Audience And Purpose; Intended Use Of The Xevo Tqd Ivd; Compliance With Medical Device Regulations - Waters Xevo TQD IVD Overview And Maintenance Manual

Audience and purpose

This guide is for operators of varying levels of experience. It gives an overview of the instrument
and explains how to prepare it for operation and maintenance.
Operators of the Xevo TQD IVD should be professionally trained and qualified laboratory
personnel.

Intended use of the Xevo TQD IVD

Waters designed the Xevo TQD IVD for use with the ACQUITY UPLC IVD system and the
ACQUITY UPLC I-Class/Xevo TQD IVD system to perform mass spectrometry for in vitro
diagnostic use.

Compliance with Medical Device Regulations

The Waters ACQUITY UPLC I-Class/Xevo TQD IVD system is CE-marked
according to the European Union In Vitro Diagnostic Device Directive 98/79/EC.
Important: The ACQUITY UPLC I-Class/Xevo TQD IVD complies with the European Union In
Vitro Diagnostic device Directive 98/79/EC only when the mass spectrometer is fitted with a
Waters ESI source. Do not fit the instrument with other Waters or third-party sources.
Environmental requirements
Temperature
The ambient temperature range required for normal operation is 15 to 28 °C (59 to 82 °F).
The optimum temperature range is 19 to 22 °C (66 to 72 °F).
Short-term (1.5 h) variations must be no more than ±2 °C (3.5 °F).
Humidity
The relative humidity in which the instrument and pumps are to operate must be in the range of
20% to 80%, non-condensing.
September 7, 2016, 715003560IVD Rev. C
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