Roche U701

cobas u 701 microscopy

analyzer
Operator’s Manual Version 2.5
Software Version 2.3
2

Document information

Manual version Software version Revision date Change description

1.0.0 2.0 May 2014 First publication
1.0.0 2.1 January 2015 Software upgrade. No content changes in operator’s manual.
2.0.0 2.2 July 2015 o Illustrations were adapted to latest hardware and software.
o New: Optional input connection unit.
o New: Optional connection to external water supply.
o Improved result presentation.
o New: Emergency stop feature
o New: Definition of notification periods.
o Changes to range tables and cross-check rule
configuration.
o New: Definition of particle subclasses.
o Various improvements in configuration features.
o New: Procedure for adjusting probe action to different
tubes and racks.
2.1.0 2.2.3 July 2016 o Improved working with Sample sequence number
mode.
o Improved manual image analysis.
o Definition of STAT racks.
2.2 2.3 March 2018 o New version (2) of control unit.
o Windows 10 operating system.
2.4 2.3 March 2020 o New layout.
o Linguistic and minor content adjustments.
2.5 2.3 November 2020 o IVDR compliance.
y Revision history
Edition notice This publication is intended for operators and

administrators of the cobas u 701 microscopy analyzer.
Every effort has been made to ensure that all the

information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.
Where to find information The Operator’s Manual and the Online Help contain all
information about the product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• A software reference
• Configuration information
• Background information
Roche Diagnostics
cobas u 701 microscopy analyzer · Software Version 2.3 · Operator’s Manual · Version 2.5
3
The Operator’s Manual and the Online Help contain

important safety information. You must read them before
operating the instrument.
The Quick Reference Guide provides you with an

overview of routine tasks.
! General attention
To avoid serious or fatal injury, ensure that you are
familiar with the system and safety information before you
use the system.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument in a way that is not
described in this publication.
r Store all publications in a safe and easily retrievable
place.
! Incident reporting
r Inform your Roche representative and your local
competent authority about any serious incidents
which may occur when using this product.
Training Do not carry out operation tasks or maintenance actions

unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
Images The screenshots and hardware images in this publication

have been added exclusively for illustration purposes.
Configurable and variable data in screenshots, such as
tests, results, or path names visible therein must not be
used for laboratory purposes.
Warranty Any customer modification to the system renders the

warranty or service agreement null and void.
For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service

representative, or perform such updates with their
assistance.
Copyright © 2014–2020, Roche Diagnostics GmbH. All rights

reserved.
Trademarks The following trademarks are acknowledged:
Roche Diagnostics
4
COBAS, COBAS U, and LIFE NEEDS ANSWERS are

trademarks of Roche.
All other product names and trademarks are the property

of their respective owners.
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 Roche representative, should you
have any such feedback.
Approvals The cobas u 701 microscopy analyzer meets the

requirements laid down in:
• Regulation (EU) 2017/746 of the European Parliament
and of the Council of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive
98/79/EC and Commission Decision 2010/227/EU.
• Directive 2011/65/EU of the European Parliament and
of the Council of 8 June 2011 on the restriction of the
use of certain hazardous substances in electrical and
electronic equipment
Compliance with the applicable directives is provided by

means of the Declaration of Conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU

regulations.
Eurasian Conformity. Demonstrates that the

product meets the Eurasian Economic Union
(EAEU)’s regulations and standards for customs
clearance and trading.
Issued by Underwriters Laboratories, Inc. (UL) for

Canada and the US.
Roche Diagnostics
5
'Laboratory Equipment' is the product identifier as

shown on the type plate.
Contact address
Roche Diagnostics GmbH

Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Hungary
Roche affiliates A list of all Roche affiliates can be found at:
www.roche.com/about/business/roche_worldwide.htm
eLabDoc Electronic user documentation can be downloaded using

the eLabDoc e-service on Roche DiaLog:
www.dialog.roche.com
For more information, contact your local affiliate or Roche

Service representative.
Roche Diagnostics
6
Roche Diagnostics
Table of contents 7
Table of contents
Document information 2 4 Software

Contact address 5 Introduction 121
Table of contents 7 Key screen elements 121
Intended use 9 Key work areas 127
How to use this manual 9 Tabs 129
Symbols and abbreviations 11 Displaying information 131
List of available accessories and Working with lists (tables) 134
consumables 14 Entering information 135
What is new in publication version 2.2 16 Working with QC charts 137
What is new in publication version 2.1.0 16 External keyboard and mouse 138
What is new in publication version 2.0.0 17 Wizards 139
Color coding 142
Online help 143
System description
1 Safety
Operation
Safety classification 25
Safety precautions 26 5 Operation
Safety summary 30 Safety 151
Safety labels on the equipment 39 Short guide to routine testing 153
Disposal of the equipment 45 Routine operating tasks 156
Result handling 174
2 Introduction Non-routine situations 185
General description 49 Urine sediment image evaluation 202
Daily operation 58 Managing patients 217
Routine maintenance actions 219
3 Hardware At the end of the shift 231
Safety 67 Checking the microscope focusing
Main components 69 mechanism 246
Covers 70 QC tasks 248
Connectors 72 Additional operating tasks 259
Power switches 78
Input and output buffers 80 6 Configuration
Tubes, racks, and rack trays 84 User management 265
Liquid containers 89 System settings: Defining the test
Solid waste container 93 environment 269
Rack transport unit 94 System configuration: Defining the operating
Fluid system 95 environment 291
Sample handling 101 Managing racks 305
Cuvette handling 102 Adjusting the probe action 307
Barcode reader 107
Barcodes 108
Radio frequency identification 109
Maintenance
Technical specifications 111
7 Maintenance
Safety 313
Routine maintenance 314
Miscellaneous maintenance actions 317
Roche Diagnostics
8 Table of contents
Troubleshooting
8 Troubleshooting
Exceptional situations 331
Screenshots 333
Log files 334
No microscope check results can be
generated 336
Detached barcode labels 337
Recovering from an irregular stop 338
Emergency stop 339
When you have accidentally pulled the waste
drawer during operation 341
Recovering from a power outage 342
Safety interlock 343
Clogged inlet water filter 343
Blocked floats 346
Glossary
9 Glossary
Index
Index 355
Roche Diagnostics
9
Intended use
The cobas u 701 microscopy analyzer is a fully

automated urine microscopy system intended for the in
vitro quantitative determination of erythrocytes and
leukocytes, the semi-quantitative determination of
squamous and non-squamous epithelial cells, bacteria,
and hyaline casts and the qualitative determination of
pathological casts, crystals, yeasts, mucus, and sperm in
urine.
These measurements are useful in the evaluation of
kidney disease and urinary tract infections.
This system is intended to be used by trained operators in
clinical laboratories.
How to use this manual
q Keep this Operator’s Manual in a safe place to

ensure that it is not damaged and remains available for
use.
This Operator’s Manual should be easily accessible at all
times.
Throughout this documentation, images of screens are
included for illustration purposes. They are not
necessarily identical with what you see on your analyzer.
To help you find information quickly, there is a table of

contents at the beginning of the manual and of each
chapter. In addition, a comprehensive index can be found
at the end.
Roche Diagnostics
10
Content overview The documentation is divided into the following parts:

• Part A — System Description: The system
description provides information on the safe operation
of the system, on its hardware and software, and an
overview of how it is used.
• Part B — Operation: The operation part describes
how to perform the various tasks that are required
when analyzing samples.
• Part C — Maintenance: The maintenance part
provides information on how to ensure continuous
problem-free operation of the system.
• Part D — Troubleshooting: The troubleshooting part
provides assistance on how to deal with exceptional
situations.
• Part E — Glossary: The glossary explains key terms
used in the user interface and in this documentation.
• Part F — Index: The index provides a quick way to
information, it consists of an alphabetical list of key
words that lead to the relevant information within this
documentation.
Roche Diagnostics
11
Symbols and abbreviations
Visual cues are used to help locate and interpret

information quickly. This section explains the conventions
used for this purpose.
Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Product name Descriptor

cobas u 701 microscopy analyzer Microscopy analyzer
y Product names
Symbols used in this publication The following symbols are used:
Symbol Explanation
o List item.
u Cross-reference to another topic.
Tip. Extra information on correct use or useful
q
hints.
I Extra information within a task.
f Result of an action within a task.
d Materials that are required for a task.
j Prerequisites of a task.
Figure. Used in figure titles and cross-
w
references to figures.
Table. Used in table titles and cross-references
y
to tables.
y Symbols used in this publication
Symbol Comment
Safety alert.
Electrical and electronic equipment marked

with this symbol are covered by the European
directive WEEE.
Label on the water container for external

water supply indicating monthly cleaning.
y Symbols used for easy recognition of information
Symbols used on product The following symbols are used:
Roche Diagnostics
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Symbol Explanation
Catalogue number.
Global Trade Item Number.
Serial number.
Date of manufacture.
Manufacturer.
Indicates that the equipment is suitable for

alternating current only; to identify relevant
terminals.
For in vitro diagnostic use.
Unique device identifier.
Complies with the provisions of the applicable

EU regulations.
Please consult instructions for use.
Issued by Underwriters Laboratories, Inc. (UL)

for Canada and the US.
Eurasian Conformity.
y Symbols used on product
Roche Diagnostics
13
Symbol Explanation
'Laboratory Equipment' is the product

identifier as shown on the type plate.
Temperature limit
Humidity limit
y Symbols used on product
Abbreviations The following abbreviations are used:
Abbreviation Explanation
ANSI American National Standards Institute
BAC Bacteria
CRY Crystals
CSA Canadian Standards Association
EC European Community
EN European standard
ESD Electrostatic discharge
HPF High-power field
HYA Hyaline casts
IEC International Electrical Commission
IVD In vitro diagnostic
IVDR In vitro diagnostics regulation
LAS Laboratory automation system
LIS Laboratory information system
MUC Mucus
n/a Not applicable
NEC Non-squamous epithelial cells
PAT Pathological casts
QC Quality control
RBC Red blood cells
RD Roche Diagnostics
RF Radio frequency
RFID Radio frequency identification
SEC Squamous epithelial cells
SPRM Sperm
STAT Short turn around time
UL Underwriters Laboratories Inc.
UPS Uninterrupted power supply
y Abbreviations
Roche Diagnostics
14
Abbreviation Explanation
VAC Volt alternating current
WBC White blood cells
WEEE Waste Electrical and Electronic Equipment
YEA Yeasts
y Abbreviations
List of available accessories and consumables
Below are lists of globally available accessories and

consumables. For ordering information, contact your local
sales representative.
Accessories
Image of product Product name
Catalog number
Tables
cobas 6500 Table
07524811001
Table Cobas Integra 400 plus
03310264001
PC Table (D)
04590457001
Racks and rack trays
RD Standard rack 0001-0050
11902997001
Std-rack 0051-0100
11903004001
Std-rack 0101-0150
11903012001
Std-rack 0151-0200
11903039001
Std-rack Control Q001-Q010 white
12025574001
Std-rack, Wash W999 green (2 pcs)
12025728001
Rack Tray, 75 pos, collapsible, RDA
05099986001
y Available accessories
Roche Diagnostics
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Catalog number
Liquid containers
Water Container
06390528001
Water Container (External Water Supply)

07524803001
Liquid Waste Container

06390536001
Kit External Water Supply

07564490001
Sample handling
Sample probe cobas u 701
07127189001
Cuvette handling
Reference cuvette cobas u 701
07127219001
Cuvette basket cobas u 701

09165789001
y Available accessories
Roche Diagnostics
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Consumables
cobas u cuvette
06390552001
Waste Box Carton

06390544001
y Available consumables
What is new in publication version 2.2
New control unit version The control unit was replaced with a new version (version
2).
Windows 10 operating system The internal PC uses the Windows 10 operating system.
Upgraded test strip tray and transporter The test strip tray and test strip transporter were
enhanced.
Replacing of reference plate The reference plate can only be replaced by a Roche
What is new in publication version 2.1.0
Illustrations and screenshots Illustrations and screenshots were adapted to reflect the
latest hardware and software.
Optional components Colored labels for Roche 5-position racks are now
available.
u Optional components (116)
Working with Sample sequence number mode The procedure for working with Sample sequence
number mode has been improved.
u Defining the sample sequence number ranges (159)
u Rerunning tests when working with Sample sequence
number mode (188)
Roche Diagnostics
17
STAT and routine results are marked when If you work with Sample sequence number mode,
working with Sample sequence number mode sample IDs for routine test results are marked with an “N”
preceding the sample sequence number, and “E” for
STAT test results.
u Validating results (175)
Manual particle classification In a given image, you can now classify multiple particles
in one go. You can also remove several classifications in
one go.
u To assign or reclassify particles (195)
u To remove the classification from particles (196)
Working with Sample sequence number mode The information on defining the validation method has
been adapted.
u Defining the validation method (276)
STAT racks You can now define dedicated STAT racks.

u To define a STAT rack (305)
What is new in publication version 2.0.0
Illustrations and screenshots Illustrations and screenshots were adapted to reflect the
latest hardware and software.
Automatic rack feed, input connection unit You can optionally connect the analyzer to a laboratory
automation system by replacing the input buffer with an
input connection unit. This allows automatic rack feed to
the analyzer.
u Input connection unit (82)
u Operation with input connection unit (167)
u To load a priority rack when working with an
LAS (170)
u To perform a QC measurement when working with an
LAS (250)
u To clean the inlet water filter (external water
supply) (345)
u To loosen the floats in the water container for external
water supply (347)
Roche Diagnostics
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External water supply You can optionally connect the analyzer to an external
laboratory water supply system. When using this feature,
the liquid waste is drained off directly to the laboratory
liquid waste system.
u Water container for external water supply (90)
u Liquid waste with external water supply (92)
supply) (345)
u To loosen the floats in the water container for external
water supply (347)
Image zoom function You can now zoom in on individual microscope images.
u Using the zoom function (132)
Technical specifications Some values were adjusted.

• External conditions
• Power requirements
• Water quality
• Wash solution
• Cleaning solution
u Technical specifications (111)
Safety information Input connection unit
Information on the proper use of the following items was

added:
u Input connection unit (82)
u Water container for external water supply (90)
u Racks (85)
u To adjust the probe action (307)
u Safety labels on the equipment (39)
Overview work area • The categorizing of the task list has been improved.
• An emergency stop button (E. Stop) was added. Use
this function if, for some reason, all activities on the
analyzer must be stopped immediately or if the
analyzer is stuck in either the Operating or Init
status.
• When working with a laboratory automation system,
the Priority rack button is available on the Overview
work area.
u Emergency stop (339)
LAS (170)
Roche Diagnostics
19
Result presentation • To assist people with color vision deficits, in addition

to the colors hatching is displayed.
• New symbols and data alarms were introduced to
provide more information about the status of the
result.
u Color coding (142)
u Checking the status of processing (171)
u Validating results (175)
u To review QC results (257)
QC charts The QC charts function has been improved.

u Working with QC charts (137)
Manually analyzing microscope images The descriptions of manually analyzing images was
adapted and extended.
u Manually analyzing images (192)
Printing and exporting information The feature was adapted and applied consistently.
Some changes:
• In the result report, the results of subclasses follow
immediately the results of their main class.
• Screenshots are no longer part of the problem report,
instead, you can save them separately.
• Particle labels can now be saved with the images.
u Printing and exporting information, generating
reports (261)
Emergency stop An emergency stop feature has been introduced for

situations when all activities on the analyzer must be
stopped immediately or if the analyzer is stuck in either
the Operating or Init status.
u Emergency stop (339)
Cleaning the pipetting stage area The procedure for cleaning the pipetting stage area was
adapted.
u Cleaning the pipetting stage area (241)
Cleaning the centrifuge chamber The procedure for cleaning centrifuge chamber was
adapted.
u Cleaning the centrifuge chamber (242)
Warning intervals You can now define how long before the event a warning
is issued for expiry of materials and maintenance actions.
u Defining when notifications should be
generated (297)
Roche Diagnostics
20
QC materials The conditions for making changes to QC materials have

changed.
u To change QC material data (253)
u To make test parameter related changes (254)
u To include or exclude tests from the QC
measurements (255)
Defining QC materials using the RFID reader The procedure for defining QC materials using the RFID
reader was adapted.
u To define a new QC material by reading the RFID
tag (252)
Report definition The items have been regrouped and complemented.

u Defining the look, content, and handling of
reports (299)
Range tables and cross-check rules The procedures for defining range tables and cross-
check rules were simplified.
u Defining range tables (280)
u Defining cross-check rules (277)
Particle subclasses You can now examine particles that cannot be classified
as a subclass of an existing main class. Such particles are
defined as subclasses of the new generic main class
Others.
u Defining particle subclasses (288)
Semi-quantitative reporting of RBC and WBC A description was added on how to proceed if you want
to display RBC and WBC results on a semi-quantitative
level.
u Displaying RBC and WBC results on a semi-
quantitative level (284)
Importing system settings You can now import system settings that were generated
using software versions other than the current one.
u Importing and exporting system settings (303)
Adjusting the probe action To enable the use of different racks and tubes, a function
is now provided to adjust the probe action to the changed
dimensions.
u To adjust the probe action (307)
Roche Diagnostics
System description
1 Safety .......................................................................................................................... 23
2 Introduction .............................................................................................................. 47
3 Hardware ................................................................................................................... 65
4 Software ...................................................................................................................119
Roche Diagnostics
23
Table of contents
Safety 1
In this chapter you find information about the safe

operation of the equipment.
In this chapter 1
Safety classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Operator qualification . . . . . . . . . . . . . . . . . . . . . . . 26
Safe and proper use of the analyzer . . . . . . . . . . . 26
Personal safety . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Personal protective equipment . . . . . . . . . . . . . 27
Accuracy and precision of measured results . 27
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Environmental conditions . . . . . . . . . . . . . . . . . 28
Approved parts . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Third-party software. . . . . . . . . . . . . . . . . . . . . . 28
Miscellaneous safety precautions . . . . . . . . . . . . . 28
Safety summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Biohazardous materials . . . . . . . . . . . . . . . . . . . 31
Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Barcode readers . . . . . . . . . . . . . . . . . . . . . . . . . 32
Foam, bubbles or films on sample . . . . . . . . . . 32
About the protection of personal data and
software security. . . . . . . . . . . . . . . . . . . . . . . . . 32
Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Mechanical safety. . . . . . . . . . . . . . . . . . . . . . . . 36
1 Safety
Working solutions . . . . . . . . . . . . . . . . . . . . . . . . 36
Insoluble contaminants in samples . . . . . . . . . 37
Influence of vibrations . . . . . . . . . . . . . . . . . . . . 37
Malfunction due to interfering
electromagnetic fields . . . . . . . . . . . . . . . . . . . . 37
Fatigue due to long hours of operation . . . . . . 37
Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
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24
Table of contents
Moving parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Spillage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Excessive ambient humidity . . . . . . . . . . . . . . . 39
Influence of vibrations . . . . . . . . . . . . . . . . . . . . 39
Safety labels on the equipment . . . . . . . . . . . . . . . . . . 39
Analyzer views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Back view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Solid waste compartment . . . . . . . . . . . . . . . . . 42
Input connection unit . . . . . . . . . . . . . . . . . . . . . 44
Disposal of the equipment . . . . . . . . . . . . . . . . . . . . . . 45
1 Safety
Roche Diagnostics
Safety classification 25
Safety classification
This section explains how precautionary information is
presented in this manual.
The safety precautions and important user notes are

classified according to the ANSI Z535.6 Standard.
Familiarize yourself with the following meanings and
icons:
! Generic hazard statements
The safety alert symbol by itself without a signal word is

used to promote awareness to hazards which are generic
or to direct the reader to safety information provided
elsewhere in the document.
These symbols and signal words are used for specific

hazards:
! WARNING
Warning
r Indicates a hazardous situation which, if not avoided,
could result in death or serious injury.
! CAUTION
Caution
could result in minor or moderate injury.
NOTICE
Notice
could result in damage to equipment.
Important information that is not safety relevant is

indicated by the following symbol:
q Tip
1 Safety
Indicates additional information on correct use or useful

tips.
Roche Diagnostics
26 Safety precautions
Safety precautions
! Generic hazard statements
Particular attention must be paid to the following safety

precautions. If these safety precautions are ignored, the
operator may suffer serious or fatal injury. Each
precaution is important.
In this section
Operator qualification (26)
Safe and proper use of the analyzer (26)
Miscellaneous safety precautions (28)
Operator qualification
Insufficient knowledge and skills Operators are required to have a sound knowledge of
relevant guidelines and standards as well as the
information and procedures contained in the Operator’s
Manual.
r Do not carry out operation and maintenance unless
you have been trained by Roche. Carefully follow the
procedures specified in the Operator’s Manual for the
operation and maintenance of the analyzer. Leave
maintenance, installation or service that is not
described in the Operator’s Manual to trained Roche
Service representatives. Follow Good Laboratory
Practices especially when working with biohazardous
material.
Safe and proper use of the analyzer

In this section
Personal safety (27)
Personal protective equipment (27)
Accuracy and precision of measured results (27)
1 Safety
Installation (27)
Environmental conditions (28)
Approved parts (28)
Third-party software (28)
Roche Diagnostics
Safety precautions 27
Personal safety
Personal injury and infection due to sharps, r Good Laboratory Practice can reduce the risk of injury.
rough edges, and/or moving parts r Be aware of your laboratory environment, well-
prepared, and follow the instructions for use.
r Some areas of the instrument 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 instrument.
r Your 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.
Personal protective equipment
Risk of injury due to missing personal r Be sure to wear appropriate protective equipment,
protective equipment including, but not limited to, eye protection with side
shields, fluid resistant lab coat, and approved lab
gloves. Wear a face shield if there is a chance of
splash or splatter.
Accuracy and precision of measured results
Incorrect measuring results An incorrect measuring result may lead to an error in

diagnosis, therefore posing danger to the patient.
r For proper use of the instrument, measure QC
samples and monitor the instrument during operation.
Do not use consumables that have exceeded their
expiry date, otherwise inaccurate data may be
obtained. For diagnostic purposes always assess the
results in conjunction with the patient’s medical
history, clinical examination, and other findings.
1 Safety
Installation
Performing installation r Installation must be performed by personnel

authorized and trained by Roche only.
Roche Diagnostics
28 Safety precautions
Environmental conditions
Unsuitable environmental conditions Operation outside the specified environmental conditions

may lead to incorrect results or malfunction of the
instrument.
r Use the instrument indoors only and avoid heat and
humidity.
r Always comply with your local laboratory regulations.
r Perform maintenance according to the specified
intervals and when instructed to do so by the system
software to maintain the required environmental
conditions for the analyzer.
r Ensure that the analyzer's ventilation openings remain
unobstructed at all times.
r Keep the Operator’s Manual in a safe place to ensure
that it is not damaged and remains available for use. It
must be easily accessible at all times.
u Technical specifications (111)
Approved parts
Use of non-approved parts Use of non-approved parts or devices may result in

malfunction and may render the warranty null and void.
r Only use parts and devices approved by Roche.
Third-party software
Installation of third-party software Installation of any third-party software that is not

approved by Roche may result in incorrect behavior of the
analyzer.
r All Roche approved software must be installed by
personnel authorized and trained by Roche.
Miscellaneous safety precautions

1 Safety
Power interruption A power failure or momentary drop in voltage may

damage the analyzer or lead to data loss. Perform regular
backups of measurement results. Roche recommends to
operate the analyzer with an uninterruptible power
supply. Do not switch off power while the PC accesses
the hard disk or an external storage device.
Roche Diagnostics
Safety precautions 29
Analyzer unused for an extended period of If the analyzer is not used for an extended period of time,
time the power switch must be set to the off position.
Relocation and transportation Do not attempt to relocate or transport the analyzer.

Leave relocation and transport to personnel trained or
authorized by Roche.
u Disposal of the equipment (45)
1 Safety
Roche Diagnostics
30 Safety summary
Safety summary
This safety summary contains the most important and
general warning, caution, and notice messages.
Additionally, you will find specific safety information at
the beginning of chapters and with procedures.
In this section
Warning messages (30)
Caution messages (36)
Notices (38)
Warning messages
! List of warning messages

r Before operating the analyzer, read the warning
messages contained in this summary carefully. Failure
to observe them may result in death or serious injury.
In this section
Electrical safety (30)
Biohazardous materials (31)
Waste (31)
Barcode readers (32)
Foam, bubbles or films on sample (32)
About the protection of personal data and software
security (32)
Electrical safety
Electrical shock by electronic equipment Removing the covers of electronic equipment can cause
electric shock, as there are high voltage parts inside.
r Do not attempt to work in any electronic
compartment.
r Do not remove any cover of the analyzer other than
those specified in this Operator’s Manual.
r Installation, service, and repair must only be
1 Safety
performed by personnel authorized and trained by

Roche.
r Observe the safety labels on the equipment.
Roche Diagnostics
Safety summary 31
Biohazardous materials
Infection by samples and associated Contact with samples containing material of human origin
materials may result in infection. All materials and mechanical
components associated with samples of human origin are
potentially biohazardous.
r Follow Good Laboratory Practices, especially when
working with biohazardous material.
r Keep the cover closed and in place during operation.
r Be sure to wear appropriate protective equipment,
including, but not limited to, eye protection with side
shields, fluid resistant lab coat, and approved lab
gloves.
r Wear a face shield if there is a chance of splash or
splatter.
r If any biohazardous material is spilled, wipe it up
immediately and apply disinfectant.
r If sample or liquid waste comes into contact with your
skin, wash it off immediately with soap and water and
apply disinfectant. Consult a physician.
Infection by injury due to sharp objects r When wiping probes, use several layers of tissue and
wipe from the top down.
r Be careful to not puncture yourself.
r Be sure to wear appropriate protective equipment, for
example gloves. Take extra care when working with
lab gloves; these can easily be pierced or cut, which
can lead to infection.
Waste
Infection by liquid waste Contact with liquid waste may result in infection. All
materials and mechanical components associated with
the waste systems are potentially biohazardous.
r Be sure to wear protective equipment. Take extra care
when working with lab gloves; these can easily be
pierced or cut, which can lead to infection.
1 Safety

r If liquid waste comes into contact with your skin, wash
it off immediately with water and apply disinfectant.
Consult a physician.
Roche Diagnostics
32 Safety summary
Contamination of the environment by liquid The waste of the analyzer is potentially biohazardous and
and solid waste must be treated in accordance with the relevant laws and
regulations.
r When disposing of any waste, do so in accordance
with the appropriate local regulations.
r Any substances contained in QC materials and other
working materials, which are legally regulated for
environmental protection, must be disposed of in
accordance with the relevant water discharge facility
regulations. For the legal regulations on water
discharge, please contact the suppliers of the
materials.
Barcode readers
Barcode readers using LED technology with very low
output power are used to scan the barcodes on samples
and racks.
Loss of sight The intense light of the LEDs may damage your eyes.
r Do not stare into the LEDs.
Foam, bubbles or films on sample
Incorrect results due to incorrect sample Foam, bubbles or films on a sample or inside a sample
volume container may cause pipetting volume shortage and lead
to deterioration in measurement accuracy.
r When loading samples or QC materials on the
instrument, ensure that they do not contain foam,
bubbles or films.
About the protection of personal data and software security

The General Data Protection Regulation (GDPR) is a
regulation in EU law on data protection and privacy for all
citizens of the European Union (EU) and the European
1 Safety
Economic Area (EEA). The regulation also covers the

processing of personal data outside the EU and EEA.
If this regulation or any other privacy protection

regulation is applicable for your country, observe the
following safety messages to prevent data breaches and
to meet the GDPR:
Roche Diagnostics
Safety summary 33
Access control Unauthorized access may lead to data breaches.

r Implement physical access controls to ensure that
only authorized personnel operate the system at all
times.
r Assign a personal, unique user ID to each user for
system access.
r Assign access rights to each user only as high as
required for the tasks of the user.
r Delete user IDs from the system for users who no
longer work on the system.
Corrupt data due to a disclosed password The security of the system and its data depends on the
password-protected access. If an unauthorized person
discovers your user ID and password, they could
compromise this security.
r Always enter your password unobserved.
r Do not write down your password anywhere, including
in a contact form, in the address book, or in a file on
the computer.
r Do not disclose your password to anyone. Roche will
never ask you for your password.
r If you ever disclose your password to anyone, change
it immediately afterwards.
r Contact your local Roche affiliate if you think your
account has been compromised.
Network security Malicious software and hacker attacks may impair IT

security. The laboratory is responsible for the IT security
of their IT infrastructure.
r To protect and separate Roche systems from other
laboratory infrastructure, the Roche-provided firewall
must be used.
r Secure all devices and services used in the lab
infrastructure against malicious software and
unauthorized access.
r Secure the network environment to be resilient
against traffic redirection and eavesdropping.
1 Safety
Roche Diagnostics
34 Safety summary
Data entry and data transfer Writing patient sensitive information in comment fields
can violate protection laws for protected health
information.
r Do not write any patient sensitive information into
comment fields.
r Do not download patient identifiers from any host
system (e.g., LIS, middleware, or HIS) onto the system.
Data transfer using any host protocol is not encrypted;
data is transferred as plain text and readable with IT
tools like sniffer.
Secure data storage Unauthorized access to data backups and archive files
can violate data protection laws.
r Any data backup or data archive that has been
exported from the instrument must be physically
stored in a secured location.
r Ensure only authorized persons may access the
secure data storage. This includes the data transfer to
remote storage locations and disaster recovery.
r Data backups must not be taken from the secure data
storage. Do not take external storage devices outside
the lab environment.
Cybersecurity and privacy awareness Insufficiently informed employees can endanger

security.
r Perform regular cybersecurity and privacy awareness
trainings for staff handling personal data. Instruct staff
how to handle data in a compliant way and according
to the privacy principles as mandated by customer
regulations.
r Check your instrument for suspicious activity and
report any suspected compromise to your local Roche
representative immediately.
r Update to the latest software versions provided by
Roche as soon as possible.
r Exercise care when using external storage devices.
Do not connect to the system any external storage
device that you use on public or home computers.
1 Safety
Failure to do so may result in data loss and render the

instrument unusable.
Roche Diagnostics
Safety summary 35
Use of storage devices Wrong handling of external storage devices may result in
data loss or system malfunction.
r Only insert or remove an external storage device after
the data export is finished.
r At any one time only one external storage device can
be in use. Before inserting an external storage device
into a USB port, check that no other external storage
device is connected.
Computer viruses If you detect an unexpected operation or program/data

damage, the PC may be infected with a computer virus.
r To avoid virus infections, scan removable storage
media by an antivirus program before using them on
the system.
r Never use a program or external storage device that is
suspected of containing a virus.
r If you think your PC is infected with a computer virus,
call your local Roche Service representative. Your
local Roche Service representative will check your
system for proper functionality.
Data backup Data may get lost due to hard disk failures or damages.
r Back up your data (measurement results and system
parameters) at regular intervals.
r Use the backup function periodically to store relevant
data on an external storage device.
r Make a backup copy if you have changed any system
parameters.
Non-approved third-party software Installation of any third-party software that is not

approved by Roche Diagnostics may result in incorrect
behavior by the system.
r Do not copy or install any software or software
patches on the system unless it is part of the system
software or your Roche Service representative advises
it.
1 Safety
Roche Diagnostics
36 Safety summary
Caution messages
! List of caution messages

r Before operating, read the caution messages
contained in this summary carefully. Failure to observe
them may result in minor or moderate injury.
In this section
Mechanical safety (36)
Working solutions (36)
Insoluble contaminants in samples (37)
Influence of vibrations (37)
Malfunction due to interfering electromagnetic fields (37)
Fatigue due to long hours of operation (37)
Mechanical safety
Personal injury due to contact with moving r Keep the main cover closed and in place while the
parts analyzer is operating.
r During operation and maintenance, proceed
according to the instructions contained in the
Operator’s Manual.
u Safety labels on the equipment (39)
Working solutions
Skin inflammation or injury caused by Direct contact with cleaning solutions or other working
working solutions solutions may cause skin irritation, inflammation, or
burns.
r If a cleaning solution or other working solution comes
into contact with your skin, wash it off immediately
with water and apply disinfectant. Consult a physician.
1 Safety
Roche Diagnostics
Safety summary 37
Insoluble contaminants in samples
Incorrect results and interruption of analysis Insoluble contaminants in samples and bubbles or films
due to contaminated samples inside a sample container may cause clogging or
pipetting volume shortage and lead to a deterioration in
measurement accuracy.
r Ensure that samples contain no insoluble
contaminants such as fibrin or dust.
Influence of vibrations
Incorrect results due to vibrations or Strong vibrations or knocking the instrument may
knocking the analyzer influence the positioning of the measuring devices and
lead to false results.
Strong vibrations or knocking the instrument may lead a
rack being moved to the rack entry position, which may
lead to incorrect sample identification.
r Ensure that no vibrations influence the surface the
analyzer stands on and take care not to knock the
analyzer while processing tests.
Malfunction due to interfering electromagnetic fields
Malfunction of analyzer and incorrect results This analyzer has been designed and tested to CISPR 11
due to interfering electromagnetic fields Class A. In a domestic environment it may cause radio
interference, in which case, you may need to take
measures to mitigate the interference.
r The electromagnetic environment should be evaluated
prior to operation of the device.
r Do not operate this analyzer in close proximity to
sources of strong electromagnetic fields (for example
unshielded intentional RF sources), as these may
interfere with the proper operation.
Fatigue due to long hours of operation

