ.
  • Page 25 2.8.2 Matching sample diluents When you use the auto-dilution option on the SM-FTN, the purge solvent serves as the sample diluent. Ensure that your sample solution is soluble and miscible in your chosen purge solvent. Notice: To avoid broad peaks and poor peak shape, ensure that your sample diluents match the initial conditions of your gradient.
  • Page 26 October 15, 2015, 715004986IVD Rev. A Page 26...
  • Page 27 Preparing the System 3.1 Preparing system hardware 3.1.1 Powering-on the system Powering-on the system entails powering-on the system’s workstation, logging in, powering on the LC modules, powering-on the mass spectrometer, and then starting the MassLynx software. Requirement: You must power-on and log in to the workstation before powering-on the system modules, to ensure that the workstation obtains the IP addresses of the system instruments.
  • Page 28 3.1.2 Monitoring system module LEDs LEDs on each system module indicate the module’s state of functioning. The LEDs are specific to their modules, so the significance of their various colors and modes can differ from one module to another. For information about the LEDs on the Xevo TQ-S micro IVD, see the instrument’s online Help file.
  • Page 29 Steady red Indicates a module’s failure that prevents its further operation. Power-off the module, and then power-on. If the LED is still steady red, contact your Waters service representative. 3.1.5 Enabling the leak sensors Rule: When you power-on the system, the leak sensors default to disabled status unless previously enabled.
  • Page 30 To refresh the system: In the ACQUITY UPLC Console, click Control > Start up system. In the Start up system dialog box, review the settings, and select a different option, if needed. • Solvent line A only (default) • Solvent line B only •...
  • Page 31 Figure 3–1: Binary solvent manager control panel Flow LED Status Solvent composition System pressure Stop flow Flow rate The following table describes the items in the binary solvent manager control panel: Table 3–2: Binary solvent manager control panel items Control panel item Description Flow LED Displays the actual flow LED on the front panel of...
  • Page 32 Table 3–3: Additional functions in the binary solvent manager control panel (continued) Control panel function Description Wash plungers Initiates the plunger wash sequence, which fills and then slowly empties the primary and accumulator chambers (with the current solvent composition) while performing a high speed/volume seal wash. This action helps prevent the buildup of precipitates on the pump plungers which can damage the high pressure seals.
  • Page 33 Table 3–4: Sample manager control panel items Control panel item Description Status Displays the status of the current operation. Current Sample Displays the current sample compartment Compartment Temperature temperature, to 0.1 °C resolution, even when active temperature control is disabled. Sample Compartment Set Displays the current sample compartment set point, Point...
  • Page 34 Instead, follow the procedure described in the ACQUITY UPLC I-Class IVD Sample Manager - Flow Through Needle Overview and Maintenance Guide (part number 715003737IVD). Before running a sample analysis, ensure that these conditions are met, to ensure optimum system performance: •...
  • Page 35 • Acquire LC/MS data with at least 12 points across each chromatographic peak. Tip: Mean smoothing preserves chromatographic peak area, and is therefore best suited for quantitative analysis. • Compare the retention times of samples with those of the Quality Controls. •...
  • Page 36 October 15, 2015, 715004986IVD Rev. A Page 36...
  • Page 37 4.1 Maintenance schedule The following tables list periodic maintenance schedules that ensure optimum instrument performance of the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System. The maintenance frequencies shown apply to instruments that normally receive moderate use. When using the system throughout the day (and on nights and weekends), or when using aggressive solvents such as buffers, perform these maintenance tasks more frequently.
  • Page 38 Table 4–1: Xevo TQ-S micro IVD maintenance procedures: (continued) Maintenance Frequency procedure Replace the roughing Annually. pump’s demister Tip: Applications that contaminate the roughing pump oil element. increase this frequency to one that must be determined from experience. Inspect and clean the Annually.
  • Page 39 Table 4–2: Column Heater maintenance procedures Maintenance Frequency procedure Replace the leak As needed. For example, when the leak sensor is damaged sensor on the column or an error message states the leak sensor is not detected. heater. Replace the column. As needed.
