cobas Urisys 1100 User manual

Urisys 1100® urine analyzer
Operator’s Manual
Publication version 10.0

2
Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Publication information
General information This document is intended for the US market only.
The contents of this document, including all graphics and
photographs, are the property of Roche. No part of this
document may be reproduced or transmitted in any form
or by any means, electronic or mechanical, for any
purpose, without the express written permission of Roche.
Revision history
Publication version Software version Revision date Amendments
9.0 and lower 6.x 2012 - 2021 Before device's update
10 7.x July 2023 • General update of the Operator’s Manual.
• Documentation updates resulting from the device’s
update which is applicable for devices with a serial
number starting with UX11.
y Revision history
Where to find information The Operator’s Manual and the User Assistance
contain all information about the product, including the
following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• Software reference
• Configuration information
• Background information
The Operator’s Manual and the User Assistance
contain important safety information. You must read them
before operating the device.
The Quick Reference Guide gives a brief introduction to
important routine tasks.
Privacy notice
When you use User Assistance online, viewing events
(topics viewed and searches performed) and IP addresses
are logged.
The data collected is for Roche internal use only. It is
never forwarded to third parties. It is anonymized, and
after one year it is automatically deleted.

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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Viewing events are analyzed to improve User Assistance
content and search functionality. IP addresses are used to
classify regional behavior.
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the system and safety information before you
use the system.
rPay particular attention to all safety precautions.
rAlways follow the instructions in this publication.
rDo not use the device in a way that is not described in
this publication.
rStore all publications in a safe and easily accessible
place.
Incident reporting
rInform your local Roche representative and your local
competent authority about any serious incidents which
may occur when using this product.
Phone number of Roche Diagnostics Customer
Support Center: [phone]
User training The operation of the Urisys1100® and the execution of
the Chemstrip®10MD and Chemstrip®10UA test is
described in the Urisys1100® Operator’s Manual. No
dedicated training is required.
Images The images in this publication have been added exclusively
for illustration purposes. Configurable and variable data
on screenshots, such as tests, results, or path names
visible therein must not be used for laboratory purposes.
Warranty Roche Diagnostics warrants the Urisys1100® against
defects in material and workmanship (except for
consumable items) for a period of one year from date of
purchase.
Roche Diagnostics will replace the device and all parts
which prove to be defective and are subject to such
warranty.
This warranty does not apply to a device not used
according to instructions or damaged by accident,
alteration, misuse, tampering, and/or abuse.

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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
THE FOREGOING WARRANTY SHALL BE IN LIEU OF ALL
OTHER WARRANTIES, WHETHER EXPRESSED, IMPLIED OR
STATUTORY, INCLUDING, BUT NOT LIMITED TO, ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE. ROCHE DIAGNOSTICS
SHALL HAVE NO FURTHER OBLIGATION OR LIABILITY
WITH RESPECT TO THE DEVICE OR PARTS THEREOF OR
ITS SALE, OPERATION, OR USE, AND ROCHE
DIAGNOSTICS NEITHER ASSUMES NOR AUTHORIZES THE
ASSUMPTION OF ANY OBLIGATION OR LIABILITY IN
CONNECTION WITH SAID DEVICES OR PARTS THEREOF.
CUSTOMERS’ SOLE AND EXCLUSIVE REMEDY IN
CONTRACT, TORT, OR UNDER ANY OTHER THEORY
AGAINST ROCHE DIAGNOSTICS, RESPECTING THE
DEVICE, PARTS THEREOF AND THE USE OF SAME SHALL
BE THE REPLACEMENT OF THE DEVICE AND ITS PARTS AS
DESCRIBED ABOVE. IN NO CASE SHALL ROCHE
DIAGNOSTICS BE LIABLE FOR SPECIAL, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES.
Copyright © 2023, Roche Diagnostics GmbH. All rights reserved.
License information Urisys1100® software is protected by contract law,
copyright law, and international treaties. Urisys1100®
contains a user license between F. Hoffmann-La Roche
Ltd. and a license holder, and only authorized users may
access the software and use it. Unauthorized use and
distribution may result in civil and criminal penalties.
Open-source and commercial software Urisys1100® incorporates components or modules of
commercial and open-source software.
This open-source and commercial software and
Urisys1100® as a whole can constitute a device
regulated in accordance with applicable law. For more
detailed information, refer to the corresponding user
documentation and labeling.
Note that the respective authorization is no longer valid
according to the corresponding legislation should any
unauthorized changes be made to Urisys1100®.
Trademarks The following trademarks are acknowledged:
COBAS, URISYS, URISYS 1100, and CHEMSTRIP are
trademarks of Roche.
All other trademarks are the property of their respective
owners.