1 Safety
Fatigue due to long hours of operation Looking at the monitor screen over an extended period of
time may lead to eye strain or body fatigue.
r Avoid spending long periods looking at the monitor
screen.
Roche Diagnostics
38 Safety summary
Notices
! List of notices
r Before operating, read the notices contained in this
summary carefully. Failure to observe them may result
in damage to equipment.
In this section
Moving parts (38)
Fuses (38)
Spillage (38)
Excessive ambient humidity (39)
Influence of vibrations (39)
Moving parts
Damage to the analyzer due to contact with Contact with moving parts may bend the sample probe or
moving parts damage some other component. If the analyzer detects a
collision, an alarm is issued and operation stops
immediately.
r Keep all covers closed and in place during operation.
r Do not touch any parts of the analyzer other than
those specified. Keep away from moving parts during
operation.
Fuses
Damage to the analyzer due to improper use r Should one of the fuses blow, do not attempt to
operate the analyzer before contacting your Roche
Spillage
Malfunction due to spilled liquid Any liquid spilled on the analyzer may result in
1 Safety
malfunction or damage.
r Do not place samples or any other liquid on the
surface of the analyzer.
r If liquid does spill on the analyzer, wipe it up
immediately and apply disinfectant. Be sure to wear
protective equipment.
Roche Diagnostics
Safety labels on the equipment 39
Excessive ambient humidity
Malfunction due to high ambient humidity Excessive ambient humidity may cause condensation
inside the analyzer and lead to short-circuiting in
electrical components.
r Always operate the analyzer in environmental
conditions defined in the technical specifications.
Influence of vibrations
Analyzer malfunction due to sample spillage Strong vibrations or knocking the instrument may lead to
spillage of sample, which may lead to malfunction of the
analyzer.
r Ensure that no vibrations influence the surface the
analyzer stands on and take care not to knock the
analyzer while processing tests.
Safety labels on the equipment

! Warning labels have been placed on the
analyzer to draw your attention to areas of
potential hazard. The labels and their
definitions are listed below according to their
location on the instrument.
The safety labels on the analyzer comply with the

following standards: ANSI Z535, IEC 61010-1, IEC 60417,
or ISO 7000.
q If the labels are damaged, they must be replaced by

a Roche Service representative. For replacement labels,
contact your local Roche Service representative.
In this section
1 Safety
Analyzer views (40)
Roche Diagnostics
40 Safety labels on the equipment
Analyzer views
In this section
Front view (40)
Back view (41)
Solid waste compartment (42)
Input connection unit (44)
Front view
Safety labels on the microscopy analyzer
(front view)
A
C
B
C
C
E
D
F
C C
A
C
w Safety labels on the microscopy analyzer (front view)
A Biohazard warning
This label indicates that there are potential biohazards within the vicinity of this
label.
The user is responsible for cleaning the area if biohazardous material is spilled.
Follow Good Laboratory Practices for working with biohazardous materials.
B This label indicates that there are hazardous situations arising within the vicinity
of this label, which may result in death or serious injury. Refer to the Operator’s
Manual for instructions on safe operation.
Any user action is forbidden while the centrifuge is in action.
1 Safety
C Moving parts
This label indicates that there is a danger of moving parts within the vicinity of
this label. Keep hands away from moving parts.
Roche Diagnostics
D ESD sensitivity
This label indicates a part that is electromagnetically sensitive.
Do not operate this analyzer in close proximity to sources of strong
electromagnetic fields (for example unshielded intentional RF sources), as these
may interfere with the proper operation.
E Laser light source (Class 1)

This label indicates that a laser light source is integrated in the vicinity of the
microscope for cuvette detection, but there is no danger of coming into contact
with the laser light. The laser is automatically switched of when the main cover is
opened. Do not manipulate the safety interlock function.
F Laser light source (Class 2)

with the laser light. The laser is automatically switched off when the main cover
is opened. Do not manipulate the safety interlock function.
Back view
Safety labels at the rear of the microscopy
analyzer
A B
w Safety labels at the rear of the microscopy analyzer (control unit version 1)
1 Safety
Roche Diagnostics
A B
w Safety labels at the rear of the microscopy analyzer (control unit version 2)
A Laser light source (Class 1)

with the laser light. The laser is automatically switched of when the main cover is
opened. Do not manipulate the safety interlock function.
B This label indicates that there are hazardous situations arising within the vicinity
of this label, which may result in death or serious injury. Refer to the Operator’s
Manual for instructions on safe operation.
Solid waste compartment

(waste drawer)
A
1 Safety
w Safety labels on the microscopy analyzer (waste drawer)
Roche Diagnostics
A Biohazard warning
label.
The user is responsible for cleaning the area if biohazardous material was
spilled.

(waste drawer removed)
w Safety labels on the microscopy analyzer (waste drawer removed)
A Electrical warning
Contact with electrical components can cause an electric shock. This label
indicates that there is a danger of coming into contact with electrical
components, when gaining access to parts of the system marked with this label.
Refer to the Operator’s Manual for instructions on safe operation.
1 Safety
Roche Diagnostics
Input connection unit

Safety labels on the input connection unit
A B
w Safety labels on the input connection unit
A Moving parts
This label indicates that there is a danger of moving parts within the vicinity of
this label. Keep hands away from moving parts.
B Biohazard warning
label.
The user is responsible for cleaning the area if biohazardous material was
spilled.
1 Safety
Roche Diagnostics
Disposal of the equipment 45
Disposal of the equipment

Disposal of control unit components
Components of your control unit (such as the computer,

monitor, keyboard) which are marked with this symbol
are covered by the European Directive on Waste Electrical
and Electronic Equipment (WEEE, 2002/96/EC).
• These items must be disposed of via designated
collection facilities appointed by government or local
authorities.
• For more information about disposal of your old
product, please contact your city office, waste
hazardal service or your Roche Service representative.
• Constraint:
It is left to the responsible laboratory organization to
determine whether control unit components are
contaminated or not. If contaminated, treat them in
the same way as the analyzer.
Contamination of the environment by The instrument must be treated as biologically

biohazardous materials contaminated hazardous waste.
r Final disposal must be organized in a way that does
not endanger the personnel responsible for the
disposal of the instrument.
r As a rule, such equipment must be sterile before it is
passed for final disposal. For more information contact
your Roche Service representative.
1 Safety
Roche Diagnostics
46
1 Safety Disposal of the equipment
Roche Diagnostics
47
Table of contents
Introduction 2
In this chapter, you find general information on the urine

analysis system and an overview of its operation.
In this chapter 2
General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Introducing the analyzer . . . . . . . . . . . . . . . . . . . . . 51
Operator assistance . . . . . . . . . . . . . . . . . . . . . . . . . 52
Principles of operation . . . . . . . . . . . . . . . . . . . . . . . 53
Checking the analyzer status . . . . . . . . . . . . . . . . . 55
Microscope check . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Quality control (QC) . . . . . . . . . . . . . . . . . . . . . . . . . 57
Daily operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Short guide to a typical work session . . . . . . . . . . 59
Result handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Viewing results . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Validating results. . . . . . . . . . . . . . . . . . . . . . . . . 63
Printing and exporting results. . . . . . . . . . . . . . 63
End of shift . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
2 Introduction
Roche Diagnostics
48
Table of contents
2 Introduction
Roche Diagnostics
General description 49
General description
In this section
Overview (49)
Introducing the analyzer (51)
Operator assistance (52)
Principles of operation (53)
Checking the analyzer status (55)
Microscope check (56)
Quality control (QC) (57)
Overview
The cobas u 701 microscopy analyzer is a fully
automated urine microscopy system for the in vitro
quantitative, semi-quantitative, or qualitative
determination of particles in urine.
It can process up to 116 tests per hour and urine can be

tested for the following particles:
Test Test characteristics

RBC Red blood cells
WBC White blood cells
NEC Non-squamous epithelial cells
SEC Squamous epithelial cells
YEA Yeasts
CRY Crystals
BAC Bacteria
HYA Hyaline casts
SPRM Sperm
MUC Mucus
PAT Pathological casts
y Parameters measured by the microscopy analyzer
2 Introduction
Roche Diagnostics
50 General description
Operation During routine operation, operator intervention is reduced

to loading and unloading samples and to validating
results. (You can set up the system to automatically
validate results that passed a series of internal checks.)
You may need to perform some routine maintenance
such as replenishing consumables, cleaning up spillages,
and performing wash actions of the fluid system. You are
informed when these actions are due and supported by
interactive online guidance (wizards); you simply follow
the online instructions. The same applies to function
checks and calibration and QC tasks. All you normally
need to do for these tasks is to prepare the tubes and
place the dedicated items on the analyzer when you are
prompted to do so.
2 Introduction
Roche Diagnostics
Introducing the analyzer

The following illustration shows the complete microscopy
analyzer.
F G H I
A J
K
B
C D E
A Touch screen G USB port

B Solid waste container H RFID reader for QC materials
C Water container I Cuvette cassette
D Liquid waste container J Input buffer
E On/off switch K Sample racks
F Output buffer
w Main hardware elements

2 Introduction
Roche Diagnostics
Operator assistance
The main tools for assisting with operation are wizards
that guide you through selected tasks, and the user
documentation.
w Assistance tab
2 Introduction
u Related topics
• Wizards (139)
• Online help (143)
Roche Diagnostics
Principles of operation
The analyzer is designed to operate with rack and sample
barcodes, but you can use the system without sample
barcodes. Rack barcodes are used to identify the various
rack types; dedicated racks are used for performing
patient tests, QC tests, and wash actions of the fluid
system. This allows a high degree of automation, whereby
the tests and activities start automatically when you load
the corresponding rack.
With patient tests, if you work with a laboratory

information system (LIS), the order is downloaded as
soon as a sample barcode is read, if you do not work with
a LIS the analyzer automatically generates the orders
during measurement.
Optionally, you can connect the analyzer to a laboratory

automation system (LAS), which allows automatic feed of
sample racks.
Performing a test consists of the following activities and

tasks:
2 Introduction
Roche Diagnostics
1. The operator places the samples on a rack, loads the

rack on a rack tray and then places the rack tray on
the input buffer.
2. The rack is automatically moved to the rack conveyor.
3. The rack and sample tube barcodes are read.
If you work with a laboratory information system (LIS),
the order is downloaded as soon as a sample barcode
is read, if you do not work with a LIS the analyzer
automatically generates the order.
4. The sample tube (on its rack) is transported to the
sampling position.
5. The sample is mixed inside the sample tube.
This is done by aspirating and dispensing sample.
6. Sample is aspirated into the fluid system and a cuvette
is removed from the cassette and placed on the
pipetting stage.(1)
7. The exact amount of sample is pipetted into the
cuvette.
The probe is washed after the pipetting action to avoid
carryover.
8. The cuvette is transported to the centrifuge.
9. The cuvette is centrifuged.
10. The cuvette is transported to the microscope stage.
11. 15 microscopic images are taken of the sample in the
cuvette. (The photographed area is divided into fifteen
equal subareas, which are photographed separately.)
12. The particle recognition software analyzes all valid
images for all parameters and generates either a
quantitative, semi-quantitative or qualitative result.
13. The cuvette is discarded into the solid waste
container.
14. On the Routine work area, the results and images are
available and can be validated.
15. When all sample tubes of the rack are processed, the
rack is moved to the rack tray on the output buffer,
from where the operator can remove it.
2 Introduction
(1) The minimal sample volume required depends on the test profile. See
Minimal sample volumes (dependent on test profile) (114)
Roche Diagnostics
Checking the analyzer status

The main tools for checking the status of the analyzer are
the task indicator (B) and the task list (A).
w Task indicator and task list
Task indicator
The task indicator provides a rough overview of the

current analyzer status. The color of the buttons
2 Introduction
represents the urgency of the tasks and the number in

the button tells you how many tasks there are of this
urgency. A task can comprise several messages.
The following table explains the meaning of the colors.
Roche Diagnostics
Color Meaning
Red The task requires immediate operator intervention. Operation may have stopped.
When such a task is generated, an acoustic signal is sounded as well, unless this
function is turned off.
Orange The task requires early operator intervention, operation may otherwise stop.
Gray Ongoing tasks. If operator intervention is required, perform it.
Light gray There are no tasks. No operator intervention is required.
y Color coding for messages
Task list The task list contains the task buttons. Choosing such a
button either leads to a list of all messages of the
category or to a panel that contains information and
functions related to the issue mentioned in the task
button (supplies, orders, results).
The messages and tasks that are represented by the

buttons are grouped first by their analyzer, then by their
thematic category (messages, supplies, orders, results)
and then their priority.
Microscope check
In order to ensure proper functioning of the focusing
mechanism in the microscope, a microscope check needs
to be performed every 4 weeks. This is done by
performing a predefined sequence of photographic
measurements of a reference cuvette. This cuvette
contains a transparent material with erythrocyte like
particles etched in it. The system must be able to
recognize these and count them correctly.
A message in the message list informs you when

microscope check is due. Results that are generated with
microscope check results that are no longer valid are
marked with Cm in the column.
2 Introduction
Roche Diagnostics
Quality control (QC)

Quality control (QC) measurements ensure the proper
functioning of the analyzer. A QC material for which the
results are known is measured and the results are then
compared against the defined ranges for these known
results. When the lot of the QC material expires or the QC
test has failed a message is added to the message list.
Test are still performed but the test results are marked
with Q in the column.
You generally perform QC tasks when instructed to do so.

Performing a QC measurement consists of preparing a
dedicated QC rack with the appropriate materials and
placing it on the analyzer; the tests are then performed
automatically.
2 Introduction
Roche Diagnostics
58 Daily operation
Daily operation
In this section
Overview (58)
Short guide to a typical work session (59)
Result handling (61)
End of shift (64)
Maintenance (64)
Overview
Daily operation consists of the following phases:
1. Preparing the system
- Ensure that all consumables are available, the
water container is full, and the liquid waste
container is empty.
- Address the issues of all red or orange entries in
the task list.
2. Performing tests and ongoing maintenance
- Load the samples.
- Clean up spills, replenish consumables as needed.
- Validate the results.
- Print results and save as PDF files as required.
- Unload the samples.
3. Keeping the data safe
- Archive the results according to your laboratory
procedures.
4. Keeping the analyzer clean
- Empty the liquid and solid waste containers.
- Perform the daily wash action and shut down the
system.
- Clean the input and output buffers.
- Clean the rack conveyors.
- Clean the probe bend detector.
2 Introduction
- Clean the pipetting stage and pipetting area and

the inside of the centrifuge chamber.
- Clean the microscope stage area.
- Remove spills and soiling from the analyzer
housing.
Roche Diagnostics
Daily operation 59
Short guide to a typical work session

The following table lists the major operator tasks when
performing routine tests.
Step Task Procedure

1 Starting the analyzer 1. Ensure that all covers are closed.
2. Power on the analyzer.
3. Wait until the Overview work area is displayed.
This may take a few minutes.
2 Logging on 1. On the Overview work area, choose the Log on

button.
A dialog box is displayed.
2. Enter your user name and password.
3. Choose the Log on button.
Your name is now displayed in the global
information area.
3 Preparing the analyzer 1. On the Overview work area, check the task
indicator.
Address any red and orange items.
2. Check the water container.(1)
If it is not full, start the appropriate wizard and fill
it.
3. Check the liquid waste container.(1)
If it is not empty, start the appropriate wizard and
empty it.
4. Check the cuvette cassette.
If it is nearly empty, ensure that there is a new one
available for when the old one needs to be
replaced.
(1) If you work with external water supply, this step is
not required.
4 Defining orders The orders are defined automatically when the rack
and tubes have passed the barcode reader.
5 Loading the samples and o Ensure that the sample barcodes point towards
2 Introduction
racks that long side of the rack where the rack barcode
is affixed.
o Ensure that the rack barcodes point outwards and
towards the back of the analyzer when placed on
the input buffer.
The analyzer detects the presence of the rack tray or
of individual racks in the priority and single rack slots
and moves a rack onto the rack conveyor.
(If you work with an input connection unit, you do not
need to load racks manually, it is done automatically.)
y Short guide for performing tests
Roche Diagnostics
60 Daily operation
Step Task Procedure

6 Start testing Testing starts automatically.
7 Monitoring the analyzer 1. On the Overview work area, check the task
indicator and the task list.
Address all red or orange items in the task list.
2. Choose a task button.
If the message list is displayed, choose a
message, check the details, and follow the on-
screen instructions.
If another panel is displayed, for example the
supplies panel, perform the appropriate task,
usually a wizard is available.
Red: Issues that require immediate operator
intervention.
Orange: Issues that require early operator
intervention, operation may otherwise stop.
Gray: Messages that inform about the status of
ongoing tasks. If operator intervention is required,
perform it.
Light gray: There are no issues of the associated
severity.
The number in a button tells you how many
messages of this severity there are.
8 Validating the results 1. Choose Routine > Manage test results, if
required.
2. Select a result in the list and check for data
alarms and the range graphics.
Green: negative
Yellow: positive (low pathological)
Red: positive (pathological)
If you work with patient demographics you can
assign a patient to each result. Choose the No
patient assigned button.
3. Choose the Validate or Rerun button as
required.
You can set up the analyzer to automatically
accept all results or to exclude results from
automatic validation if they have certain data
alarms associated with them. You can also choose
to validate all results manually.
2 Introduction
9 Printing or exporting To print selected or all results, choose Routine

selected or all results > Manage test results.
1. In the result list, select the check box of all results
that you want to print or save to a PDF file.
2. Choose the Report button.
3. Choose whether to print the results or save them
to a file.
4. Choose the Yes button.
Roche Diagnostics
Daily operation 61
Step Task Procedure

10 Printing or exporting the To print the results of selected patients, choose
results of selected patients Routine > Manage patients.
1. In the patient list, select the check box of all
patients whose results you want to print or save to
a PDF file.
to a file.
4. Define which results you want to print.
11 Clearing the output buffer 1. Remove the rack tray and replace it with an empty
one.
12 Performing end of shift If the next shift does not follow immediately after,
maintenance and shutting perform the following tasks:
down the analyzer 1. Archive the results according to your laboratory
procedures, if required.
2. Empty the liquid and solid waste containers.
3. Perform the daily wash action and shut down the
system.
4. Clean the input and output buffers.
5. Clean the rack conveyors.
6. Clean the probe bend detector.
7. Clean the pipetting stage, pipetting area, and the
inside of the centrifuge chamber.
8. Clean the microscope stage area.
9. Remove spills and soiling from the analyzer
housing.
Result handling
In this section
Overview (61)
Viewing results (62)
Validating results (63)
Printing and exporting results (63)
2 Introduction
Overview
You can set up the analyzer to automatically validate all
results or to exclude results from automatic validation if
they have certain data alarms associated with them. You
can also choose to validate all results manually.
Details of results can be displayed and studied, and with

microscopy, particles can be reclassified if necessary.
Roche Diagnostics
62 Daily operation
Viewing results
Results are displayed in a dedicated panel, and both full-
screen and split-screen displays are available. Exactly
which results are displayed can be defined with the help
of views; for example you can display only results that
have not been validated yet. You can also search for
specific results or a group of results by entering part of
the sample ID in the Search field.
2 Introduction
w Result display
Roche Diagnostics
Daily operation 63
Validating results
Value ranges and limits are used to determine whether a
result is positive or negative and whether to trigger data
alarms and actions such performing additional tests. If
these ranges and values are exceeded data alarms are
generated and the results are marked accordingly; these
indications help you identify critical results and point to
possible actions that need to be taken.
The analyzer provides several aids for validating results:

• You can set up the analyzer to automatically accept all
results or to exclude results from automatic validation
if they have certain data alarms associated with them.
You can also choose to validate all results manually.
u For information on setting up the analyzer, see
Defining the validation method (276).
q If you work with a laboratory information system,

validated results are sent automatically to the host
computer.
• In the result list, results that have a data alarm

associated with them are marked with in the
column.
• If you work with Sample sequence number mode,
the sample IDs for routine test results are marked with
an “N” preceding the sample sequence number, and
“E” for STAT test results.
• In the result details, the results are color coded to
indicate whether the values are normal ( green),
low pathological ( yellow) or pathological ( red).
• For microscopy results, you can also display the
individual images and you can reclassify particles in
unvalidated results.
• You can print the results and save them in PDF format.
• You can export the results in CSV format and process
them on an external computer.
2 Introduction
Printing and exporting results

You can print selected results or save them to a file in
PDF format. You can also save the related images as
individual files in a graphics file format and export the
results in the character separated values (CSV) data
format for reporting purposes or for processing in a
spreadsheet program.
The analyzer can be connected to a network or directly to

a printer.
Roche Diagnostics
64 Daily operation
End of shift
If the next shift does not follow immediately after, Roche
recommends to perform the following tasks:
1. Archive the results according to your laboratory
procedures.
system.
7. Clean the pipetting stage and pipetting area and the
9. Remove spills and soiling from the analyzer housing.
Maintenance
For routine operation, all maintenance actions can be
performed using wizards, which are sets of interactive
step-by-step instructions. You are informed by a message
in the message list when a maintenance action is due,
choosing such a message leads to detailed information
and to the appropriate wizard.
2 Introduction
Roche Diagnostics
65
Table of contents
Hardware 3
In this chapter, the hardware elements are introduced

that the operator might need to handle during daily
operation or maintenance.
In this chapter 3
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Main components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
About connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Liquid connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . 75
About liquid connectors . . . . . . . . . . . . . . . . . . 75
With external water supply . . . . . . . . . . . . . . . . 77
Power switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Input and output buffers . . . . . . . . . . . . . . . . . . . . . . . . 80
Input buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Output buffer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Input connection unit. . . . . . . . . . . . . . . . . . . . . . . . 82
Tubes, racks, and rack trays . . . . . . . . . . . . . . . . . . . . . 84
Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Rack trays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
3 Hardware
Liquid containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Water container. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Water container for external water supply . . . . . . 90
Liquid waste container. . . . . . . . . . . . . . . . . . . . . . . 91
Liquid waste with external water supply . . . . . 92
Solid waste container. . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Rack transport unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Fluid system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
About the fluid system . . . . . . . . . . . . . . . . . . . . . . . 95
Roche Diagnostics
66
Table of contents
Pipetting unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
About the pipetting unit. . . . . . . . . . . . . . . . . . . 99
Probe calibration. . . . . . . . . . . . . . . . . . . . . . . . . 99
Rinse station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Sample handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Cuvette handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Cuvette cassettes . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Cuvette cassette compartment . . . . . . . . . . . . . . . . 104
Microscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Focusing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Barcode reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Radio frequency identification . . . . . . . . . . . . . . . . . . . 109
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . 111
List of technical specifications . . . . . . . . . . . . . . . . 111
Storage conditions . . . . . . . . . . . . . . . . . . . . . . . 112
Environmental conditions . . . . . . . . . . . . . . . . . 112
Physical dimensions . . . . . . . . . . . . . . . . . . . . . . 112
Effective footprint . . . . . . . . . . . . . . . . . . . . . . . . 112
Allowed tilt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Power requirements . . . . . . . . . . . . . . . . . . . . . . 113
Uninterruptible power supply (UPS) . . . . . . . . 113
Heat output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Noise level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Measurement principles . . . . . . . . . . . . . . . . . . 114
Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Throughput . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Minimal sample volumes (dependent on test
profile) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Water quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Wash solution . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Cleaning solutions . . . . . . . . . . . . . . . . . . . . . . . 115
Waste handling . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Mouse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Standard supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Optional components. . . . . . . . . . . . . . . . . . . . . . . . 116
Concentration ranges (International). . . . . . . . . . . 117
3 Hardware
Roche Diagnostics
Safety 67
Safety
! Read and understand the information in the
Safety chapter
The following safety messages are particularly relevant:

u Warning messages:
Electrical safety (30)
Biohazardous materials (31)
u Caution messages:
Mechanical safety (36)
u Notice messages:
Excessive ambient humidity (39)
Spillage (38)
! CAUTION
Personal injury and damage to the analyzer due to
improper handling
Touching the probe with bare fingers may leave residues
on its surface and consequently influence the accuracy of
the results.
The analyzer is quite heavy. Attempting to move it without
the appropriate resources, tools and techniques may lead
to personal injury and to damage to the analyzer by
dropping it from some height.
r Do not attempt to lift the analyzer by yourself.
r To move the analyzer, always use the resources, tools
and techniques in accordance with the regulations
that apply to you locally.
NOTICE
Malfunction due to inappropriate placing of the
analyzer
Placing the analyzer on an uneven or slanting surface
may impair its proper functioning.
Placing the analyzer on a surface that cannot be reached
comfortably by all operating personnel may lead to
3 Hardware
incorrect operation of the analyzer.

r Place the analyzer on an even surface with a
maximum tilt as defined in:
u Allowed tilt (113)
r Adjust the height of the surface so all operating
personnel can comfortably open and close the main
cover.
Roche Diagnostics
68 Safety
NOTICE
Malfunction due to incompatible monitor drivers
For proper functioning of the monitor, the appropriate
drivers must be installed.
r Do not replace the monitor yourself. If it needs
replacing, contact your Roche Service representative.
3 Hardware
Roche Diagnostics
Main components 69
Main components
The following illustration highlights the main components.
F G H I
A J
K
B
C D E
A Touch screen G USB port

B Solid waste container H RFID reader for QC materials
C Water container I Cuvette cassette
D Liquid waste container J Input buffer
E On/off switch K Sample racks
F Output buffer
w Main hardware elements

3 Hardware
Roche Diagnostics
70 Covers
Covers
All covers must be kept closed during processing. They
should only be opened when instructed to do so by on-
screen instructions or as part of maintenance and
troubleshooting activities.
! WARNING
Personal injury due to contact with moving parts
r Keep the main cover closed and in place while the
analyzer is operating.
r During operation and maintenance, proceed
according to the instructions contained in the
Operator’s Manual.
! CAUTION
Personal injury due to incorrect handling of the
main cover
If the main cover is not fully opened, it may fall back to its
closed position and possibly trap your fingers in the
process.
r Always open the main cover fully to its upright
position.
r When closing the main cover, be sure not to position
your hands or fingers on the side frame of the
analyzer.
! CAUTION
Loss of data and sample due to opening covers or
drawers
Opening the main cover during operation interrupts the
power supply to all units, processing stops immediately
and no status information can be stored. Incomplete tests
and other activities will have to be redone.
Opening a waste drawer interrupts the current measuring
activities. No results are generated for the tests that have
3 Hardware
been started.
r Do not open any cover while the analyzer is
performing some activity. Only do so in an emergency.
For information on how to recover from such a
situation, see the following topics:
u When you have accidentally pulled the waste drawer
during operation (341)
u Recovering from an irregular stop (338)
Roche Diagnostics
Covers 71
A Main cover B Waste drawer
w Covers
3 Hardware
Roche Diagnostics
72 Connectors
Connectors
In this section
About connectors (72)
Liquid connectors (75)
About connectors
At the rear of the analyzer, there are connectors for mains
electricity, liquids, and data.
The fittings of the external liquid connectors differ to

prevent mix-up.
! CAUTION
Damage to the analyzer due to connecting
inappropriate devices
Connecting external devices that are not intended to be
used with the analyzer may damage the analyzer or
impair its functioning.
r Only connect external devices to the analyzer that are
intended to be used with the analyzer and mentioned
in the Operator’s Manual.
3 Hardware
Roche Diagnostics
Connectors 73
B
C Q
R
F
N O P
G H I J K L M
A System water inlet K Not in use

B Water level sensor connector L Monitor connector (DVI)
C Liquid waste outlet M Not in use
D Liquid waste level sensor connector N LAN port to LIS or network printer
E Liquid waste safety outlet O LAN port to test strip analyzer
F Input buffer connector to serial connector G P USB ports to touch screen, mouse, keyboard, printer
G Serial connector to input buffer connector F Q Microscope connector to LAN port J
H Serial connector to output buffer connector R R Output buffer connector to serial connector H
I USB ports to touch screen, mouse, keyboard, printer S Mains connector with power switch and fuse
J LAN port to microscope connector Q
w Connectors on the microscopy analyzer (control unit version 1) 3 Hardware
Roche Diagnostics
74 Connectors
B
C
D
V
F
O P Q R S T U
G H I J K L M N
A System water inlet M USB ports to touch screen, mouse, keyboard, printer
B Water level sensor connector N Not in use
C Liquid waste outlet O Not in use
D Liquid waste level sensor connector P Not in use
E Liquid waste safety outlet Q LAN port to test strip analyzer
F Input buffer connector to serial connector G R LAN port to LIS or network printer
G Serial connector to input buffer connector F S Microscope cable to LAN port U
H Serial connector to output buffer connector V T Not in use
I Not in use U LAN port to microscope cable S
J USB port to touch screen, mouse, keyboard, printer V Output buffer connector to serial connector H
K Not in use W Mains connector with power switch and fuse
L Monitor connector (DVI)
w Connectors on the microscopy analyzer (control unit version 2)
NOTICE
Operating complications due to simultaneous use of
3 Hardware
virtual keyboard and external keyboard

The system is designed to be operated using the touch
screen, but you can use the supplied external keyboard
instead.
Setting up the instrument to work with the virtual
keyboard and at the same time connecting the external
keyboard may lead to operating complications.
r Only work with either the virtual keyboard or the
external keyboard.
Roche Diagnostics
Connectors 75
A B
A Connection line B Analyzer
w Connectors on the input connection unit
Liquid connectors
In this section
About liquid connectors (75)
With external water supply (77)
About liquid connectors

The external liquid connectors must be properly fixed
before you power on the analyzer.
! CAUTION
Incorrect results due to air in the tubing
If liquid connectors are not properly connected, air may
enter the tubing and consequently incorrect amounts of
liquid may be aspirated and dispensed, which can lead to
incorrect results.
r Be sure to screw on all liquid connectors properly,
place the connectors square on when connecting
them.
3 Hardware
Roche Diagnostics
76 Connectors
F G H I J
A
B
C
D
E
K
A System water inlet G Water level sensor connection

B Water level sensor connector H Tubing for liquid waste
C Liquid waste level sensor connector I Tubing to liquid waste safety outlet
D Liquid waste outlet J Liquid waste level sensor connection
E Liquid waste safety outlet K Liquid waste container
F Tubing for system water L Water container
w Liquid connectors (control unit version 1)
F G H I J
A
B
C
D
E
K
A System water inlet G Water level sensor connection

B Water level sensor connector H Tubing for liquid waste
C Liquid waste level sensor connector I Tubing to liquid waste safety outlet
3 Hardware
D Liquid waste outlet J Liquid waste level sensor connection

E Liquid waste safety outlet K Liquid waste container
F Tubing for system water L Water container
w Liquid connectors (control unit version 2)
Roche Diagnostics
Connectors 77
With external water supply

With external water supply, the laboratory water supply is
connected to the 5 L water container, which itself is
A B C
connected to the analyzer in the same way as a standard
water container. (The two liquid waste outlets on the
analyzer are connected directly to the laboratory waste
system.)
A Tubing to laboratory C Water level sensor

water system connection
B Tubing to system
water inlet on the
analyzer
3 Hardware
Roche Diagnostics
78 Power switches
Power switches
q The analyzer automatically adjusts to 100 to 240 V
and 50 to 60 Hz mains electricity.
A Power switch C Mains connector

B Fuse compartment D On/off switch
w Power switches (control unit version 1)
C
3 Hardware
A Power switch C Mains connector

