Roche Diagnostics
2 Operator's Manual · Version 2.0.1
cobas u 411
Revision history
Edition notice cobas u 411 analyzer Operator's Manual
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of printing. However, Roche Diagnostics GmbH
reserves the right to make any changes necessary without notice as part of ongoing
product development.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Intended use The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer. It is
designed to read the Combur
10
Test M test strips which are marketed in the United
States as the Chemstrip 10 UA test strips and Chemstrip 10 MD test strips for
urinalysis. This analyzer is intended for the measurement of bilirubin, blood,
glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and
color (if selected). These measurements are useful in the evaluation of renal, urinary
and metabolic disorders. Tests performed using the cobas u 411 are intended for
prescription, in vitro diagnostic use only. Only trained personnel working in a
professional laboratory environment may operate the cobas u 411 analyzer.
Copyright © 2007-2013, Roche Diagnostics GmbH. All rights reserved.
Manual
version
Software
version
Revision date Amendments
1.0 3.0 March 2007
1.1 3.1 April 2010 Implementation of reference ranges
Intended use revised,
Abbreviation QC added
Chapter Controls&Lots: Note controls (QC) added.
2.0 3.2 December 2010 Test strip handling updated, note for barcode
handling added, range information updated.
2.0.1 3.2 January 2013 Chemstrip 10 MD test strips added to intended use.
