Waters ACQUITY UPLC I-Class IVD Parts list manual

ACQUITY UPLC
I-Class IVD
System Guide
715003736IVD / Revision C
Copyright © Waters Corporation 2014
All rights reserved

ii July 7, 2014, 715003736IVD Rev. C

July 7, 2014, 715003736IVD Rev. C iii
General Information
Copyright notice
© 2014 WATERS CORPORATION. PRINTED IN THE UNITED STATES OF
AMERICA AND IN IRELAND. ALL RIGHTS RESERVED. THIS
DOCUMENT OR PARTS THEREOF MAY NOT BE REPRODUCED IN ANY
FORM WITHOUT THE WRITTEN PERMISSION OF THE PUBLISHER.
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. In no event shall Waters Corporation be liable for incidental or
consequential damages in connection with, or arising from, its use. For the
most recent revision of this document, consult the Waters Web site
(waters.com).
Trademarks
ACQUITY, ACQUITY UPLC, Connections INSIGHT, UPLC, Xevo, and
Waters are registered trademarks, and eCord, MassLynx, TargetLynx, and
“THE SCIENCE OF WHAT’S POSSIBLE.” are trademarks of Waters
Corporation.
PEEK is a trademark of Victrex Corporation.
Other registered trademarks or trademarks are the sole property of their
owners.

iv July 7, 2014, 715003736IVD Rev. C
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.
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, and consult your organization’s
standard operating procedures.
Waters contact information:
Contacting medium Information
Internet The Waters Web site includes contact
information for Waters locations worldwide.
Visit www.waters.com.
Telephone and fax From the USA or Canada, phone 800
252-HPLC (800 252-4752) or fax [phone].
For other locations worldwide, phone and fax
numbers appear in the Waters Web site.
Conventional mail Waters Corporation
34 Maple Street
Milford, MA 01757
USA

July 7, 2014, 715003736IVD Rev. C v
Considerations specific to the ACQUITY UPLC I-Class IVD
instruments
See also: For safety considerations regarding specific system modules,
consult the appropriate information on the user documentation CD (part
number 715003740IVD).
FCC radiation emissions notice
Changes or modifications not expressly approved by the party responsible for
compliance, could void the users authority to operate the equipment. This
device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful 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.
Electrical power safety notice
Do not position the instrument so that it is difficult to operate the
disconnecting device.
Warning: To avoid injury, if the ACQUITY UPLC I-Class IVD system
must be relocated, drain and remove all liquids, including solvents and
waste, from the system.
Warning: To avoid injury, if the ACQUITY UPLC I-Class IVD system
must be relocated, disconnect the power cord and all cables.
Warning: To prevent incorrect reporting of results, verify proper sample
vial placement and positioning against the sample list, prior to sample
injection.

vi July 7, 2014, 715003736IVD Rev. C
Safety hazard symbol notice
Documentation needs to be consulted in all cases where the symbol is
used to find out the nature of the potential hazard and any actions which have
to be taken.
Equipment misuse notice
If the equipment is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired.
Safety advisories
Consult Appendix A for a comprehensive list of warning and caution
advisories.
Operating the ACQUITY UPLC I-Class IVD system
When operating the ACQUITY UPLC I-Class IVD system, follow standard
quality control (QC) procedures and the guidelines presented in this section.
Applicable symbols
Symbol Definition
Indicates the medical device manufacturer as
defined in EU Directive 98/79/EC
Indicates the authorized representative in the
European Community
Confirms that a manufactured product complies
with all applicable European Community
directives
Australia C-Tick EMC compliant

July 7, 2014, 715003736IVD Rev. C vii
Audience and purpose
This guide is intended only for professionally trained and qualified laboratory
personnel who install, operate, and maintain ACQUITY UPLC I-Class IVD
system modules. It gives an overview of the system’s technology and
operation.
Intended use of the ACQUITY UPLC I-Class IVD system
The ACQUITY UPLC I-Class IVD system is a general purpose in vitro
diagnostic instrument used to quantify and qualify of a wide variety of
compounds in biological sample matrices. The system is intended to be used
only by qualified operators.
Calibrating
To calibrate LC systems, follow acceptable calibration methods using at least
five standards to generate a standard curve. The concentration range for
Confirms that a manufactured product complies
with all applicable United States and Canadian
safety requirements
Consult instructions for use
Electrical and electronic equipment with this
symbol may contain hazardous substances and
should not be disposed of as general waste.
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 in vitro diagnostic use
The Waters ACQUITY UPLC I-Class IVD system is CE-marked
according to the European Union In Vitro Diagnostic Device
Directive 98/79/EC.
Symbol Definition