B Fuse compartment D On/off switch
w Power switches (control unit version 2)
Pressing the on/off switch for several seconds shuts

down the whole analyzer.
Roche Diagnostics
Power switches 79
! CAUTION
Loss of data and sample due to turning off the
analyzer using the on/off switch
Pressing the on/off switch for several seconds stops all
processing and shuts down the internal PC. No status
information can be stored. Incomplete tests and other
activities will have to be redone.
r Do not use the on/off switch to turn off the analyzer
except in an emergency, e.g. when the screen is
“frozen” and analyzer does not react to any user
action on-screen or otherwise.
u For information on recovering from such an emergency
situation, see To recover from a forced shutdown (339).
! CAUTION
Loss of data and sample and damage to equipment
due to switching off power
Switching off the power using the power switch stops all
processing and no status information can be stored.
Incomplete tests and other activities will have to be
redone. Equipment may be damaged.
r Do not switch off power during operation.
r Ensure that the mains cables are placed safely away
from areas where personnel might pass through.
r Roche recommends using an uninterruptible power
supply.
u Uninterruptible power supply (UPS) (113)
u For information on recovering from such an emergency
situation, see To recover from a power outage (342).
3 Hardware
Roche Diagnostics
80 Input and output buffers
Input and output buffers

The input and output buffers are positioned at the side of
the analyzer. They remain uncovered for easy access.
! CAUTION
Racks are moved automatically on the input and output
buffers by the rack pusher. If you place your hands or
fingers on a buffer while racks are moved you may get
your fingers caught.
r Do not place your hands on the input or output buffer
or the racks while the analyzer moves racks.
r Do not load racks while the analyzer moves racks on
the input buffer.
r Do not unload racks while the analyzer moves racks
on the output buffer.
In this section
Input buffer (81)
Output buffer (82)
Input connection unit (82)
3 Hardware
Roche Diagnostics
Input and output buffers 81
Input buffer
The space is divided into the area for the input rack tray
with up to 15 racks, the single rack slot and the priority
rack slot.
A B
A Priority rack slot C Rack tray

B Single rack slot D Rack pusher
w Input buffer
3 Hardware
Roche Diagnostics
82 Input and output buffers
Output buffer
There is space for up to 15 racks on the output rack tray.
A message is generated in the message list when the
output rack tray is full. No new racks can be processed
when the rack is full.
A Rack tray C Rack pusher

B Rack conveyor
w Output buffer
Input connection unit

For automated rack input, you can link the microscopy
analyzer to a laboratory automation system (LAS).
This is done with the help of an input connection unit,

which itself is connected to an external connection line as
part of an LAS. The input connection unit, in conjunction
with the LAS and LIS, automatically feeds racks to the
analyzer.
q The input connection unit and connection line must

3 Hardware
be installed by a Roche Service representative.
Roche Diagnostics
Input and output buffers 83
! CAUTION
Incorrect results and damage to the analyzer due to
use of non-recommended type of rack
Using racks that do not conform to the established
dimensions may lead to malfunction or pipetting errors
and consequently to incorrect results.
Racks with unsuitable colors may lead to barcode reading
errors.
r Only use racks defined in the following table:
u Supported tube types for allowed rack types y (84)
NOTICE
Malfunction due to placing items on the ICU
r Do not place anything on the ICU.
r Always make sure that the rack conveyor belt of the
input connection unit is unobstructed.
B C
A Rack conveyor belt of the input connection unit C Input connection unit
B Connection line
w Input connection unit
The rack conveyor belt of the input connection unit

3 Hardware
automatically passes on the racks to the analyzer when it

is ready to perform the tests. This belt also serves as the
input location for STAT racks, wash racks, and QC racks.
LAS (170)
u To perform a QC measurement when working with an
LAS (250)
u To wash the fluid system when working with an
LAS (225)
Roche Diagnostics
84 Tubes, racks, and rack trays
Tubes, racks, and rack trays

This section introduces the containers for handling
samples.
In this section
Tubes (84)
Racks (85)
Rack trays (87)
Tubes
The following table lists the supported tube types for the
allowed rack types.
Rack type Round bottom tube Conical bottom tube False bottom tube
ø 13 mm ø 16 mm ø 13-16 mm ø 13 mm ø 16 mm ø 13 mm ø 16 mm
Standard RD 5 rack l l l x l l l
(gray)
RD 5 wash rack (green) l l l x l x x
RD 5 QC rack (white) l l l x l l l
URISYS rack (yellow) x l x x l x x
y Supported tube types for allowed rack types
The tube length can be between 65 mm and 115 mm.
For identification purposes, tubes should have a barcode

label attached, but you can process non-barcoded tubes.
q The same rack/tube type combination must be used

for urine and QC materials, but you can use a different
combination for the wash rack.
Tubes must be loaded on racks to be processed by the
analyzer.
q Which tubes and racks are being used is defined by

a Roche Service representative, typically during initial
3 Hardware
installation.
Roche Diagnostics
Tubes, racks, and rack trays 85
! CAUTION
Malfunction or incorrect results due to using
inappropriate tubes
The analyzer has been designed and tested for the use of
specific types of tubes.
Using tubes that do not conform to the specified
dimensions and that are not defined for this analyzer may
lead to malfunction or pipetting errors and consequently
to incorrect results.
r Only use the tubes defined for this analyzer.
Racks
The analyzer is designed to handle the racks defined in
the following table:
u Tubes (84)
A rack can hold up to 5 tubes of 13 to 16 mm diameter

and 65 to 115 mm length. Racks can be loaded on the
analyzer either individually or on a rack tray, which holds
up to 15 racks. For identification purposes, racks must
have a barcode label attached. This ID identifies a rack
either as a sample rack for routine tests, sample rack for
STAT tests, QC rack, or as a wash rack, and the
corresponding actions are started automatically as soon
as such a rack is identified.
q The barcode label of the rack must always face

towards the rear of the analyzer when loaded on the input
buffer.
! CAUTION
inappropriate racks
Using racks that do not conform to the established
dimensions may lead to malfunction or pipetting errors
3 Hardware
r Only use racks defined in the following table:

u Tubes (84)
Roche Diagnostics
! CAUTION
inappropriate rack rubber disks
Using rack rubber disks that differ in height from the
original ones may lead to malfunction or pipetting errors
r Do not replace individual rack rubber disks, if one is
damaged, replace the whole rack.
A B
B
A Sample barcode D Rack rubber disk

B Rack ID E Racks on a rack tray that is placed on the input buffer
C Rack barcode
w Roche 5-position rack
q Roche recommends using racks with rack rubber

disks.
3 Hardware
Sample rack All racks that are not specifically defined as STAT racks,
wash racks, or QC racks are treated as sample racks.
STAT rack The STAT rack is a dedicated sample rack for performing
STAT tests.
Roche Diagnostics
Tubes, racks, and rack trays 87
To visually distinguish STAT racks from routine sample

racks, Roche recommends to mark them with dedicated
colored labels for Roche 5-position racks.
u Optional components (116)
Wash rack The wash rack is a dedicated rack for performing the
daily wash maintenance action. It contains the required
wash solution.
u For information on how to define a wash rack and how
to assign it to the analyzer, see Managing racks (305).
QC rack The QC rack is a dedicated rack for performing QC

measurements. It contains the required QC materials at
predefined positions on the rack.
u For information on how to define a QC rack and how
to assign it to the analyzer, see Managing racks (305).
Rack IDs The software is able to manage the following human

readable rack IDs.
Sample rack IDs 0001-9999
QC rack IDs Q001-Q999
Wash rack IDs W001-W999
Rack trays
A rack tray can hold up to 15 racks. Generally, racks are
loaded onto rack trays for loading on and unloading from
the analyzer. For processing single racks there is a priority
rack slot and a single rack slot.
3 Hardware
You can load one rack tray on the input buffer and one
on the output buffer. The analyzer monitors the fill level of
the output buffer and whether there is a rack tray or
individual racks on the input buffer.
Roche Diagnostics
NOTICE
Malfunction due to damaged rack tray
A rack tray that is dented or bent or damaged in any other
way may impede the locking mechanism.
r Be sure to use undamaged rack trays only.
NOTICE
Malfunction due to unsupported rack trays
Using unsupported rack trays can cause the analyzer to
block or the sensor to malfunction.
r Only use supported rack trays.
3 Hardware
Roche Diagnostics
Liquid containers 89
Liquid containers
The water containers and the liquid waste containers are
positioned under the table on which the analyzer is
placed. Their fill levels are monitored and messages in the
message list inform you when certain levels have been
reached or when a container is full or empty.
In this section
Water container (89)
Water container for external water supply (90)
Liquid waste container (91)
Water container
The white water containers hold up to 5 L of water.
The fill level is monitored and messages in the message

list inform you when the level is getting low and when the
container is empty.
A
q Use water of the quality defined in:
u Water quality (114)
C
D
A Water tubing C Floats

B Float assembly rod D Inlet water filter
3 Hardware
Roche Diagnostics
90 Liquid containers
Water container for external water supply

The white water container for external water supply holds
up to 5 L of water. It serves as an intermediary water
reservoir between the laboratory water supply and the
analyzer. It is continually and automatically replenished.
! CAUTION
Incorrect results due to incorrect water pressure in
the external water supply
Working with incorrect water pressure may lead to
hardware malfunction and consequently insufficient or
irregular water supply to the analyzer and possibly air
bubbles in the fluid system.
r The water pressure at the water inlet on the water
container must not exceed 4 bar.
r Use water of the specified quality:
! CAUTION
Contamination due to deposits of algae and bacteria
In the inside of the bottle where it is exposed to air,
deposits of algae and bacteria may build up over time.
r Clean the water container once a month.
u To clean the water container for external water
supply (318)
! CAUTION
Overfilling of the water container when the analyzer
is switched off
When the analyzer is switched off, the water level sensors
do not work and consequently cannot warn the operator
if the water container accidentally becomes too full.
r Turn off the external water supply when you switch off
the analyzer.
3 Hardware
Roche Diagnostics
Liquid containers 91

A list inform you when for some reason the water level
B cannot automatically be kept at the required level.
A Water level sensor E Float ball

connection
B Tubing to system F Float
water inlet on the
analyzer
C Tubing to laboratory G Inlet water filter
water supply
D Float valve
Liquid waste container

The yellow liquid waste container holds up to 5 L of
waste. Treat the waste as potentially biohazardous
material.
! CAUTION
Infection by liquid waste
Contact with liquid waste may result in infection. All
3 Hardware

Roche Diagnostics
92 Liquid containers

list inform you when the level is getting high and when
D the container is full.
A
In this section
B
Liquid waste with external water supply (92)
C
A Waste tubing C Floats

B Tubing to liquid waste D Float assembly rod
safety outlet
Liquid waste with external water supply

When working with external water supply, the liquid
waste is led directly to the laboratory waste system.
! CAUTION
Spilling and infection by liquid waste
If you work with external water supply, the waste outlets
are directly connected to the laboratory waste system,
and no liquid waste container is required. Connecting the
liquid waste container could lead to overflow of the liquid
waste container, because the liquid level sensors are
disabled.
r Never install the liquid waste container if you work
with external water supply.
! CAUTION
Incorrect results due to inefficient wash actions
3 Hardware
Insufficient flow in either the pumped or the gravitational

liquid waste connection may lead to backflow, which can
lead to decreased efficiency of the wash actions and
consequently to carryover.
r The liquid waste connectors at the laboratory waste
system must be lower than the ones on the analyzer.
The gradient must be at least 3%.
Roche Diagnostics
Solid waste container 93
Solid waste container

The solid waste container is designed to hold at least as
many cuvettes as are contained in a full cuvette cassette.
There is a disposable Waste Box Carton that must be
installed properly. The analyzer monitors whether the
drawer is closed properly. The fill level is monitored using
counters. When a certain fill level is reached a message is
added to the message list.
u For information on defining the fill levels, see To
define the warning limits (286).
NOTICE
Analyzer damage due to overfilled solid waste
container
If the solid waste container is full, cuvettes may get stuck
in the waste chute and they may interfere with the cuvette
transport mechanism.
r Be sure to empty the solid waste container when you
are alerted by a message in the task list.
r Roche recommends emptying the solid waste
container whenever you load a new cuvette cassette.
q The system automatically assumes that the solid

waste container is empty at the end of the Empty solid
waste container maintenance action.
C
3 Hardware
A Waste drawer C Solid waste container

B Waste Box Carton
w Solid waste container
Roche Diagnostics
94 Rack transport unit
Rack transport unit

The rack conveyor picks up the racks at the input buffer
and transports them to the sampling position. When all
tubes are processed the rack is transported to the output
buffer.
q If you work with an input connection unit, the racks

are picked up from the rack conveyor belt of the input
connection unit.
A D
B C
A Output buffer rack conveyor C Rack conveyor

B Sampling position D Input buffer rack conveyor
w Rack transport unit
Rack handling consists of the following steps:

1. The operator loads the rack on the input buffer, either
on the rack tray, the single rack slot or the priority
rack slot.
2. The rack pusher moves the rack, if required, to the
priority rack slot, which also serves as the feed to the
rack conveyor.
3. The rack conveyor moves the rack to the sampling
3 Hardware
position.
All samples on the rack are pipetted.
4. When all tubes on the rack are processed, the rack
conveyor moves the rack to the rack exit position on
the output buffer.
5. The rack pusher moves the rack onto the rack tray on
the output buffer.
6. The operator removes the rack, either by itself or by
removing the rack tray.
Roche Diagnostics
Fluid system 95
Fluid system
In this section
About the fluid system (95)
Pipetting unit (98)
Rinse station (100)
About the fluid system

The fluid system consists of all the valves, pumps, tubing,
syringe, fluid sensors, water and waste containers, the
rinse station, and the probe. The fluid system transports
all fluids around the instrument, including urine, system
water, and waste. The fluid system also delivers the
correct amounts of urine to the cuvettes.
3 Hardware
Roche Diagnostics
96 Fluid system
D
E
A Water level sensor connector and liquid waste level sensor E Rinse station
connector at the back of the analyzer
B Transfer head F External liquid connectors at the back of the analyzer
C Pipetting unit with probe G Peristaltic pumps
D Pipetting stage H Syringe
w Fluid system of the microscopy analyzer (control unit version 1)

3 Hardware
Roche Diagnostics
Fluid system 97
D
E
A Water level sensor connector and liquid waste level sensor E Rinse station
connector at the back of the analyzer
B Transfer head F External liquid connectors at the back of the analyzer
C Pipetting unit with probe G Peristaltic pumps
D Pipetting stage H Syringe
w Fluid system of the microscopy analyzer (control unit version 2)
Pipetting unit The pipetting unit moves the probe to the appropriate
positions for aspirating and dispensing liquid. It is
equipped with liquid detection and probe crash
prevention mechanisms.
u Pipetting unit (98)
3 Hardware
Probe The probe is rinsed internally and externally with water

after each pipetting action. It has a flat tip, which is
required for liquid level and tube bottom detection.
If the probe is damaged it can be replaced.

u For details on replacing the probe, see Issues with the
probe (322).
Roche Diagnostics
98 Fluid system
! WARNING
Incorrect results due to touching the probe
the results.
r Do not touch the probe except for maintenance as
described on screen or in this documentation.
Rinse station The rinse station serves to clean the probe after each
pipetting action to prevent carryover between samples.
u Rinse station (100)
Fluid system The fluid system with its syringes and pumps controls the
aspiration and dispensing of sample. It also controls the
supply of system water and wash solution. The probe is
rinsed with system water after every pipetting action to
prevent carryover between samples.
External liquid connectors There is a water and two waste connections, one of them
being a safety outlet for cases when the tubing of the
main connection is blocked.
You can connect the liquid waste to the waste system of

your facility. Ensure that the facility installation is lower
than the connector on the analyzer (gravity driven).
The external liquid containers must be properly

connected before you power on the analyzer.
u Liquid connectors (75)
Pipetting unit
In this section
About the pipetting unit (99)
Probe calibration (99)
3 Hardware
Roche Diagnostics
Fluid system 99
About the pipetting unit
A The pipetting unit moves the probe to the appropriate

positions for aspirating and dispensing liquid. Mixing of
the sample liquid is done by aspirating and dispensing
B liquid inside the sample tube. The pipetting unit is
equipped with liquid level detection and probe crash
prevention mechanisms. If there is insufficient liquid in
C the tube the sample is not pipetted, the order is marked
with in the orders list and a message is added to the
message list.
A Transfer head C Probe

B Probe release button D Rinse station
Probe calibration
During initialization of the analyzer the probe positioning
is automatically calibrated and its position adjusted. This
is done by moving the probe in the horizontal and vertical
plane along a reference block.
w Probe bend detector on the microscopy analyzer

3 Hardware
Roche Diagnostics
100 Fluid system
Rinse station
The probe is rinsed after each pipetting. It is lowered in
the probe chamber of the rinse station and then water is
pumped through the probe to wash it in and outside.
A During the Daily wash maintenance action, wash

solution is dispensed into the probe chamber of the rinse
station several times. With the last of these actions, the
wash solution remains in the chamber, the probe
aspirates wash solution from the tube and with solution
inside is lowered into the probe chamber, where it
remains for a certain time. The last step is to wash the
probe and the rinse station with water.
A Probe chamber
3 Hardware
Roche Diagnostics
Sample handling 101
Sample handling
Before urine is pipetted, it is mixed to ensure even
distribution of particles. This process is performed by
aspirating and dispensing urine in the sample tube on the
sampling position.
The probe aspirates urine and then dispenses the exact

amount into the cuvette. The cuvette is then centrifuged
to collect the particles in one layer in the cuvette in
preparation for analysis under the microscope. The
cuvette is then placed on the microscope stage and
photographed, and finally discarded into the solid waste
container.
F
B
C
3 Hardware
A Microscope lamp D Centrifuge

B Cuvette measurement position E Probe
C Waste chute F Cuvette pipetting position
w Sample stages on the microscopy analyzer
Roche Diagnostics
102 Cuvette handling
Cuvette handling
During the testing process, a cuvette is removed from the
cuvette cassette and placed on the pipetting stage. The
exact amount of urine is pipetted into the cuvette, which
is then moved to the cuvette holder on the centrifuge.
After centrifuging, the cuvette is placed on the
microscope stage, where it is photographed. The
photographic images are analyzed using image
evaluation software and results are calculated. The
cuvette is then discarded into the solid waste container.
G
B
C D E
A Centrifuge E Pipetting stage

B Microscope arm F Cuvette cassette
C Waste chute G Cuvette cassette compartment
D Microscope stage
w Hardware involved in cuvette handling
In this section
Cuvettes (103)
Cuvette cassettes (103)
Cuvette cassette compartment (104)
Microscopy (105)
3 Hardware
Roche Diagnostics
Cuvette handling 103
Cuvettes
Sample is pipetted through the injector hole and is then
A distributed across the photographic area of the cuvette.
The capillary qualities of the cuvette ensure even
distribution. Centrifuging collects the particles in one
layer in the cuvette, which then can be photographed
under the microscope.
B C
A Photographic area, C Overflow area

holds urine
B Injector hole
Cuvette cassettes
A cuvette cassette (cobas u cuvette) holds 400 cuvettes.
Each cuvette cassette is identified by a unique ID
contained in the radio frequency identification (RFID) tag.
This tag also contains the date of manufacturing, lot
number, and the number of cuvettes left in the cassette.
3 Hardware
Roche Diagnostics
Cuvette cassette compartment

The cuvette cassette compartment holds the cuvette
cassette, and it provides the mechanism for releasing
cuvettes to the cuvette transporter.
B C D
A Cuvette pipetting position D Cuvette cassette compartment

B Cuvette transporter E RFID reader
C Cuvette discharging position F Cuvette cassette
w Cuvette cassette compartment

3 Hardware
Roche Diagnostics
Cuvette handling 105
Microscopy
Microscopy is used for quantitative, semi-quantitative,
and qualitative determination of particles in urine. The
sediment in a cuvette is photographed and the individual
particles are identified and quantified using sophisticated
image evaluation software.
C D
A Microscope arm D Cuvette rail

B Waste chute E Microscope lamp
C Microscope stage
w Microscope
The photographic area on the cuvette is divided into 15

equal virtual sections. For the test measurement, each
3 Hardware
section is photographed separately.
In this section
Focusing (106)
Roche Diagnostics
Focusing
Various sizes of sediment particles are present in the
urine. The subsidence level is also different for the
different particles. Therefore, to achieve maximum
contrast, the optimal focus level is established separately
for each section on the photographic area of the cuvette.
3 Hardware
Roche Diagnostics
Barcode reader 107
Barcode reader
Barcode readers using LED technology with very low
output power are used to scan the barcodes on samples
and racks.
! WARNING
Loss of sight
The intense light of the LEDs may damage your eyes.
r Do not stare into the LEDs.
The following barcode formats are supported:

• Codabar (NW7)
• Code 39
• ITF (interleaved 2 of 5 barcode)
• Code 128
w Barcode reader
3 Hardware
Roche Diagnostics
108 Barcodes
Barcodes
Barcodes are used on racks and sample tubes. The
minimum resolution of a barcode line is 0.2 mm and the
maximum barcode length is 72 mm. The barcode must be
at least 35 mm away from the bottom of the rack.
q For more information about barcode specification,

contact your Roche Service representative.
A Barcode line resolution min. 0.2 mm C Distance from rack bottom min. 35 mm
B Barcode length max. 72 mm
w Tubes on rack, both barcoded
The sample barcode can contain the sample ID and a

checksum. The rack barcode contains the rack ID.
! WARNING
Unidentified samples due to undetected reading
errors
Barcode reading errors could potentially go undetected if
a checksum is not used, which could lead to sample
mismatch.
3 Hardware
r Always work with the checksum feature on.

r Use only barcode labels of a good print quality.
Roche Diagnostics
Radio frequency identification 109
Radio frequency identification

Roche consumables are equipped with radio frequency
identification (RFID) tags. With cassettes the tag is
automatically read when they are installed, and certain
information is written to the tag every time a cassette is
used and when it is removed, e.g. the number of items left
in the cassette. There is also an RFID reader for
identifying QC materials from outside the analyzer
housing.
q Always use cuvette cassettes with RFID tags.
A RFID reader for QC materials B RFID reader for cuvette cassette
w RFID readers
The following table lists the consumables that are

equipped with RFID tags and the information items
contained in the tags.
q When identifying QC materials with RFID tags,

present the tag to the reader at a distance of between 1
and 25 mm (0.04-1 in).
3 Hardware
Roche Diagnostics
110 Radio frequency identification
Consumable item Information items contained in the RFID tag

cobas u cuvette o Lot number
o Expiry date
o Number of cuvettes left
QC material o QC level
o Target ranges
o Lot number
o Expiry date
y RFID tag information
3 Hardware
Roche Diagnostics
Technical specifications
q Technical specifications may change without
notice
Every effort has been made to ensure that all the
information contained in these specifications is correct at
the time of publication. However, Roche reserves the right
to make any changes necessary without notice as part of
ongoing product development.
In this section
List of technical specifications (111)
Standard supplies (116)
Optional components (116)
Concentration ranges (International) (117)
List of technical specifications

In this section
Storage conditions (112)
Environmental conditions (112)
Physical dimensions (112)
Effective footprint (112)
Allowed tilt (113)
Power requirements (113)
Uninterruptible power supply (UPS) (113)
Heat output (113)
Noise level (113)
Measurement principles (114)
Interfaces (114)
Throughput (114)
Minimal sample volumes (dependent on test
profile) (114)
Water quality (114)
Wash solution (114)
3 Hardware
Cleaning solutions (115)

Waste handling (115)
Display (115)
Keyboard (115)
Mouse (116)
Roche Diagnostics
112 Technical specifications
Storage conditions
Temperature range 5 to 40°C (41 to 104°F)

Relative humidity 75% at 30°C (86°F), non condensing
Altitude and pressure Max. 2000 m (6561 feet) above sea level, 80-106 kPa
y Storage conditions
Environmental conditions
Ambient room temperature 18 to 32°C (64.4 to 90°F)

Relative humidity 30%-80%, non condensing
Altitude and pressure Max. 2000 m (6561 feet) above sea level, 80-106 kPa
Pollution Degree 2 (EN 61010-1)
Ambient light influence Up to 2 kLux of artificial direct light
Up to 20 kLux of direct light (solar radiation)
Minimum ambient light 500 Lux of ambient light
y Environmental conditions
Physical dimensions
Width (with buffers) 107.9 cm (42.48 in)

Width (with output buffer and input 104.5 cm (41.12 in)
connection unit)
Width (without buffers) 68.7 cm (27.05 in)
Depth 53.2 cm (20.94 in)
Height 64.4 cm (25.35 in)
Weight (with buffers) 88.8 kg (195.8 lb)
Weight (with output buffer and input 85.5 kg (188.5 lb)
connection unit)
Weight (without buffers) 76.6 kg (168.9 lb)
y Physical dimensions
Effective footprint
3 Hardware
The effective footprint represents the analyzer footprint

plus the user and service access requirements.
Width 107.9 cm (42.48 in)

Depth 130.0 cm (51.18 in)
y Effective footprint
Roche Diagnostics
Allowed tilt
Incline < 3º
y Allowed tilt
Power requirements
Line voltage 100 to 240 VAC

Line voltage variation ± 10%
Line frequency 50 to 60 Hz
Line frequency variation ± 5%
Current Max. 3 A
Power consumption (control unit version 1) Max. 180 VA, typical 150 VA
Power consumption (control unit version 2) Max. 180 VA, typical 150 VA
Effective power consumption See the name plate on the analyzer.
Line fuse 2 x T8AL
Insulation coordination Installation category II (EN/IEC 61010-1)
y Power requirements
Uninterruptible power supply (UPS)
Output power capacity 1500 VA

Battery runtime Min. 5 min
y Uninterruptible power supply (UPS)
Heat output
Heat dissipation Control unit version 1: 125 W

Control unit version 2: 125 W
Thermal load Control unit version 1: 427 Btu/h (450 kJ/h)
Control unit version 2: 427 Btu/h (450 kJ/h)
3 Hardware
y Heat output
Noise level
cobas u 701 microscopy analyzer 61 dB

y Noise level
Roche Diagnostics
Measurement principles
Automated microscopy
Automatic image evaluation
y Measurement principles
Interfaces
USB1.1/2.0 Connection to external storage devices

USB1.1/2.0 Connection to peripherals
RJ45 Connection to network
y Interfaces
Throughput
Microscopy analysis 116 samples per hour

y Throughput
Minimal sample volumes (dependent on test profile)
Microscopy 2.0 mL
y Minimal sample volumes (dependent on test profile)
Water quality
Type II/IF (according to CLSI C3-A4 guidelines) (Conductivity: 1μS/cm; 25°C)

Water temperature between 18 and 32°C.
y Water quality
3 Hardware
Wash solution
Recommended solution for performing the daily wash action: 1.2% - 4% Na-hypochlorite solution
y Wash solution
Roche Diagnostics
q Roche recommends to use a concentration near the

lower value (1.2%) of the recommended range, and no
higher than 2%. Higher concentrations do not enhance
the cleaning efficacy. Solutions with higher
concentrations can be diluted with water.
Cleaning solutions
Recommended solutions for manually o Isopropyl alcohol, 70%

cleaning the instrument: o Ethanol, 70%
o Mikrozid® (EtOH/Propanol)
y Cleaning solutions
Waste handling
Solid waste container for cuvettes Capacity: 400 cuvettes

Inside dimensions: (W x D x H): 13.34 cm x 8.34 cm x 11.82 cm (5.25 in x 3.28 in
x 4.65 in)
Liquid waste container Capacity: 5 L
Dimensions: (diameter x H): 16.2 cm x 32.5 cm (6.38 in x 12.80 in)
Water container Capacity: 5 L
Water container for external water supply Capacity: 5 L
y Waste handling
Display
Touch screen 19 inch (1280 x 1024 pixels)

y Display
Keyboard
3 Hardware
Standard US QWERTY layout Only use supplied keyboard.

y Keyboard
Roche Diagnostics
Mouse
Only use supplied mouse.

y Mouse
Standard supplies
The analyzer has been tested for the following Roche
supplies:
• cobas u cuvette
Optional components
The following optional components are available:
• cobas® 6500 installation kit for LAS
• Colored labels for Roche 5-position racks:
- Label for Std-rack, color yellow
- Label for Std-rack, color light blue
- Label for Std-rack, color dark blue
- Label for Std-rack, color light green
- Label for Std-rack, color orange
- Label for Std-rack, color pink
- Label for Std-rack, color brown
3 Hardware
Roche Diagnostics
Concentration ranges (International)

The following table lists the international concentration
ranges for the cobas u 701 microscopy analyzer.
Test parameter Conventional Field of view Arbitrary

Range Unit Range Unit Range
RBC(1) n/a /μL n/a /HPF n/a
WBC(2) n/a /μL n/a /HPF n/a

NEC neg neg neg
5 /μL 1 /HPF 1+
15 /μL 3 /HPF 2+
SEC neg neg neg
15 /μL 3 /HPF 1+
40 /μL 8 /HPF 2+
75 /μL 15 /HPF 3+
YEA neg neg neg
pos pos pos
CRY neg neg neg
pos pos pos
BAC neg neg neg
150 /μL 30 /HPF 1+
500 /μL 100 /HPF 2+
1000 /μL 200 /HPF 3+
HYA neg neg neg
5 /μL 1 /HPF 1+
15 /μL 3 /HPF 2+
SPRM neg neg neg
pos pos pos
MUC neg neg neg
pos pos pos
PAT neg neg neg
pos pos pos
y International concentration ranges for the cobas u 701 microscopy analyzer
(1) Quantitative parameter, measuring range: 1-1800 p/μL
(2) Quantitative parameter, measuring range: 1-900 p/μL
3 Hardware
Roche Diagnostics
118
3 Hardware Technical specifications
Roche Diagnostics
119
Table of contents
Software 4
In this chapter, the major software elements are

introduced and you find information on how to best work
with the user interface.
In this chapter 4
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Key screen elements . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Key work areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Displaying information . . . . . . . . . . . . . . . . . . . . . . . . . . 131
About displaying information . . . . . . . . . . . . . . . . . 131
Using the zoom function . . . . . . . . . . . . . . . . . . . . . 132
Working with lists (tables) . . . . . . . . . . . . . . . . . . . . . . . 134
About sorting lists. . . . . . . . . . . . . . . . . . . . . . . . . . . 134
About filtering table information . . . . . . . . . . . . . . 134
About selecting table items. . . . . . . . . . . . . . . . . . . 134
Entering information. . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Working with QC charts. . . . . . . . . . . . . . . . . . . . . . . . . 137
External keyboard and mouse . . . . . . . . . . . . . . . . . . . 138
Wizards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
About wizards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
4 Software
Example: Starting a wizard . . . . . . . . . . . . . . . . 140

Example: Using a wizard for performing a
task that is due . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Color coding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Online help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Roche Diagnostics
120
Table of contents
4 Software
Roche Diagnostics
Introduction 121
Introduction
q Throughout this documentation, images of screens
are included for illustration purposes. They are not
The user interface is designed to make the operation of

the analyzer easy and intuitive. Its logical and visual
structure and its color coding help you identify and
perform the necessary tasks. It is designed to be operated
from the touch screen, but you can instead connect the
supplied keyboard and mouse.
Key screen elements

A screen is divided into a global information area at the
top and the work area beneath.
4 Software
A Global information area B Work area
w Basic screen structure
The global information area contains permanently

available elements.
Roche Diagnostics
122 Key screen elements
The work areas consist of tabs and panels, each of which

containing thematically related information. They can
contain buttons, wizards that guide you through tasks,
information items such as lists and tables, graphics
elements such as symbols representing hardware
elements, input fields, as well as navigation and display
aids. The following figure illustrates the various parts.
4 Software
Roche Diagnostics
Key screen elements 123
A
H
I
E
F G
A Global information area F Main panel

B Task button G Detail panel
C Task list H Overview work area
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D Tabs representing work areas I Routine tab in split-screen mode display (two panels)
E Navigation bar with back and forward buttons and
navigation path
w Key screen elements
The following sections explain the various elements in

more detail.
Global information area Contains permanently available elements.
Roche Diagnostics
A B C D E F G H I
A Overview work area F System name

B Task indicator G System status
C Assistance button H Online help button
D Name of the user who is currently logged on I Screenshot button
E Button for logging on and off
w Global information area
Task indicator The task indicator provides a rough overview of the

current analyzer status. The color of the buttons
represents the urgency of the tasks and the number in
the button tells you how many tasks there are of this
urgency. A task can comprise several messages.
The following table explains the meaning of the colors.
Color Meaning
Red The task requires immediate operator intervention. Operation may have stopped.
When such a task is generated, an acoustic signal is sounded as well, unless this
function is turned off.
Orange The task requires early operator intervention, operation may otherwise stop. When
such a task is generated, an acoustic signal is sounded as well, unless this function
is turned off.
Gray Ongoing task. If operator intervention is required, perform it.
Light gray There are no tasks. No operator intervention is required.
y Color coding for messages
Task list, message list, and buttons Use the task buttons to display a list of all messages of a
given category and severity (message list). Choose a
message to display details of the message. These could
for example contain a button for starting a wizard that
guides you through the various steps of dealing with the
issue.
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Roche Diagnostics
Key screen elements 125
C D E
A Task buttons E Tab or panel where the issue can be addressed

