Waters ACQUITY UPLC I-Class IVD Operating manual

ACQUITY UPLC
I-Class IVD
Column Heater
Overview and Maintenance Guide
715003738IVD / Revision C
Copyright © Waters Corporation 2019
All rights reserved

ii Rev. C, 715003738IVD

September, 2019, 715003738IVD Rev. C iii
General Information
Copyright notice
© 2012–2019 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.
Trademarks
ACQUITY, ACQUITY UPLC, UPLC, Waters Quality Parts, and Waters are
trademarks of Waters Corporation, and eCord and “THE SCIENCE OF
WHAT’S POSSIBLE.” are trademarks of Waters Corporation.
PEEK is a trademark of Victrex Corporation.
Phillips is a trademark of Phillips Screw Company.
TORX is a trademark of Textron Corporation.
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:
Contacting medium Information
Internet The Waters Web site includes contact
information for Waters locations worldwide.
Visit www.waters.com.

iv Rev. C, 715003738IVD
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
safety representative for guidance.
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
Global Support Services
34 Maple Street
Milford, MA 01757
USA
Waters contact information:
Contacting medium Information

September, 2019, 715003738IVD Rev. C v
Considerations specific to the column heater
High voltage hazard
Relocation
FCC radiation emissions notice
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s 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 electric shock, do not remove the device’s protective
panels. The components within are not user-serviceable.
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 burn injuries, set the column temperature to Off,
and then allow the column compartment and its components to cool for
60 minutes before touching them. Monitor the column compartment's
internal temperature to ensure that all components are cool.

vi Rev. C, 715003738IVD
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 that 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 this device
When operating this device, 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.
Date of manufacture.
Authorized representative of the European
Community.
Part number, catalog number.
Confirms that a manufactured product complies
with all applicable European Community
directives.

September, 2019, 715003738IVD Rev. C vii
Australia C-Tick EMC compliant.
Confirms that a manufactured product complies
with all applicable United States and Canadian
safety requirements.
Environmentally friendly use period (China
RoHS): indicates the number of years from the
date of manufacture until the product, or
components within the product, are likely to be
discarded or degrade into the environment.
Consult instructions for use.
Alternating current.
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 indoor use only.
No pushing.
Serial number.
For in vitro diagnostic use.
Symbol Definition

viii Rev. C, 715003738IVD
Audience and purpose
This guide is intended for use only by professionally trained and qualified
laboratory personnel who operate and maintain ACQUITY UPLC I-Class IVD
column heaters.
Intended use of the column heater
Waters designed the ACQUITY UPLC I-Class IVD column heater for use with
the ACQUITY UPLC I-Class IVD system to perform ultra-performance liquid
chromatography for in vitro diagnostic use.
Calibrating
To calibrate LC systems, follow acceptable calibration methods using at least
five standards to generate a standard curve. The concentration range for
standards must 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 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.
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.

September, 2019, 715003738IVD Rev. C ix
• 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.
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 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.

x Rev. C, 715003738IVD
Manufacturing information
Australian sponsor information
Waters Corporation
34 Maple Street
Milford, MA 01757
USA
Australian Sponsor
Emergo, Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia

September, 2019, 715003738IVD Rev. C xi
General Information .................................................................................... iii
Copyright notice .................................................................................................. iii
Trademarks ........................................................................................................... iii
Contacting Waters ............................................................................................... iii
Safety considerations .......................................................................................... iv
Considerations specific to the column heater..................................................... v
High voltage hazard ........................................................................................ v
Relocation ........................................................................................................ 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 this device .......................................................................................... vi
Applicable symbols ............................................................................................. vi
Audience and purpose...................................................................................... viii
Intended use of the column heater ................................................................. viii
Calibrating ....................................................................................................... viii
Quality control ................................................................................................. viii
ISM classification ................................................................................................. ix
ISM Classification: ISM Group 1 Class B ......................................................... ix
Manufacturing information .............................................................................. x
Australian sponsor information ........................................................................ x
1 Overview ................................................................................................... 15
Column heater description .............................................................................. 15
Active preheater ................................................................................................. 16
Table of Contents