  • Page 40 Sample Manager Flow-Through-Needle maintenance procedures Maintenance Frequency procedure Clean the instrument Perform as part of your annual routine scheduled with a soft, lint-free maintenance and when solvent or dust accumulates. cloth, or paper dampened with water. Replace the leak As needed. For example, when the leak sensor is damaged sensor.
  • Page 41 Binary Solvent Manager maintenance procedures (continued) Maintenance Frequency procedure Replace the pump Replace as part of the annual scheduled routine interconnect tubing. maintenance and, thereafter, as needed. The typical failure modes are as follows: • You see a visible leak. •...
  • Page 42 4.2 Spare parts Warning: To ensure that your system operates as designed, produces accurate results, and is not damaged, use only Waters Quality Parts®. Visit www.waters.com/wqp for information about Waters Quality Parts, including how to order them. To minimize system downtime, Waters recommends that you keep on hand the performance maintenance kits and the spare parts listed here.
  • Page 43 4.3 Troubleshooting with Connections INSIGHT Connections INSIGHT is an “intelligent” device management (IDM) Web service that enables Waters to provide proactive service and support for the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System. To use Connections INSIGHT, you must install its service agent software on your workstation.
  • Page 44 Data Sheets for the solvents in use). Warning: To avoid electric shock, do not remove the instrument’s panels. The panels cover components that are serviceable only by Waters technicians. Warning: To avoid electric shock, ensure that the instrument is in Standby mode before beginning any maintenance operation.
  • Page 45 The following symbols warn of risks that can arise when you operate or maintain a Waters instrument or device or component of an instrument or device. When one of these symbols appear in a manual’s narrative sections or procedures, an accompanying statement identifies the applicable risk and explains how to avoid it.
  • Page 46 A.1.1.1 Burst warning This warning applies to Waters instruments and devices fitted with nonmetallic tubing. Warning: To avoid injury from bursting, nonmetallic tubing, heed these precautions when working in the vicinity of such tubing when it is pressurized: •...
  • Page 47 Also a gas-fail device must be installed, to interrupt the flow of LC solvent should the nitrogen supply fail. A.1.1.4 Biohazard warning The following warning applies to Waters instruments and devices that can process material containing biohazards, which are substances that contain biological agents capable of producing harmful effects in humans. Warning:...
  • Page 48 A.1.1.5 Chemical hazard warning These warnings apply to Waters instruments and devices that can process corrosive materials or toxic materials. Warning: To avoid personal contamination with toxic materials or corrosive materials, you must understand the hazards associated with their handling.
  • Page 49 Use eye protection when refilling or replacing solvent bottles. Requirement: Wear clean, chemical-resistant, powder-free gloves when handling samples. A.5 Warnings that apply to all Waters instruments and devices When operating this device, follow standard quality-control procedures and the equipment guidelines in this section.
  • Page 50 注意：規制機関か ら 明確な承認 を 受け ず に 本装置の変更や改造 を ⾏ う と 、 本装置の ユ ー ザ ー と し て の承認が無効 に な る 可能性が あ り ま す。 Warning: Use caution when working with any polymer tubing under pressure: •...
  • Page 51 Advertencia: se recomienda precaución cuando se trabaje con tubos de polímero sometidos a presión: • El usuario deberá protegerse siempre los ojos cuando trabaje cerca de tubos de polímero sometidos a presión. • Si hubiera alguna llama las proximidades. • No se debe trabajar con tubos que se hayan doblado o sometido a altas presiones.
  • Page 52 Vorsicht: Der Benutzer wird darauf aufmerksam gemacht, dass bei unsachgemäßer Verwendung des Gerätes die eingebauten Sicherheitseinrichtungen unter Umständen nicht ordnungsgemäß funktionieren. Attenzione: si rende noto all'utente che l'eventuale utilizzo dell'apparecchiatura secondo modalità non previste dal produttore può compromettere la protezione offerta dall'apparecchiatura. Advertencia: el usuario deberá...