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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Feedback Every effort has been made to ensure that this publication
fulfills the intended use. All feedback on any aspect of this
publication is welcome and is considered during updates.
Contact your local Roche representative, should you have
any such feedback.
Approvals The Urisys1100® meets the requirements laid down in:
For in vitro diagnostic use.
Issued by Underwriters Laboratories, Inc. (UL) for Canada
and the US.
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Hungary
Distributed in the U.S.A. by:
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
eLabDoc Electronic user documentation can be downloaded using
the eLabDoc e-service on the navify® Portal:
navifyportal.roche.com
For more information, contact your local affiliate or local
Roche representative.
Additional help Roche Diagnostics provides technical support. If
you have any questions or need assistance, contact
Roche Diagnostics Customer Support Center.
Phone number: [phone]

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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Guarantee
The statutory guarantee provisions on rights in consumer
goods sales in the country of purchase shall apply.

7Table of contents
Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Table of contents
Publication information 2
Contact addresses 5
Guarantee 6
Intended use 9
Additional information 9
Symbols and abbreviations 9
What is new in publication version 10.0 13
List of available accessories and
consumables 13
Safety
1 General safety information
Safety classifications 19
Safety precautions 20
Warning messages 22
Caution messages 25
Notices 26
Safety information for disposal 27
Recommendations for the protection of
personal data and software security 28
System description
2 Overview of the system
About the system 39
About the device 40
Measuring principle 41
Software overview 43
Menu structure (Flowchart) 45
Buttons and icons overview 46
Results table 49
Technical specifications 51
Operation
3 Installation
Getting started 57
About logging on/off 59
4 Routine and non-routine operation
About reading test strips 65
Entering information about consumables 67
Performing a measurement 72
Result handling 76
Inserting the test strip tray 81
Inserting printer paper 82
Calibration 83
Quality control (QC) 86
Configuration
5 Configuration
About settings 95
Settings summary 96
Device settings 100
Measurement settings 107
User management 109
ID setup 114
Connecting to other devices 117
Maintenance and troubleshooting
6 Maintenance and troubleshooting
About cleaning and disinfecting the device 125
Acceptable cleaning solutions and
disinfectants 126
Daily cleaning and disinfecting the device 127
Daily cleaning and disinfecting the test strip
tray 128
Error messages and troubleshooting 130
Index

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Urisys 1100® urine analyzer · · Publication version 10.0
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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Intended use
The Urisys1100® Urine Analyzer is a reflectance
photometer designed to automatically read and evaluate
the results of Chemstrip®10MD(1) urine test strips for
various urine analytes: specific gravity, pH, leukocytes,
nitrite, protein, glucose, ketones, urobilinogen, bilirubin
and blood.
Additional information
The Urisys1100® is manufactured for a lifetime of 5 years
after date of manufacture, or 35 000 measurements. After
reaching the end of lifetime, no measurements can be
performed anymore on the device.
Using the Urisys1100® eliminates factors known to affect
visual evaluation of urine test strips, such as:
• Variable lighting conditions at the workplace
• Individual skill levels at matching test strip pad colors
• Different reaction times for the test strips
• Clerical errors
• Strong color of the urine sample
Rx only Caution: Federal law restricts this device to sale by or on
the order of a physician.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Product name Descriptor
Urisys1100® Device
Chemstrip®10MD Urine test strips
Chemstrip®10UA Urine test strips
Chemstrip® Calibration Strips Calibration strips
cobas® infinity edge Service system
y Product names
(1) Hospitals may use Chemstrip®10UA urine test strips (Cat. No. 11895354160).