xii September, 2019, 715003738IVD Rev. C
Major components ............................................................................................. 17
2 Preparing the column heater ............................................................... 19
Installation recommendations for fittings ................................................... 19
Installing the column heater ........................................................................... 22
Installing the MS extension bracket ............................................................ 22
Required materials ........................................................................................ 23
Required tools ................................................................................................ 23
Installing the optional column stabilizer assembly .................................... 36
Required materials ........................................................................................ 38
Required tools ................................................................................................ 38
Installing the optional in-line filter ............................................................... 41
Required materials ........................................................................................ 42
Required tools ................................................................................................ 42
Installing the column ........................................................................................ 44
Required materials .................................................................................... 44
Required tool .............................................................................................. 44
3 Using the column heater ....................................................................... 49
Resolving column heater leak sensor errors ............................................... 49
Required materials ........................................................................................ 50
4 Maintenance Procedures ...................................................................... 57
Maintenance schedule ...................................................................................... 58
Spare parts .......................................................................................................... 61
Safety and handling .......................................................................................... 61
Contacting Waters Technical Service ........................................................... 61
Locating system serial numbers ....................................................................... 62
Configuring maintenance warnings .............................................................. 63
Replacing the column heater’s leak sensor ................................................. 63
Required materials ........................................................................................ 63

September, 2019, 715003738IVD Rev. C xiii
Required tools ................................................................................................ 63
Replacing the column ....................................................................................... 69
Required materials ........................................................................................ 69
Replacing the active preheater assembly .................................................... 70
Required materials ........................................................................................ 71
Required tools ................................................................................................ 71
Replacing the column stabilizer assembly .................................................. 73
Required materials ........................................................................................ 74
Required tools ................................................................................................ 74
Replacing the frit in the in-line filter unit ................................................... 77
Required materials ........................................................................................ 77
Required tools ................................................................................................ 77
Cleaning the instrument’s exterior ............................................................... 79
A Safety Advisories .................................................................................... 81
Warning symbols ................................................................................................ 81
Specific warnings ............................................................................................... 83
Burst warning ............................................................................................... 83
Biologically hazardous materials warning .................................................. 83
Biologically hazardous materials and chemical hazard warning ............... 84
Caution advisory ................................................................................................ 84
Warnings that apply to all Waters instruments and devices ................... 85
Warnings that address the replacing of fuses ............................................. 90
Electrical and handling symbols .................................................................... 92
Electrical symbols .............................................................................................. 92
Handling symbols .............................................................................................. 93
B Specifications .......................................................................................... 95
Physical specifications ..................................................................................... 95
Environmental specifications ......................................................................... 96

xiv September, 2019, 715003738IVD Rev. C
Electrical specifications ................................................................................... 96
Performance specifications ............................................................................. 97
Wetted materials of construction ................................................................... 98

Column heater description
September, 2019, 715003738IVD Rev. C 15
1Overview
Column heater description
A standard component of the basic ACQUITY UPLC I-Class IVD system, the
column heater heats the column compartment to any temperature, from 20ºC
to 90 ºC, that is at least 5 ºC above the ambient temperature. For example, if
the ambient temperature is 25 ºC, the range is 30 to 90 ºC.
A standard, active preheater heats the incoming solvent before it enters the
column. Additionally, you can install a passive preheater.
Important: Changes in the ambient temperature, such as those caused by air
conditioning or heating, affect the performance of the column preheater (also
known as a stablilizer).
Ensure that the temperature limits you set are in accordance with your
analysis method.
The column heater can accommodate UPLC™columns with dimensions of as
much as 4.6 mm, internal diameter (ID) and 150-mm long.
To reduce dispersion associated with dead volume and minimize the length of
tubing between system instruments, the column compartment is directly
above the sample manager. To reduce the distance to the mass spectrometer’s
inlet probe, you can mount the column compartment on a bracket to the
right-hand side of the system stack.
Contents:
Topic Page
Column heater description .............................................................. 15
Active preheater............................................................................... 16
Major components ............................................................................ 17

