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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. March 17, 2020, 715005210IVD Ver. 01 (previously released as rev. A)
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Milford, MA 01757 Safety considerations Some reagents and samples used with Waters instruments and devices can pose chemical, biological, or radiological hazards (or any combination thereof). You must know the potentially hazardous effects of all substances you work with. Always follow Good Laboratory Practice (GLP), and consult your organization’s standard operating procedures as well as your local...
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Consult the "Safety advisories" appendix in this publication for a comprehensive list of warning advisories and notices. Operating the ACQUITY UPLC I-Class/Xevo TQD IVD System When operating the system, follow standard quality control (QC) procedures and the guidelines presented in this section.
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For compliance with the Waste Electrical and Electronic Equipment Directive (WEEE) 2012/19/EU, contact Waters Corporation for the correct disposal and recycling instructions For indoor use only No pushing Indicates the maximum load you can place on...
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Audience and purpose This guide is intended only for professionally trained and qualified laboratory personnel who install, operate, and maintain the ACQUITY UPLC I-Class/Xevo TQD IVD system and associated modules. It gives an overview of the system's technology and operation.
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• Use one or more internal standard compounds, preferably isotopically labeled analytes. • To ensure data integrity, Waters recommends that you run QC samples before and after test samples within a single analysis. Also, you can periodically run known or PT/EQA samples as unknowns to verify assay results for a single analysis.
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interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 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. ISM classification: ISM group 1 class A This classification has been assigned in accordance with CISPR 11 Industrial Scientific and Medical (ISM) instruments requirements.
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Australia March 17, 2020, 715005210IVD Ver. 01 (previously released as rev. A) Page ix...
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Trademarks ............................ii Contacting Waters..........................ii Safety considerations..........................iii Safety hazard symbol notice ......................iii Considerations specific to the ACQUITY UPLC I-Class/Xevo TQD IVD System ......iii Electrical power safety notice ......................iv Equipment misuse notice ....................... iv Safety advisories ..........................iv Operating the ACQUITY UPLC I-Class/Xevo TQD IVD System............iv Applicable symbols.........................
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1.1.9 Vials, plates, and seals ......................19 1.2 For additional information......................19 2 Performance optimization..................20 2.1 General guidelines ........................20 2.2 Carryover ............................21 2.3 Contamination ..........................22 2.4 Pressure limits..........................22 2.5 Temperature limits......................... 22 2.6 Cycle time (between injections) ....................22 2.7 Preventing leaks..........................23 2.8 Sample preparation........................23 2.8.1 Particulates ..........................
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A.1.1 Specific warnings ........................ 45 A.2 Notices............................47 A.3 Bottles Prohibited symbol ......................47 A.4 Required protection ........................47 A.5 Warnings that apply to all Waters instruments and devices ............48 A.6 Warnings that address the replacement of fuses................52 A.7 Electrical symbols ......................... 53 A.8 Handling symbols ......................... 54 B Specifications......................56...
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E FlexCart assembly ....................79 E.1 Assembling the FlexCart....................... 79 E.2 Adjusting the FlexCart's height ..................... 81 E.3 Attaching the system drainage ..................... 82 E.4 Locking the FlexCart in place ....................... 82 E.5 Moving the assembled FlexCart ....................83 March 17, 2020, 715005210IVD Ver. 01 (previously released as rev. A) Page xiv...
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1.1 System components Figure 1–1: Major components of the ACQUITY UPLC I-Class/Xevo TQD IVD System Column heater CH-A Sample manager - FTN...
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The Waters ACQUITY UPLC I-Class IVD Binary Solvent Manager (BSM) delivers solvent compositions for isocratic and binary gradient methods at flow rates of between 0.01 and 2.0 mL per minute. Its features include in-line filters upstream of a primary check valve, the Waters Intelligent Intake Valve (I Valve), automated priming functions, and daily system-setup routines.
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MS-compatible flow rates, and matched outlet tubing minimizes the effect of extra-column volume. 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. See also: The care and use guide for the column required for your application.
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1.1.8 Optional columns The standard column used with the ACQUITY UPLC I-Class/Xevo TQD IVD system is the ACQUITY UPLC BEH C column, 1.7 µm, 2.1 × 50 mm, IVD. The following additional columns may be used: March 17, 2020, 715005210IVD Ver.