viii July 7, 2014, 715003736IVD Rev. C
standards should include the entire range of QC samples, typical specimens,
and atypical specimens.
When calibrating mass spectrometers, consult the instrument’s online Help
system for instructions.
Quality control
Routinely run three QC samples that represent subnormal, normal, and
above-normal levels of a compound. If sample trays are the same or very
similar, vary the location of the QC samples in the trays.
Ensure that QC sample results fall within an acceptable range, and evaluate
precision from day to day and run to run. Data collected when QC samples are
out of range might not be valid. Do not report these data until you are certain
that the instrument performs satisfactorily.
You can use TargetLynx software to set quality parameters that incorporate a
range of confirmatory checks to identify samples outside of user-specified or
regulatory thresholds. See the TargetLynx Online help topic “QC Monitor
properties.” Data should also be manually inspected prior to the reporting of
any results.
When analyzing samples from a complex matrix such as soil, tissue,
serum/plasma, whole blood, and other sources, 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 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 samples as unknowns to verify assay results
for a single analysis.

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ISM classification
ISM Classification: ISM Group 1 Class B
This classification has been assigned in accordance with IEC CISPR 11
Industrial Scientific and Medical (ISM) instruments requirements. Group 1
products apply to intentionally generated and/or used conductively coupled
radio-frequency energy that is necessary for the internal functioning of the
equipment. Class B products are suitable for use in both commercial and
residential locations and can be directly connected to a low voltage,
power-supply network.
EC authorized representative
Waters Corporation
Stamford Avenue
Altrincham Road
Wilmslow SK9 4AX
United Kingdom
Telephone: [phone]
Fax: [phone]
Contact: Quality manager

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July 7, 2014, 715003736IVD Rev. C xi
General Information .................................................................................... iii
Copyright notice .................................................................................................. iii
Trademarks ........................................................................................................... iii
Contacting Waters ............................................................................................... iv
Safety considerations .......................................................................................... iv
Considerations specific to the ACQUITY UPLC I-Class IVD instruments...... v
FCC radiation emissions notice .......................................................................... v
Canada spectrum management emissions notice .............................................. v
Electrical power safety notice ............................................................................. v
Safety hazard symbol notice............................................................................... vi
Equipment misuse notice ................................................................................... vi
Safety advisories................................................................................................. vi
Operating the ACQUITY UPLC I-Class IVD system .................................... vi
Applicable symbols ............................................................................................. vi
Audience and purpose....................................................................................... vii
Intended use of the ACQUITY UPLC I-Class IVD system ............................ vii
Calibrating ........................................................................................................ vii
Quality control ................................................................................................. viii
ISM classification ................................................................................................. ix
ISM Classification: ISM Group 1 Class B ......................................................... ix
EC authorized representative ........................................................................... ix
1 ACQUITY UPLC I-Class IVD System .................................................. 17
System components ........................................................................................... 17
Binary solvent manager .................................................................................... 18
Sample manager-flow through needle.............................................................. 19
Column heater with active preheater............................................................... 19
Xevo TQ-S IVD mass spectrometer................................................................... 19
Column technology ............................................................................................ 20
Table of Contents

xii July 7, 2014, 715003736IVD Rev. C
Software and data system ................................................................................. 20
Optional columns ............................................................................................... 21
Vials, plates, and seals ...................................................................................... 22
For additional information .............................................................................. 22
2 Optimizing Performance ....................................................................... 23
General guidelines ............................................................................................. 23
Carryover ............................................................................................................. 25
Contamination .................................................................................................... 26
Temperature ....................................................................................................... 26
Reproducibility .................................................................................................. 26
Cycle time (between injections) ..................................................................... 26
Preventing leaks ................................................................................................ 27
Sample preparation ........................................................................................... 28
Particulates ........................................................................................................ 28
Matching sample diluents ................................................................................. 28
3 Preparing the System ............................................................................ 29
Preparing system hardware ............................................................................ 29
Powering-on the system .................................................................................... 29
Monitoring system module LEDs ..................................................................... 30
Power LED ......................................................................................................... 30
Status LEDs....................................................................................................... 30
Enabling the leak sensors ................................................................................. 31
Starting the system ........................................................................................... 32
Configuring MassLynx software .................................................................... 33
ACQUITY control panels .................................................................................. 33
Binary solvent manager control panel.............................................................. 33
Sample manager control panel ......................................................................... 36