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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Product name Descriptor
cobas® infinity POC Data management
system
y Product names
Symbols used in the Operator’s Manual Symbol Explanation
oList item
uCross-reference to another topic
wFigure, used in figure titles and cross-
references to figures
yTable, used in table titles and cross-references
to tables
qTip, used for extra information on correct use
or for useful hints
IExtra information within a task
fResult of an action within a task
cFrequency of a task
nDuration of a task
dMaterials that are required for a task
jPrerequisites of a task
y Symbols used in the Operator’s Manual
Symbols used in the User Assistance Symbol Explanation
oList item
Tip, used for extra information on correct use
or for useful hints
Extra information within a task
Result of an action within a task
Frequency of a task
Duration of a task
Materials that are required for a task
Prerequisites of a task
y Symbols used in the User Assistance

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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Symbols used for easy recognition of
information
Symbol Explanation
Safety alert.
y Symbols used for easy recognition of information
Symbols used on product and packaging Symbol Explanation
For in vitro diagnostic use.
Biohazardous.
Urine can potentially be infectious. The device
can come into contact with urine even when
used as intended.
Serial number.
Issued by Underwriters Laboratories, Inc. (UL)
for Canada and the US.
Refer to safety information included in this
publication.
Used to indicate that the equipment is suitable
for direct current only; to identify relevant
terminals.
Manufacturer.
Date of manufacture.
Unique device identifier.
Lot number.
y Symbols used on product and packaging

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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Symbol Explanation
Consult instructions for use.
Temperature limits.
Humidity limit.
Catalogue number.
Global Trade Item Number.
USB.
Quantity contained in the package.
y Symbols used on product and packaging
Abbreviations The following abbreviations are used.
Abbreviation Definition
BIL Bilirubin
BLD Blood
CSA Canadian Standards Association
DMS Data management system
EC European Community
EMC Electromagnetic compatibility
ERY Erythrocytes
ESD Electrostatic discharge
GLU Glucose
IEC International Electrical Commission
IVD In vitro diagnostic
IVDR In vitro diagnostics regulation
KET Ketones
y Abbreviations

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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Abbreviation Definition
LEU Leukocytes
LIS Laboratory information system
NIT Nitrite
pH Potential of hydrogen
PRO Protein
QC Quality control
SG Specific gravity
TR Trace
UBG Urobilinogen
UL Underwriters Laboratories Inc.
y Abbreviations
What is new in publication version 10.0
Update The publication contains updates resulting from the
device’s update referring to:
• Graphic color display
• Touch screen
• Updated user interface
• Enhanced connectivity (LAN, USB, Wi-Fi, cloud access)
• Larger memory (up to 1000 results can be stored)
• Additional QC functions
• Lot management for strips and QC material
• Option to enter user IDs and lot information using a
barcode reader
• Updated user management
• Possibility of remote software updates
Illustrations and screenshots Illustrations and screenshots were adapted to reflect the
latest hardware and software.
List of available accessories and consumables
Below is a list of globally available accessories and
consumables. For ordering information, contact your local
Roche representative.
Contents of the package

