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

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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

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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
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Roche Diagnostics
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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.

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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

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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

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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.

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Safety information
Electrical safety
Connect the analyzer to grounded power outlets only (protection class 1). All
peripheral devices that are connected to the URISYS 2400 must comply with safety
standard IEC 950 (UL 1950) for information technology equipment, or with IEC
1010 (UL 3101) for laboratory use instruments.
Instrument in use
Keep hands or other objects away from the sampling probe area to prevent personal
injury while the instrument is in use. Do not touch parts of the analyzer other than
those specified.
User qualification
Only appropriately trained operators are qualified to operate the analyzer.
Correct use
Any disregard of the instructions in the Operator’s Manual may result in a safety risk.
Use the URISYS 2400 analyzer to analyze urine samples only. It is not intended for
any other application.
Transport
At least two persons must carry the analyzer, by holding the baseplates on the left
side and right side of the analyzer. Be careful not to hurt your hands or fingers when
putting the analyzer in place.
Environmental conditions
The URISYS 2400 is approved for indoor use only.
Biological safety
Liquid waste and strip waste are potentially biologically hazardous. Always wear
gloves if handling those materials. Do not touch parts of the analyzer other than
those specified. Consult your laboratory protocol for handling biohazardous
materials.
Spilling and cleaning
If a sample is spilled on the analyzer, wipe up immediately and apply disinfectant.
When handling the washing solution, ensure that you wear gloves and safety
goggles to avoid direct contact with the solution. If the solution contacts the body,
wash immediately with a large volume of water. Consult your laboratory protocol for
handling biohazardous materials.

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Radio interference
URISYS 2400 is a class A device. In residential areas it may cause radio
interference. The user must take precautions as required.
Installation
Follow the specified installation conditions carefully. Otherwise, inaccurate results,
or damage to the analyzer may occur.
Waste
Handle liquid waste and used test strips properly, according to legislation on water
pollution, and on the treatment of drainage and waste matter.
Electromagnetic waves
Devices that emit electromagnetic waves may affect measured data, or cause the
analyzer to malfunction. Do not operate the following devices in the same room
where the analyzer is installed: mobile phone, transceiver, cordless phone, other
electrical devices that generate electromagnetic waves.
o Operating and maintenance
Carefully follow the procedures specified in the Operator’s Manual for the
operation and maintenance of the analyzer. Leave maintenance of other areas to
trained Roche Technical Support personnel.
o Calibration
Calibrate the analyzer every four weeks to ensure the analyzer operates
optimally. Failure to do so may lead to inaccurate results.
o Test strips
Handle and store test strips according to the instructions provided by Roche
Diagnostics. Refer to the instructions in the package insert of the URISYS 2400
cassette.
o Particular care must be taken when performing the following procedures:
Preparing and processing samples (routine, STAT and control)
Using the washing solution
Draining the liquid waste tank
Cleaning the TS transfer base
Disposing of used test strips
Cleaning the waste box

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Figure 0-1 URISYS 2400 analyzer with labels
AHousing
BSTAT sample position
CHousing before sampling area
DStrip waste container door
EPower supply
A
C
E
D
B
Symbol Validity Symbol Validity
oSTAT position
oRack transfer
oWaste box
oTS transfer base
oPower supply
oSTAT position
oRack transfer
oSampling probe
oRack transfer
oRinsing station
oWaste box
oTS transfer base
oSTAT sample position

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Part A is an overview of the URISYS 2400.
Overview A

Roche Diagnostics
Operator’s Manual ·Version 1.0 A-1
URISYS 2400 1 Introduction to the system
Table of contents
Introduction to the system
This chapter contains an introduction to the URISYS 2400 analyzer.
Description of the URISYS 2400 analyzer .........................................................2
Measuring principle ......................................................................................2
In this chapter AChapter 1

