Roche URISYS 2400 User manual

Operator’s Manual
Version 1.0
URISYS 2400

Roche Diagnostics
ii Operator’s Manual · Version 1.0
URISYS 2400
Revision History
Edition notice URISYS 2400 Operator’s Manual
This manual is for users of the URISYS 2400.
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 URISYS 2400 is a fully automated urinalysis system intended for in vitro
qualitative or semi-quantitative determination of urine analytes, including
pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and
erythrocytes.
Copyrights © 2001, Roche Diagnostics GmbH. All rights reserved.
Trademarks The following trademarks are acknowledged:
, URISYS 2400 are registered trademarks of the Roche group. All other
trademarks that are mentioned in this manual are the property of the
respective trademark holders: KOVA® and Monovette®.
Instrument approvals The URISYS 2400 analyzer meets the requirements stated in
Directive 98⁄79⁄EC of the European Parliament and the Council of the
European Union (EU) on in vitro diagnostic medical devices. Furthermore,
the URISYS 2400 analyzer is manufactured and tested according to
International Standard IEC 1010-1, "Safety requirements for electrical
equipment for measurement, control, and laboratory use, Part 1: General
requirements". This International Standard is equivalent to the standards UL
3101-1 for the USA, CSA C 22.2 No. 1010.1 for Canada, and DIN EN 61010-1
for Germany.
The URISYS 2400 fulfils the EMC immunity requirements for laboratory use
equipment in industrial areas, according to the EMC standards EN 50082-2
and EN 61326-A1. According to EN 55011, the URISYS 2400 analyzer is a
device of limit class A.
Version Revision date
1.0 April 2001
Language Order No.
English 03184315.018

Roche Diagnostics
Operator’s Manual ·Version 1.0 iii
URISYS 2400
Compliance is demonstrated by the following marks:
Contact addresses
Manufacturer:
Authorized Representative
Warranty
Refer to the URISYS 2400 analyzer purchase agreement for warranty
conditions. Contact your local Roche Technical Support for further
information.
Complies with the IVD directive 98⁄79⁄EC.
CUS
®
Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.
Hitachi Science Systems
Ltd.
Ibaraki
Japan
EC REP Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
USA Roche Diagnostics
Corporation
9115 Hague Road
PO Box 50457
Indianapolis, IN 46250
USA

Roche Diagnostics
iv Operator’s Manual ·Version 1.0
URISYS 2400

URISYS 2400
Roche Diagnostics
Operator’s Manual ·Version 1.0 v
Table of contents
Revision History ii
Table of contents v
Preface vii
How to use this manual vii
Conventions used in this manual viii
Safety classifications x
Safety information xi
Overview Part A
1 Introduction to the system
Description of the URISYS 2400 analyzer A-2
System description Part B
2Hardware
Hardware description B-2
Installation B-5
3Software
Installation B-12
4 Cassette
First-time installation B-30
Operation Part C
5 Daily operation
Initial preparations C-3
System start C-4
Sample preparation C-8
Termination of analysis C-11
Remove processed samples C-12
Process additional samples C-13
Process STAT (emergency) samples C-14
Process control samples C-17
Replace an empty URISYS 2400 cassette C-18
Replace an expired URISYS 2400 cassette C-19
Re-insert a used URISYS 2400 cassette C-20
Analysis and documentation of results C-21
Switch off the analyzer C-34
6 Special operations
Calibration C-36
Checks C-41
Maintenance Part D
7 General maintenance actions
Maintenance procedures D-2
Maintenance menu D-4
Exchange user-replaceable parts D-8
Troubleshooting Part E
8 Data alarms (flags)
Flags on result data printout E-2
Handle alarms E-3
Reset the analyzer E-9
9 Instrument alarms (messages)
Instrument alarms (messages) E-12
Appendix Part F
10 Technical specifications
Technical specifications F-2
Barcode specifications F-3
Concentration ranges F-5
Glossary and index Part G
Glossary G-1
Index G-5