July 7, 2014, 715003736IVD Rev. C xiii
Starting the ACQUITY UPLC Console .......................................................... 38
4 Maintenance Procedures ...................................................................... 39
Maintenance schedule ...................................................................................... 39
Spare parts .......................................................................................................... 45
Troubleshooting with Connections INSIGHT ............................................. 46
Safety and handling .......................................................................................... 47
Configuring maintenance warnings .............................................................. 48
A Safety Advisories .................................................................................... 49
Warning symbols ................................................................................................ 49
Task-specific hazard warnings.......................................................................... 49
Specific warnings ............................................................................................... 51
Caution advisory ................................................................................................ 53
Warnings that apply to all Waters instruments .......................................... 53
Electrical and handling symbols .................................................................... 59
Electrical symbols .............................................................................................. 59
Handling symbols .............................................................................................. 60
B Specifications .......................................................................................... 61
Physical specifications ..................................................................................... 61
Binary solvent manager .................................................................................... 61
Sample manager - FTN ..................................................................................... 62
Column heater ................................................................................................... 62
TQ-S mass spectrometer ................................................................................... 63
Environmental specifications ......................................................................... 63
Binary solvent manager input/output specifications....................................... 65
Sample manager - FTN input/output specifications........................................ 66
Xevo TQ-S input/output specifications ............................................................. 67
Wetted materials of construction ................................................................... 67
Binary solvent manager .................................................................................... 67

xiv July 7, 2014, 715003736IVD Rev. C
Sample manager - FTN ..................................................................................... 67
Column Heater................................................................................................... 68
C External Connections ............................................................................ 69
System tubing connections .............................................................................. 69
External wiring connections ........................................................................... 71
ACQUITY UPLC I-Class IVD instrument external wiring connections ........ 71
Ethernet connections ......................................................................................... 72
Column heater connection................................................................................. 72
Signal connections ............................................................................................. 73
Connecting signal cables ................................................................................... 73
Connecting to the electricity source ............................................................. 78
D Solvent Considerations ......................................................................... 81
Solvent guidelines .............................................................................................. 81
Clean solvents .................................................................................................... 81
Solvent quality ................................................................................................... 82
Solvent preparation ........................................................................................... 82
Water .................................................................................................................. 82
Solvent recommendations ............................................................................... 83
Recommended solvents...................................................................................... 83
Solvents to avoid ................................................................................................ 84
Recommended additives/modifiers.................................................................... 84
Recommended sample diluents......................................................................... 85
Recommended cleaning agents ......................................................................... 85
System recommendations ................................................................................ 86
ACQUITY UPLC I-Class IVD system recommendations ................................ 86
Binary solvent manager recommendations...................................................... 86
Sample manager recommendations.................................................................. 87
Properties of common solvents ...................................................................... 87
Solvent miscibility ............................................................................................. 88
Using miscibility numbers (M-numbers).......................................................... 89

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Solvent viscosity ................................................................................................. 90
E FlexCart Assembly ................................................................................. 91
Assembling the FlexCart .................................................................................. 91
Adjusting the FlexCart’s height ..................................................................... 93
Locking the FlexCart in place ........................................................................ 94
Moving the assembled FlexCart ..................................................................... 95

xvi July 7, 2014, 715003736IVD Rev. C

System components
July 7, 2014, 715003736IVD Rev. C 17
1ACQUITY UPLC I-Class IVD
System
The ACQUITY UPLC I-Class IVD system is a general purpose, in vitro, tool
for quantifying and qualifying diverse compounds in biological sample
matrices. The system is intended to be used by only highly qualified operators.
System components
Major components of the ACQUITY UPLC I-Class IVD System:
The ACQUITY UPLC I-Class IVD system includes the following components:
Contents:
Topic Page
System components.......................................................................... 17
For additional information .............................................................. 22
Sample manager -
FTN
Binary solvent
manager
Column heater CH-A
Xevo TQ-S