B Message list F Message that can be selected and which leads to detailed
information
C Color code for severity G Wizard button
D Thematic group, summary of underlying issues
w Example of using task buttons and message lists
Tabs
Tabs group information and tasks of the work areas such

as performing tests and result handling, maintenance
actions, or defining the analyzer work environment.
u Tabs (129)
Navigation bar
The navigation bar helps you move between the various

panels. A "history" function registers which panels have
been displayed so far, use the back and forward buttons
to display the previous or next panel within this history.
The navigation path tells you how to navigate to the
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current panel (the blue element denotes the current

panel). You can choose any of the path elements to
display the corresponding panel.
Roche Diagnostics
Main panel, detail panel
Information is often displayed in two panels, the

information in panel on the right (detail panel) contains
detailed information of an item selected in the panel on
the left (main panel).
Assistance
Choose the Assistance tab to access operation aids

such as wizards and user documentation.
u For details on the Assistance work area, see
Wizards (139) and Online help (143).
Callouts
Callouts are a kind of work areas that are displayed on

top of the current panel, for example for displaying
messages, entering information, or confirming an action.
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Roche Diagnostics
Key work areas 127
Key work areas

Related tasks are grouped in separate work areas.
The Overview work area is displayed when you start the

analyzer. It contains general status information of the
analyzer and lists the user actions that are due to ensure
the proper functioning of the analyzer and the smooth
progress of tasks and actions. Its main elements are:
• The Tasks panel contains the task list and the task
buttons, which lead to the relevant panels for
addressing the issues they concern.
• The Overview panel provides access to a graphic
overview of the analyzer hardware components. You
can choose these elements if some intervention is
required, and callouts provide the required functions.

the sample sequence number that will be used next is
also displayed below the Overview panel, both for
routine samples and for STAT samples.
The Assistance work area provides operation aids such

as:
• User documentation
• Wizards that guide you through selected tasks
• Legal notice
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Roche Diagnostics
128 Key work areas
The Routine tab encompasses all activities directly

related to performing tests and handling results.
• Patient management
• Order definition and handling
• Result viewing, validation, and reporting
• QC materials and QC result handling
• Manage sample sequence numbers (if you work with
Sample sequence number mode)
The Monitoring tab encompasses the activities related to

ensuring the trouble-free operation of the analyzer:
• Dealing with messages and related tasks
• Checking the hardware status and performing
hardware related tasks
• Performing consumables related tasks
• Performing maintenance actions
• Performing calibration measurements
• Managing racks and rack IDs
The Administration tab provides the functions required

for setting up and maintaining the analyzer’s operating
environment.
• Defining and managing users
• Defining the characteristics for result display,
measurements, QC, and tests
• Configuring the analyzer environment
• Displaying the audit trail
• Displaying the message log
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Roche Diagnostics
Tabs 129
Tabs
When choosing a tab, a list is displayed with the buttons
for the items dealt with in this work area (A). Choosing
one of these buttons displays two panels next to each
other (B); the panel on the left (the main panel) usually
contains a list whose elements can be selected. It may
also contain buttons for starting tasks and features for
preselecting the type of information that should be
contained in the list. The panel on the right (the detail
panel) contains information related to the item selected in
the left panel, and it may also contain buttons.
w Main elements in a tab

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Display modes Another feature of some tabs is the fact that they can be
displayed in either full-screen or split-screen mode.
In split-screen mode, two panels are displayed next to

each other, whereby the information contained in the
detail panel on the right depends what is selected in the
main panel on the left. In full-screen mode one panel
covers the whole width of the screen.
Roche Diagnostics
130 Tabs
Use the panel splitter to switch between the two display

modes. Its function depends on its relative position to the
panel. The following table illustrates how it works:
Position relative to panel Resulting panel(s)
1 2 1
1 1 2
1 2 2
2 1 2
y Functions of the display-mode buttons (panel splitters)

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Roche Diagnostics
Displaying information 131
Displaying information
In this section
About displaying information (131)
Using the zoom function (132)
About displaying information

There are several features that help you access panels
and their functions:
• The global information area contains permanently
available information and control elements
• The navigation bar contains buttons for displaying
panels that were displayed before (back, forward) and
shows how you can navigate to the current panel
(navigation path).
• Tabs and panels can contain lists and tables, buttons,
and graphic elements to access further information.
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A Global information area C Navigation bar

B Tabs D Panels
w Features for accessing information and functions
Roche Diagnostics
132 Displaying information
Using the zoom function

For studying details of microscopic images, a zoom
function is provided.
B C D
A Grid scale C Zoom in

B Zoom out D Enable grid toggle button
w Image details screen
r To use the zoom functions
1 Choose Routine > Manage test results > Show

images.
2 Choose the image.
3 Select the Enable grid toggle button to display the

grid, if required ( ).
I If you display the grid, the current scale is
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indicated. (A).
Roche Diagnostics
Displaying information 133
4
4 Choose the Zoom in button.
I If you work with a mouse, the mouse pointer
changes to the symbol.
5
5 In the image, touch the area you are particularly
interested in.
I The image is enlarged and the spot where you
touched the image is in the center of the image.
The grid label indicates the current scale.
6 Use the scroll bars to display the area of interest, if

required.
7 To enlarge the image further, make sure the Zoom in

button is blue and touch the area you are
particularly interested in.
q You can enlarge an image up to three times

(200%, 300%, 400%).
8 To return to the normal view, choose the Zoom out

button.
q Choosing the Zoom out button always sets

the image to its normal size (100%).
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Roche Diagnostics
134 Working with lists (tables)
Working with lists (tables)

In this section
About sorting lists (134)
About filtering table information (134)
About selecting table items (134)
About sorting lists

You can sort lists by choosing a column head.
The sort order is marked by for ascending and for

descending order.
About filtering table information

In some tables you can choose what kind of items are
contained. You do so by either selecting one of the
predefined filters from drop-down lists or by entering in
the Search field the first part of the items you are looking
for and then choosing the button; for example, if you
enter 7, all items beginning with 7 are displayed.
Press the button to cancel the search.
About selecting table items

You can select items by selecting the check box to the
left of the item.
Selected items are colored blue.

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You can select all items in the table by selecting the

check box to the left of the table headers.
Roche Diagnostics
Entering information 135
Entering information
Normally the virtual keyboard is displayed whenever you
need to enter information. (The system is designed to be
operated using the touch screen, but you can use the
supplied external keyboard and mouse instead. If you do
so ensure that the virtual keyboard is not displayed
(Administration > Basic configuration 2)).
A Close the keyboard callout B Go to the next input field or to the next tab
w Keyboard on the touch screen
q Keyboard layout
The virtual keyboard layout corresponds to the US English
QWERTY keyboard layout. This cannot be changed.
Entry fields with compulsory information are marked with

an asterisk and colored yellow.
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w Compulsory entry fields
The validity of the information you enter is continuously

checked. As long as the value is not valid the entry field
shows a red border (A). When the entry is valid, the field
has its normal active display (B).
Roche Diagnostics
136 Entering information
A B
w Validity checking of text entries

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Roche Diagnostics
Working with QC charts 137
Working with QC charts

The QC chart allows you to review QC results over a
period of time.
Choose this button to move back the displayed time interval by one month.
To continuously move back the displayed time interval, keep the button pressed.
Use this button to move forward the displayed time interval by one month.
To continuously move forward the displayed time interval, keep the button pressed.
Use this button to double the size of the displayed items, i.e. to increase the scale.
You can increase the scale four times.
Use this button to half the size of the displayed items, i.e. to decrease the scale.
You can decrease the scale until normal view is displayed (100%).
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Roche Diagnostics
138 External keyboard and mouse
External keyboard and mouse

You can connect the supplied external standard US
English keyboard and the mouse to the analyzer using
any of the USB ports.
q The system is designed to be operated using the

touch screen, but you can use the supplied external
keyboard and the mouse instead. If you do so ensure that
the virtual keyboard is not displayed (Administration
> Basic configuration 2).
w USB ports (control unit version 1)
w USB ports (control unit version 2)
q When working with a host system, non-ASCII

characters are converted to spaces. Therefore, if you work
with a host system, only use standard ASCII characters.
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Roche Diagnostics
Wizards 139
Wizards
In this section
About wizards (139)
Examples (139)
About wizards
A wizard is an interactive set of step-by-step instructions
for performing a certain task. The instructions that are
currently displayed depend on checks the analyzer
performs continuously and on user input, for example a
confirmation that a certain step has been completed or
on entering data.
You start wizards by choosing their buttons. All wizards

are listed in Assistance > Wizards. Wizards are also
available for example when you follow up a message in
the message list; they guide you through the actions
required to deal with the issue mentioned in the message.
Examples
In this section
Example: Starting a wizard (140)
Example: Using a wizard for performing a task that is
due (140)
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Roche Diagnostics
140 Wizards
Example: Starting a wizard
r To start a wizard
1 Choose Assistance > Wizards u 701.
2
2 Choose the button for the task you want to perform,
for example for filling the water container.
Example: Using a wizard for performing a task that is due

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w Choosing an element from the list in the main panel
Roche Diagnostics
Wizards 141
r To use a wizard for performing a task

that is due
1 Choose the Overview work area.
2 Choose a red or orange task button that leads either

to the message list or the Supplies panel.
3 Choose an element from the list in the main panel.
4 In the detail panel, choose the button for the wizard.
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Roche Diagnostics
142 Color coding
Color coding
The color of buttons and other display items inform you
about the status of the display item or the item it
represents.
Color Meaning
Light gray You cannot currently select this element.
Gray For information purposes. No operator intervention is required.
Orange Your intervention is required to ensure continuous operation.
Red Your immediate intervention is required. Operation may have stopped.
Yellow This field must contain content (compulsory information).
Blue This item is selected for display.
Light blue Multiple items are selected.
y General color concept for user interface elements
In result related displays, the colors indicate the degree of

pathology of the result. To assist people with color vision
deficits, result related elements additionally display
hatching.
Color Result range

Green Normal.
Yellow Low pathological.
Red Pathological.
y Color concept for degree of pathology in results

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Roche Diagnostics
Online help 143
Online help
The analyzer provides online user information and
assistance, which can be accessed in the following ways:
• To display information that is relevant to the currently

displayed screen, choose .
• To display the table of contents of the complete user

information, choose Assistance > Online help.
A
E
B
A Button for closing online help D Help button

B Table of contents E Display area for content
C Selected section
w Online help page
Choose to display the titles of the subtopics.
Choose to hide (collapse) the titles of the subtopics.

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Choose to close the online help and return to the

screen from where you started it.
Roche Diagnostics
144 Online help
q Note that the function does not work if you

started the online help from the Overview work area;
instead, to close the online help, choose the Overview
tab.
4 Software
Roche Diagnostics
Operation
5 Operation.................................................................................................................147
6 Configuration .........................................................................................................263
Roche Diagnostics
147
Table of contents
Operation 5
In this chapter, you find instructions on how to perform

the daily operation tasks.
In this chapter 5
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Short guide to routine testing . . . . . . . . . . . . . . . . . . . . 153
Routine operating tasks. . . . . . . . . . . . . . . . . . . . . . . . . 156
Starting the analyzer . . . . . . . . . . . . . . . . . . . . . . . . 156
Logging on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Preparing the analyzer . . . . . . . . . . . . . . . . . . . . . . . 158
Managing sample sequence numbers . . . . . . . . . 159
Defining the sample sequence number
ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Defining the next sample sequence number
to be used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Defining orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Defining orders . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Defining an order manually when working
with Sample sequence number mode . . . . . . . 163
Loading racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
About loading racks . . . . . . . . . . . . . . . . . . . . . . 164
Priority racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Starting the testing process . . . . . . . . . . . . . . . . . . 168
Starting sample testing . . . . . . . . . . . . . . . . . . . 168
5 Operation
Loading a priority rack . . . . . . . . . . . . . . . . . . . . 169

Checking the status of processing. . . . . . . . . . . . . 171
Result handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Viewing results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Validating results . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Assigning patients . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Generating reports . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Non-routine situations . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Rerunning tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
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148
Table of contents
Rerunning tests when working with sample

barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
Rerunning tests when working with Sample
sequence number mode . . . . . . . . . . . . . . . . . . 188
Manually analyzing images . . . . . . . . . . . . . . . . . . . 192
Analyzing images . . . . . . . . . . . . . . . . . . . . . . . . 194
Questionable images . . . . . . . . . . . . . . . . . . . . . 197
Editing microscopy counts and
concentrations. . . . . . . . . . . . . . . . . . . . . . . . . . . 200
Adjusting sample information . . . . . . . . . . . . . . . . . 201
Urine sediment image evaluation. . . . . . . . . . . . . . . . . 202
Epithelial cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
SEC, NEC, RBC, BAC, HYA, and artifacts . . . . . 204
SEC, NEC, RBC, WBC, BAC, HYA CRY, MUC,
and macrophage. . . . . . . . . . . . . . . . . . . . . . . . . 205
White blood cells, bacteria, and yeast . . . . . . . . . . 205
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
WBC, BAC, RBC, HYA, MUC, and WBC
clumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
WBC, BAC, YEA, RBC, SEC, and MUC . . . . . . . 208
Macrophage, WBC, BAC, and MUC . . . . . . . . . 209
Red blood cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
RBC, BAC, CRY, and MUC . . . . . . . . . . . . . . . . . 210
RBC / RBC 200% magnification . . . . . . . . . . . . 212
Casts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
PAT, HYA, RBC, WBC, BAC, NEC, CRY, and
MUC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
HYA and MUC. . . . . . . . . . . . . . . . . . . . . . . . . . . 214
Crystals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
CRY, RBC, BAC, and HYA. . . . . . . . . . . . . . . . . . 215
CRY, WBC, BAC, and SEC . . . . . . . . . . . . . . . . . 216
Spermatozoa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216
Managing patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
Routine maintenance actions . . . . . . . . . . . . . . . . . . . . 219
About routine maintenance actions. . . . . . . . . . . . 219
Checking the status of the system . . . . . . . . . . . . . 220
Checking the status of order processing . . . . 221
Checking for tasks that require intervention. . 221
Checking the current hardware status . . . . . . 222
Checking the status of supplies . . . . . . . . . . . . 223
5 Operation
Washing the fluid system. . . . . . . . . . . . . . . . . . . . . 224

Air purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
Filling the water container . . . . . . . . . . . . . . . . . . . . 226
Emptying the liquid waste container . . . . . . . . . . . 227
Emptying the solid waste container . . . . . . . . . . . . 228
Replacing the cuvette cassette. . . . . . . . . . . . . . . . 229
At the end of the shift . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Logging off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Shutting down the analyzer. . . . . . . . . . . . . . . . . . . 232
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149
Table of contents
Shutting down the analyzer. . . . . . . . . . . . . . . . 232

Putting the analyzer into standby . . . . . . . . . . . 233
Switching off the power supply . . . . . . . . . . . . 234
Keeping the analyzer clean . . . . . . . . . . . . . . . . . . . 234
About keeping the analyzer clean . . . . . . . . . . 235
Cleaning the input and output buffers . . . . . . 236
Cleaning the analyzer housing . . . . . . . . . . . . . 237
Cleaning the rack conveyors. . . . . . . . . . . . . . . 237
Cleaning the rack trays . . . . . . . . . . . . . . . . . . . 238
Cleaning the probe bend detector . . . . . . . . . . 241
Cleaning the pipetting stage area . . . . . . . . . . 241
Cleaning the centrifuge chamber. . . . . . . . . . . 242
Cleaning the microscope stage area . . . . . . . . 245
Checking the microscope focusing mechanism . . . . 246
QC tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Performing QC measurements . . . . . . . . . . . . . . . . 248
About performing QC measurements . . . . . . . 249
Preparing the QC rack . . . . . . . . . . . . . . . . . . . . 249
Performing a QC measurement . . . . . . . . . . . . 250
Performing a QC measurement when
working with an LAS . . . . . . . . . . . . . . . . . . . . . 250
Defining QC materials . . . . . . . . . . . . . . . . . . . . 250
Changing QC material data . . . . . . . . . . . . . . . . 253
Making test parameter related changes . . . . . 254
Including or excluding tests from the QC
measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . 254
Deleting QC materials . . . . . . . . . . . . . . . . . . . . 255
Reviewing QC results . . . . . . . . . . . . . . . . . . . . . . . . 255
Additional operating tasks. . . . . . . . . . . . . . . . . . . . . . . 259
Stopping and restarting sample processing . . . . . 259
Changing the password. . . . . . . . . . . . . . . . . . . . . . 260
Printing and exporting information, generating
reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261
5 Operation
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150
Table of contents
5 Operation
Roche Diagnostics
Safety 151
Safety
Safety chapter
Warning messages:
u Biohazardous materials (31)
u Waste (31)
Caution messages:
u Mechanical safety (36)
u Working solutions (36)
u Influence of vibrations (37)
Notice messages:
u Spillage (38)
u Excessive ambient humidity (39)
! CAUTION
Incorrect results due to contaminated samples
Solid particles in the sample may influence the
functioning of the fluid system, which may lead to
incorrect pipetting volumes and consequently to incorrect
results.
Food and drink particles in the sample may influence the
image evaluation.
r Store and transport samples in a manner that prevents
contamination with foreign substances.
r Do not store or consume food and drink in the vicinity
of the analyzer.
! CAUTION
Incorrect results due to carryover of samples
Hands that are contaminated with urine can transfer
5 Operation
urine to the touch screen monitor or mouse, from where it

may be transferred to samples, leading to carryover.
r Avoid getting into contact with urine.
r If you get into contact with urine, either dispose of the
lab gloves immediately or clean them using one of the
recommended cleaning solutions.
Roche Diagnostics
152 Safety
! CAUTION
Incorrect results due to foamy and contaminated
samples
Foam in samples may lead to incorrect amounts of liquid
being aspirated and dispensed, which can lead to
incorrect results.
Insoluble contaminants in samples may cause clogging or
pipetting volume shortage and lead to deterioration in
measurement accuracy.
r Ensure that samples are clear of foam and insoluble
contaminants such as fibrin or dust.
! CAUTION
Loss of data and analyzer damage due to
disconnection of mains power
Disconnecting the mains cable while the analyzer is
processing may lead to loss of data and hardware
damage.
r Do not disconnect the mains cable while the analyzer
has not been shut down properly.
q Throughout this documentation, images of screens

are included for illustration purposes. They are not
5 Operation
Roche Diagnostics
Short guide to routine testing 153
Short guide to routine testing

This section provides a short guide to performing routine
testing. You can find detailed descriptions of the steps
and information on non-routine operating tasks in the
subsequent sections.
Step Task Procedure

1 Starting the analyzer 1. Ensure that all covers are closed.
2. Power on the analyzer.
3. Wait until the Overview work area is displayed.
This may take a few minutes.
2 Logging on 1. On the Overview work area, choose the Log on

button.
A dialog box is displayed.
2. Enter your user name and password.
3. Choose the Log on button.
Your name is now displayed in the global
information area.
3 Preparing the analyzer 1. On the Overview work area, check the task
indicator.
Address any red and orange items.
2. Check the water container.(1)
If it is not full, start the appropriate wizard and fill
it.
3. Check the liquid waste container.(1)
If it is not empty, start the appropriate wizard and
empty it.
4. Check the cuvette cassette.
If it is nearly empty, ensure that there is a new one
available for when the old one needs to be
replaced.
(1) If you work with external water supply, this step is
not required.
4 Defining orders The orders are defined automatically when the rack
and tubes have passed the barcode reader.
5 Operation
5 Loading the samples and o Ensure that the sample barcodes point towards
racks that long side of the rack where the rack barcode
is affixed.
o Ensure that the rack barcodes point outwards and
towards the back of the analyzer when placed on
the input buffer.
The analyzer detects the presence of the rack tray or
of individual racks in the priority and single rack slots
and moves a rack onto the rack conveyor.
(If you work with an input connection unit, you do not
need to load racks manually, it is done automatically.)
Roche Diagnostics
154 Short guide to routine testing
Step Task Procedure

6 Start testing Testing starts automatically.
7 Monitoring the analyzer 1. On the Overview work area, check the task
indicator and the task list.
Address all red or orange items in the task list.
2. Choose a task button.
If the message list is displayed, choose a
message, check the details, and follow the on-
screen instructions.
If another panel is displayed, for example the
supplies panel, perform the appropriate task,
usually a wizard is available.
Red: Issues that require immediate operator
intervention.
Orange: Issues that require early operator
intervention, operation may otherwise stop.
Gray: Messages that inform about the status of
ongoing tasks. If operator intervention is required,
perform it.
Light gray: There are no issues of the associated
severity.
The number in a button tells you how many
messages of this severity there are.
8 Validating the results 1. Choose Routine > Manage test results, if
required.
2. Select a result in the list and check for data
alarms and the range graphics.
Green: negative
Yellow: positive (low pathological)
Red: positive (pathological)
If you work with patient demographics you can
assign a patient to each result. Choose the No
patient assigned button.
3. Choose the Validate or Rerun button as
required.
You can set up the analyzer to automatically
accept all results or to exclude results from
automatic validation if they have certain data
alarms associated with them. You can also choose
to validate all results manually.
9 Printing or exporting To print selected or all results, choose Routine
selected or all results > Manage test results.
5 Operation
1. In the result list, select the check box of all results

that you want to print or save to a PDF file.
to a file.
Roche Diagnostics
Short guide to routine testing 155
Step Task Procedure

10 Printing or exporting the To print the results of selected patients, choose
results of selected patients Routine > Manage patients.
1. In the patient list, select the check box of all
patients whose results you want to print or save to
a PDF file.
to a file.
4. Define which results you want to print.
11 Clearing the output buffer 1. Remove the rack tray and replace it with an empty
one.
12 Performing end of shift If the next shift does not follow immediately after,
maintenance and shutting perform the following tasks:
down the analyzer 1. Archive the results according to your laboratory
procedures, if required.
system.
7. Clean the pipetting stage, pipetting area, and the
9. Remove spills and soiling from the analyzer
housing.
5 Operation
Roche Diagnostics
156 Routine operating tasks
Routine operating tasks

The following sections describe in detail the various tasks
you need to perform during routine operation.
In this section
Starting the analyzer (156)
Logging on (157)
Preparing the analyzer (158)
Managing sample sequence numbers (159)
Defining orders (161)
Loading racks (164)
Starting the testing process (168)
Checking the status of processing (171)
Starting the analyzer

Before you start the analyzer, ensure that the following
preconditions are met:
• The analyzer is properly connected to the mains
electricity.
• All covers are closed.
r To start the analyzer
1
1 Power on the analyzer.
5 Operation
Roche Diagnostics
Routine operating tasks 157
2
2 The analyzer software starts automatically. Performing
all the initialization and check procedures can take a
few minutes. During this process the Overview work
area is displayed.
Logging on
Results are always associated with the name of the
person who operated the analyzer at the time when the
test was performed. (This may be a legal requirement for
storing results.) Therefore, an operator must be logged on
to perform tests.
r To log on
1 In the global information area, choose Log on.

f A dialog box for entering the user name and
password is displayed.
2 Enter your user name and password.
q Note that both user name and password are case

sensitive, this means for example that Operator and
operator are two different names.
o When you log on for the first time, you may have to
change your password. (Whether this is the case
depends on how the system is set up.)
u Changing the password (260)
5 Operation
3 Choose the Log on button.

f Your name is displayed in the global information
area.
Roche Diagnostics
Preparing the analyzer

The preparation tasks ensure trouble-free uninterrupted
processing.
q Roche recommends emptying the corresponding

waste container whenever you refill supplies.
r To prepare the analyzer for test

processing
1
1 On the Overview work area, check that there are no
red or orange buttons in the task list.
2 Address the issues of all red or orange entries in the

task list.
q Typical tasks that need doing are emptying waste

containers and filling up consumables, and
performing QC.
u Checking the status of the system (220)
3 CAUTION! Sample mismatch due to pending sample

orders
Having pending sample orders in the order list may
lead to sample mismatch.
Delete any pending sample orders from the order list
before starting the measurement.
3 On the Overview work area, check that there are no
pending sample orders in the task list.
• To delete pending sample orders, choose Routine
> Manage sample orders and delete them from
the order list.
4 Choose Monitoring > Manage supplies.
5 Check the fill level of the liquid containers (water,

liquid waste).
5 Operation
• Choose an entry in the list and check the number

of tests that can still be performed.
• To refill the water container, choose System
water > Fill water container.
• To empty the liquid waste container, choose
Liquid waste > Empty liquid waste container.
6 Choose Cuvette and check the number of available

cuvettes. Ensure that you have a new cuvette cassette
available to replace the installed one when it is empty.
Roche Diagnostics
7 CAUTION! Loss of results due to resetting the sample

sequence number
If you reset the sample sequence number counter, all
associated results are deleted.
Only reset the sample sequence number if you do no
longer need the results.
7 If you work with Sample sequence number mode,
Roche recommends to reset the counter at the
beginning of the day:
• Choose Routine > Manage sample sequence
numbers.
• Choose the Edit button.
• In the Next Sequence No. area, choose the
Reset button for both the routine and STAT
samples.
The first number to be used will be the lowest
number in the sample sequence number range
that is defined.
• Choose the Save button.
u Related topics
• Defining the sample sequence number ranges (159)
Managing sample sequence numbers

In this section
Defining the sample sequence number ranges (159)
Defining the next sample sequence number to be
used (160)
Defining the sample sequence number ranges

You can either work with barcodes on sample tubes for
sample identification or you can use the Sample
sequence number mode.
The sample sequence number that will be used next is

displayed on the Overview tab.
5 Operation
To work with Sample sequence number mode, the

following needs to be set up:
• The analyzer works in Sample sequence number
mode.
u Defining how the sample IDs are generated (279)
• Ranges for sample sequence numbers are defined for
routine and STAT samples.
u To define the sample sequence number ranges (160)
Roche Diagnostics
• The counters for the sample sequence numbers are

reset to ensure sufficient available numbers.
r To define the sample sequence

number ranges
1 Choose Routine > Manage sample sequence
numbers.
2 Choose the Edit button.
3 Enter the lower and upper limits of the sample

sequence number range for both the routine and the
STAT samples.
I The ranges typically contain enough numbers to
cover one day’s number of tests.
4 Choose the Save button.
Defining the next sample sequence number to be used

The procedure is the same for routine and STAT samples.
r To define the next sample sequence

number to be used
1 Choose Routine > Manage sample sequence
5 Operation
numbers.
3 To re-start the counter with the lower limit of the

range, choose the Reset button.
f All results are deleted.
Roche Diagnostics
4 To use a specific sample sequence number as the

next number to use, enter a number from within the
defined range.
f This number will be the next sample sequence
number to be used.
q What happens to already used numbers?

If you enter a number lower than the next free sample
sequence number, the results of the numbers greater
than the one you entered are deleted. For example:
The next number would be 150 and you enter 140, the
results for numbers 140 to 149 are deleted.
If you enter a number higher than the next free
sample sequence number, the numbers between are
blocked. For example: The next number would be 150
and you enter 160, numbers 150 to 159 are blocked
and cannot be used.
Defining orders
In this section
Defining orders (161)
Defining an order manually when working with Sample
sequence number mode (163)
Defining orders
The system is designed to operate with rack and sample
barcodes. The orders are generated automatically on the
basis of the barcode information.
You can also use the analyzer without sample barcodes

and use sample sequence numbers for identifying
samples.
If you work with a laboratory information system (LIS), the

5 Operation
order is downloaded as soon as a sample barcode is read,

if you do not work with a LIS the analyzer automatically
generates the order.
q When working with a host system, non-ASCII

characters are converted to spaces. Therefore, if you work
with a host system, only use standard ASCII characters.
u To define how the sample IDs are generated (280)
Roche Diagnostics
When working with Sample sequence number If you work with Sample sequence number mode, the
mode number is assigned when the tube is on the
measurement position.
! WARNING
Incorrect results due to sample mismatch when
working without sample barcodes
When working with Sample sequence number mode, it
is up to the operating staff to ensure that the sample
placement on the racks matches the definitions in the
orders.
If the rack number, rack position and sample ID of the
order do not agree with the actual racks and positions,
the results may not be associated with the correct patient
by the medical personnel.
r When working without sample barcodes, be sure to
load the samples according to the definitions in the
orders.
r Avoid empty positions within the racks. Do not place
non-registered samples in any empty rack position.
r When manually assigning rack positions, ensure the
position is not already assigned.
r Always follow strictly the rules and regulations for
sample preparation and handling that apply to your
facility.
r To define orders automatically when

working with Sample sequence
number mode
1 WARNING! Sample mismatch due to inappropriate
sample loading
Do not place a routine sample rack on the priority
input slot if there are already routine sample racks on
the input buffer.
1 Place the sample tubes on an appropriate rack in the
order that agrees with your order sheets.
2 Place the rack on the analyzer.

5 Operation
I If it is a priority rack, place it on the priority rack

slot.
f The rack barcode is scanned, the sample
sequence number is assigned to each sample
when it is on the measuring position, and the
orders are automatically defined, using the test
profile and validation rules that are currently
defined for the analyzer.
Roche Diagnostics
Defining an order manually when working with Sample sequence number

mode
r To define an order manually when

working with Sample sequence
number mode
1 Choose Routine > Manage sample orders.
f The samples list is displayed.
2 Choose the Create button.
3 Enter the rack ID.

I You find the 4 digit ID above the rack barcode.
4 Enter the rack position.
5 Enter a comment, if required.
6 If you work with patient demographics choose the No

patient assigned button to (if necessary define and)
assign a patient to the order.
• Select a patient and choose the Assign button.
• Choose the Create button and fill in the patient
demographics, then choose the Assign button.
7 WARNING! Incorrect results due to cell lysis

Dilution of sample may lead to cell lysis and therefore
incorrect results may be obtained.
Always use appropriate dilution procedures.
7 You can enter a dilution factor (≥1.00: dilution, <1.00:
concentration) in the Dilution field, if required. (If
previously no result could be generated for this
sample, the sample can be diluted and measured
again. For diluted samples the dilution factor must be
entered.)
I If you entered a dilution factor ≠1.00, the result will
be marked with D in the column.
8 In the detail panel, choose the Save button.