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Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Product name Description Catalogue number
Urisys1100® Contents:
• Power adapter USB-C
• Power cable
• Test strip tray, type C
• Printer paper
• Operator’s Manual
• Quick Reference Guide
REF 03617556001
y Contents of the package
Accessories
Product name Description Catalogue number
Spare reference pads (5 pieces) Spare reference pads REF 11907131001
Test strip tray, type C Test strip tray REF 03666735001
Datalogic QD2590 2D handheld barcode reader with
Datalogic USB cable
REF 9831053001
y Available accessories
Consumables
Product name Description Catalogue number
Thermal paper (20 rolls) Printer paper REF 06431321001
Chemstrip®10MD (100 test strips) Test strips REF 03260763160
Chemstrip®10UA (100 test strips) Test strips REF 11895354160
Chemstrip® Calibration Strips (50
calibration strips)
Calibration strips REF 11379194160
y Available consumables
Spare parts
Product name Description Catalogue number
Power cable Power cable REF 4340612001
Power supply unit USB-C/5V/3.6A Power adapter with USB-C output without
power cable
REF 9963138001
y Available spare parts
Commercially available accessories The following commercially available accessories can be
connected to the device:
• USB keyboard
• USB device, FAT-32 format (max. 16 GB)
• Wi-Fi stick
• Ethernet LAN cable, quality CAT5 or higher

Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Safety
1 General safety information............................................................ 17

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17Table of contents
Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
General safety information
In this chapter 1
Safety classifications ................................................. 19
Safety precautions..................................................... 20
Warning messages ..................................................... 22
Caution messages...................................................... 25
Notices ....................................................................... 26
Safety information for disposal.................................. 27
Recommendations for the protection of personal
data and software security ........................................ 28
1 General safety information

18 Table of contents
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1 General safety information

19General safety information
Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Safety classifications
The safety precautions and important user notes are
classified according to the applicable standards.
Familiarize yourself with the following meanings and icons:
Safety alert
rThe safety alert symbol is used to alert you to potential
physical injury hazards. Obey all safety messages that
follow this symbol to avoid possible damage to the
system, injury, or death.
These symbols and signal words are used for specific
hazards:
WARNING!
Warning…
r…indicates a hazardous situation that, if not avoided,
could result in death or serious injury.
CAUTION!
Caution…
r…indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.
NOTICE!
Notice...
r...indicates a hazardous situation which, if not avoided,
may result in damage to the system.
Important information that is not safety relevant is
indicated with the following icon:
iTip...
...indicates additional information on correct use or
useful tips.
1 General safety information

20 Safety precautions
Roche Diagnostics
Urisys 1100® urine analyzer · · Publication version 10.0
Safety precautions
To avoid serious or fatal injury, read and comply
with the following safety precautions.
Insufficient knowledge and skills To ensure correct operation of the device:
rOnly healthcare professionals may operate the device.
rUsers must have received a comprehensive instruction
in the operation, QC, and care of the device.
Safe and proper use of the system Do not use the device, test and calibration strips, or QC
material if they are damaged.
Make sure the power supply of the device is always
accessible so that you can disconnect it in an emergency.
The device is only suitable for indoor use.
Non-specified consumables and accessories Use of non-specified consumables and accessories may
result in malfunction of the system and may render the
warranty null and void.
rOnly use consumables and accessories specified by
Roche Diagnostics.
Personal injury and infection due to sharps,
rough edges, and/or moving parts
rGood Laboratory Practice can reduce the risk of injury.
rBe aware of your laboratory environment, well-
prepared, and follow the instructions for use.
rSome areas of the device may have sharps, rough
edges, and/or moving parts.
Wear personal protective equipment to minimize the
risk of injury from bodily contact with such parts,
especially in less accessible areas, or while cleaning
the device.
rYour personal protective equipment should be
appropriate to the degree and type of potential
hazard, e.g. suitable lab gloves, eye protection, lab
coat, and footwear.
Electromagnetic compatibility (EMC) The system complies with the emission and immunity
requirements described in IEC 61326-2-6. It has been
designed and tested to CISPR 11 Class B.
Electrostatic discharge (ESD) The device complies with the electrostatic discharge (ESD)
immunity requirements as specified in IEC 61326-2-6.
Electrostatic discharge (ESD) is an electrical charge at
rest, most commonly known as static electricity.
1 General safety information