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• ACQUITY UPLC I-Class Binary Solvent Manager (BSM)
• ACQUITY UPLC I-Class Sample Manager - Flow-Through-Needle (SM -
FTN)
• 50 µL extension loop for SM-FTN
• Column Heater with active pre-heating (CH-A) and tubing
• Column Heater (CH-A) extension kit for mass spectrometer
•Xevo TQ-S IVD mass spectrometer
• ACQUITY UPLC I-Class System Startup kit, including solvent tray
module
•Leak sensors
•ACQUITY UPLC BEH C
18 column, 1.7 µm, 2.1 x 50 mm, IVD
• ACQUITY UPLC I-Class IVD system documentation CD, part number
715003740IVD
• Workstation and MassLynx, ACQUITY UPLC Console software, and
Connections INSIGHT software
•FlexCart, optional
Binary solvent manager
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 (i2Valve), automated priming functions, and daily system-setup
routines.
The design of the binary solvent manager is optimized for sub-2-µm particle
liquid chromatography. The upper pressure limit is set at 124,106 kPa
(1241 bar, 18,000 psi) per pump. A maximum flow rate of 1 mL/min is
permitted at system backpressures to 124,106 kPa (1241 bar, 18,000 psi),
which falls within the range of optimal linear velocity for sub-2-µm particle
columns of ID 1.0 mm to 3.0 mm.
See also: The ACQUITY UPLC I-Class IVD Binary Solvent Manager
Overview and Maintenance Guide (part number 715003739IVD) for more
details.

System components
July 7, 2014, 715003736IVD Rev. C 19
Sample manager-flow through needle
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. The needle serves as
part of the injection flow path when the sample is pushed onto the column.
A 50-µL extension loop (installed between the sample needle and the injection
valve) can increase the injection volume beyond that of the sample needle.
The flow-through-needle mechanism operates similarly to most traditional
HPLC systems.
See also: The ACQUITY UPLC I-Class IVD Sample Manager - Flow Through
Needle Overview and Maintenance Guide (part number 715003737IVD) for
more details.
Column heater with active preheater
The ACQUITY UPLC I-Class IVD column heater (CH-A) controls the column
temperature independent of flow rate.
The column heater (CH-A) heats the column compartment to any temperature
between 20 ºC and 90 ºC that is at least 5 °C above the ambient temperature.
For example, if the ambient temperature is 25 °C, the range is 30 to 90 °C. A
low dispersion, active preheating device heats the incoming solvent to match
the temperature of the column before the solvent enters the column. The
column compartment can accommodate columns of up to 4.6 mm I.D. and up
to 150 mm length.
See also: The ACQUITY UPLC I-Class IVD Column Heater Overview and
Maintenance Guide (part number 715003738IVD) for more details.
Xevo TQ-S IVD mass spectrometer
The Waters® Xevo® TQ-S is a tandem quadrupole, atmospheric-pressure
ionization (API) mass spectrometer. Designed for routine HPLC/MS/MS and
UPLC®/MS/MS analyses in quantitative and qualitative applications, it can
operate at fast acquisition speeds compatible with UltraPerformance LC®.
See also: The Xevo TQ-S IVD Mass Spectrometry System Operator’s Overview
and Maintenance Guide for more details.

1 ACQUITY UPLC I-Class IVD System
20 July 7, 2014, 715003736IVD Rev. C
Column technology
ACQUITY UPLC IVD columns are packed with sub-2-µm, bridged,
ethylsiloxane, hybrid or 1.8-µm high-strength silica particles that can
mechanically endure high-pressure conditions. The column hardware can
withstand as much as 124,106 kPa (1241 bar, 18,000 psi). The column
dimensions allow optimal MS-compatible flow rates, and matched outlet
tubing minimizes the effect of extra-column volume.
eCord technology
ACQUITY UPLC columns include an eCord™ column chip that tracks the
usage history of the column. The eCord column chip interacts with the system
software, recording information for as many as 50 sample queues run on the
column. The eCord column chip provides documentation of the column used
for each chromatographic run and records the following information:
•Number of injections onto the column
• Number of samples injected onto the column
• The highest pressure that the column has experienced (and the date)
• The highest temperature the column has experienced (and the date)
In addition to the variable column usage data, the eCord column chip also
stores these fixed, column-manufacturing data:
• Unique column identification
• Certificate of Analysis
•QC test data
When you attach the eCord column chip to a receptacle on the column heater
or column manager, information is automatically recorded by the system. No
user action is required.
Software and data system
MassLynx software, which includes the TargetLynx™ application manager,
controls the mass spectrometer and analyzes, manages, and distributes its
data.