  • Page 53 Advertencia: Para evitar incendios, sustituir los fusibles por aquellos del tipo y características impresos en los paneles adyacentes a las cubiertas de los fusibles del instrumento. 警告 ：為了避免火災，更換保險絲時，請使用與儀器保險絲蓋旁面板上所印刷之相同類型與 規格的保險絲。 警告：为了避免火灾，应更换与仪器保险丝盖旁边面板上印刷的类型和规格相同的保险丝。 화재의 위험을 막으려면 기기 퓨즈 커버에 가까운 패널에 인쇄된 것과 동일한 타입 경고...
  • Page 54 A.7 Electrical and handling symbols A.7.1 Electrical symbols The following electrical symbols and their associated statements can appear in instrument manuals and on an instrument’s front or rear panels. Symbol Description Electrical power on Electrical power off Standby Direct current Alternating current Alternating current (3 phase) Safety ground...
  • Page 55 Symbol Description Keep dry! Fragile! Use no hooks! Upper limit of temperature Lower limit of temperature Temperature limitation October 15, 2015, 715004986IVD Rev. A Page 55...
  • Page 56 October 15, 2015, 715004986IVD Rev. A Page 56...
  • Page 57 715003724) and the Xevo TQ-S micro Site Preparation Guide (part number 715004573), or contact Waters Technical Service for details. B.1 Physical specifications B.1.1 Binary solvent manager IVD The following table lists the physical specifications for the ACQUITY UPLC I-Class IVD BSM: BSM physical specifications Attribute...
  • Page 58 B.1.3 Column heater IVD The following table lists the physical specifications for the ACQUITY UPLC I-Class IVD column heater-A: CH-A physical specifications Attribute Specification Height 7.6 cm (3.0 inches) Width 34.3 cm (13.5 inches) Depth 62.9 cm (24.8 inches) Weight 5.7 kg (12.5 pounds)
  • Page 59 Shipping and storage temperature 0 to 40 °C Shipping and storage humidity Less than 80%, noncondensing B.2.1 Binary solvent manager input/output specifications The following table lists the input/output specifications for the ACQUITY UPLC I-Class IVD BSM: BSM input/output specifications Attribute Specification...
  • Page 60 0 to 2 volts full scale, screw terminal (digital to analog converter range is -0.1 to 2.1 to allow for offsets) B.2.2 Sample manager - FTN input/output specifications The following table lists the input/output specifications for the ACQUITY UPLC I-Class IVD SM - FTN: Sample manager - FTN input/output specifications...
  • Page 61 B.2.3 Xevo TQ-S micro IVD input/output specifications For input/output specifications for the Xevo TQ-S micro IVD, see the Xevo TQ-S micro IVD Overview and Maintenance Guide (part number 715004599IVD). B.3 Wetted materials of construction B.3.1 Binary solvent manager The following table lists the wetted materials of construction for the ACQUITY UPLC I-Class IVD BSM: BSM wetted materials of construction Description...
  • Page 62 October 15, 2015, 715004986IVD Rev. A Page 62...
  • Page 63 External Connections A Waters Technical Service representative must unpack and install your ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System modules. Notice: To avoid damaging system modules, Contact Waters Technical Service (see page iii). If you must transport a system...
  • Page 64 C.1 System tubing connections The system’s external tubing connections for solvent flow and drainage are shown below: Solvent flow for the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System: SM wash Solvent tray solvent BSM solvents Column Column heater...
  • Page 65 C.2 External wiring connections C.2.1 ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System external wiring connections The rear panel connections for ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System modules are shown below. Solvent tray Drain tube outlet...
  • Page 66 C.2.3 Column heater connection The sample manager powers and communicates with the column heater. The external communication cable must be connected to the rear of the column heater and the sample manager. To make column heater connections: Notice: To avoid damaging electrical parts, never disconnect an electrical assembly while power is applied to a system module.
  • Page 67 To connect signal cables: Use a flat-blade screwdriver to attach the positive and negative leads of the signal cable to ports 3 and 4, respectively, of a 12-pin I/O connector. BSM connector II Xevo TQ-S micro IVD connector I Stop Flow −...
  • Page 68 Binary solvent manager I/O signal connectors: Connector I Connector II Auxiliary 1 In Start Gradient In − Auxiliary 1 In − Start Gradient In Auxiliary 2 In Stop Flow − Auxiliary 2 In − Stop Flow Ground Ground Run Stopped Out Switch 2 Out Run Stopped Out Switch 2 Out...