5 Operation
f The order is now defined.
9 To process the order, place the rack with the sample

tube on the correct position on the analyzer.
I If it is a priority rack, place it on the priority rack
slot.
u Related topics
• Managing patients (217)
Roche Diagnostics
Loading racks
In this section
About loading racks (164)
Priority racks (166)
About loading racks
! CAUTION
Racks are moved automatically on the input buffer by the
rack pusher. If you place your hands or fingers on the
buffer while racks are moved you may get your fingers
caught.
r Do not place your hands on the input buffer or the
racks while testing is in progress.
NOTICE
Impaired tube content level detection due to metal
objects on tubes
Metal objects attached to tubes can impair the
functioning of the liquid level detection mechanism.
r Do not attach any materials to tubes other than
barcodes.
NOTICE
Stand-alone operation
Malfunction and analyzer damage due to
obstructions
Placing objects on the rack tray or the input buffer may
cause rack jamming and malfunction when moving the
racks.
Placing racks or a rack tray on the input buffer when the
rack pusher is not in its resting position may cause rack
jamming and malfunction.
r Ensure that the rack trays and the input buffer are
always free of any foreign objects.
5 Operation
r Do not load racks or rack trays when the rack pusher

is not in its resting position.
q If you work with an input connection unit, rack

loading is done automatically.
Roche Diagnostics
A B C D
A Priority rack slot C Single rack slot

B Rack tray D Rack pusher in resting position
w Rack loading with input buffer
You have several options for loading racks:

• You can load a rack tray with racks on the buffer (B).
• You can place a single rack on the single rack slot (C).
• You can place a single rack on the priority rack slot
(A).
In all cases, the analyzer automatically registers that a

rack is present and proceeds to process the rack on the
priority rack slot or the one nearest to it.
Ensure that the sample barcodes point towards that long

side of the rack where the rack barcode is affixed.
5 Operation
w Samples on a rack
Roche Diagnostics
Operation with input connection unit The racks are automatically fed onto the rack conveyor
belt of the input connection unit (A) by the rack conveyor
belt on the connection line (B).
A Rack conveyor belt of the input connection unit B Rack conveyor belt of the connection line
w Rack loading with an input connection unit
u Related topics
• Racks (85)
Priority racks
Any rack that is placed on the priority rack slot is treated
as a priority rack.
Ensure that the rack barcode faces you and that sample
barcodes point towards that long side of the rack where
the rack barcode is affixed.
! WARNING
Incorrect results due to sample mismatch when
loading samples on the wrong rack
If you work with Sample sequence number mode and
5 Operation
place a STAT sample on a routine rack, the next routine

sample sequence number is assigned to this STAT
sample and the sample is processed as a routine sample
and not a STAT sample. Equally, if you place a routine
sample on a STAT rack, the next STAT sample sequence
number is assigned to this routine sample and the sample
is processed as a STAT sample and not a routine sample.
r Make sure you place every sample on the appropriate
rack.
Roche Diagnostics
NOTICE
Stand-alone operation
inappropriate rack loading
Loading a rack on the priority rack slot while the rack
conveyor belt of this slot is moving or when the rack
pusher is not in its resting position may cause
malfunction of the instrument.
r Do not load a rack on the priority rack slot while the
rack conveyor belt is moving.
r Do not load a rack on the priority rack slot if the rack
pusher is not in its resting position.
Priority racks are loaded on the priority rack slot (A).
w Priority rack slot
Processing of the priority rack starts as soon as all

samples of the rack are processed that is currently on the
rack conveyor.
u Loading a priority rack (169)
Operation with input connection unit Priority racks are loaded on the rack conveyor belt of the
input connection unit (A).
5 Operation
Roche Diagnostics
A Rack conveyor belt of the input connection unit B Rack conveyor belt of the connection line
w Rack loading with an input connection unit

LAS (170)
Starting the testing process

In this section
Starting sample testing (168)
Loading a priority rack (169)
Starting sample testing
! CAUTION
Sample mismatch due to pending sample orders
Having pending sample orders in the order list may lead
to sample mismatch.
r Delete any pending sample orders from the order list
before starting the measurement.
5 Operation
Roche Diagnostics
q Sample barcode could not be read

If a sample barcode cannot be read, the analyzer
automatically defines an order using a generated sample
ID and the default test profile. The samples on the rack
whose barcodes could be read will be processed as
normal.
If you work with a laboratory information system, results
of samples whose barcode could not be read are not
transmitted to the host computer.
To identify results whose sample barcode could not be
read, check the message list and in the result list, check
for and for unusual sample IDs.
If you work with Sample sequence number mode, the
next sample sequence number is assigned to the sample
when the tube is on the measuring position.
u Non-routine situations (185)
r To start sample testing
1 Start sample testing:

• Place the rack on the input buffer.
f Processing starts automatically.
Loading a priority rack
! CAUTION
Racks are moved automatically on the input buffer by the
rack pusher. If you place your hands or fingers on the
input buffer while racks are moved you may get your
fingers caught.
r Do not place your hands on the input buffer or the
racks while the analyzer moves racks.
r Do not load racks while the analyzer moves racks on
the input buffer.
5 Operation
Roche Diagnostics
NOTICE
inappropriate rack loading
Loading a rack on the priority rack slot while the rack
conveyor belt of this slot is moving or when the rack
pusher is not in its resting position may cause
malfunction of the instrument.
r Do not load a rack on the priority rack slot while the
rack conveyor belt is moving.
r Do not load a rack on the priority rack slot if the rack
pusher is not in its resting position.
q You can load priority racks any time, as long as the

analyzer is not in the process of moving racks on the
input buffer.
q If you work with Sample sequence number mode,

the next STAT sample sequence number is assigned to
the sample when the tube is on the measuring position,
provided you use an assigned STAT rack.
r To load a priority rack
1 Place the rack on the priority rack slot. Ensure that the
barcodes face towards the back of the analyzer.
r To load a priority rack when working

with an LAS
1 On the Overview work area, choose the Priority rack
button.
f A callout is displayed, asking you to wait until the
current operation is finished.
5 Operation
2 When the message on the callout asks you to do so,

place the priority rack on the rack conveyor belt of the
input connection unit.
f When the rack is placed, the callout disappears
and processing starts automatically.
Roche Diagnostics
Checking the status of processing

The analyzer constantly monitors the status of its
hardware and software components, and it tracks the
progress of the testing activities.
The starting point for checking the analyzer status is the

task list. The following table provides an overview of the
various possibilities that are open to you.
Task list Tab or panel Key status elements

Message list Red Immediate user
intervention is required.
Orange Earliest possible user
Gray Information about
ongoing tasks. If operator
intervention is required,
perform it.
Light gray There are no messages.
No operator intervention
is required.
Manage supplies Error All analyzer activities have
stopped. An exceptional
hardware situation has
occurred, for example a
connector is unplugged.
Alarm All analyzer activities have
stopped. The situation can
be resolved by user
intervention, for example
by refilling some
consumable.
Warning Operator intervention is
required as soon as
possible, otherwise
processing may stop, for
example because the
system water level is
getting low.
OK Everything is fine. No
y Checking the operation status
5 Operation
Roche Diagnostics
Task list Tab or panel Key status elements

Order list Pending, measurement
has not started yet.
The order is being

processed.
An error occurred during

measurement, no result
was generated. (Check
the Status information in
the detail panel. The
associated message will
give you more detailed
information, you may need
to rerun the test.)(1)(2)
Order for routine sample
testing.
Order for STAT sample

testing.
Order for QC testing.
Result list
The order is being
processed.
Measuring or under
evaluation.
Ready for validation.
Validated.
Validated and successfully

sent to the host computer.
An error occurred during

measurement, no result
was generated. (Check for
messages in the message
list, you may need to rerun
the test.)(1)(2)
Result cannot be
validated. User
intervention is required,
check its status.
Not applicable. No
5 Operation
measurement is required
on this analyzer.
y Checking the operation status
(1) If more than one erroneous event has occurred that would trigger the error symbol, the associated message describes the event that occurred
first.
(2) In some cases, an erroneous event has to occur three times before the measurement is stopped. The error symbol is displayed after the first
occurrence of such an event.
q When all tests of an order have successfully been

performed the order is deleted from the orders list.
Roche Diagnostics
r To check the status of order

processing
1 Choose Routine > Manage sample orders.
2 Choose a view if required or use the search function

to find a particular order or group of orders.
3
3 Display the complete orders list and check the status
indicators. (u 171)
4
4 If there are errors:
• Choose the entry in the main panel.
• Choose the Status field in the detail panel.
f The message details are displayed.
5 Operation
Roche Diagnostics
174 Result handling
Result handling
! CAUTION
Data loss due to failure of performing regular data
backup
The analyzer has limited storage space for results (for up
to 10 000 test results, depending on the system setup,
and for 300 each for QC and microscope check.
Depending on the analyzer setup, when these limits are
reached, the oldest results may automatically be
overwritten or testing may stop.
r Periodically back up the database to an external
storage device and export the results.
u Managing the result storage capacity (318)
In this section
Viewing results (174)
Validating results (175)
Assigning patients (180)
Generating reports (181)
Viewing results
Results are displayed in a dedicated panel, both overview
and detail displays are available. Exactly which results are
displayed can be defined with the help of views or the
text filter.
r To view test results
1 Choose Routine > Manage test results.
2 To determine which results should be listed, select a

view from the drop-down list.
3 To find the results of a certain sample ID or ID range,

5 Operation
enter the ID or part of it in the Search field and

choose .
4 In the main panel, choose the sample whose results

you are interested in.
f The result is displayed in the detail panel.
5 To view the associated sample information, choose

the sample button at the top of the panel.
Roche Diagnostics
Result handling 175
6 To view microscopy images, choose the Show

images button (u 194).
7 If rules were applied to a result, choose the Show

rules button to see exactly which.
Validating results
All results need to be validated, the analyzer provides
several aids for doing so:
• You can set up the analyzer to automatically accept all
results or to exclude results from automatic validation
if they have certain data alarms associated with them.
You can also choose to validate all results manually.
u Defining the validation method (276)

validated results are automatically sent to the host
computer.
• In the result list, results that have a data alarm

associated with them are marked with in the
column.
the sample IDs for routine test results are marked with
an “N” preceding the sample sequence number, and
“E” for STAT test results.
• In the result details, the results are color coded to
indicate whether the values are normal ( green),
low pathological ( yellow) or pathological ( red).
• For microscopy results, you can also display the
individual images and reclassify particles.
• You can print the results and save them in PDF format.
• You can export the results in CSV format and process
them on an external computer.
The examination of the results may lead to further

activities.
u Rerunning tests (186)
5 Operation
u Generating reports (181)

If you work with patient demographics, you need to

assign the patients to the results.
u Assigning patients (180)
Roche Diagnostics
176 Result handling
Progress statuses
The order is being processed.
Measuring or under evaluation.
Ready for validation.
Validated.
Validated and successfully sent to host computer.
An error occurred during measurement, no result

was generated. (Check for messages in the message
list, you may need to rerun the test.)
Result cannot be validated. User intervention is

required, check its status.
Data alarms
No data alarm was generated.
! The result was manually changed.
A Abnormal result.
Cm Calibration. The microscope check results were no

longer valid when the result was generated.
D Dilution. The customer has set a dilution factor in the

sample order.
F1 Defocused image found. All particle counts are zero.

Review the images and repeat measurement.
F2 Defocused image found. The focus position deviates

too much from that of the previous image.
F3 Defocused image found. The focus position is

outside the predefined range.
F4 Defocused image found. Inhomogeneous MUC

distribution in the images.
M The result of the image was manually changed.
O Parameter is out of range.

5 Operation
Q Invalid QC. QC failed or QC material has expired.
T Trace result. Borderline or "soft positive" result.
Roche Diagnostics
Result handling 177
Ub Unreliable image found. There may be bubbles in the

cuvette.
Review is recommended.
If between 5 and 14 images yielded an automatic
result you can validate the test result manually
straight away, or you can adjust the values for any of
the images first (either by defining the results
directly or by reassigning particles) and then validate
the test result. If you adjust any values before
validating the result, the M or ! data alarm will be
added to the result.
You can decide not to validate the test result and to
repeat the test.
u Editing microscopy counts and
concentrations (200)
Rerunning tests (186)
(If fewer than 5 images yielded an automatic result,
no test result is displayed and you must first ensure
that there are results for at least 5 images (either by
defining the results directly or by reassigning
particles) before you can validate the test result. The
M or ! data alarm will be added to the resulting test
result.)
Uc Unreliable image found. There are too many cells in

the image (crowded), automatic evaluation is not
possible.
If between 5 and 14 images yielded an automatic
result you can validate the test result manually
straight away, or you can adjust the values for any of
the images first (either by defining the results
directly or by reassigning particles) and then validate
the test result. If you adjust any values before
validating the result, the M or ! data alarm will be
added to the result.
You can decide not to validate the test result and to
repeat the test.
(If fewer than 5 images yielded an automatic result,
no test result is displayed and you must first ensure
that there are results for at least 5 images (either by
defining the results directly or by reassigning
particles) before you can validate the test result. The
M or ! data alarm will be added to the resulting test
result.)
5 Operation
X A cross-check rule has been triggered.
# A Roche Service representative did not cancel a

service or troubleshooting function, and it can only
be canceled by a Roche Service representative. All
results have this data alarm and the validity of these
results cannot be guaranteed. (For example, expired
materials may have been used).
If you find this data alarm, contact your Roche
Service representative immediately.
Roche Diagnostics
178 Result handling
r To validate a result
2
2 From the Views drop-down list, choose Unvalidated
results.
f All results that have not been validate are listed.
f If your analyzer is connected to a LIS, all validated
results are automatically sent to the host computer
and would not be displayed in the result list.
f Results for which a data alarm was generated are
marked with in the column.
f In the column, the progress status is indicated.
q For more information on progress statuses, see

the following section:
u Progress statuses (176)
3 In the result list, check for visual cues and unusual

sample IDs.
• indicates that the result cannot be validated.
User intervention is required, check its status. The
status for these results is Action required.
See step 5.
• If you work with Sample sequence number
mode, the sample IDs for routine test results are
marked with an “N” preceding the sample
sequence number, and “E” for STAT test results.
q In cases where the sample barcode could not be

read, you must define the sample ID as defined in the
barcode before you can validate the result.
u Adjusting sample information (201)
4
4 In the main panel, check for entries with a symbol
and choose one.
I The results are displayed in the detail panel.
5 Operation
Roche Diagnostics
Result handling 179
5
5 Observe the status information in the detail panel.
q The Action required status may have the one of

the following reasons:
o The barcode could not be read. You need to enter
the correct barcode information manually.
o There already exists an order for this result. Delete
the order or rerun the test.
o Fewer than five images yielded an automatic
result. You need to include at least five images. To
achieve this number, you need to manually analyze
images.
Manually analyzing images (192)
6 Check for data alarms in the column.
q For more information on data alarms, see the

following section:
u Data alarms (176)
7 Check the Information column.
q Whether there is an Information column

depends on the measurement units you work with.
For more information, see:
u Defining the units in which results are displayed and
reported (273)
8 To add a comment, choose the Edit button in the

detail panel.
9 When you have entered the comment, choose the

Save button.
10 If there is an X entry in the column, a rule was

triggered and the Show rules button would be
available. Choose the Show rules button to see which
rules were triggered.
5 Operation
11 To examine the sediment images, choose the Show

images button. (For more information, see 4 ff.)
Roche Diagnostics
180 Result handling
12
12 To validate the result, choose the Validate button.
f Accepted (validated) results are marked with in
the status column in the result list.
13 To manually send validated results, select them in the

results list and choose the Send button.

validated results are automatically transmitted to the
host computer.
Validated results that were successfully sent to the
host computer are marked with the symbol.
Assigning patients
You typically use patient demographics if you want to
generate a patient report for the physician.
u Managing patients (217)
u Generating reports (181)
q If the patient data is sent from the host to the

analyzer, then the patient data cannot be changed on the
analyzer. You can view and delete patient data.
r To assign a patient to a result
2 In the result list, choose the result to which you want

to assign a patient.
f The result details are displayed in the detail panel.
3 In the detail panel, choose the No patient assigned

button.
f A list of defined patients is displayed.
5 Operation
f If there is already a patient assigned and you want

to change it, choose the button containing the
patient name instead of No patient assigned,
then proceed as described below.
4 Select the patient by selecting the check box next to

its name.
I To unassign a patient, clear the check box.
Roche Diagnostics
Result handling 181
5 Choose the Assign button.

f The result list is displayed again, and the patient is
indicated in the detail panel.
Generating reports
You can print selected results or save them to a file in
PDF format. You can also save the related images as
individual files in a graphics file format and export the
results in the character separated values (CSV) data
format for reporting purposes or for processing in a
spreadsheet program.
u To export all results (319)
Result report To print or save to file results of certain samples, you can
filter and select results in the result list.
u To print results (result report) (181)
To save results to files (result report) (182)
Patient report To print or save to file results of certain patients, you can
select the patients in the patient list and then choose
which results of these patients you want to report.
u To print results (patient report) (182)
To save results to files (patient report) (183)
The analyzer can be connected to a network or directly to

a printer.
u Defining the look, content, and handling of
reports (299)
r To print results (result report)
2 Select the results that you want to print.
q Use the View or Search function if required and

select one or several samples.
5 Operation
u About filtering table information (134)
3 Choose the Report button.

f A callout is displayed.
Roche Diagnostics
182 Result handling
4 From the Output mode drop-down list, choose Print

to print the results on your default printer.
I You cannot print images directly on a printer. You
need to save them as files first and then use a
graphics tool to print them.
5 Choose the Yes button.

f The results are printed.
r To print results (patient report)
1 Choose Routine > Manage patients.
2 Select the patients whose results you want to print.
q Select one, several or all check boxes.


4 Select one of the Result selection options.
5 From the Output mode drop-down list, choose Print

to print the results on your default printer.
I You cannot print images directly on a printer. You
need to save them as files first and then use a
graphics tool to print them.

f The results are printed.
r To save results to files (result report)
2 Select the results that you want to export.
q Use the View or Search function if required and

select one or several samples.
5 Operation

Roche Diagnostics
Result handling 183
4 Using the Output mode drop-down list, define where

the results should be saved to.
• To save the results in a file in PDF format, choose
Export to PDF.
• To save each image in a file in a graphics file
format, choose Export images only. (You cannot
print images directly on a printer. You need to save
them as files first and then use a graphics tool to
print them.)
• If you want to save the data to a location other
than the default location, choose the Select
button and define the file location. (This can either
be a USB storage device connected with the USB
port, preferably on the front of the instrument, or a
mapped network path.)
q For information on the USB port location, see the

following illustration:
u Main components (69)

f The results are saved to files.
r To save results to files (patient

report)
2 Select the patients whose results you want to print.


4 Select one of the Result selection options.

5 Operation
Roche Diagnostics
184 Result handling
5 Using the Output mode drop-down list, define where

the results should be saved to.
• To save the results in a file in PDF format, choose
Export to PDF.
• To save each image in a file in a graphics file
format, choose Export images only. (You cannot
print images directly on a printer. You need to save
them as files first and then use a graphics tool to
print them.)
• If you want to save the data to a location other
than the default location, choose the Select
button and define the file location. (This can either
be a USB storage device connected with the USB
port, preferably on the front of the instrument, or a
mapped network path.)


f The results are saved to files.
5 Operation
Roche Diagnostics
Non-routine situations 185
Non-routine situations
The examination of the results and the messages in the
message list may point to one of the following situations.
Situation Possible tasks See …

Questionable result Rerun the test. u Rerunning tests (186)
Perform maintenance actions as indicated
in a message in the message list and then
rerun the test.
Dilute the sample and rerun the test.
Examine the images and reclassify particles u Manually analyzing images (192)
or adjust the results.
Sample barcode could not be read If a normal result was generated: u Adjusting sample information (201)
o Select the result and correct the sample
ID before you validate the result.
If a normal result was generated and you
work with a LIS:
o Obtain the correct order information
from the LIS or someone with access to
the LIS.
o Select the result, correct the order
information and add a comment before
you validate the result.
q Note that such results are only

transmitted to the host if the sample and
order information agrees with the
information of the LIS order.
o If the test that was performed does not u Rerunning tests (186)
agree with the one defined in the LIS
order, rerun the test.
If a questionable result was generated: u Rerunning tests (186)
o Rerun the test using the Rerun
function.
If no result was generated: u Rerunning tests when working with
o Adjust the order information and reload sample barcodes (186)
the sample.
o Make sure you are using a type of rack u Adjusting sample information (201)
that is recommended by Roche. u Tubes (84)
Rack barcode could not be read 1. Remove the rack from the output buffer.
2. Check the barcode for soiling, clean it.
5 Operation
If you could clean it, reload the rack.

3. If the barcode looks damaged, transfer
the tubes to another rack and load the
new rack.
y Exceptional processing situations
In this section
Manually analyzing images (192)
Adjusting sample information (201)
Roche Diagnostics
186 Non-routine situations
Rerunning tests
You would typically rerun a test if no result could be
generated, for example because of particle “crowding”
and the sample needs to be diluted.
q To rerun a test that yielded a result you use the

Rerun function. To rerun a test that did not yield a result,
you need to re-define the associated order first.
(If you work with sample barcodes and rerun a test for a
sample using the same barcode, the second result
overwrites the first result, provided it has not been
validated yet.)
! WARNING
Incorrect results due to cell lysis
Dilution of sample may lead to cell lysis and therefore
incorrect results may be obtained.
r Always use appropriate dilution procedures.
In this section
Rerunning tests when working with sample
barcodes (186)
Rerunning tests when working with Sample sequence
number mode (188)
Rerunning tests when working with sample barcodes
q You can rerun a test as long as its results have not

been validated.
Situation before rerun What you need to do What the analyzer does
The test has yielded a result. o Choose Routine > Manage test
results.
o From the result list, choose the result.
o Choose the Rerun button. The new order is added to the orders list
automatically.
5 Operation
o If dilution or concentration is needed,

enter the dilution factor (>1.00: dilution,
<1.00: concentration).
o Prepare the sample, if required. If
dilution or concentration is needed,
dilute or concentrate the sample.
o Place the sample tube on a rack, then The test is performed.
load the rack.
y Rerunning tests when working with sample barcodes
Roche Diagnostics
The test has not yielded a result. o Check the message in the message list. A message alerts you of the fact that no
result was generated.
The order is still on the analyzer.
o Choose Routine > Manage sample
order.
o In the main panel, choose the order.
o In the detail panel, choose the Edit
button.
o Choose the Save button.
o Place the sample tube on a rack, then The test is performed.
load the rack.
The sample yielded results and the o Make a note of the sample IDs of the The orders are no longer available in the
results are already validated samples you want to rerun. orders list.
o Choose Routine > Manage test
results.
o Delete the results of the samples you
want to rerun.
o Place the sample on the rack, then load The test is performed.
the rack.
If you want to dilute or concentrate the sample:
o Make a note of the sample IDs of the The orders are no longer available in the
samples you want to rerun. orders list.
orders.
o Choose the Create button.
o Enter the original sample ID.
o Assign the patient, if required.
o Choose the Save button. The new order is created.
o Place the sample on the rack, then load The test is performed.
the rack.
5 Operation
y Rerunning tests when working with sample barcodes
Roche Diagnostics
The sample does not have a o Make a note of the sample IDs of the The orders are no longer available in the
barcode label, the test has yielded a samples you want to rerun. orders list.
result and the result has been o Choose Routine > Manage test
validated. results.
want to rerun.
order.
o Enter the original sample ID.
o Enter the rack ID.
o Enter the rack position.
o Assign a patient, if required.
o Choose the Save button. A new order is created.
o Be sure to place the sample on the rack The test is performed.
and position as defined above, then
load the rack.
y Rerunning tests when there is no barcode label and there is an already validated result for the test
Rerunning tests when working with Sample sequence number mode
q You can rerun a test as long as its results have not

been validated.
The following table lists a few typical situations and it

illustrates how the analyzer reacts in these situations and
what you need to do to rerun a test.
5 Operation
Roche Diagnostics
The test has yielded a result (not o Choose Routine > Manage test
validated) results.
o Select the result in question.
(You can select more than one result.)
o Choose the Rerun button. A new order is created.
(If you selected more than one result, a new
order is created for each of them.)
orders.
o Select the order that was just created.
o In the detail panel, choose the Edit The original sample ID and the current date
button. and time are contained in the form.
(You cannot change this ID if you work with
Sample sequence number mode.)
load the rack.
The test has not yielded a result o Choose Routine > Manage sample The order remains in the orders list.
orders.
o In the detail panel, choose the Edit The original sample ID and the current date
button. and time are contained in the form.
(You cannot change this ID if you work with
Sample sequence number mode.)
load the rack.
y Rerunning tests when working with Sample sequence number mode and without sample barcodes
5 Operation
Roche Diagnostics
The sample yielded results and the o Make a note of the sample IDs of the The orders are no longer available in the
results are already validated samples you want to rerun. orders list.
o Choose Routine > Manage test
results.
want to rerun.
orders.
o Choose the Save button. The new order is created. It gets the next
free sequence number, the deleted
sequence number cannot be re-used.
load the rack.
The STAT sample was placed on a o Choose Routine > Manage test
routine rack results.
o Select the sample and choose the
Rerun button.
orders.
o Select the order and choose the Edit
button.
o Adjust the rack ID and the rack The STAT rack ID is entered.
position. Order type is set to STAT .
o Place the rack on the priority rack slot. The rack barcode is read and the sample is
processed.
The routine sample was placed on a o Choose Routine > Manage test
STAT rack results.
o Select the sample and choose the
Rerun button.
o Select the order and choose the Edit
button.
o Adjust the rack ID and the rack The routine rack ID is entered.
position. Order type is set to routine .
o Place the rack on the priority rack slot. The rack barcode is read and the sample is
processed.
y Rerunning tests when working with Sample sequence number mode and without sample barcodes
5 Operation
Roche Diagnostics
You detect a sample mismatch and Reset the sample sequence number and
need to rectify the situation. run all tests of the rack again.
sequence numbers.
o Choose the Edit button.
o As the Next sequence No., enter the If you enter a number lower than the next
lowest sample sequence number that free sample sequence number, the results
was used for samples on the rack. Enter of the numbers greater than the one you
it in either the Routine or STAT entry entered are deleted. For example: The next
field, as appropriate. free sample sequence number is 150 and
you enter 140, the results for numbers 140
to 149 are deleted.
If you enter a number higher than the next
free sample sequence number, the
numbers between are blocked. For
example: The next free sample sequence
number is 150 and you enter 160, numbers
150 to 159 are blocked and cannot be used.
o Choose the Save button.
o Place the tubes in the correct potions
on the rack.
o Load the rack. New sample sequence numbers are
assigned to the samples and the tests are
processed.
y Rectifying sample mismatch
5 Operation
Roche Diagnostics
Manually analyzing images

Results that fail certain internal checks are automatically
excluded from the overall result calculation. You can
manually examine individual images, adjust the counts
and then include the results in the calculation.
u For information on interpreting images, see Urine
sediment image evaluation (202).
q Only non-validated results can be manually

changed.
o You can only reclassify individual particles or change
results if the analyzer has been configured to do so.
o The same images are taken into account for result
calculation, both for a main class and all its
subclasses. Therefore, if you classify or reclassify
particles of a subclass, do so for all images that are
taken into account.
u To define image handling (287)
You can adjust counts by doing one of the following:

• Reclassifying individual particles
• Changing the count values of particles
u To reclassify particles using the count table (196)
• Identifying and assigning particles
• Editing the counts
u To adjust the total count or the concentration for a
particle (200)
• Editing the concentrations
particle (200)
q If particles were classified or reclassified manually in

an image, the corresponding parameter entries are
marked with M in the column of the result list.
5 Operation
If concentrations and counts were adjusted manually, the

corresponding parameter entries are marked with ! in the
column of the result list.
Result adjustments for consistency with The counts generated by the microscopy analyzer do not
standard manual microscopy result correspond with those that would result from standard
presentation manual microscopy (p/HPF).
Roche Diagnostics
The differences relate to the examined sample volumes,

the methods of particle recognition, and the units the
results are reported in.
w Counts and concentrations
q The analyzer recalculates the total count when you

reclassify particles of one or several images. If you do not
adjust the counts for all images that are taken into
account, the result may be lower than expected.
5 Operation
Roche Diagnostics
Image gallery statuses

Blue This image is selected.
Yellow This image has been reclassified.
Red This image did not yield a reliable

result, it is excluded from the
result calculation. Manual
examination is recommended.
See also the indication at the top
of the tests list.
In this section
Analyzing images (194)
Questionable images (197)
Editing microscopy counts and concentrations (200)
Analyzing images
r To analyze images
2 In the result list, choose the result that you want to

examine.
3
3 In the detail panel, choose the Show images button.
f The image gallery is displayed.
f On this screen, you can edit the total count or the
concentration of the particles.
q For more information, see the following section:

5 Operation

particle (200)
Roche Diagnostics
4
4 Choose an image.
f The image is displayed.
5 Enlarge the image if required. (u 132)
6 Classify or reclassify the particles, if required.
q You can either reclassify individual particles in

the image or correct the count in the count table.
To reclassify particles using the count table (196)
To remove the classification from particles p (196)
7 Check that the Include image in evaluation check

box is selected.
I If you cannot satisfactorily analyze the image
manually, exclude the image from the result
calculation by clearing the Include image in
evaluation check box.
q Excluding the image this way does not change

the definitions made in the particle table.
Enabling and disabling main classes enables and
disables their subclasses as well.
r To assign or reclassify particles
1 In the count table, choose the particle that you want to

assign.
2 Choose the button, if required.
4
4 In the image, select the particles of the selected type
that need assigning or changing.
• To change a labeled particle to the current one,
simply select it.
f The appropriate blue particle label is added to
each particle as soon as you select it.
5 Operation
f The counts in the table are not yet updated.
Roche Diagnostics
5
5 To save the classifications, choose the button.
f This action may take a few seconds.
f The affected entries in the table are marked yellow;
the old values are given in brackets.
r To reclassify particles using the count

table
2
2 In the table, choose the particle whose count you want
to change and then choose its count number.
I The virtual keyboard is displayed.
3 Enter the correct number.
4 If you want to undo all the changes you have made so

far, choose the Reset button.

f The affected entry in the table is marked yellow;
the old value is given in brackets.
r To remove the classification from

particles
1 Choose the button, if required.

5 Operation
3 In the image, select all particles whose classification

you want to remove.
f The label is removed from each particle as soon as
you select it.
f The counts in the table are not yet updated.
Roche Diagnostics
4
4 To save the assignments, choose the button.
I This action may take a few seconds.
f The affected entries in the table are marked yellow;
the old values are given in brackets.
Questionable images
Small drops of liquid on the cuvette or air bubbles inside
can make it difficult to identify particles.
q If the analyzer generated a result, the liquid drops or

air bubbles did not interfere with the measurement to
such a degree that a valid result could not be generated.
u For information on technically unreliable images, see the
information on the U data alarms: Data alarms (176).
The following illustrations show some typical examples of

images that would trigger a U data alarm.
5 Operation
A In this light area, particles cannot be identified.
w Example of liquid drop
Roche Diagnostics
A The drop caused focusing problems, the particles do not have sharp contours.
w Example of liquid drop
A
5 Operation
A Edge of the air bubble
w Example of an air bubble
Roche Diagnostics
w Example of an air bubble
w Example of a crowded image

5 Operation
Roche Diagnostics
Editing microscopy counts and concentrations

Instead of reclassifying particles for individual images,
you can adjust the total count or the concentration for a
particle.
q You can change counts and concentrations as long

as the results have not been validated yet.
You can change either the count or the concentration of
a parameter.
o The count is the sum of all particles in all images that
rendered a valid result.
o If you change the total count, the result is
recalculated.
o At least five images must be reliable, otherwise no
concentration or count is displayed.
o Results that are based on a changed total count or
concentration are marked with !.
o If subclasses are available, the count and
concentration of the main class cannot be changed.
r To adjust the total count or the

concentration for a particle
2 In the result list, choose the result that you want to

examine.
3
3 In the detail panel, choose the Show images button.
f The image gallery is displayed.
4 In the main panel, choose the Edit button.

I The Save and Reset buttons become available.
5 In the main panel, choose the appropriate field.

• To change a count, choose the Count field for the
particle whose data you want to change.
5 Operation
• To change a concentration, choose the

Concentration field for the particle whose data
you want to change.
f The keyboard is displayed.
6 Enter the correct value.
Roche Diagnostics
7
f If you changed the count, the concentration is
recalculated.
f If you changed the concentration, the count is not
recalculated.
f The field where you made the changes is colored
yellow .
q If you changed the Count you cannot change

the Concentration later, and if you changed the
Concentration you cannot later change the Count.
Adjusting sample information

You need to adjust the sample information if the sample
barcode could not be read and the analyzer generated a
default sample ID.
This situation is indicated by the icon in the column

of the result list.
r To change the sample ID
2 Select the result for which you want to change the

sample ID.
3 At the top detail panel, choose the sample button.
4 In the detail panel, choose the Edit button.
5 In the Sample ID field, enter the new sample ID.

