Teledyne XTRX500 User Manual page 15

B. Regulatory and Safety
General safety statements
Intended Use
The sample preparation extractor (XTRX500) is a semi-
automated sample preparation unit for improved repeatability
over traditional methods and intended for sample preparation in
the process of further analysis.
The XTRX500 is thus intended to be a tool for use by laboratory
scientists to release their time from the existing process, but not
to replace their involvement or their responsibility. As such,
correct functioning of the dissolution process as a whole relies
not just on the XTRX500, but also involves normal laboratory
functions and responsibilities, such as, method validation,
standard operating procedures (SOP's), operator diligence and
decision-making, etc. When used with volatile and flammable
extraction solvents the XTRX500 should be operated in a fume
cupboard. It is recommended as best practice that XTRX500 is
always operated within a fume cupboard regardless of the
solvent being used. The instrument is not to be used with
chemicals that self-ignite. If the XTRX500 is used with materials
that are a biohazard then the material must be handled
appropriately according to existing SOP's.
Declaration of Conformity
See Declaration of Conformity sheet enclosed with the
instrument.
General considerations
Changes or modifications to this unit not expressly approved by
the party responsible for compliance could void the user's
authority to operate the equipment.
The user should be aware that if the equipment is used in a
manner not specified by the manufacturer, the protection
provided by the equipment might be impaired.
When using the sample preparation extractor, follow the
generally accepted procedures for quality control and method
development.
When using the sample preparation extractor in the field of solid
dosage form analysis, if a change is observed in resultant data
compared to known data, immediately determine the reason for
the change(s). Until the cause of a change is determined, do not
rely on the analysis.
46-208-208 Rev. B—XTRX500 User Guide B-3