Waters ACQUITY UPLC I-Class IVD Manuale operativo
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 508-872 1990.
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
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