URISYS 2400
Roche Diagnostics
vi Operator’s Manual ·Version 1.0

Roche Diagnostics
Operator’s Manual ·Version 1.0 vii
URISYS 2400
Preface
The URISYS 2400 analyzer is a fully automated, benchtop urine analyzer. It is
designed for use with URISYS 2400 cassettes.
The URISYS 2400 is optimized for workloads of between 100 and 1000 urine
samples per day. Only trained personnel working in a professional laboratory
environment must operate the URISYS 2400. The analyzer has been
developed and designed to assay urine samples only.
It is important that the operator reads this manual thoroughly before using
the analyzer.
Any disregard of the instructions in the Operator’s Manual may result in a
safety risk.
How to use this manual
This manual is designed to help you perform all tasks required as part of your
work with the URISYS 2400.
Content The manual is divided into the following parts:
oPart A – Overview: The overview provides general information about the
URISYS 2400 analyzer and specific details about the safety precautions.
oPart B – System description: The system description outlines the hardware
and software components of the analyzer, the installation procedure, and
the use of the touch screen.
oPart C – Operation: This section defines the daily and special operations of
the URISYS 2400 analyzer in a step-by-step guide.
oPart D – Maintenance: This section provides details on all of the general
maintenance actions.
oPart E – Troubleshooting: This section contains information on how to
respond to data and instrument alarms, and provides troubleshooting
guidelines for alarms that cannot be solved by the operator. Alarms that
require intervention by trained Roche Technical Support personnel are
indicated.
oPart F – Appendix: This section contains additional information,
including technical specifications, glossary, and index.

Roche Diagnostics
viii Operator’s Manual ·Version 1.0
URISYS 2400
Conventions used in this manual
Visual cues are used to help locate and interpret information in this manual
quickly. This section explains formatting conventions used in this manual.
Symbols The following symbols are used:
Abbreviations The following abbreviations are used:
Symbol Used for
aProcedural step
oList item
eCross-reference
iNote and tip
[Parameter] Name of screen (enclosed in brackets)
<Start> Name of button (enclosed in less and greater)
Abbreviation Definition
A
ASCII American Standard Code for Information Interchange
B
BIL Bilirubin
C
CCD Charge-coupled device
C/D Check digit
CLA Clarity
COL Color
COM Compensation pad
COMM.Parameter Communication parameters for host-communication
available on the [System Parameters] screen
E
EMC Electromagnetic Compatibility
EN European Standard
ERY Erythrocytes
G
GLU Glucose

Roche Diagnostics
Operator’s Manual ·Version 1.0 ix
URISYS 2400
I
ID Identification number
IEC International Electrotechnical Commission
K
KET Ketones
L
LED Light Emitting Diode
LEU Leukocytes
L.TRB Lightly turbid
N
NEG Negative
NIT Nitrite
nm Nanometer
NORM Normal
O
ORANG Orange
P
P.YEL Pale Yellow
POS Positive
PRO Protein
S
SG Specific Gravity
SI Standard International
T
TS Test strip
TURBD Turbid
U
UBG Urobilinogen
Y
YELLO Yellow
Abbreviation Definition

Roche Diagnostics
xOperator’s Manual ·Version 1.0
URISYS 2400
Safety classifications
Before operating with the URISYS 2400 it is essential that the warnings,
cautions, and safety requirements contained in this manual are read and
understood by the user. This section explains how precautionary information
is formatted in the manual.
The safety precautions and important user notes are classified according to
ANSI Z535 standards. Familiarize yourself with the following meanings and
icons:
Warning
Indicates a possibly hazardous situation which, if not avoided, may result in death or
serious injury.
Examples of a “serious injury” include loss of eyesight, burn (high temperature, low
temperature), electric shock, bone fracture, or poisoning. These injuries require
medical assistance.
Biohazard
Samples containing material of human origin must be treated as potentially
infectious. The relevant laboratory guidelines on safe use must be observed.
Caution
Indicates a possibly hazardous situation which, if not avoided, may result in slight or
minor injuries, and/or damage to equipment.
“Minor injury” refers to injuries that may require medical assistance.
“Equipment” refers to extended damage to buildings, furniture, and so on.
Spillage
Avoid all liquid spills on the analyzer.