5 Operation
Roche Diagnostics
202 Urine sediment image evaluation
Urine sediment image evaluation

This section provides examples of sediment images and
their evaluation.
In this section
Epithelial cells (202)
White blood cells, bacteria, and yeast (205)
Red blood cells (209)
Casts (212)
Crystals (214)
Spermatozoa (216)
Epithelial cells
In this section
Overview (203)
SEC, NEC, RBC, BAC, HYA, and artifacts (204)
SEC, NEC, RBC, WBC, BAC, HYA CRY, MUC, and
macrophage (205)
5 Operation
Roche Diagnostics
Urine sediment image evaluation 203
Overview
SEC, NEC, WBC, BAC, and YEA
Squamous epithelial cells (SEC) (1), non-squamous epithelial cells (NEC) (2), white blood cells (WBC) (3), bacteria (BAC) (4), and
yeast (YEA) (5). This image shows characteristic features of acute or chronic urinary tract infection.
5 Operation
Roche Diagnostics
SEC, NEC, RBC, BAC, HYA, and artifacts
SEC SEC and BAC
Squamous epithelial cells (SEC) are the largest cells in the urinary Contiguous bacterial growth on squamous epithelial cells (SEC).
sediment (30 – 50 μm). They originate from the distal third of the Bacteria (BAC) tend to stick to the surface of large epithelial cells.
female and male urethra and the female vulva. The bacteria grow and possibly feed on SEC or, if they just stick to
the surface receptors of the SEC, they are ready to be taken up by
the SEC.
NEC and RBC NEC, HYA, RBC, BAC, and artifact
Renal tubular epithelial cells (reported as NEC) (1), a granular Renal tubular epithelial cell (reported as NEC) (1), hyaline cast
cast (reported as PAT) (2), red blood cells (RBC) (3), one (HYA) with a red blood cell (RBC) (2) on top, bacteria (BAC) (3),
dysmorphic red blood cell (RBC) (4), and some bacteria (BAC). and an artifact (4). The identification of renal tubular epithelial
Renal tubular cells are a subclass of the non-squamous epithelial cells, which are probably the most clinically important epithelial
cells (NEC). They are the smallest epithelial cells in a urine, cells in the sediment, often proves difficult.
slightly larger than white blood cells.
5 Operation
Roche Diagnostics
SEC, NEC, RBC, WBC, BAC, HYA CRY, MUC, and macrophage
NEC, RBC, and CRY NEC, RBC, WBC, HYA, and BAC
Transitional epithelial cell (reported as NEC) with two nuclei (1), Group of transitional epithelial cells (reported as NEC) (1),
red blood cell (RBC) morphologies: isomorphic (2), acanthocyte hyaline cast (HYA) with two white blood cells (WBC) on top
(3), and ghost (4), transitional epithelial cell (reported as NEC) (2), hyaline casts (HYA) (3), red blood cells (RBC) (4), and some
with one nuclei (5) and amorphous crystals (CRY) (6). bacteria (BAC) (5).
Transitional epithelial cells are a subclass of the non-squamous
epithelial cells (NEC).
SEC, NEC, WBC, and BAC Macrophage, WBC, BAC and MUC
Transitional epithelial cells (reported as NEC) (1), squamous Macrophage (1),white blood cells (2), some bacteria (BAC), and
epithelial cell (SEC) (2), white blood cells (WBC) (3), and some mucus. (MUC). Macrophages or histiocytic cells, which can easily
bacteria (BAC) (4). Transitional epithelial cells (urethelial cells) be mistaken for renal tubular epithelial cells, exhibit substantial
originate in the transitional epithelium, lining the lumen of the variations in size. They usually contain numerous vacuoles,
urinary tract from the renal pelvis to the urethra. granules and other phagocytic material.
White blood cells, bacteria, and yeast

5 Operation
In this section
Overview (206)
WBC, BAC, RBC, HYA, MUC, and WBC clumps (207)
WBC, BAC, YEA, RBC, SEC, and MUC (208)
Macrophage, WBC, BAC, and MUC (209)
Roche Diagnostics
Overview
WBC, RBC, NEC, and BAC
One non-squamous epithelial cell (NEC) (1), some red blood cells (RBC) (2), and some bacteria (BAC) (3), in addition to numerous
white blood cells (WBC) (4). Polymorphonuclear neutrophils (12 – 15 μm) are easily recognized by their segmented nucleus.
5 Operation
Roche Diagnostics
WBC, BAC, RBC, HYA, MUC, and WBC clumps
WBC and BAC WBC clump, WBC, BAC, and MUC
White blood cells (WBC) (1) and large quantities of bacteria White blood cells clump (WBC) (1), white blood cells (WBC) (2)
(BAC) (cocci). If the dominating bacterial species is so plentiful, with bacteria (BAC) and mucus (MUC). WBC clumps should not
it is likely that the bacteria do not origin from a contamination be confused with WBC casts. These WBC clusters, which occur
but are the cause of urinary tract infection. during phagocytosis of BAC and particles of decaying WBC, are a
typical finding in urinary tract infection (UTI).
WBC and BAC WBC, RBC, BAC, HYA, and MUC
White blood cells (WBC) (1) with rod-shaped bacteria (BAC) White blood cells (WBC) (1), red blood cells (RBC) (2), bacteria
(2). Note numerous rod-shaped bacteria. Clinical finding: acute (BAC) (3), a small hyaline cast (HYA) (4), and some mucus
pyelonephritis in patient with renal calculus. (MUC). The RBC and WBC exhibit signs of cytolysis (alkaline
reaction of urine in presence of bacterial infection). Note the rod
shaped BAC.
5 Operation
Roche Diagnostics
WBC, BAC, YEA, RBC, SEC, and MUC
WBC, SEC, BAC, and MUC WBC, YEA, and RBC
White blood cells (WBC) (2), squamous epithelial cells (SEC) White blood cells (WBC) (1), yeast (YEA) (2), and red blood
(1), bacteria (BAC) (3), and mucus (MUC) (4). The presence, in cell ghost (reported as RBC) (3). YEA and WBC are a frequent
female patients, of large numbers of SEC and granulocytes in the finding. In women Candida sp. often originate from the vulva and
sediment of spontaneously voided urine may be an indication of therefore are of limited clinical importance.
vaginal contamination, but cannot be avoided in patients with
UTI.
WBC and BAC YEA
White blood cells (WBC) (1) in the process of phagocyting Single yeast (YEA) cells can be confused with RBC. Hyphal
bacteria (BAC) (2). Many WBC may have been lysed, thus a branching of budding yeast forms should therefore be noted.
discrepancy between the leukocyte approximation using strip Absence of inflammatory cells may be due to contamination with
testing and the much lower microscopic count will occur. vaginal fluid, but may also occur in immunosuppressed patients.
5 Operation
Roche Diagnostics
Macrophage, WBC, BAC, and MUC
Macrophage, WBC, BAC and MUC
Macrophage (1),white blood cells (2), some bacteria (BAC), and

mucus. (MUC). Macrophages or histiocytic cells, which can easily
be mistaken for renal tubular epithelial cells, exhibit substantial
variations in size. They usually contain numerous vacuoles,
granules and other phagocytic material.
Red blood cells

In this section
Overview (210)
RBC, BAC, CRY, and MUC (210)
RBC / RBC 200% magnification (212)
5 Operation
Roche Diagnostics
Overview
RBC, NEC, SEC, PAT, HYA, and BAC
Presence of isomorphic red blood cells (RBC) (1) as well as dysmorphic red blood cells (reported as RBC) (2), renal tubular cells
(NEC) (3), transitional epithelial cells (NEC) (4), pathological casts (PAT) (5), hyaline casts (HYA) (6), squamous epithelial cells (SEC)
(7) and some bacteria (BAC) (8). The overall picture is compatible with chronic glomerulonephritis.
RBC, BAC, CRY, and MUC

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Roche Diagnostics
RBC, CRY, BAC, and MUC RBC
Morphologically normal (isomorphic) red blood cells (RBC), Morphologically normal red blood cells (RBC). RBCs tend to
some crystals (CRY) (1), bacteria (BAC) (2), and little mucus change their shape, depending on the osmotic pressure of the
(MUC) (3). The urine sediment provides important diagnostic liquid that surrounds them. In concentrated hypertonic urine,
information as to whether hematuria is caused by glomerular erythrocytes shrink very rapidly, developing into crenated forms.
disease or by a damage of other tissues of the urinary tract.
RBC and CRY RBC
Morphologically normal biconcave red blood cells (RBC) (1), red Isomorphic red blood cells (RBC). In alkaline or hypotonic urine,
blood cell ghosts (reported as RBC) (2), and some crystals (CRY) RBC swell (1 to 2) and eventually undergo hemolysis. The cell
(3). RBC, crenated forms, and RBC ghosts are referred to as membrane remnants are also designated “pale erythrocytes” or
morphologically normal. They do not exhibit the cell membrane RBC “ghosts” (3).
changes typically found in RBC of glomerular origin.
5 Operation
Roche Diagnostics
RBC / RBC 200% magnification
RBC 5%&PDJQLÀFDWLRQ
Dysmorphic red blood cells (reported as RBC). RBC designated Dysmorphic red blood cells (reported as RBC). RBC showing
“dysmorphic” have undergone morphological changes in the various membrane lesions (loss of cytoplasm, cytoplasmic
kidneys (glomerular cells). Acanthocytes (reported as RBC) are extrusion from the cell membrane, granular elements on the cell
considered to be almost exclusively of glomerular origin. membrane, etc.).
RBC 5%&PDJQLÀFDWLRQ
Dysmorphic red blood cells (reported as RBC) (1) and some Different types of dysmorphic red blood cells (reported as
isomorphic red blood cells (RBC) (2). Dysmorphic RBC are RBC). RBC of glomerular origin may exhibit widely varying
assumed to be morphologically altered by the passage through morphological abnormalities ranging from protrusions, cell
damaged glomerular basal membranes. membrane fenestration, etc.
Casts
5 Operation
In this section
PAT, HYA, RBC, WBC, BAC, NEC, CRY, and MUC (213)
HYA and MUC (214)
Roche Diagnostics
PAT, HYA, RBC, WBC, BAC, NEC, CRY, and MUC
PAT, RBC, and WBC PAT, WBC, HYA, and CRY
RBC cast (reported as PAT) (1), isomorphic RBC (2), dysmorphic WBC cast (reported as PAT) (1), white blood cell (WBC) (2),
RBC (reported as RBC) (3), RBC ghosts (all reported as RBC) hyaline cast (HYA) (3), uric acid crystal (reported as CRY) (4),
(4) and white blood cell (WBC) (5). The presence of RBC casts some bacteria (BAC) and mucus (MUC).
is pathognomonic of glomerulonephritis. Due to their relatively WBC casts are pathognomonic of pyelonephritis, They also occur
rapid lysis, examination of the urine should be undertaken as in acute glomerulonephritis.
soon as possible.
PAT, HYA, NEC, WBC, BAC, and MUC PAT
Granular casts (reported as PAT) (1), hyaline casts (HYA) (2) , Mixed cellular cast (reported as PAT) with renal tubular cells
non-squamous epithelial cell (NEC) (3), white blood cell (WBC) (1) and white blood cells (2). Epithelial cell casts are seen very
(4), bacteria (BAC) and mucus (MUC). Granular casts are found rarely in a sediment. They are formed from desquamated
in nearly all forms of specific renal disease. Their appearance tubular epithelial cells incorporated into hyaline cast matrix.
should invariably prompt further tests of renal function. Clinical
finding: chronic glomerulonephritis.
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Roche Diagnostics
HYA and MUC
HYA and MUC
Hyaline casts (HYA) (1) and mucus (MUC) (2). HYA, which
may also appear in the urine of healthy subjects, often escape
detection because of their low refractive index. They are bounded
by continuous lines, parallel sides and rounded ends that are not
fringed. They may be confused with MUC threads.
Crystals
In this section
CRY, RBC, BAC, and HYA (215)
CRY, WBC, BAC, and SEC (216)
5 Operation
Roche Diagnostics
CRY, RBC, BAC, and HYA
CRY CRY, RBC, and BAC
Cystine crystals (reported as CRY) (1) and bihydrate calcium Uric acid crystals (reported as CRY) (1) with some red blood
oxalate crystals (reported as CRY) (2). Cystine crystals are a cells (RBC) (2), bacteria (BAC) (3), and mucus (MUC). Uric acid
severe pathological finding. They can be found in the event crystals can have different shapes, like rosettes, rhombic plates,
of severe liver damage or protein metabolism disorders as whetstones, dumbbells, barrels or rods.
cystinuria. Cystine crystals are very rare!
CRY, HYA, and BAC CRY
Monohydrate calcium oxalate crystals (reported as CRY), a lot of Bihydrate calcium oxalate crystals (reported as CRY). They
mucus (MUC), some bacteria (BAC) (4), and hyaline casts (HYA) are very common in urine sediments. They occur mostly after
(5). Monohydrate calcium oxalates in the shape of a sandglass (1), uptake of certain vegetables, fruits and nuts i.e. tomatoes,
oval shaped (2) and amorphic (3). Round or slightly oval shaped rhubarb, okra, but are also produced in the body itself. 80 %
monohydrate calcium oxalates are easily mixed up with RBC. of kidney stones are at least partly made of calcium oxalate
bihydrate. 5 Operation
Roche Diagnostics
CRY, WBC, BAC, and SEC
CRY, WBC, and BAC CRY, WBC, BAC, and SEC
Triple phosphates (reported as CRY) (1), cell debris from white Amorphous crystals (reported as CRY) (1), bacteria (BAC) (2),
blood cells (WBC) (2), and bacteria (BAC) (3). Triple phosphate white blood cell (WBC) (3), squamous epithelial cell (SEC) (4),
crystal (“coffin lids”) are a frequent finding in infected alkaline together with mucus (MUC). Amorphous crystals can be easily
urines. Their massive appearance in fresh urines may, however, mistaken for BAC but their shape is much more varied and
indicate stasis in the lower urinary tract. they are usually very dark in appearance.
Spermatozoa
SPRM, RBC, SEC, BAC, and MUC
Spermatozoa (SPRM) (1), red blood cells (RBC) (2), bacteria

(BAC) (3), squamous epithelial cells (SEC) (4), and some mucus
(MUC) (5). SPRM can hardly be mixed up with anything else, but
some artifacts can look like SPRM. Clinical importance is very
limited. Maybe they should only be reported when they are found
5 Operation
in children.
Roche Diagnostics
Managing patients 217
Managing patients
Patient demographics can be defined separately or when
you assign patients. You can assign patients to results
and orders, and you can change patient demographics
later.
q If the patient data is sent from the host to the

analyzer, then the patient data cannot be changed on the
analyzer. You can view and delete patient data.
u Assigning patients (180)
r To define a new patient

f In the detail panel the callout for entering
information is displayed for the first information
item that needs to be defined, i.e. the patient’s first
name.
3 Enter the first name and choose the Enter key.

f The virtual keyboard for entering the last name is
displayed.
4 Enter the last name and choose the Enter key.

f The calendar for defining the date of birth is
displayed.
5 Define the date of birth.

• From the year drop-down list, select the year.
• From the month drop-down list, select the month.
• In the calendar, select the day.
• Close the callout.
6 From the Gender drop-down list, choose the gender.
7 If you want to define the patient’s physician, select the

5 Operation
Ordering doctor field and in the virtual keyboard

enter the doctor’s name, then choose the Enter key.
f The callout for entering a comment is displayed.
8 Enter a comment, if required, then choose the Enter

key.
Roche Diagnostics
218 Managing patients
r To change patient demographics
2 In the patient list, choose the patient name whose

data you want to change.

f You can now select the fields and change their
content.
4 Select a field whose content you want to change.

f The virtual keyboard is displayed.
f Enter the required information or choose it from
lists.
5 Change all fields that need changing in the same way.
r To delete patient demographics
2 In the patient list, choose the patient name whose

data you want to delete.
3 Choose the Delete button.
4 On the callout, confirm the deletion.

f All data relating to this patient are deleted,
including its association with results.
5 Operation
Roche Diagnostics
Routine maintenance actions

In this section
About routine maintenance actions (219)
Checking the status of the system (220)
Washing the fluid system (224)
Air purge (225)
Filling the water container (226)
Emptying the liquid waste container (227)
Emptying the solid waste container (228)
Replacing the cuvette cassette (229)
About routine maintenance actions

The following sections describe how to perform the
maintenance actions that you may have to perform during
routine testing.
NOTICE
Malfunction due to failure of performing due
maintenance actions
Failing to perform maintenance actions that are due may
impair the functioning of the analyzer.
r Always perform all maintenance actions as soon as
they become due.
NOTICE
Damage to the analyzer due to use of inappropriate
cleaning solution
Using inappropriate cleaning solutions may damage the
parts you cleaned.
r Only use recommended cleaning solutions.
u Cleaning solutions (115)
r Never use the wash solution for manually cleaning the
analyzer.
5 Operation
Roche Diagnostics
220 Routine maintenance actions
These are the maintenance actions you routinely need to

perform:
u Washing the fluid system (224)
u Air purge (225)
u Filling the water container (226)
u Emptying the liquid waste container (227)
u Emptying the solid waste container (228)
u Replacing the cuvette cassette (229)
Checking the status of the system

The analyzer constantly monitors the status of its
hardware and software components, and it tracks the
progress of the testing activities. Various sensors and
counters allow the monitoring of fill levels and the
determination of dates when maintenance actions are
due.
To check for tasks that need doing you can use the
Tasks and Overview groups in the Overview work area.
w Task list in the Overview work area

5 Operation
In this section
Checking the status of order processing (221)
Checking for tasks that require intervention (221)
Checking the current hardware status (222)
Checking the status of supplies (223)
Roche Diagnostics
Checking the status of order processing
r To check the status of order

processing
1 Follow the instructions in Checking the status of
processing (u 171).
Checking for tasks that require intervention
r To check for tasks that require

intervention
1
1 Check the task indicator and the task list in the
Overview work area for red or orange items.
q The messages and tasks that are represented by

the buttons are grouped first by their analyzer, then by
their thematic category (supply, messages, orders,
results) and then their priority.
In the rightmost part of a task button, there is
indicated which panel will be displayed if you choose
it (message list or a panel for managing either the
supplies, the orders, or the results).
2 Choose a red or orange task button.
3 Deal with the issues.

• In the message list, choose a red or orange
message. In the detail panel a description of the
issue is displayed, together with possible causes
and remedies. If a wizard is available its button
would be displayed as well.
5 Operation
• In the supplies list, choose a task with a status

other than OK. (u 223)
• In the orders list, make the necessary adjustments.
(u 163)
• In the result list, check for unusual results. (u 174)
4 Deal with the issues until there is no red or orange

task button.
Roche Diagnostics
Checking the current hardware status
Color Meaning
Red There is at least one issue that
requires immediate operator
attention. Operation may have
stopped.
Orange There is at least one issue that
requires early operator attention.
Operation may otherwise stop.
Light gray There are no current issues. The
hardware element works fine.
y Color coding for hardware elements
r To check the current hardware status
1
1 In the Overview work area, choose the analyzer in the
Overview illustration.
f A schematic representation of key hardware
elements is displayed.
f The color of the elements represents the severity of
the underlying issues.
q For more information on element colors, see the

following table:
u Color coding for hardware elements y (222)
2
2 In the analyzer overview, choose a colored element.
I A callout is displayed containing a description of
the issue and possibly a wizard button. The
described issue is the one with the highest priority.
3 Address the issues as described on screen.

5 Operation
Roche Diagnostics
Checking the status of supplies
Status Meaning
Error All analyzer activities have stopped. An
exceptional hardware situation has occurred,
for example a connector is unplugged.
Alarm All analyzer activities have stopped. The
situation can be resolved by user intervention,
for example by refilling some consumable.
Warning Operator intervention is required as soon as
possible, otherwise processing may stop, for
example when the system water level gets low.
OK Everything is fine. No intervention is required.
y List of statuses
r To check the status of supplies
1
1 Choose Monitoring > Manage supplies.
I In the Status column, the status is indicated.
q For more information on statuses, see the

following table:
u List of statuses y (223)
2 In the main panel, choose an item.

f In the detail panel, information such as fill levels
are displayed. If user intervention is required, a
wizard button is displayed at the bottom of the
detail panel.
3 Choose the wizard button at the bottom of the detail

panel to deal with the issue.
5 Operation
Roche Diagnostics
Washing the fluid system

The fluid system must be washed daily with wash solution
to prevent proteinization and buildup of other pollutants
in the probe and the fluid system.
The fluid system is typically washed in the following

situations:
• As part of shutting down the system.
u Shutting down the analyzer (232)
• When a message in the message list indicates that
this action is due.
During the fluid system wash, the analyzer performs the

following actions:
1. The rack ID is scanned, the rack is recognized as a
wash rack.
2. Wash solution is aspirated.
3. The probe is lowered into the rinse station and
solution is pumped into the probe chamber.
4. The solution remains in the tubing, probe, and probe
chamber for a predefined amount of time to dissolve
any residues.
5. The wash solution is pumped into the liquid waste
container.
6. The whole fluid system is rinsed with water.
Wash racks q Be sure to use a defined wash rack. If you use a

different rack, the analyzer will treat the wash solution as
a normal sample and perform tests on it.
j m A wash rack is defined.

m Wash solution is available.
u To define a wash rack (305)
u Wash solution (114)
r To wash the fluid system

5 Operation
1 Prepare the wash rack.

• Fill a tube with at least 4 mL of wash solution and
place it on the wash rack.
2 Place the wash rack on the input buffer, if the wash

should be performed immediately, place it on the
priority rack slot.
f The wash action starts automatically.
Roche Diagnostics
3 When the wash is complete, remove the wash rack

from the output buffer, dispose of the left-over wash
solution according to the relevant local regulations
and store the rack in its accustomed place.
r To wash the fluid system when

working with an LAS
1 Prepare the wash rack.
• Fill a tube with about 4 mL of wash solution and
place it on the wash rack.

button.

place the prepared wash rack on the rack conveyor
belt of the input connection unit.
4 When the wash is complete, remove the wash rack

from the output buffer, dispose of the left-over wash
solution according to the relevant local regulations
and store the rack in its accustomed place.
Air purge
Air purge is periodically performed to remove any
possible air pockets in the tubing. This is achieved by
pumping system water through the whole fluid system.
You may also need to perform this action as a result of a
message in the message list or as part of troubleshooting.
u To define how frequently automatic air purge is
performed see Defining the operating
environment (291).
5 Operation
q Air purge is normally performed automatically,

without operator intervention.
Roche Diagnostics
r To perform air purge
1 Start the air purge maintenance action.

• In the message list, choose the message that
indicates that air purge is due, then choose the
Perform air purge button in the detail panel.
• Choose Monitoring > Analyzer > u 701, then
choose the Perform air purge button.
f The maintenance action is started, the system
status changes to Operating.
2 Wait until the system status changes to Idle.
Filling the water container

The fill level is continuously monitored and when the level
is getting low, a message is added to the message list.
When the water container is empty processing stops and
another message is added to the message list and an
acoustic signal sounded, if so configured.
q Roche recommends emptying the corresponding

liquid waste container whenever you refill a water
container.
! CAUTION
Incorrect results due to using unsuitable system
water
Using unsuitable system water may influence the
measured values and lead to incorrect results.
r Always use water of the specified quality:
NOTICE
Analyzer damage due to using unsuitable system
5 Operation
water
Using unsuitable system water may cause proteinization
and buildup of other pollutants in the probe and the fluid
system.
r Always use water of the specified quality:
Roche Diagnostics
! CAUTION
Incorrect results due to not using the wizard
Failing to use the Fill water container wizard when
refilling water may lead to air bubbles in the fluid system,
which may lead to incorrect pipetting and consequently
to incorrect results.
r Always use the Fill water container wizard when
refilling water.
r To refill a water container
1 Start the Fill water container wizard.

indicates that the water container needs filling,
then choose the Fill water container button in
the detail panel.
• Choose Monitoring > Manage supplies
> System water, then choose the Fill water
container button in the detail panel.
f The wizard is started.
2 Follow the on-screen instructions.
Emptying the liquid waste container

The analyzer monitors the fill level of the liquid waste
containers. When a certain fill level is reached a message
is added to the message list. Processing still continues as
normal, but you should empty the waste container as
soon as possible. When the container is full, processing
stops and another message is added to the message list.
r To empty a liquid waste container
1 Start the Empty liquid waste container wizard.

5 Operation
indicates that the liquid waste container needs

emptying, then choose the Empty liquid waste
> Liquid waste, then choose the Empty liquid
waste container button in the detail panel.
I The wizard is started.
Roche Diagnostics
Emptying the solid waste container

The analyzer monitors the fill level using counters. When
a certain fill level is reached a message is added to the
message list. Processing still continues as normal, but you
should empty the waste container as soon as possible.
When the container is full, processing stops and another
message is added to the message list.
! CAUTION
Incorrect results due inappropriate removal of the
solid waste container
If you remove the solid waste container while the analyzer
performs tests, it is possible that a pipetted cuvette
remains on the microscope stage. During this time
sample evaporation takes place, which could lead to
incorrect results when the cuvette is eventually measured.
r Do not remove the solid waste container while the
analyzer performs tests.
NOTICE
Incorrect fill level indication and analyzer damage
due to re-insertion of non-empty waste container
Fill level monitoring is performed with the help of a
counter. When you confirm that you have emptied the
container, the counter is reset to zero.
If the solid waste container is full, cuvettes may get stuck
in the waste chute and interfere with the measuring
mechanism.
r Always empty the waste container before you confirm
its emptying and placing it on the analyzer again.
NOTICE
Incorrect counters due to not using the wizard
Failing to use the Empty solid waste container wizard
when emptying the solid waste may lead to incorrect
counters and consequently to inaccurate fill level
warnings. If the solid waste container is full, cuvettes may
5 Operation
get stuck in the waste chute and interfere with the

measuring mechanism.
r Always use the Empty solid waste container wizard
when emptying the solid waste.
Roche Diagnostics
! CAUTION
Personal injury due to touching internal mechanism
If the solid waste container is removed, parts of the rack
transport mechanism can be accessed from the opening
for the solid waste container. If you insert your hands
while the analyzer is processing, you may get your fingers
caught in the mechanism.
r Do not touch any internal mechanisms through the
opening for the solid waste container.
r To empty a solid waste container
1 Start the Empty solid waste container wizard.

indicates that the solid waste container needs
emptying, then choose the Empty solid waste
• Choose Monitoring > Manage supplies > Solid
waste, then choose the Empty solid waste
Replacing the cuvette cassette

When the number of cuvettes left in the cassette reaches
a certain low level, a message is added to the message
list. Processing still continues as normal, but you should
get ready a new cuvette cassette. When there is no
cuvette left in the cassette no further pipetting takes
place and a further message is added to the message list.
Cuvette cassettes are equipped with RFID tags, which

contain the following information:
• Lot number
• Expiry date
5 Operation
• Number of cuvettes left
q Roche recommends emptying the solid waste

container whenever you replace a cuvette cassette.
Roche Diagnostics
r To change the cuvette cassette
1 Start the Exchange cuvette cassette wizard.

indicates that the cuvette cassette needs
replacing, then choose the Exchange cuvette
cassette button in the detail panel.
> Cuvette, then choose the Exchange cuvette
cassette button in the detail panel.

5 Operation
Roche Diagnostics
At the end of the shift 231
At the end of the shift

The following sections describe the typical tasks you may
want to perform at the end of a work shift.
In this section
Logging off (231)
Shutting down the analyzer (232)
Keeping the analyzer clean (234)
Logging off
Only one user can be logged on the analyzer at any time.
You can log off any time, even while the analyzer is
processing tests.
q Relation between the user who is logged on

and orders and results
Generally, orders and their results are associated with the
operator who is logged on at the time of their generation
and processing (for auditing purposes).
o If the operator logs off during processing and nobody
else logs on, the assignments remain.
o If the operator logs off during processing and
somebody else logs on, the results of the tests that
were processing while logging off remain associated
with the previous operator, all remaining results will
be associated with the operator who just logged on.
q Automatic logging off

You can set up the analyzer to automatically log off the
current user after a predefined period of time of inactivity
on the analyzer.
u Defining the operating environment (291)
5 Operation
r To log off
1 Choose Overview > Log off.

f The Log on button is displayed in the global
information area.
Roche Diagnostics
232 At the end of the shift
Shutting down the analyzer
! CAUTION
Loss of data due to using the power switch
Switching off the analyzer by pressing the on/off switch
or the power switch does not allow for an orderly
software shut-down and may lead to loss of data.
r Do not use the on/off switch or the power switch to
shut down the analyzer, instead use the Shut down
button on the Overview work area.
! CAUTION
Incorrect results due to using the on/off or the
power switch while processing tests
Switching off the analyzer while processing tests does not
allow for an orderly software shut-down and may lead to
incorrect results and to loss of data.
r Do not use the on/off switch or the power switch
while processing is going on.
In this section
Shutting down the analyzer (232)
Putting the analyzer into standby (233)
Switching off the power supply (234)
Shutting down the analyzer

Status indicator in the global information area
NOTICE
Possible analyzer damage due to using the on/off
switch
Using the on/off switch during shutdown may cause
hard-disk damage.
5 Operation
r Do not use the on/off switch during shutdown.
Roche Diagnostics
r To shut down the analyzer
1 Ensure that the analyzer status in the global

information area is Idle.
2 On the Overview work area, choose the Shut down

button.
f A callout is displayed, asking you whether you
want to perform the daily wash maintenance
action.
3 If you want to perform the wash now, choose the Yes

button.
f A confirmation callout is displayed.
4 To perform the wash, do the following:

• Prepare the wash rack.
• Load the wash rack on the input buffer.
• On the callout, choose the Confirm button.
f The wash action starts.
f When the wash action is complete, the software is
shut down and the analyzer is switched off.
5 If you want to perform the wash later, choose the No

button.
f The software is shut down and the analyzer is
switched off.
Putting the analyzer into standby
q This function sets the analyzer in a state of minimal

power consumption.
r To put the analyzer into standby
1 Choose Overview > Stand by.

f The screen goes black.
q You can re-activate the analyzer by touching the

5 Operation
screen anywhere.
Roche Diagnostics
Switching off the power supply
q Roche recommends to switch off the power supply if

you intend not to use the analyzer for some time or if you
want to relocate it.
r To switch off the power supply
1 Shut down the analyzer. (u 232)
2
2 Put the power switch at the back of the analyzer in the
A
off position .
A Control unit version 1 B Control unit version 2
Keeping the analyzer clean

In this section
5 Operation
About keeping the analyzer clean (235)

Cleaning the input and output buffers (236)
Cleaning the analyzer housing (237)
Cleaning the rack conveyors (237)
Cleaning the rack trays (238)
Cleaning the probe bend detector (241)
Cleaning the pipetting stage area (241)
Cleaning the centrifuge chamber (242)
Cleaning the microscope stage area (245)
Roche Diagnostics
About keeping the analyzer clean
! CAUTION
Skin inflammation or injury caused by working
solutions
Direct contact with cleaning solutions or other working
solutions may cause skin irritation, inflammation, or
burns.
NOTICE
cleaning solution
parts you cleaned.
analyzer.
NOTICE
Damage to the analyzer due to excessive liquid
Any liquid spilled on the analyzer may result in
malfunction or damage.
r Do not spray any liquid on any of the analyzer
surfaces.
5 Operation
Roche Diagnostics
q All the following cleaning tasks are performed with

the analyzer shut down and switched off.
To ensure trouble free operation of the system, Roche

recommends cleaning the following items and parts:
• Input and output buffer
u Cleaning the input and output buffers (236)
• Housing
u Cleaning the analyzer housing (237)
• Rack conveyors
u Cleaning the rack conveyors (237)
• Rack trays
u Cleaning the rack trays (238)
• Probe bend detector
u Cleaning the probe bend detector (241)
• Pipetting stage area
• Centrifuge chamber
• Microscope stage area
u Cleaning the microscope stage area (245)
Materials required • Paper towel

• Lint-free cotton swabs
• Cleaning solution
Cleaning the input and output buffers
r To clean the input and output buffers
1 Remove all racks and rack trays from the buffers.

5 Operation
2 Wipe all surfaces of the buffers, including the rack

conveyors, using a paper towel moistened with
cleaning solution.
3 Remove all residual moisture from all surfaces of the

buffers, using a dry paper towel.
Roche Diagnostics
Cleaning the analyzer housing
r To clean the analyzer housing
1 If there are rack trays on the input and output buffers,

remove them and wipe them using a paper towel
moistened with cleaning solution, then dry them with
a clean paper towel. (u 236)
2 Wipe the analyzer housing using a paper towel

moistened with cleaning solution, then dry it with a
clean paper towel.
Cleaning the rack conveyors
r To clean the rack conveyors
1
1 Wipe the rack conveyors near the input and output
buffers using a paper towel moistened with cleaning
solution.
2
2 Fold down the rack transport rail. Hold the rail at both
ends and pull it out firmly.
3 Wipe the rack conveyor using a paper towel

moistened with cleaning solution.
4 Fold up the rack transport rail. Hold the rail at both

ends and push it in firmly.
5 Operation
Roche Diagnostics
Cleaning the rack trays
! WARNING
Infection by samples and associated materials
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples of human origin are
potentially biohazardous.
r If any biohazardous material is spilled on the rack tray
surface, wipe it up immediately and apply disinfectant.
! WARNING
Personal injury and infection due to the edges on
the rack tray’s center guide rail
The edges on the rack tray’s center guide rail may cause
personal injury and infection.
r Avoid contact with all edges, even when wearing lab
gloves.
r Wear personal protective equipment such as lab
gloves.
r Carefully observe all instructions given in this task.
r To clean the rack trays
1
1 Use personal protective equipment when cleaning the
rack tray.
A B C D
A Rail edge C Rail center
5 Operation
B Rail grove D Rack tray
Roche Diagnostics
2
2 Wipe the rail center in both directions with a cotton
swab moistened with cleaning solution.
• If there is sticking and crystallized dirt on the rack
tray, scrape it with a cotton swab.
3
3 Wipe the rail edge in both directions with a cotton
4
4 Wipe the rail groove in both directions with a cotton
5
5 Wipe the edges on the bottom of the rack tray in both
directions with a cotton swab moistened with cleaning
solution.
5 Operation
Roche Diagnostics
6
6 Wipe the surface of the rack tray, starting from the
center in both directions with an at least 10 mm thick
pile of lint-free cloth moistened with cleaning solution.
• Hold the rack tray with one hand, the pile of lint-
free cloth with your fingers, and wipe the surface
of the rack tray.
7
7 Wipe the rear surface of the rack tray, starting from
the center in both directions with an at least 10 mm
thick pile of lint-free cloth moistened with cleaning
solution.
of the rack tray.
8
8 Wipe the bottom surface of the rack tray, starting from
the center in both directions with an at least 10 mm
thick pile of lint-free cloth moistened with cleaning
solution.
of the rack tray.
9 Visually check the rack trays.