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1.1.9 Vials, plates, and seals For information on vials, plates, and seals, refer to the following: • Waters Autosampler Vials, Plates, and Seals for use with the ACQUITY UPLC Systems Family Reference Guide (720004278EN). • Waters Sample Vials and Accessories Brochure (720001818EN).
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Performance optimization Follow the advice and guidelines in this chapter to help ensure optimum performance from your system. 2.1 General guidelines ACQUITY UPLC I-Class 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.
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• Do not add fresh buffer to old, which can promote microbial growth. • Make fresh buffer solutions daily. • 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 (715003739IVD).
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Controlling Contamination in LC/MS Systems Best Practices (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.
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(downstream of the i Valves) can leak solvent but do not introduce air. To prevent leaks, follow Waters’ recommendations for the proper tightening of system fittings. Different techniques apply to retightening fittings versus installing them for the first time. See also: •...
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Notice: To avoid broad peaks and poor peak shape, ensure that your sample diluents match the initial conditions of your gradient. March 17, 2020, 715005210IVD Ver. 01 (previously released as rev. A) Page 24...
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System preparation 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.
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Start the MassLynx software, and monitor the Instrument Console software for messages and LED indications. Evacuate (pump down) the mass spectrometer (see the Xevo TQD IVD Overview and Maintenance Guide). 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.
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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.
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BSM Recommendations: • Prime the binary solvent manager for one minute for each solvent when the system has been idle for four or more hours, and you intend to use the solvents already in the system. • Prime the binary solvent manager for four minutes for each solvent when you intend to use fresh solvents of the same composition as those already in the system.
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3.3 ACQUITY control panels You can monitor control panels for the binary solvent manager, sample manager, and mass spectrometer from MassLynx software. The LC modules control panels appear on the Additional Status tab of the Inlet Editor window. 3.3.1 Binary solvent manager control panel The binary solvent manager control panel displays flow status, system pressure, total flow rate, and solvent composition parameters.
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Table 3–2: Additional functions in the binary solvent manager control panel Control panel function Description Start up system Brings the system to operational conditions after an extended idle period or when switching to different solvents. Prime solvents Displays the Prime solvents dialog box. Prime seal wash Starts priming the seal wash.
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Run LED – Displays on the front panel of the solvent manager the status of the flow state, unless communications are lost. Current column heater temperature – Displays the current column heater temperature to 0.1 °C resolution, even when active temperature control is disabled. Display console –...
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To prevent data loss in the event of workstation failure, potentially leading to a delay in patient treatment, regularly back up project settings and data. When loading the 3777C's well plates, follow the procedure described in the Waters 3777C Sample Manager IVD Overview and Maintenance Guide (715005553IVD).
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3.6 Performing sample analysis During a sample analysis, follow these guidelines to ensure a successful sample report: • Prepare and analyze samples according to the validated method. A full set of calibrators should be run with every batch of samples analysed. •...
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See also: • For complete procedures, refer to the component’s Overview and Maintenance Guide on your ACQUITY UPLC I-Class/Xevo TQD IVD System documentation CD (part number 715005216IVD). • For information on how to schedule routine preventative maintenance based on system usage, see the "Configuring maintenance warnings"...
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Table 4–1: Xevo TQD IVD maintenance procedures (continued) Maintenance procedure Frequency Replace the roughing pump’s demister Annually. element. Tip: Applications that contaminate the roughing pump oil increase this frequency to one that must be determined from experience. Inspect and clean the dry roughing pump’s inlet Annually.
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Table 4–2: Column Heater maintenance procedures (continued) Maintenance procedure Frequency Replace the column As needed. The typical failure modes are as follows: • High back pressure. The column causes a high pressure shutdown. • Method requirements are not attained. This can be exhibited by poor peak shape, resolution between peaks lost, tailing, etc.
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Table 4–2: Column Heater maintenance procedures (continued) Maintenance procedure Frequency Replace the column in-line filter unit As needed. The typical failure modes are as follows: • High back pressure. The column in-line causes a high pressure shutdown. In this case, disconnect the in-line filter. If the system exhibits pressure decay, check the system pressure at known conditions.
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Table 4–3: Sample Manager Flow-Through-Needle maintenance procedures (continued) Maintenance procedure Frequency Replace the sample needle Replace when the needle breaks, when the error message Drawing sample rate excessive <value> appears, or the needle seal readiness test is failed. Replace the sample syringe Replace as part of the annual scheduled routine maintenance and as needed.