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A-2 Operator’s Manual ·Version 1.0
1 Introduction to the system URISYS 2400
Description of the URISYS 2400 analyzer
Description of the URISYS 2400 analyzer
The URISYS 2400 analyzer 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. In addition, the analyzer determines specific
gravity, color, and clarity. The URISYS 2400 is intended for professional use
only.
The primary functions of the URISYS 2400 analyzer include:
oSample identification
oAutomatic dispensing of test strips
oRobotic pipetting of samples
oControlled incubation period
oPhotometric measurements
oResult memory
oOptional formats for data output
The URISYS 2400 analyzer uses the URISYS 2400 cassette containing 400 test
strips. Each test strip has ten individual test pads that are used to test for
different substances or characteristics. The test strips are analyzed as they
move automatically through the analyzer. One strip is used per sample. When
a strip is dispensed for use, an aliquot of the urine sample is pipetted onto
each of the test pads. The test results are based on the measurement of
reflected light intensity. The specific gravity, color, and clarity of each sample
are also measured.
Measuring principle
The URISYS 2400 is a fully automated reflectance photometer for in vitro
semi-quantitative measurements of urine test strips. The light sources (LED’s
[light-emitting diodes]) and reading times are optimized for the reaction
chemistry and color development that occur on the test pads.
The measuring head of the URISYS 2400 contains LED’s of three different
wavelengths. The test strip remains stationary at the measuring position as the
measuring head moves over each test pad. Measurement starts at the reference
plate, which is used to test the optical system.
The URISYS 2400 verifies that the test strip is properly positioned under the
measuring head, by measuring the reflected light. If a test strip is not properly
positioned under the measuring head, the URISYS 2400 displays a message.

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Operator’s Manual ·Version 1.0 A-3
URISYS 2400 1 Introduction to the system
Description of the URISYS 2400 analyzer
Reflected light is measured electro-optically, and the process is illustrated in
the following figure.
An LED (A) transmits light of a defined wavelength, at an optimum angle,
onto the surface of a test pad (B). The light hits the surface of the test pad and
is reflected with an intensity that is dependent on the color of the test pad.
A photodiode detector (C), positioned directly above the test pad, receives the
reflected light. The photodiode detector transmits an analog electrical signal
to the analog-to-digital converter (D), which changes the analog signal to a
digital value.
A microprocessor (E) adjusts the digital value, based on a value from an
internal reference plate. It converts the digital value to a relative value by using
a calibration standard scale. Then, the microprocessor calculates a reflectance
value.
The semi-quantitative concentration result (F) is determined by comparing
the reflectance value with the so-called range limits (parameter-specific
reflectance values stored in the analyzer). The full list of concentration range
values for all test parameters is shown in:
The results are stored in the memory and can be printed, saved to a diskette,
or sent to another computer.
Each of the three LED’s transmits light of a different wavelength. The use of
different wavelengths improves the results that are obtained from measuring
each of the test strip parameters. The wavelengths used to measure the
different parameters are listed in the table below.
Figure A-1 Process of measuring
ALED
BTest pad
CPhotodiode detector
DAnalog-to-digital converter
EMicroprocessor
FConcentration result
E
CD
F
A
B
Optical transmission Electronic transmission
Table F-1 on page F-5

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1 Introduction to the system URISYS 2400
Description of the URISYS 2400 analyzer
The photometric reflectance measurement for all of the test parameters is
performed after an incubation time of 60 seconds. As with previous urine
analyzers from Roche Diagnostics, compensation for intrinsic urinary color,
which is a recognized interfering factor, is made through the measurement of
a blank compensation pad on the test strip. The compensation pad assists in
the prevention of false positives when a urine sample is strongly colored.
The URISYS 2400 determines the urine color by evaluating the reflectance
values of all three measuring wavelengths (470 nm, 555 nm, and 620 nm) on
the compensation pad. Color results are reported as PALE YELLOW,
YELLOW, AMBER, BROWN, ORANGE, RED, GREEN, or OTHERS.
The measurement of specific gravity (SG) is performed in a flow cell that is
filled with a urine sample during aspiration of the sample. An LED (650 nm)
transmits light to the flow cell. A charge-coupled device (CCD) determines
the angle of total reflection. The refractive index of the sample is calculated
from the angle of total reflection using a calibration curve. Transformation
into the SG value is performed by a nomogram stored in the analyzer.
The flow cell that is used to measure specific gravity also determines the
clarity of the sample. However, light of a different LED is used to measure
clarity. This LED (660 nm) transmits light to the flow cell, and the amount of
light that passes through the flow cell is measured.
The system is blanked (zeroed) during the washing process, between sample
measurements, by setting the water transmission to 100%. The transmission
values of samples are transformed to clarity results (CLEAR, LIGHT TURBID
or TURBID), by using the clarity range table that is programmed in the
software of the URISYS 2400.
Test parameter Measuring wavelength (nm)
pH 555, 620
Leukocytes 555
Nitrite 555
Protein 555
Glucose 555
Ketones 555
Urobilinogen 555
Bilirubin 555
Erythrocytes 555, 620
Color 470, 555, 620
Table A-1 Wavelengths used to measure the reflectance values