1 Overview
16 September, 2019, 715003738IVD Rev. C
A receptacle on the column heater’s right-hand side receives the column’s
eCord™ chip. The eCord column chip stores column manufacturing and usage
data, which you can access from the ACQUITY UPLC Console.
The column heater does not have its own power supply; it draws power from
the sample manager. Thus, the column heater is automatically powered-on
when you power-on the sample manager.
Active preheater
The standard active preheater uses an electric heating element to directly
heat the column inlet tubing. The rapid heating, low-volume design reduces
gradient delay and extra-column bandspreading. It ensures that high flow
rate separations occur at the column temperature, not at the temperature of
the incoming solvent. By controlling the temperature of the mobile phase at
the point of use, the active preheater eliminates the column-inlet temperature
differences that accompany variations in the system configuration.
Active preheater:
If you use the active preheater when running an HPLC or UPLC method
originally developed for use with a column stabilizer, adjustments to the
column temperature can be necessary.

Major components
September, 2019, 715003738IVD Rev. C 17
Major components
The following diagram shows the column heater’s major components:
Column heater components:
Component Description
Column
compartment
Contains the column, column heater, in-line filter, and
active preheater or column stabilizer assembly. The
column compartment insulates the column from changes
in ambient temperature. To reduce the distance to the
inlet probe of a mass spectrometer, you can mount the
assembly on an external bracket on the right-hand side
of the chassis.
In-line filter Protects the analytical column against contamination by
trapping impurities before they reach the column.
Active preheater
assembly
Heats the incoming solvent to the specified column
temperature before the solvent enters the column.
Active preheater
retainer
Secures the active preheater in the column
compartment.
eCord receptacle Receives the column eCord chip, which stores column
manufacturing and usage data.
Column compartment tray Location of
column
Fitting Active preheater
retainer
Active preheater
assembly

1 Overview
18 September, 2019, 715003738IVD Rev. C
Column stabilizer
(optional)
Passively heats the incoming solvent before the solvent
enters the column.
Originally used in the ACQUITY UPLC system, the
column stabilizer can be useful when you transfer
methods from that system.
Drip tray Captures any leakage from the column or column
connections and routes it into the drip management
system.
Column heater components: (Continued)
Component Description

Installation recommendations for fittings
September, 2019, 715003738IVD Rev. C 19
2Preparing the column heater
Installation recommendations for fittings
The system uses gold-plated compression screws and two-piece ferrules. See
the diagram below for assembly orientation:
Recommendations:
• To prevent bandspreading, ensure that the tubing reaches the bottom of
its fitting hole before tightening the compression screw.
• For easier accessibility, use long compression screws to attach tubes to
the injector and vent valve.
Contents:
Topic Page
Installation recommendations for fittings ...................................... 19
Installing the column heater ........................................................... 22
Installing the optional in-line filter ................................................ 41
Installing the column....................................................................... 44
Warning: To avoid personal contamination with biologically
hazardous materials, toxic compounds, or their residues, wear
clean, chemical-resistant, powder-free gloves when reinstalling
the fittings.
TubingCompression screw
Ferrule with
locking ring

2 Preparing the column heater
20 September, 2019, 715003738IVD Rev. C
• Whenever you loosen fittings during maintenance, examine them for
cracks, stripped threads, and deformations.
• Do not reuse stainless steel fittings more than six times.
• When installing or removing a column or optional in-line filter, always
hold the active preheater’s reusable compression fitting in place and
rotate the column or in-line filter onto the fitting.
When tightening system fittings, consult the following table:
Installation recommendations for ACQUITY UPLC I-Class IVD column
compartment fittings:
Fitting Recommended tightening
First use
Reusable finger-tight Finger-tight, plus 1/6-turn
Reinstalled
Reusable finger-tight Finger-tight, plus up to
1/6-turn; if leaking, tighten
another 1/8-turn
TP02728
1/6-turn
Collet
removal tool
1/6-turn
Additional 1/8-turn