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Table 4–4: Binary Solvent Manager maintenance procedures (continued) Maintenance procedure Frequency Replace the pump interconnect tubing Replace as part of the annual scheduled routine maintenance and as needed. The typical failure modes are as follows: • You see a visible leak. •...
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Table 4–4: Binary Solvent Manager maintenance procedures (continued) Maintenance procedure Frequency Replace the accumulator check valve Replace as part of the annual scheduled routine maintenance and as needed. The typical failure modes are as follows: • Late eluting peaks are exhibited and/or after a dynamic leak test was performed where the leak rate is above the acceptable limit.
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Connections INSIGHT is an intelligent device management (IDM) Web service that enables Waters to provide proactive service and support for a system. To use Connections INSIGHT, you must install its service agent software on a MassLynx workstation. In a client/server system, you must also install the service agent on the computer that controls the system.
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Click Submit, and allow approximately 5 min to save the service profile. Result: A ZIP file containing your Connections INSIGHT profile is forwarded to Waters Technical Service for review. Note: Saving a service profile or plot file from the console can require as much as 150 MB of file space.
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Notice: When performing maintenance inside the source enclosure, ensure that the following criteria are met: • Instrument is in Standby mode. • LC flow is diverted to waste or set to Off. • Desolvation gas is turned off. See the Safety Advisories section for additional safety information. 4.5 Configuring maintenance warnings Maintenance counters provide real-time usage status information that can help you determine when to schedule routine maintenance for specific components.
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Heed all warnings when you install, repair, or operate any Waters instrument or device. Waters accepts no liability in cases of injury or property damage resulting from the failure of individuals to comply with any safety precaution when installing, repairing, or operating any of its instruments or devices.
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(Risk of high-pressure gas release.) A.1.1 Specific warnings 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: •...
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A.1.1.4 Biohazard warning The following warning applies to Waters instruments and devices that can process biologically hazardous materials. Biologically hazardous materials are substances that contain biological agents capable of producing harmful effects in humans.
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A.1.1.5 Biohazard and chemical hazard warning This warning applies to Waters instruments and devices that can process biohazards, corrosive materials, or toxic materials. Warning: To avoid personal contamination with biologically hazardous, toxic, or corrosive materials, you must understand the hazards associated with their handling.
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Use eye protection when performing this procedure. Requirement: Wear clean, chemical-resistant, powder-free gloves when performing this procedure. 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.
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Warning: Use caution when working with any polymer tubing under pressure: • Always wear eye protection when near pressurized polymer tubing. • Extinguish all nearby flames. • Do not use tubing that has been severely stressed or kinked. • Do not use nonmetallic tubing with tetrahydrofuran (THF) or concentrated nitric or sulfuric acids.
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Avvertenza: fare attenzione quando si utilizzano tubi in materiale polimerico sotto pressione: • Indossare sempre occhiali da lavoro protettivi nei pressi di tubi di polimero pressurizzati. • Spegnere tutte le fiamme vive nell'ambiente circostante. • Non utilizzare tubi eccessivamente logorati o piegati. •...
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い。 • 塩化メチレンやジメチルスルホキシドは、非金属チューブの膨張を引き起こす場合があり、その場 合、チューブは極めて低い圧力で破裂します。 This warning applies to Waters instruments fitted with nonmetallic tubing. This warning applies to instruments operated with flammable solvents. Warning: The user shall be made aware that if the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired.
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警告: 使用者必須非常清楚如果設備不是按照製造廠商指定的方式使用,那麼該設備所 提供的保護將被消弱。 경고: 제조업체가 명시하지 않은 방식으로 장비를 사용할 경우 장비가 제공하는 보호 수단이 제대로 작동하지 않을 수 있다는 점을 사용자에게 반드시 인식시켜야 합니다. 警告: ユーザーは、製造元により指定されていない方法で機器を使用すると、機器が提供している 保証が無効になる可能性があることに注意して下さい。 A.6 Warnings that address the replacement of fuses The following warnings pertain to instruments and devices equipped with user-replaceable fuses. Information describing fuse types and ratings sometimes, but not always, appears on the instrument or device.
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警告: 火災予防のために、ヒューズ交換では機器ヒューズカバー脇のパネルに記載されているタイプお よび定格のヒューズをご使用ください。 Finding fuse types and ratings when that information does not appear on the instrument or device: Warning: To protect against fire, replace fuses with those of the type and rating indicated in the “Replacing fuses” section of the Maintenance Procedures chapter. Avertissement : pour éviter tout risque d'incendie, remplacez toujours les fusibles par d'autres du type et de la puissance indiqués dans la rubrique "Remplacement des...