• Make sure that there is no textile remaining on the
rack tray.
• Make sure that there are no wet areas on the rack
tray.
10 NOTICE Only use supported rack trays.

10 Ensure that the rack tray is supported by the analyzer
before using.
5 Operation
Roche Diagnostics
Cleaning the probe bend detector
r To clean the probe bend detector
1 Wipe the top and the inside of the probe bend

1
detector using a cotton swab moistened with
isopropyl alcohol or ethanol.
2 Wipe the top and the inside of the probe bend

detector with a dry cotton swab to remove all residual
cleaning solution.
Cleaning the pipetting stage area
r To clean the pipetting stage area
1
1 Remove the pipetting stage and wipe it using a paper
towel moistened with cleaning solution. Then dry it
with a dry paper towel.
5 Operation
Roche Diagnostics
2
2 Wipe the pipetting stage area using a paper towel
moistened with cleaning solution.
3 Wipe the pipetting stage area with a dry paper towel

to remove all residual cleaning solution.
4
4 Insert the pipetting stage. Be sure to insert it below
the guide post on the left.
Cleaning the centrifuge chamber
! CAUTION
Personal injury or damage to the analyzer due to
contact with moving parts
r Do not perform any operation or maintenance action
5 Operation
while the centrifuge is in action.
Roche Diagnostics
r To clean the centrifuge chamber
1
1 Disengage the safety pin and at the same time pull out
the centrifuge cover.
2
2 Turn the centrifuge arm to the horizontal position and
remove it. Hold it in the center and lift it off.
3
3 Wipe the centrifuge cover and the inside of the
centrifuge chamber using a paper towel moistened
with cleaning solution.
4 Wipe the centrifuge cover and the inside of the

centrifuge chamber with a dry paper towel to remove
all residual cleaning solution.
5 Clean the centrifuge arm with cleaning solution.
6 Wipe the centrifuge arm with a dry paper towel to

5 Operation
remove all residual cleaning solution.
Roche Diagnostics
7
7 Insert the centrifuge arm.
• Hold the centrifuge arm in the center.
• Make sure the cuvette holder faces away from the
centrifuge chamber.
• Align the holes in the arm with the two pins in the
centrifuge chamber.
• Push in the arm firmly until the pins protrude
through the holes in the arm (A).
8 Insert the centrifuge cover, push it in firmly.
A
5 Operation
Roche Diagnostics
Cleaning the microscope stage area
r To clean the microscope stage area
1
1 Pull out the cuvette rail (A).
2 Wipe the cuvette rail using a paper towel moistened

with cleaning solution, then dry it with a clean paper
towel.
3 Wipe the cuvette rail with a dry paper towel to remove

all residual cleaning solution.
4 Wipe the microscope stage area using a cotton swab

moistened with isopropyl alcohol or ethanol, then dry
it with a clean cotton swab.
5 Wipe the microscope stage area with a dry paper

towel to remove all residual cleaning solution.
6 Re-insert the cuvette rail.

A I Push it in firmly.
5 Operation
Roche Diagnostics
246 Checking the microscope focusing mechanism
Checking the microscope focusing

mechanism
In order to ensure proper functioning of the focusing
mechanism of the microscope, a microscope check needs
A to be performed every 4 weeks. This is done by
performing a predefined sequence of photographic
measurements of a reference cuvette. This cuvette
contains a transparent material with erythrocyte like
B
particles etched in it. The system must be able to
recognize these and count them correctly.
A The reference cuvette B Measurement area
is marked with R A message in the message list informs you when
microscope check is due. Results that are generated with
microscope check results that are no longer valid are
marked with Cm in the column.
! CAUTION
Incorrect results due to soiling of measurement
area
Soiling of the measurement area of the reference cuvette
may adversely affect the measurements.
r Do not touch the measurement area of the reference
cuvette.
r If the cuvette is soiled, you can clean it using a soft
lint-free cloth moistened with isopropyl alcohol or
ethanol.
To perform the cuvette check, you need the reference

cuvette and the reference cuvette basket. They are stored
at the back of the microscope unit (A).
The reference cuvette is designed to be used throughout

A
the shelf life of the analyzer, therefore neither lot number
nor expiry date are printed on the reference cuvette box.
5 Operation
Roche Diagnostics
Checking the microscope focusing mechanism 247
r To check the microscope focusing

mechanism
1 Ensure that the analyzer is in Idle status.
2 Start the Check microscope wizard.

indicates that the microscope check is due, then
choose the Check microscope button in the
detail panel.
• Choose Monitoring > Manage calibrations
> Check microscope, then choose the Check
microscope button in the main panel.
5 Operation
Roche Diagnostics
248 QC tasks
QC tasks
When the lot of the QC material expires or the QC test has
failed a message is added to the message list. Tests are
still performed but the test results are marked with Q in
the column.
You generally perform QC tasks when instructed to do so:
w Displaying a QC message
u To check for tasks that require intervention (221)
In this section
Performing QC measurements (248)
Reviewing QC results (255)
Performing QC measurements
In this section
About performing QC measurements (249)
Preparing the QC rack (249)
Performing a QC measurement (250)
Performing a QC measurement when working with an
LAS (250)
5 Operation
Defining QC materials (250)

Changing QC material data (253)
Making test parameter related changes (254)
Including or excluding tests from the QC
measurements (254)
Deleting QC materials (255)
Roche Diagnostics
QC tasks 249
About performing QC measurements

Perform QC measurements according to your laboratory
regulations. When the lot of the QC material expires or
the QC test has failed a message is added to the message
list. Test are still performed but the test results are
marked with Q in the column.
! CAUTION
Incorrect results due to sample mix-up
Tubes on QC racks are not individually identified. It is
assumed that the fluids are valid and placed as defined in
the QC rack definitions.
r Be sure to use the QC material that has been defined
on the analyzer.
r Be sure to fill the tubes with the prescribed QC
materials and place them on the predefined positions.
Preconditions • There is sufficient QC material in the tubes.

• A QC rack is defined.
u Managing racks (305)
q If you use QC materials of a new lot, define the new

lot first.
u Defining QC materials (250)
Preparing the QC rack
r To prepare the QC rack
1 Choose Monitoring > Routine > Manage racks.
2 Select a defined QC rack.
3 Note which position on the rack must contain which

liquid.
5 Operation
4 Place the tubes on the appropriate positions on the

rack.
Roche Diagnostics
250 QC tasks
Performing a QC measurement
r To perform a QC measurement
1 Prepare the QC rack. (u 249)
2 Place the prepared QC rack in the priority rack slot.

f The rack is recognized as the QC rack, the tests
are performed.
3 Check the results for possible data alarms. (u 255)
4 Remove the QC rack from the output buffer.
Performing a QC measurement when working with an LAS
r To perform a QC measurement when

working with an LAS
1 Prepare the QC rack. (u 249)

button.

place the prepared QC rack on the rack conveyor belt
of the input connection unit.
4 Check the results for possible data alarms. (u 255)
5 Remove the QC rack from the output buffer.
Defining QC materials
5 Operation
QC materials, including the lot information, can be

defined manually or by reading the RFID tag on the
material packaging. You can change the data later and
you can also exclude tests from being performed during
the QC measurements.
Roche Diagnostics
QC tasks 251
q There are separate data for each QC level.

Each QC material is, when it is defined, associated with
the currently active range table.
u To manually define a new QC material (253)

u To define a new QC material by reading the RFID
tag (252)
u To change QC material data (253)
u To include or exclude tests from the QC
measurements (255)
u To delete QC materials (255)
u To print QC results or save them to a file (258)
About defining a new QC material by reading • If the new QC material has more levels than the
the RFID tag currently defined maximum number, this maximum
number is automatically increased to the number of
levels of the new QC material.
• If the number of QC levels of the new QC material is
different from that of the current QC material, a yellow
message is generated.
• If the number of QC levels is higher than the defined
maximum level, there are no current QC results for the
highest level and you need to perform QC. Check the
yellow messages.
• If the number of QC levels is smaller than the defined
maximum level, change the number of QC levels to
reflect the number of levels coming from the QC RFID.
u To define the number of QC levels (290)
When reading the RFID tag the following data are read
and stored on the analyzer:
• QC level
• Target ranges
• Lot number
• Expiry date
5 Operation
Roche Diagnostics
252 QC tasks
r To define a new QC material by

reading the RFID tag
1 Choose Routine > Manage QC > Manage QC
materials.
2
2 Present the RFID tag of the QC material to the RFID
reader at a distance of between 1 and 25 mm (0.04-
1 in).
f The QC material data are registered and displayed
on screen.
q If the RFID tag is not valid, an acoustic signal is

sounded.
If there is more than one QC level, a material entry is
created for each level, and you need to perform the
following steps for each of them.
3 In the QC material list, choose the new entry, if

required.
4 In the QC material field, enter the material name.

I If the new material is of the same lot as the
previous material, make sure to enter the same
name. This ensures that the results will be included
in the QC chart.
6
6 If you want to use the QC material straight away you
need to activate it: select the material and choose the
Activate/deactivate button.
f Active materials are marked with in the Active
column.
q To be able to activate the QC material, a QC

material name must have been defined and the
system status must be Idle.
o Only one lot can be active per QC level.
o Lots that have expired are automatically
deactivated.
o To be able to perform a QC measurement, all levels
5 Operation
of the QC material must be activated.

o When you try to perform a QC measurement and
no QC material is activated, then a yellow message
is generated. Check this message.
Roche Diagnostics
QC tasks 253
r To manually define a new QC material

materials > Create.
I To define a material on the basis of an existing
one, choose Routine > Manage QC > Manage
QC materials, select the entry of the existing
material and choose the Copy button. Then
change the values as required.
2 Open the Instructions for Use.
3 Enter the values exactly as defined in the Instructions

for Use.

f The material is added to the QC materials list.
5
5 If you want to use the QC material straight away you
need to activate it: select the material and choose the
Activate/deactivate button.
I Only one lot can be active per QC level. Lots that
have expired are automatically deactivated.
Active materials are marked with in the Active
column.
Changing QC material data
q You can only change QC data of materials that are

not currently activated or with which no QC
measurements have been performed yet.
r To change QC material data

materials.
2 In the main panel, choose the material you want to

change.
5 Operation
4 In the detail panel, enter the new values as required.
5 If you want to change test parameter related values,

choose the Manage ranges button. (u 254)
Roche Diagnostics
254 QC tasks
7 If you want to change the current usage status,

choose the Activate/deactivate button in the QC
materials list.
Making test parameter related changes
q You can only change QC data of materials that are

not currently activated or with which no QC
measurements have been performed yet.
In the QC results list, only those test parameters are
displayed that are enabled.
r To make test parameter related

changes
materials.
2 In the main panel, choose the material.
3 In the detail panel, choose the Manage ranges

button.
f The QC material screen is displayed.
5 In the test list, use the drop-down lists to enter the

new values as required.
Including or excluding tests from the QC measurements
q You can define which tests are performed with the

QC measurements, for example, you can exclude tests for
which there are no range values defined for the QC
material you use.
5 Operation
You can only change QC data of materials that are not

currently activated or with which no QC measurements
have been performed yet.
In the QC results list, only those test parameters are
displayed that are enabled.
Roche Diagnostics
QC tasks 255
r To include or exclude tests from the

QC measurements
materials.
2 In the main panel, choose the material.
3 In the detail panel, choose the Manage ranges

button.
f The QC material screen is displayed.
5 To enable or disable a parameter, select or clear its

Enabled box.
I You must enable a parameter before you can
change its limit values.
Deleting QC materials
q You can only delete QC materials that are not

currently activated or with which no QC measurements
have been performed yet.
r To delete QC materials

materials.
2 In the main panel, choose the material you want to

delete.
4 In the callout, confirm the deletion.

f The QC material is deleted.
5 Operation
Reviewing QC results
Possible result symbols
Passed
Roche Diagnostics
256 QC tasks
Not passed
Color coding
Green The result is within target range.
Red The result is outside target range.
Possible data alarms

There are no data alarms.
Cm Calibration. The microscope check results

were no longer valid when the result was
generated.
F1 Defocused image found. All particle counts

are zero.
Review the images and repeat
measurement.
F2 Defocused image found. The focus position

deviates too much from that of the previous
image.
measurement.
F3 Defocused image found. The focus position

is outside the predefined range.
measurement.
F4 Defocused image found. Inhomogeneous

MUC distribution in the images.
measurement.
O Parameter is out of range.

5 Operation
Roche Diagnostics
QC tasks 257
Ub Unreliable image found. There may be

bubbles in the cuvette.
Uc Unreliable image found. There are too

many cells in the image (crowded),
automatic evaluation is not possible.
# A Roche Service representative did not

cancel a service or troubleshooting
function that can only be canceled by a
Roche Service representative. (As a result,
for example, expired materials may have
been used.) All results have this data alarm
and the validity of these results cannot be
guaranteed.
If you encounter this data alarm, contact
your Roche Service representative
immediately.
q You typically delete results if you find you made a

mistake in the QC material definition or in performing the
QC test, or if you want to exclude results from the QC
chart.
You can store up to 300 QC results on the analyzer. When
this number is reached, the oldest result is overwritten
when the next QC test is performed.
r To review QC results
1
1 Choose Routine > Manage QC > Review QC
results.
f The results are displayed.
2 Select a result. (u 255)

f The details are displayed in the detail panel.
3 To view the results in chart format, choose the QC

chart button.
q For more information, see:

u Working with QC charts (137)
5 Operation
4 To add a comment to the result, choose the Edit

button and enter the text in the Comment field.
Roche Diagnostics
258 QC tasks
r To delete QC results

results.
2 Select the results you want to delete.

I Select individual check boxes at the beginning of
the result entries or select the check box in the
table header to select all results in the list.

f In the callout, the progress of the deletion process
is indicated.
r To print QC results or save them to a

file
results.
2 In the main panel, select the results you want to print

or save to file.

3 In the main panel, choose the Report button.

4 In the callout, define whether to print or export the

data (Output mode).
5 In the callout, if you want to save the data to a location

other than the default location, choose the Select
button and define the file location. (This can either be
a USB storage device connected with the USB port,
preferably on the front of the instrument, or a mapped
network path.)

5 Operation
6 In the callout, choose the Yes button.
Roche Diagnostics
Additional operating tasks 259
Additional operating tasks

This section describes some tasks that you may need to
perform occasionally.
In this section
Stopping and restarting sample processing (259)
Changing the password (260)
Printing and exporting information, generating
reports (261)
Stopping and restarting sample processing

Sample processing can be stopped any time. You may
want to do so, for example, to perform some routine
maintenance actions.
Stopping the sample processing has the following

consequences:
• All tests for which orders are defined are completed.
• While testing goes on, the Stop status is displayed in
the global information area, when the testing activities
are complete the Idle status is displayed and there are
no messages in the message list that refer to ongoing
analysis.
• If there are unprocessed samples on the rack, it
remains on the conveyor.
q Ensure that all covers and drawers are closed.
r To interrupt sample processing
1 Choose Overview > Stop.
2 Wait until the system status is Idle.

5 Operation
r To resume sample processing
1 Choose Overview > Start.

f Testing resumes where it stopped when you used
the Stop button.
Roche Diagnostics
260 Additional operating tasks
Changing the password

There are two possible password modes: With Simple
password mode the system administrator (user of the
Supervisor user group) defines the password and the
general user cannot change it. With Strong password
mode, the system defines the initial password and the
user then can change it, in fact, he or she must change
the initial password during their first logon, and from then
on they must change it every 60 days.
When working with Simple password mode, password

information is case-sensitive and must contain at least
one alphanumeric character. Spaces are allowed.
When working with Strong password mode, password

information is case-sensitive and must meet the following
conditions:
• At least eight characters
• At least one upper case letter
• At least one lower case letter
• At least one digit
• Must not repeat a character more than four times
• Must not contain any part of the user name of more
than four characters
• Must not be identical to the previous password
q As a user of the User user group, you can change

the password only if the system works with Strong
password mode.
r To change the password
1 Choose the Log on button.

f A dialog box is displayed.
2 Enter your user name and password.
3 Choose the Change password button.

5 Operation
f A dialog box is displayed.
4 Enter your new password and then re-enter it.
5 Choose the Confirm button.

f If the change was not successful a message is
displayed. Read the information carefully and then
change the passwords again.
Roche Diagnostics
Additional operating tasks 261
Printing and exporting information, generating reports

You can print and export critical information to files. The
process usually involves the steps described in the
following section:
u To print or export information (262)
The following table lists which data can be printed and

exported, and it provides information on the various
options that are available.
Type of information Navigation path Callout items Comment on callout item

Any listed below ... > Report Output mode (1) Print: Print on the default printer.
Export to PDF: Save the information in
PDF format to the default file location.
File path(1) Available with Export to PDF Output
mode.
If you want to save the data to a location
other than the default location, choose
the Select button and define the file
location. (This can either be a USB
storage device connected with the USB
port, preferably on the front of the
instrument, or a mapped network path.)
Axeda is intended for direct upload to
Roche Service. Do not use this
destination unless instructed to do so by
your Roche Service representative.
Selected results Routine > Manage test results Analyzer Available if you work with cobas® 6500
(result report) urine analyzer series.
u To print results (result Output mode Export images only: Available if your
report) (181) system includes a microscopy analyzer.
To save results to files Save each image in a file. (You cannot
print images directly on a printer. You
(result report) (182)
need to save them as files first and then
use a graphics tool to print them.)
Results of a patient Routine > Manage patients Analyzer Available if you work with cobas® 6500
(patient report) urine analyzer series.
u To print results Result selection Define which results of this patient
(patient report) (182) should be printed or saved to files.
To save results to files Output mode Export images only: Available if your
(patient report) (183) system includes a microscopy analyzer.
Save each image in a file. (You cannot
print images directly on a printer. You
need to save them as files first and then
use a graphics tool to print them.)
5 Operation
QC results Routine > Manage QC > Review

u To print QC results or QC results
save them to a
file (258)
Microscope check results Monitoring > Manage
calibrations > Check microscope
y Printing and exporting information, generating reports
Roche Diagnostics
262 Additional operating tasks
Type of information Navigation path Callout items Comment on callout item

Screenshots Monitoring > Perform Save the last 100 screenshots that were
maintenance > Export screen generated using the print screen
shots function to a location that is
accessible by the user.
System settings and Administration > System Analyzer Available if you work with cobas® 6500
configuration configuration > Import or export urine analyzer series.
u To generate a report system settings > Report system
settings
of the system
settings (304)
Cross-check rule Administration > System settings Analyzer Available if you work with cobas® 6500
definitions > Measurement settings urine analyzer series.
> Cross-check rules
Limit definitions Administration > System settings The report includes the limits for trace
> Measurement settings > u 701 and abnormal of all parameters.
> Limit configuration
Range table definitions Administration > System settings
> Measurement settings > u 701
> Range table configuration
Range table activities Administration > System settings List of all actions performed with range
> Measurement settings > u 701 tables.
> Range table configuration
> History
y Printing and exporting information, generating reports
(1) This option is available for all types of information.
r To print or export information
1 Access to the relevant screen and select the data, if

required.

3 In the callout, define whether the data should be

printed on a printer or exported to files, for example in
PDF format or, for images, in a graphics file format
(Output mode).
4 In the callout, if you want to save the data to a location

other than the default location, choose the Select
button and define the File path. (This can either be a
USB storage device connected with the USB port,
5 Operation
preferably on the front of the instrument, or a mapped

network path.)
q For information on defining default values, see:

u Defining the look, content, and handling of reports (299)

f The information is processed as defined.
Roche Diagnostics
263
Table of contents
Configuration 6
This chapter describes how to adjust the operating

environment to your local needs.
In this chapter 6
User management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
Defining a new user . . . . . . . . . . . . . . . . . . . . . . . . . 265
Changing user data . . . . . . . . . . . . . . . . . . . . . . . . . 267
Resetting the password . . . . . . . . . . . . . . . . . . . . . . 268
Activating and deactivating a user . . . . . . . . . . . . . 268
System settings: Defining the test environment. . . . . 269
About system settings . . . . . . . . . . . . . . . . . . . . . . . 270
Defining whether and how particle labels are
displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
Defining the units in which results are displayed
and reported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Defining the order in which test parameters are
shown. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275
Defining the validation method . . . . . . . . . . . . . . . 276
Defining cross-check rules . . . . . . . . . . . . . . . . . . . 277
Defining a cross-check rule . . . . . . . . . . . . . . . 277
Changing a cross-check rule . . . . . . . . . . . . . . 278
Deleting a cross-check rule . . . . . . . . . . . . . . . 278
Managing the result storage capacity . . . . . . . . . . 279
6 Configuration
Defining how the sample IDs are generated . . . . 279

Defining range tables. . . . . . . . . . . . . . . . . . . . . . . . 280
Choosing the range table . . . . . . . . . . . . . . . . . 281
Defining a new range table. . . . . . . . . . . . . . . . 282
Making changes to range tables . . . . . . . . . . . 283
Displaying RBC and WBC results on a semi-
quantitative level . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
Limit configuration . . . . . . . . . . . . . . . . . . . . . . . . . . 284
Defining warning limits for supplies and solid
waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
Microscopy related definitions . . . . . . . . . . . . . . . . 286
Image handling . . . . . . . . . . . . . . . . . . . . . . . . . . 286
Roche Diagnostics
264
Table of contents
Particle configuration . . . . . . . . . . . . . . . . . . . . . 287

Defining particle subclasses . . . . . . . . . . . . . . . 288
Defining the QC environment . . . . . . . . . . . . . . . . . 290
System configuration: Defining the operating
environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291
Defining the operating environment . . . . . . . . . . . 291
About defining the operating environment . . . 292
About the Basic configuration 1 panel . . . . . . 293
About the Basic configuration 2 panel . . . . . . 294
Performing basic configuration. . . . . . . . . . . . . 296
Defining when notifications should be generated 297
Defining the barcode check parameters. . . . . . . . 298
Configuring the host connection . . . . . . . . . . . . . . 299
Defining the look, content, and handling of
reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299
Installing a new language . . . . . . . . . . . . . . . . . . . . 301
Changing the user interface language . . . . . . . . . 302
Importing and exporting system settings . . . . . . . 303
Checking the versions of the installed software
components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304
Managing racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 305
Adjusting the probe action . . . . . . . . . . . . . . . . . . . . . . 307
6 Configuration
Roche Diagnostics
User management 265
User management
User management consists of the following tasks:
• Defining new users
• Changing user data
• De-activating users
• Defining new passwords
• Resetting passwords
In this section
Defining a new user (265)
Changing user data (267)
Resetting the password (268)
Activating and deactivating a user (268)
Defining a new user

For defining user data you must have Supervisor rights.
q During the installation of the analyzer, a user of the

Supervisor and User user group are defined.
User group rights

User group Description
User Users with User rights can perform all
actions that are required for daily
operation.
o Order management
o Test activities
o Calibration activities
o QC activities
o Result handling
o Result reporting
o Daily maintenance
o Reporting and exporting system
settings
Supervisor In addition to all actions of the User group,
6 Configuration
users with Supervisor rights can perform

the following tasks:
o User configuration
o System settings (test definition,
profiles)
o User interface language installation
o System configuration (operating
system, communication)
o Screen sharing
Service In addition to all actions of the User and
Supervisor groups, users with Service
rights can perform the following tasks:
o Software installation
y List of user group rights
Roche Diagnostics
266 User management
User statuses
Status Description
Active The user can log on to the analyzer.
Inactive The user cannot log on to the analyzer but
remains on the analyzer and can be activated
any time.
u Activating and deactivating a user (268)
y List of user statuses
r To define a new user
1 Choose Administration > User management.

f A detail panel is displayed that contains all items
that need to be defined.
q Items marked with an asterisk are mandatory.
3 Define the user’s first name.

I Enter 1 to 32 alphanumeric characters, spaces are
allowed. This name will be displayed in the global
information area of the screen. This entry is
compulsory.
4 Define the user’s last name.

I Enter 1 to 50 alphanumeric characters, spaces are
allowed. This name will be displayed in the global
information area of the screen. This entry is
compulsory.
5 Define the user name.

I Enter 4 to 20 alphanumeric characters. This will be
required during logon and it will be displayed with
results and log information.
6 Choose the user group. (u 265)
7 Choose the user status. (u 265)

6 Configuration
I Because every result must be associated with a

user, you cannot delete users from the database,
they are deactivated instead.
Roche Diagnostics
User management 267
8 Choose the Create password button.

• If you work with Simple password mode, enter
the password in the callout and choose the
Confirm button.
• If you work with Strong password mode the
system automatically defines a password and
displays it in a callout. Choose the Confirm button.
The user will have to change the password when
logging on for the first time and from then on every
60 days.
q When working with Simple password mode,

password information is case-sensitive and must
contain at least one alphanumeric character. Spaces
are allowed.
When working with Strong password mode,
password information is case-sensitive and must meet
the following conditions:
o At least eight characters
o At least one upper case letter
o At least one lower case letter
o At least one digit
o Must not repeat a character more than four times
o Must not contain any part of the user name of
more than four characters
o Must not be identical to the previous password
Changing user data

For changing user data you must have Supervisor rights.
r To change user data

6 Configuration
2 In the main panel, choose the user whose data you

want to change.
f In the detail panel, this user’s details are displayed.
3 Choose the Edit button and change the information as

required. (u 265)
Roche Diagnostics
268 User management
Resetting the password

For resetting a password, you must have Supervisor
rights.
r To reset the password
2 In the main panel, choose the user whose password

you want to reset.
f In the detail panel this user’s details are displayed.
4 Choose the Create Password button.

5 If you work with Simple password mode, enter the

password twice in the callout and choose the
Confirm button.
6 If you work with Strong password mode, make a

note of the password and in the callout choose the
Confirm button.
Activating and deactivating a user

Active users can log on to the analyzer, inactive users
cannot, but they remain on the analyzer and can be
reactivated any time.
q Because every result must be associated with a user,

you cannot delete users from the database, they are
6 Configuration
deactivated instead.
For activating and deactivating a user, you must have

Supervisor rights.
Roche Diagnostics
System settings: Defining the test environment 269
r To activate or deactivate a user
2 In the main panel, choose the user that you want to

deactivate.
f In the detail panel, this user’s details are displayed.
4 From the Status drop-down list, choose Active or

Inactive.
System settings: Defining the test

environment
In this section
About system settings (270)
Defining whether and how particle labels are
displayed (272)
Defining the units in which results are displayed and
reported (273)
Defining the order in which test parameters are
shown (275)
Defining the validation method (276)
Defining cross-check rules (277)
Managing the result storage capacity (279)
Defining how the sample IDs are generated (279)
Defining range tables (280)
Displaying RBC and WBC results on a semi-quantitative
level (284)
Limit configuration (284)
6 Configuration
Defining warning limits for supplies and solid waste (286)

Microscopy related definitions (286)
Defining the QC environment (290)
Roche Diagnostics
270 System settings: Defining the test environment
About system settings
q Generally, users with the user group User can view

all definitions, but to define and change them, you need
the Supervisor user group. All users can create a
problem report and export and report the system settings.
Choose Administration > System settings to access

the test related settings.
6 Configuration
Roche Diagnostics
System settings
Result presentation
Measurement settings QC settings
settings
QC settings
Format particle label Validation
• Automatic validation of all • Number of QC levels

Particle label
• Automatic validation rules
• Manual validation
• Show particle labels on images
Label format Cross-check rules
• Font • Delete
• Style • Activate/deactivate
• Size • Report
• Color • Create
Cross-check rules
Select measurement units
• Rule name
Measurement unit on u 701 • Suggestion
• Items
• Unit • Referenced range table u 701
• Enable semi-quantitative values for
RBC and WBC
General
Change test result order

Database limits for samples
u 701 • Storage limit

• Warning limit
• If database is full
Change test result order
in report Sample ID
• Generation mode
u 701
Multiple measurement
• Number of measurements
u 701
Range tables
• Active range table
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Limits for data alarms
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Warning limits for cuvettes
• Remaining capacity in solid waste

container
• Remaining capacity in cuvette
6 Configuration
cassette
Microscopy images
• Enable automatic evaluation
Available to all users Item To new screen, panel, or callout • Item Item, function summary
Available to users with Supervisor rights only Item Panel on same screen
w Navigation map for System settings (International)
Roche Diagnostics
Defining whether and how particle labels are displayed
r To define whether and how particle

labels are displayed
1 Choose Administration > System settings
> Result presentation settings > Format particle
label.
3 Select or clear the Show particle label on image

check box to define whether labels should be
displayed on images or not.
4 In the Label format group, define the look of the

labels (font family, style, size, color).
u Related topics
• Displaying RBC and WBC results on a semi-
quantitative level (284)
6 Configuration
Roche Diagnostics
Defining the units in which results are displayed and

reported
You can define the units in which results are displayed
and reported.
The following tables show examples of how the results

are displayed, depending on the unit convention that was
selected.
Display examples for cobas u 701 microscopy

analyzer
Quantitative values enabled for RBC and WBC
(Enable semi-quantitative values for RBC and WBC is cleared in Administration > System settings > Result presentation
settings)
Unit Test column Result column Information column Example for
Conventional RBC 181.2/μL quantitative
BAC 500/μL semi-quantitative
PAT pos qualitative
Field of view RBC 41.1/HPF quantitative
BAC 100/HPF semi-quantitative
PAT pos qualitative
Arbitrary RBC 181.2/μL quantitative
(conventional) BAC 2+ semi-quantitative
PAT pos qualitative
Arbitrary (field of RBC 41.1/HPF quantitative
view) BAC 2+ semi-quantitative
PAT pos qualitative
Conventional and RBC 181.2/μL quantitative
arbitrary BAC 500/μL 2+ semi-quantitative
PAT pos pos qualitative
Field of view and RBC 41.1/HPF quantitative
arbitrary BAC 100/HPF 2+ semi-quantitative
Arbitrary and counts RBC 181.2/μL quantitative
(conventional) BAC 2+ ~695.4/μL semi-quantitative
PAT pos ~6.2/μL qualitative
6 Configuration
Arbitrary and counts RBC 41.1/HPF quantitative

(field of view) BAC 2+ ~157.9/HPF semi-quantitative
PAT pos ~1.4/HPF qualitative
y Result display of the cobas u 701 microscopy analyzer with quantitative values enabled for RBC and WBC (International)
Roche Diagnostics
Quantitative values disabled for RBC and WBC

(Enable semi-quantitative values for RBC and WBC is selected in Administration > System settings > Result presentation
settings)
Unit Test column Result column Information column Example for
Conventional RBC 150/μL quantitative
BAC 500/μL semi-quantitative
PAT pos qualitative
Field of view RBC 30/HPF quantitative
BAC 100/HPF semi-quantitative
PAT pos qualitative
Arbitrary RBC 4+ quantitative
(conventional) BAC 2+ semi-quantitative
PAT pos qualitative
Arbitrary (field of RBC 4+ quantitative
view) BAC 2+ semi-quantitative
PAT pos qualitative
Conventional and RBC 150/μL 4+ quantitative
arbitrary BAC 500/μL 2+ semi-quantitative
Field of view and RBC 30/HPF 4+ quantitative
arbitrary BAC 100/HPF 2+ semi-quantitative
Arbitrary and counts RBC 4+ ~181.2/μL quantitative
(conventional) BAC 2+ ~695.4/μL semi-quantitative
PAT pos ~6.2/μL qualitative
Arbitrary and counts RBC 4+ ~41.1/HPF quantitative
(field of view) BAC 2+ ~157.9/HPF semi-quantitative
PAT pos ~1.4/HPF qualitative
y Result display of the cobas u 701 microscopy analyzer with quantitative values disabled for RBC and WBC (International)
q Results calculated with the setting Arbitrary and

counts (conventional) or Arbitrary and counts (field
of view) are preceded with a tilde "~" to indicate that
they were not actually evaluated on a quantitative level.
Values in the Information column that are preceded by
"~" do not have an upper limit associated with them.
6 Configuration
r To define the display units

> Result presentation settings > Select
measurement units.
Roche Diagnostics
3 From the Measurement unit on u 701 drop-down

list, choose the unit convention for the microscopy
analyzer.
Defining the order in which test parameters are shown

You can define the order of test parameters as they are
displayed in the results displays, printouts, and exports.
r To define the order in which

parameters are displayed in result
displays
> Result presentation settings.
2 Choose where the order applies.