  • Page 69 Binary solvent manager analog-out/event-in connections (continued) Signal connection Description Switch 3 Out Used to send time-based contact closure signals to external devices. 0−2V Analog 2 Out Outputs the analog signal to a device such as an integrator or strip-chart recorder. Via the MassLynx software, you can select one of the following signals as the chart out signal: •...
  • Page 70 Use a line conditioner and uninterruptible power supply (UPS) for optimum, long-term, input voltage stability. For sizing and selection of the UPS or line conditioner, contact Waters technical support. Connect the female end of the power cord to the receptacle on the rear panel of each module.
  • Page 71 FlexCart power connections (optional) To circuit A AC line Network switch (not required) Sample manager Binary solvent manager FlexCart power strips LCD/monitor Computer workstation TP02578 To circuit B AC line All cord lengths are 1 meter long except the LCD/ monitor cord, which is 2 meters long.
  • Page 72 October 15, 2015, 715004986IVD Rev. A Page 72...
  • Page 73 Solvent Considerations This information applies to the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System modules. Warning: To avoid injury from corrosive, biohazardous, and flammable materials, familiarize yourself with materials and their hazards, observe Good Laboratory Practice (GLP), and consult your organization’s safety representative regarding proper use and...
  • Page 74 To avoid salt precipitation, nonvolatile buffer concentrations must not exceed 100 mM. D.2 Solvent recommendations The ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System was designed for reversed-phase chromatography. Waters evaluated the system’s reliability using traditional reversed-phase solvents. October 15, 2015, 715004986IVD Rev. A...
  • Page 75 This section lists solvents recommended for the system. Contact Waters Customer Service to determine whether you can use solvents that do not appear in the list without adversely affecting instrument or system performance. D.2.1 Recommended solvents • Acetonitrile • Acetonitrile/water mixtures •...
  • Page 76 • Contact your Waters sales representative or local technical support organization to determine the typical chromatography conditions and/or instrument operating parameters suitable for the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System. • Methanesulfonic acid is not recommended for use in ACQUITY UPLC I-Class / Xevo TQ-S micro IVD Systems.
  • Page 77 D.4 Solvent viscosity Generally, viscosity is not a consideration when you operate with a single solvent or under low pressure. However, with gradient chromatography, the viscosity changes that occur as the solvents are mixed in different proportions can effect pressure changes during the run.
  • Page 78 October 15, 2015, 715004986IVD Rev. A Page 78...
  • Page 79 If your system includes the optional FlexCart, follow the procedure below to unpack and assemble it. Recommendation: Because the assembled system weighs at least 140.6 kg, Waters recommends that you assemble the instruments and components on the FlexCart. To assemble the FlexCart Remove the contents from the box packaged in the FlexCart.
  • Page 80 Remove the 4 Phillips screws from the support plate at the rear of the monitor, and mount the monitor onto the movable arm assembly. Refer to the IBM instruction book, if necessary. Screws (4) Line cord Video cable Plastic channel Movable arm bracket Loosen the 2 T25 TORX screws, at the bottom left-hand side of the cart, that...
  • Page 81 To avoid personal contamination with toxic and biohazardous solvents, prevent pooling in the system’s drip trays by ensuring that the ACQUITY UPLC I-Class / Xevo TQ-S micro IVD System is installed on a level surface to within 1 degree of horizontal.
  • Page 82 Rationale: Properly routing the drainage tubing ensures proper drainage by eliminating sags. Note: The cart has a barbed fitting that protrudes through the bottom of the of the cart top. The fitting drains leaked fluid from the channel that runs along the outer edge of the cart top.
  • Page 83 Once it is assembled, you can move the cart to other areas of a lab to minimize tubing runs between the ACQUITY UPLC instruments and a mass spectrometer. Use the lip on top of the cart to pull it. TP02500 October 15, 2015, 715004986IVD Rev.
  • Page 84 October 15, 2015, 715004986IVD Rev. A Page 84...

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