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Symbol Description Electrical power off Standby Direct current Alternating current Alternating current (three phase) Safety ground Frame or chassis terminal connection Fuse Functional ground Input Output Indicates that the device or assembly is susceptible to damage from electrostatic discharge (ESD) A.8 Handling symbols The following handling symbols and their associated statements can appear on labels affixed to the packaging in which instruments, devices, and component parts are shipped.
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Symbol Description Fragile! Use no hooks! Upper limit of temperature Lower limit of temperature Temperature limitation March 17, 2020, 715005210IVD Ver. 01 (previously released as rev. A) Page 55...
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The specifications presented in this document depend on the conditions that exist in individual laboratories. Refer to the ACQUITY UPLC I-Class IVD System Site Preparation Guide (715003724) and the Waters Xevo TQD Site Preparation Guide (715003099), or contact Waters Technical Service for additional information about specifications.
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The following table lists the environmental specifications for the ACQUITY UPLC I-Class/Xevo TQD IVD System: Warning: To prevent inaccurate results, do not operate the instrument outside the operating temperature and humidity specified. B.2.1 ACQUITY UPLC I-Class/Xevo TQD IVD System environmental specifications Attribute Specification Acoustic noise <65 dBA, system...
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Attribute Specification Shipping and storage humidity Less than 80%, noncondensing B.3 Input/output specifications The following tables list the input/output specifications for the ACQUITY UPLC I-Class/Xevo TQD IVD System. B.3.1 Binary solvent manager IVD Attribute Specification Contact closure outputs (SW1 to SW3) Maximum voltage: 30 VDC Maximum current: 0.5 A Maximum VA rating: 10 W...
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Attribute Specification Auxiliary input 1 TTL signal or contact closure: Input voltage range: ±30 VDC Logic High: ≥3.0 VDC Logic Low: ≤1.9 VDC Minimum pulse width: 100 msec Screw terminal connector Auxiliary input 2 TTL signal or contact closure: Input voltage range: ±30 VDC Logic High: ≥3.0 VDC Logic Low: ≤1.9 VDC Minimum pulse width: 100 msec...
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B.3.4 Xevo TQD IVD Attribute Specification Xevo TQD IVD 200-240 V, 50/60 Hz, 2 kW maximum XDS 46i scroll pump 200-230 V, 50/60 Hz XDS 100B scroll pump 200-230 V, 50/60 Hz SV65 BI rotary pump (two included) 200-240 V, 50/60 Hz B.4 Wetted materials of construction The following tables list the wetted materials of construction for the ACQUITY UPLC I-Class/Xevo TQD IVD System.
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To avoid damaging the mass spectrometer, observe the following precautions: • Contact Waters Technical Service before moving the instrument. • If you must transport the instrument, or remove it from service, contact Waters Technical Service for recommended cleaning, flushing, and packaging procedures.
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Figure C–1: Solvent flow for a Xevo TQD IVD mass spectrometer Callout # Component Callout # Component From the LC column Reservoir A Waste Pump Wash reservoir Source Reservoir B Selector valve The mass spectrometer is located on the left-hand side of the BSM, SM-FTN, and CH. Warning: To avoid electric shock, ensure that you connect the probe to the selector valve, which is grounded.
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Figure C–2: Solvent flow for ACQUITY UPLC I-Class IVD system with an SM-FTN Callout # Component Callout # Component SM wash solvent Degasser block Solvent tray Solvent selection valves (A & B) Active pre-heater Binary solvent (APH) manager (BSM) Column Vent valve Waste Needle...
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Callout # Component Callout # Component Pumps (A & B) Column heater Filters BSM solvents C.1.1 Waste connections Warning: To avoid personal contamination from solvents exposed to toxins or biohazards, prevent pooling in the system's drip trays by ensuring that the system is installed, either initially or after being moved, on a level surface that measures within one degree of horizontal.
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Requirement: To ensure optimum performance and signal integrity, use only approved (or Waters supplied), shielded, CAT 5 ethernet cables. See also: Waters Ethernet Instrument Getting Started Guide (715004803). March 17, 2020, 715005210IVD Ver. 01 (previously released as rev. A)
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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 supplied to an instrument or device.
