Responsible Person (Ukrp); Intended Use Statement; Incident Reporting; Quality Control - Agilent Technologies BioTek Epoch Instructions For Use Manual

Preface
UK Responsible Person (UKRP)
Agilent LDA UK Ltd.
5500 Lakeside
Cheadle Royal Business Park
Cheadle, Cheshire SK8 3GR

Intended Use Statement

The Epoch is an absorbance microplate spectrophotometer and intended to be used for
the examination of clinical specimens to analyze their characteristics in relation to a variety
of analytes including in human serum and cells.

Incident Reporting

Any serious incident that has occurred in relation to the device shall be reported to the
manufacturer and the competent authority, or appropriate regulatory body, in the country
or region in which the user is established.

Quality Control

It is considered good laboratory practice to run laboratory samples according to
instructions and specific recommendations included in the assay package insert for the
test to be conducted. Failure to conduct Quality Control checks could result in erroneous
test data.

Safety Notices

Pay special attention to the following safety notices in all product documentation.
A WARNING notice denotes a hazard. It calls attention to an operating
-WARNING-
procedure, practice, or the like that, if not correctly performed or adhered
to, could result in personal injury or death. Do not proceed beyond a
WARNING notice until the indicated conditions are fully understood and
met.
A CAUTION notice denotes a hazard. It calls attention to an operating
-CAUTION-
procedure, practice, or the like that, if not correctly performed or adhered
to, could result in damage to the product or loss of important data. Do not
proceed beyond a CAUTION notice until the indicated conditions are fully
understood and met.
Agilent BioTek Epoch Instructions for Use
7201009I Revision C
Page 4 of 31
Agilent Technologies, Inc.