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BSM connector II Xevo TQD IVD connector I Port 3: + Stop flow Port 4: - Stop flow Port 6: + Stop flow (out) Port 7: - Stop flow (out) Insert the connector into the BSM’s I/O port II. Attach the free end of the signal cable leads to port 6 and port 7 of a 10-pin I/O connector using the flat-blade screwdriver.
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C.3.1.1 Binary solvent manager I/O signal connectors The rear panel of the binary solvent manager includes two removable connectors that hold the screw terminals for I/O signal cables. These connectors are keyed so that they can be inserted only one way. Connector I Connector II + Auxiliary 1 In...
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Run Stopped Out Switch 1 Out Switch 1 Out Ground + 0-2V Analog 1 Out - 0-2V Analog 1 Out + Start Gradient In - Start Gradient In + Stop Flow - Stop Flow Ground Switch 2 Out Switch 2 Out Switch 3 Out Switch 3 Out Ground...
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Table C–1: Binary solvent manager analog-out/event-in connections (continued) Signal connection Description Run Stopped Out Indicates (with a contact closure) the binary solvent manager has ceased operation because of an error condition or operator request. Switch 1 Out Used to send time-based contact closure signals to external devices.
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Table C–2: Chart-out signal conditions (continued) Signal Parameter Setting at 0 Volts Parameter Setting at 2.000 (Minimum) Volts (Maximum) System Pressure –345 kPa (–3.45 bar, –50 psi) 124,106 kPa (1241 bar, 18,000 psi) Composition 0.0% 100.0% C.3.1.2 Sample manager I/O signal connectors The rear panel of the sample manager includes a removable connector that holds the screw terminals for I/O signal cables.
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To avoid electric shock, observe these precautions: • Use SVT-type power cords in the United States and HAR-type power cords, or better, in Europe. For requirements elsewhere, contact your local Waters distributor. • Inspect the power cords for damage and replace them if necessary.
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Figure C–4: FlexCart power connections (optional) Network switch (if needed) Sample manager Binary solvent manager LCD/monitor Computer workstation AC line To circuit B FlexCart power strips AC line To circuit A All cord lengths are one meter long except the LCD/ monitor cord, which is two meters long.
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Solvent considerations This information applies to the ACQUITY UPLC I-Class/Xevo TQD IVD System modules. Warning: To avoid personal contamination with biologically hazardous, toxic, or corrosive materials, you must understand the hazards associated with their handling. Guidelines prescribing the proper use and handling of such materials appear in the latest edition of the National Research Council's publication, Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards.
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Store mobile phases in borosilicate glass reservoirs type 1, class A or type 3.3 . Use brown- stained glassware to inhibit microbial growth. Use aluminum foil or Waters caps to cover the reservoirs. D.1.4 Water Use water only from a high-quality water purification system. If the water system does not deliver filtered water, filter the water through a 0.2-μm membrane filter.
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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 •...
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• Contact Waters for recommended system cleaning and flushing procedures. • Methanesulfonic acid is not recommended for use in the RenataDX system. • Always use properly cleaned (detergent-free) and dedicated glassware.
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• Do not use nonvolatile buffers as seal wash solvents. • Ensure that the mobile phase is completely soluble in and compatible with all of the solvents in use on the system. D.3.3 Sample manager recommendations Do not use buffers as needle wash solvents. You can use acids and bases. D.4 Solvent viscosity Generally, viscosity is not a consideration when you operate with a single solvent or under low pressure.
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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.
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Top tray Monitor mounting bracket Shelf mounting holes Lock knobs (2) Height adjusting screw TORX screws Power connectors (2) Remove the four 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.
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Route the monitor’s power and video cables through the plastic channel provided, and plug them into the monitor. Refer to the IBM instruction book, if necessary. Insert the keyboard shelf’s two captive thumbscrews into slots on the cart’s front panel at a level that affords comfortable and safe operation.
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Tip: If your system includes a mass spectrometer and it is positioned on the right-hand side of the system stack, set the cart to a height that minimizes the length of tubing needed between the instruments stacked on the cart and the mass spectrometer. Tighten the side lock knobs after reaching the desired height.
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Release bar Lock pedal E.5 Moving the assembled FlexCart Notice: To avoid spills of damaging solvent, remove all solvent reservoirs from the solvent tray before moving the cart. Notice: To avoid striking low doorways, lower the cart fully before moving it. Notice: To avoid toppling the instruments stacked on the cart, do not move the cart by pushing on them.
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