• To define the order for on-screen displays choose
the Change test result order button.
• To define the order for result printouts and exports,
choose the Change test result order in report
button.
4 Select a parameter and choose or to move it up

or down in the list.
5 Do the same for all parameters you want to move.

6 Configuration
Roche Diagnostics
Defining the validation method

You can set up the analyzer to automatically accept all
results or to exclude results from automatic validation if
they have certain data alarms associated with them. You
can also choose to validate all results manually.
Validation methods
Methods Description
Automatic All results are automatically validated.
validation of all If you work with a LIS validated results
are automatically sent to the host.
Automatic All results are automatically validated,
validation rules unless an additional condition (rule)
applies, (a cross-check rule was
triggered, a trace alarm was
generated, an abnormal result was
generated).
If you work with a LIS validated results
are automatically sent to the host.
Manual validation All results must be validated manually.
y List of validation methods
r To define the validation method

> Measurement settings > Validation.
3 From the drop-down list, choose a method. (u 276)
q In the following situations, automatic validation is

never applied:
o The sample barcode could not be read (if you work
with the generation mode Barcode).
o There already exists an order for this result.
o The result displays a Ub or Uc data alarm.
o The result displays an F1 or F2 or F3 or F4 data
alarm.
6 Configuration
o Fewer than five images yielded a valid result.

o A dilution factor has been defined.
4 If you chose the Automatic validation rules

condition, select all boxes of the rules that you want
applied.
Roche Diagnostics
Defining cross-check rules

In this section
Defining a cross-check rule (277)
Changing a cross-check rule (278)
Deleting a cross-check rule (278)
Defining a cross-check rule

Cross-check rules serve to define additional actions that
should be taken as a result of certain result qualities or
values.
• Each cross-check rule is, when it is defined,
associated with the currently active range table.
• You can activate and deactivate a cross-check rule
that is associated with a result, but you cannot change
or delete it.
• You can make changes to a cross-check rule or delete
it if it is not associated with a result and if it is
associated with the currently active range table.
• You can print and export the cross-check rules.
r To define a cross-check rule

> Measurement settings > Cross-check rules.
3 Enter or select the values.

I Rule name: Alphanumeric characters.
Suggestion: Describe what needs to be done if
the rule applies.
Item: Choose values from the drop-down lists to
define a condition.
6 Configuration
5 In the main panel, choose the Activate / deactivate

button.
Roche Diagnostics
Changing a cross-check rule
q You can make changes to a cross-check rule if it is

not associated with test results. If you need to make
changes to a cross-check rule that is associated with test
results, you have to define a new cross-check rule.
You can activate or deactivate a cross-check rule if it is
associated with the active range table.
r To change a cross-check rule

3 Change the values as required.

I Rule name: Alphanumeric characters.
Suggestion: Describe what needs to be done if
the rule applies.
Item: Choose values from the drop-down lists to
define a condition.
Deleting a cross-check rule
q You can delete a cross-check rule if it is not

associated with results.
r To delete a cross-check rule

6 Configuration
2 In the rule list, choose the rule you want to delete.

f The rule is deleted.
Roche Diagnostics
Managing the result storage capacity

You can define what should happen when the storage
capacity for result data is exhausted.
r To manage the sample storage

capacity
> Measurement settings > General.
3 In the Storage limit field, enter the maximum number

of sample test results that can be stored (1000-
10 000). The limits for QC and microscope check are
300 each and cannot be changed.
4 In the Warning limit field, enter the threshold value

when a messages should be added to the message
list.
5 Define whether the oldest data should be overwritten

when the database is full or whether processing
should stop.
Defining how the sample IDs are generated

Sample IDs are either read from the sample barcode or
they are automatically generated using a sample
sequence number.
q If the analyzer is connected to an LAS, the

Generation mode Sample sequence number is not
6 Configuration
available. The mode is automatically set to Barcode

during startup of the system.
Generation modes
Mode Description
Barcode Use this value if you work with sample
barcodes and the sample ID is
contained in your sample barcodes.
Sample sequence Use this value if you do not work with
number sample barcodes.
y Generation modes
Roche Diagnostics
r To define how the sample IDs are

generated
> Measurement settings > General.
3 Define the Generation mode. (u 279)
4 The number of measurements for each sample is set

by the manufacturer. Your Roche Service
representative can change it.
Defining range tables

Test results, QC materials, and cross-check rules are
always associated with the range table that was active
when they were generated or defined. The associated
range table is indicated when you display the results, QC
materials, or cross-check rules.
Range tables that are associated with a result, cross-

check rule or a QC material cannot be changed. If you
need changes in such a range table, you first need to
define a new range table or delete the associated results.
q Choosing a different range table as the active range

table affects some settings:
o It deactivates the cross-check rules and QC materials.
Therefore, you need to define the QC materials anew
and, if required, define new cross-check rules.
The deactivated cross-check rules and QC materials
can only be reactivated by choosing the associated
range table again, but they can be deleted if they are
not associated with any results.
6 Configuration
o It resets the limits of ranges to their default values.

u To define the limit values (285)
Range table types

Table type Description
International The predefined range table reflects the
legal and customary requirements for
result validation.
Name of user- For details on such range tables, see:
defined range tables u To define a new range table (282)
y Range table types
Roche Diagnostics
q Use a predefined range table as the basis for a new

range table and then change the ranges as required. You
cannot use a user-defined range table as the basis for a
new one.
q You can change user-defined range tables, provided

they are not associated with any test results, QC material,
or cross-check rule. If you need to make changes to a
range table that is associated with any test results, you
need to define a new one instead.
You cannot change or delete predefined range tables.
In this section
Choosing the range table (281)
Defining a new range table (282)
Making changes to range tables (283)
Choosing the range table
r To choose the range table

> Measurement settings.
2 Choose the u 701 button.
4 From the Active range table drop-down list, choose

the range table.
q For more information on range table types, see:

u Range table types y (280)
6 Configuration
6 Define new QC materials. (u 250)
7 Define new cross-check rule, if required. (u 277)
Roche Diagnostics
Defining a new range table
r To define a new range table

3 Choose the Range table configuration button.
4 From the Range table drop-down list, choose the

base range table.
6 In the callout, enter the name of the new table, then

choose the Save button.
f The values of the base range table are displayed.
7 Choose a parameter.
f The current ranges are displayed in the detail
panel.
8 Use the panel splitter to display the complete range.
10 If there are no values displayed for the selected

parameter, choose the Create range button.
11 Choose the first of the range fields and enter the

required new value. Choosing Enter on the keyboard
takes you to the next field.
I The fields of changed values and empty fields that
must contain a value are marked yellow .
If you want to revert to the original values of the
base range table, choose the Set to default
button. This discards all changes that you have
made so far.
6 Configuration
q You can also delete an existing range and add

new ranges.
o If you add a new range, it is added at the bottom of
the table.
o Delete range always deletes the last range in the
table.
13 Activate the table. (u 281)
Roche Diagnostics
14 Define new QC materials. (u 250)
15 Define new cross-check rules, if required. (u 277)
Making changes to range tables
r To make changes to range tables

3 Choose the Range table configuration button.
4 In the Range table configuration panel, choose a

parameter.
f In the detail panel, the range values are displayed.
5 Use the panel splitter to display the complete range.
7 Choose a value you want to change and enter the new

value. Do this for all items you want to change.
I The fields of changed values and empty fields that
must contain a value are marked yellow .
If you want to revert to the original values of the
base range table, choose the Set to default
button. This discards all changes that you have
made so far.
q You can also delete an existing range and add

new ranges.
o If you add a new range, it is added at the bottom of
the table.
o Delete range always deletes the last range in the
table.
6 Configuration

f In the Range table configuration main panel, the
parameter name is marked yellow to indicate that
a range has been changed.
Roche Diagnostics
Displaying RBC and WBC results on a semi-quantitative

level
RBC and WBC are evaluated on a quantitative level. If you
are used to reporting both tests on a semi-quantitative
level, you can achieve this by defining a new range table
and defining the ranges for RBC and WBC.
q Because the predefined range table does not

contain values for the RBC and WBC parameters, you first
need to create ranges for these.
r To display RBC and WBC results on a

semi-quantitative level
1 Define a new range table. (u 282)
2 Activate the new range table. (u 281)
3 Enable semi-quantitative values for RBC and WBC.

• Choose Administration > System settings
> Result presentation settings > Select
measurement units.
• Select the Enable semi-quantitative values for
RBC and WBC check box.
• Choose Save.
Limit configuration
Value ranges and limits are used to determine whether a
result is positive or negative and whether to trigger data
alarms and actions such performing additional tests.
Limits are used in several ways: In a straight limit, a result

6 Configuration
is either below or above the limit value and renders a

positive or negative result. In a range, two limit values are
defined, which can be interpreted in two ways: The result
is either within the range (negative) or outside the range
(positive); or the values within the range render a "soft"
positive result and values outside the range render a
positive and negative result.
The following illustrations show examples of how

different kinds of data alarm can be triggered.
Roche Diagnostics
1+ 2+ 3+ 4+ 5+
A Limit for abnormal data alarm
w Limit for abnormal data alarms
1+ 2+ 3+ 4+ 5+
A B
A Limit for trace data alarm B Limit for abnormal data alarm
w Limits for abnormal and trace data alarms
You can also define your own ranges by creating new

range tables.
u To define a new range table (282)
Limit values
Value Description
Trace value Value that defines when a sample
should have a follow-up test. It must be
≤ Abnormal value.
Abnormal value Values ≥ this value are outside the
normal or trace range. It must be ≥
Trace value.
y Limit values
r To define the limit values


6 Configuration
3 Choose the Limit configuration button.
4 In the main panel, choose a test and then choose the

Edit button in the detail panel.
5 Define the values as required (u 284), then choose

the Save button.
6 Define the values for the other tests in the same

manner.
Roche Diagnostics
Defining warning limits for supplies and solid waste
r To define the warning limits

4 Define the limits.
Microscopy related definitions

In this section
Image handling (286)
Particle configuration (287)
Defining particle subclasses (288)
Image handling
You can define whether automatic image evaluation is
used, whether reclassification is allowed, and whether to
work with particle subclasses.
You can also define how individual particle counts are

treated and how results are handled.
q For disabling automatic evaluation, you need the

6 Configuration
Supervisor user group.

Your Roche Service representative can additionally
enable the following functions:
Enable reclassification: Allow manual adjustment of
results.
Enable subclasses: Allow the definition of particle
subclasses and the manual assignment of particles to
such particle subclasses.
Roche Diagnostics
r To define image handling

> Measurement settings > u 701.
3 Select or clear the Enable automatic evaluation

check box.
I Clearing this check box stops the analyzer from
automatically examining images, no results would
be generated and you would have to examine all
images manually.
u Related topics
• Manually analyzing images (192)
• Particle configuration (287)
• Defining particle subclasses (288)
Particle configuration
You can define which particles are included in the result
calculation.
q You can include and exclude main classes of

particles, not individual subclasses.
You can only exclude particles that are not associated
with a result.
r To define which particles are taken

into account
> Measurement settings > u 701 > Particle
6 Configuration
configuration.
3 To include or exclude particles from result calculation,

select or clear the check boxes next to the particle
names.
Roche Diagnostics
Defining particle subclasses

You can define subclasses to any of the predefined main
classes.
If you want to examine and record a particle other than a

variant of a predefined main class particle, define a
subclass of the Others main class, for example
trichomonads, macrophages, or artifacts.
q Values associated with subclasses are not evaluated

automatically, they are based on manual reclassification.
q The use of subclasses has the following

consequences:
o With the generation of the first subclass of a main
class, a generic subclass with the name extension _X
is created. The counter for this subclass represents
the number of "normal" main class particles.
o The necessary conversion factors are applied during
result calculation to achieve result presentation that
corresponds to that of standard manual microscopy.
o Subclasses use the range table, limits, and cross-
check rule types of their main class. You can define
separate cross-check rules for a subclass.
q You can delete a subclass only if the following

preconditions are fulfilled: (You can add subclasses any
time.)
o There are no sample and QC results.
o There are no QC materials and cross-check rules
defined.
o There are no orders.
You need to delete these items before you can delete the
subclass.
6 Configuration
Roche Diagnostics
r To define a particle subclass

> Measurement settings > u701.
2
2 In the detail panel, choose Particle configuration.
I The currently defined main and subclasses are
displayed.
4
4 Select the main class for which you want to define a
subclass.
I The buttons for defining and deleting subclasses
are displayed.
5 Choose the Create subclass button.
6 In the callout, enter the name of the subclass.
6 Configuration
Roche Diagnostics
7
7 In the callout, choose the Save button.
I The new subclass is displayed.

f An additional generic subclass with the name
extension _X is created. The counter for this
subclass represents the number of "normal" main
class particles.
q The subclasses are available in the image gallery

and on the image detail screen.
Defining the QC environment
q If you define a new QC material using the RFID

reader and this QC material has more levels than the
currently defined maximum number, this maximum
number is automatically increased to the number of levels
of the new QC material.
r To define the number of QC levels

1 Choose Administration > System settings > QC
settings.
6 Configuration
3 Enter the number of levels you want to work with.

I You can work with up to five levels.
Roche Diagnostics
System configuration: Defining the operating environment 291
System configuration: Defining the

operating environment
In this section
Defining the operating environment (291)
Defining when notifications should be generated (297)
Defining the barcode check parameters (298)
Configuring the host connection (299)
Defining the look, content, and handling of reports (299)
Installing a new language (301)
Changing the user interface language (302)
Importing and exporting system settings (303)
components (304)
Defining the operating environment

In this section
About defining the operating environment (292)
About the Basic configuration 1 panel (293)
Performing basic configuration (296)
6 Configuration
Roche Diagnostics
292 System configuration: Defining the operating environment
About defining the operating environment

Choose Administration > System configuration to
access configuration items that define the operating
environment.
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6 Configuration
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w Navigation map for System configuration
Roche Diagnostics
About the Basic configuration 1 panel

This panel serves to define the following items:
• Name of the system
• User interface language
• The way passwords are generated and checked
• The volume of the alarm sounds and how often they
should be repeated
• Whether the virtual keyboard should be displayed on
screen
• Whether and if so after what period of inactivity on the
analyzer users should automatically be logged off
NOTICE
Basic configuration 1 items
Using both virtual and external keyboard
Using the virtual keyboard and the external keyboard at
the same time could lead to operating complications.
r Do not use both keyboards at the same time.
Item Description
System name Any alphanumeric characters. This is
displayed in the global information area.
Language de: German
selection(1) en: English
es: Spanish
fr: French
it: Italian
ko: Korean
pl: Polish
pt: Portuguese
ru: Russian
tr: Turkish
zh: Chinese
Only the installed languages are
available.
Password mode o Simple password mode: The
password is defined manually
during user definition. It cannot be
changed by the general user.
o Strong password mode: The
system generates a random
6 Configuration
password of 8 character length

during user definition, which has to
be changed at the first logon by the
user, and consequently every
60 days.
u To define a new user (266)
y Basic configuration 1 items
Roche Diagnostics
Item Description
Enable virtual Clear the check box if you want to use
keyboard the external keyboard instead of the
virtual keyboard.
Enable automatic If you select the check box also enter a
logoff time-out value between 1 and
1000 minutes.
(1) This list is not necessarily complete, further languages may become
available and different languages may be installed on your analyzer.
u Related topics
• Performing basic configuration (296)
About the Basic configuration 2 panel

This panel serves to define the following items:
• Whether screen sharing with remote access is
permitted
• Whether quantitative values should be reported on the
microscopy analyzer.
• The way lower measurement limit values are reported
• The geographic area where the system is installed
• Date and time settings
6 Configuration
Roche Diagnostics
Basic configuration 2 items

Item Description
Enable screen Allow screen sharing when remote
sharing service is active.
Enable You select this check box to display
quantitative particle concentration values. Clear the
values on u 701 check box if, e.g. for legal reasons, this
is not allowed.
Clearing this check box has the
following effects:
o The effects apply only to the
microscopy analyzer measurement
units Arbitrary and counts
(conventional) and Arbitrary and
counts (field of view).
o Results calculated with this setting
are preceded with a tilde "~" to
indicate that they were not actually
evaluated on a quantitative level.
o In the result list, the heading of the
Information columns have an
asterisk added, and a legend is
displayed informing the user that
the values in this column will not be
reported in the patient report. In the
customer file of the result export to
CSV format, the Information
columns are empty.
o If you send the results to a host
using a protocol version 8.0 or older,
the values are send but the
Information columns are empty.
o If you send the results to a host
using a protocol version 9.0 or more
recent, no values for the
Information columns are sent.
q Note that this setting does not

affect RBC and WBC results, these are
always quantitative and the
Information columns are always empty.
y Basic configuration 2 items 6 Configuration
Roche Diagnostics
Item Description
Lower This definition affects the quantitative
measurement parameters RBC and WBC only.
limit(1) International: Limit of Blank(2). Values
below the Limit of Blank are reported as
< LoB.
Regional settings Regional settings as supported by the
operating system.
Change date and Define system date and time.
time settings
q Note that the format in which date

and time are displayed is linked to the
Regional settings and cannot be
changed.

(1) The Limit of Blank, Limit of Detection and Limit of Quantitation are
determined in accordance with the CLSI (Clinical and Laboratory
Standards Institute) EP17-A2 requirements.
(2) The Limit of Blank is the 95th percentile value from n ≥ 60
measurements of analyte-free samples over several independent
series. The Limit of Blank corresponds to the concentration below
which analyte-free samples are found with a probability of 95%.
u Related topics
• Performing basic configuration (296)
Performing basic configuration
r To perform configuration
1 Choose Administration > System configuration

> Basic configuration 1 or Basic configuration 2.
3 Define the items as required.
q For more information, see:

6 Configuration
u About the Basic configuration 1 panel (293)

Roche Diagnostics
Defining when notifications should be generated

You can adjust some intervals to suite your local
laboratory requirements. They are divided into groups:
• Warnings before expiration
- Advanced expiry warnings for QC materials and
calibrations.
• Maintenance intervals
- Frequency for system initialization.
Periodic initialization is required to ensure the
proper functioning of the analyzer, for example for
the correct probe bend detection.
- Frequency for air purge.
Air purge is periodically performed to remove any
possible air bubbles in the tubing. Your Roche
Service representative can change this interval.
• Warnings before preventive maintenance
- Frequency for preventive maintenance.
During preventive maintenance, a number of items
are cleaned or replaced, for example the tubing
and filters are replaced.
This interval reflects the number of tests performed
and the time since the last maintenance. Your
Roche Service representative can reset the counter
for this interval.
r To adjust selected advance

notification times
> Warning intervals.
3 From the drop-down lists, choose the required time

indications.
6 Configuration
Roche Diagnostics
Defining the barcode check parameters

Enabling the checks increases the reliability of the
barcode readings.
! CAUTION
Incorrect results due to undetected reading errors
Barcode reading errors could potentially go undetected if
a checksum is not used, which could lead to sample
mismatch.
r Use only barcodes with checksum.
r Use only barcode labels of a good print quality.
Barcodes contain Enable checksum check? Transmit and show checksum characters?(1)
checksum characters?
Yes
The checksum character is transmitted to the host and also included
in the sample ID.
Yes Yes
No
The checksum character is not transmitted to the host and it is not
included in the sample ID.
No No(2) No
y Recommended barcode checksum configurations

(1) Definition made by Roche Service representative during installation of the analyzer
(2) Enabling checksum checking while using barcodes that do not contain checksum characters causes the analyzer to generate its own sample
IDs.
r To define the barcode checks that are

applied
> Barcode configuration.
3 Define whether the checksum should be checked.
4 Define whether the barcode length should be

6 Configuration
checked.
5 If you defined that the barcode length should be

checked, use the slider to define how many characters
long the checksum should be.
Roche Diagnostics
Configuring the host connection

The exact values depend on your IT infrastructure. Refer
to the relevant documentation of your IT components.
q Instrument priority when working with Sample

sequence number mode
Orders are always processed and results marked
according to the type of rack and the way it was loaded
on the analyzer, irrespective of the order type (e.g. STAT)
that might have been issued by the host.
Port settings
Port Description
c 6500 Host protocol versions 8 and older.
c 6500_09 Host protocol versions 9 or more recent.
This version is not backward compatible
with version 8 and older.
y Port settings
r To configure the host connection

> Host configuration.
3 Select or clear the check boxes and enter the

information in the fields as required.
I Port settings: Refer to the relevant documentation
for the host interface and drivers you are using.
q For more information on port settings, see the

following table:
u Port settings y (299)

6 Configuration
Defining the look, content, and handling of reports

Reports are usually used as handouts to physicians, either
as printed copies or as PDF files.
You can define default values for the content of the report
header, the printer, the analyzer whose results should be
reported, the file location and the type of reporting you
want to use.
Roche Diagnostics
Parameter Description
Report header The Report header definitions are used for patient
reports.
Title e.g. facility name.
Subtitle 1 e.g. laboratory name.
Subtitle 2 e.g. department name.
Printer settings Printer Printer that is connected to the analyzer or any defined
network printer.
Report creation The Report creation definitions are used as default
values in all reports. They can be changed during report
creation.
File path The paths the user can select when saving data to files or
creating a report. It must be a mapped network drive.
Axeda is intended for direct upload to Roche Service.
Output mode Print: Send the report to the printer.
PDF: Save the report as a PDF file.
Export only images: Each image is saved as a separate
file in the File path location.
Image output mode With labels: Include the particle labels in the exported
images.
Without labels: Do not include the particle labels in the
exported images.
Both: For each image two copies will be generated, one
without particle labels (in GIF format) and one with (in
PNG format).
Report condition Automatic: Generate a report for every result.
Data alarm: Generate a report for results with the data
alarms listed in Assigned data alarms. (To include a data
alarm in this list, choose the data alarm from the Available
data alarms drop-down list and then choose the Create
button. To remove the data alarms from the list, choose the
Clear button.)
Manual: Only generate a report when requested to do so.
Image copy The Image copy definitions are used as default values
when automatically sending a copy of the images to an
external storage device.
Image path The external storage device where images are
automatically stored.
Image condition No images: No images are automatically stored in the
Image path location.
All images: All images are automatically stored in the
Image path location.
Pathological images: Only pathological images (with
data alarm A) are automatically stored in the Image path
6 Configuration
location.
Image copy mode With labels: Include the particle labels in the exported
images.
Without labels: Do not include the particle labels in the
exported images.
Both: For each image two copies will be generated, one
without particle labels (in GIF format) and one with (in
PNG format).
y Report items
Roche Diagnostics
r To define how reports should look,

what they should contain and where
they should be printed or saved
> Report configuration.
3 Define the items as required.(u 299)
Installing a new language

You can update language files and add additional
languages. The language code in the file name defines
the language.(1)
Code Definition
de German
en English
es Spanish
fr French
it Italian
ko Korean
pl Polish
pt Portuguese
ru Russian
tr Turkish
zh Chinese
y Language codes
r To install a new language or update it

6 Configuration

> Installation > Install language.
2 Navigate to the folder where the language file is

stored and select the language file.
3 Choose the Install button.

I A callout is displayed when the installation is
complete.
4 Choose the OK button.

(1) This list is not necessarily complete, further languages may become
available and different languages may be installed on your analyzer.
Roche Diagnostics
Changing the user interface language

You can change the user interface language any time to
any language that is currently installed on the analyzer.
Code Definition
de German
en English
es Spanish
fr French
it Italian
pl Polish
pt Portuguese
ru Russian
tr Turkish
zh Chinese
y User interface languages
q This list is not necessarily complete, further

languages may become available and different languages
may be installed on your analyzer.
r To change the user interface

language
1 Ensure that the analyzer is not performing any test or
action.

> Basic configuration 1.
4 In the Language selection drop-down list, choose

the language you want to use. (u 302)
6 Configuration

6 On the callout, choose the Restart button.

f The system software will be restarted. Wait until
the Overview work area is displayed, it will be in
the new language.
Roche Diagnostics
Importing and exporting system settings

The system settings do not include data that relate to
users, patients, results, orders, and maintenance
counters.
q You need to delete all sample and QC results before

you can import system settings.
Importing system settings You can import system settings that were previously
exported, even if they were saved with a different
software version. In the latter case, you need to have
installed software version 2.1.1 or more recent.
• If the configuration file to be imported contains an
item that does not exist in the current setup it is
ignored and not imported.
• If a setting value does not exist in the configuration
file to be imported, but is defined in the current
software, the default value is set during next software
startup.
System settings report The system settings report provides the system settings in
an easily readable form.
All users can generate a report of the system settings.
r To import the system settings

> Import or export system settings > Import
system settings.
2 In the callout that is displayed, confirm the action.

• If there are results on the analyzer, choose the Yes
button to confirm their deletion and to continue
with the import.
• If there are no results on the analyzer, choose the
6 Configuration
Confirm button to continue.
3 Choose the device where the settings file is stored,

e.g. a USB storage device.
4 Choose the Open button.

f The analyzer software will shut down and restart
automatically.
f When the Overview tab is displayed again and the
analyzer status is Idle the import has been
successful.
Roche Diagnostics
r To export the system settings

> Import or export system settings > Export
system settings.
I All users can export the system settings.
2 In the callout, choose the device where the settings

file should be stored, e.g. the USB storage device, then
choose the Save button.
r To generate a report of the system

settings
> Import or export system settings > Report
system settings.
2 In the callout, choose the output mode.

• If you choose Export to PDF, also choose the
Select button to define the file path.
f If you choose Print, the report will be printed on
your default printer.

components
This information may be helpful for the Roche Service
representative during troubleshooting.
q All users can view the system information.

6 Configuration
r To display the versions of the

installed software components
> Versions.
f The information is displayed in the detail panel.
Roche Diagnostics
Managing racks 305
Managing racks
You can define STAT racks, QC racks, and wash racks,
which means that STAT testing, QC testing and the wash
action start automatically as soon as you place such a
rack on the input buffer. This is achieved by assigning
certain rack IDs to the STAT testing, QC testing and wash
actions.
u Rack IDs (87)
! WARNING
Sample mismatch due to inconsistent rack ID
definition
It may be possible that you have several racks with the
same rack ID. For a given analyzer, rack IDs must be
unique.
r Make sure that the rack IDs that you assign to STAT
racks are not used at the same time for routine racks
that might be processed on your analyzer.
r To define a STAT rack
1 Choose Monitoring > Manage racks.
3 Note the human readable rack ID of the rack you want

to use as the STAT rack and enter it without any
spaces or special characters in the Rack ID field.
4 From the Assignment drop-down list, choose STAT.
r To define a wash rack

6 Configuration

to use as the wash rack and enter it without any
spaces or special characters in the Rack ID field.
4 From the Assignment drop-down list, choose Wash.
Roche Diagnostics
306 Managing racks
r To define a QC rack

to use as a QC rack and enter it without any spaces or
special characters in the Rack ID field.
4 From the Assignment drop-down list, choose QC.
5 Define at least one rack position for each QC level you

are using by choosing a QC level from the drop-down
list. You can assign the same level to several positions.
q The positions do not have to be adjacent, but

Roche recommends to choose positions that are easily
remembered.

6 Configuration
Roche Diagnostics
Adjusting the probe action 307
Adjusting the probe action

If you decide to use a different type of tube or rack on the
cobas u 701 microscopy analyzer, a teaching procedure
for the probe must be performed.
This ensures that the probe does not touch the tube
bottom and that it is properly immersed in liquid when
aspiring.
You perform this task with the help of the Adjust rack
and tube wizard.
Urine Monovettes For Urine Monovettes, performing the standard teaching

procedure is not sufficient to guarantee trouble-free
operation. In this case, your Roche Service representative
must perform the rack and tube teaching.
Materials required m 5 mL pipette with selection of variable volumes

m 1 sample rack with a tube containing 1.8 mL tap water
on rack position 1
m 1 wash rack with a tube containing 3.8 mL tap water
on rack position 1
The values for the sample rack are automatically valid for
the QC rack as well, therefore, no QC rack needs to be
prepared.
r To adjust the probe action
1 Choose the Assistance tab.
2 Choose Wizards on u 701 task button.
3 To start the wizard, choose the Adjust rack and tube

task button.

6 Configuration
Roche Diagnostics
308
6 Configuration Adjusting the probe action
Roche Diagnostics
Maintenance
7 Maintenance ..........................................................................................................311
Roche Diagnostics
311
Table of contents
Maintenance 7
In this chapter, you find instructions on how to perform

maintenance actions that are not part of the daily routine
operation.
In this chapter 7
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313
Routine maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 314
Miscellaneous maintenance actions . . . . . . . . . . . . . . 317
Cleaning the water container . . . . . . . . . . . . . . . . . 317
Managing the result storage capacity . . . . . . . . . . 318
Keeping your data safe . . . . . . . . . . . . . . . . . . . . . . 320
About exporting and importing the setup
data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320
Backing up the database. . . . . . . . . . . . . . . . . . 321
Issues with the probe. . . . . . . . . . . . . . . . . . . . . . . . 322
If you are not going to use the analyzer for some
time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324
7 Maintenance
Roche Diagnostics
312
Table of contents
7 Maintenance
Roche Diagnostics
Safety 313
Safety
Safety chapter
Warning messages:
u Biohazardous materials (31)
u Waste (31)
Caution messages:
u Mechanical safety (36)
u Working solutions (36)
u Influence of vibrations (37)
Notice messages:
u Spillage (38)
u Excessive ambient humidity (39)
NOTICE
cleaning solution
parts you cleaned.
analyzer.
7 Maintenance
Roche Diagnostics
314 Routine maintenance
Routine maintenance
All routine maintenance actions can be performed using
wizards. They are grouped into actions relating to
consumables (supplies) and actions related to keeping
the analyzer working (maintenance).
When a maintenance action is due you are informed by a

message in the task list. Choosing such a message
displays detailed information including a description,
possible causes and recommended remedies. If a wizard
is available, its button is available in the detail panel.
The following table provides an overview of when a

routine maintenance action is due.
Interval Routine maintenance action

Daily u Washing the fluid system (224)
End of shift u Cleaning the input and output buffers (236)
u Cleaning the analyzer housing (237)
u Cleaning the rack conveyors (237)
u Cleaning the rack trays (238)
u Cleaning the microscope stage area (245)
Every 4 weeks u Checking the microscope focusing mechanism (246)
u Cleaning the water container (317)
y Intervals of routine maintenance actions
You can always start consumables related wizards by

choosing Assistance > Wizards or Monitoring
> Manage supplies.
Wizard name When to be performed Purpose

Fill water container At the beginning of a shift or when The fill level is monitored and a message is
prompted to do so generated when the level gets low. When the
container is empty processing stops. Use type
II/IF water.
7 Maintenance
u Filling the water container (226)

Exchange cuvette cassette When prompted to do so The fill level is monitored and a message is
generated when the level gets low. When the
cassette is empty processing stops.
u Replacing the cuvette cassette (229)
Empty the solid waste container When loading a new cuvette cassette or The fill level is monitored and a message is
when prompted to do so generated when the level gets high. When the
container is full processing stops. Dispose of
the waste according to the relevant local
regulations.
y Wizards on the cobas u 701 microscopy analyzer
Roche Diagnostics
Routine maintenance 315
Wizard name When to be performed Purpose

Empty the liquid waste container When filling the water container or when The fill level is monitored and a message is
prompted to do so generated when the level gets high. When the
container is full processing stops. Dispose of
the waste according to the relevant local
regulations.
Check microscope When prompted to do so In order to ensure proper functioning of the
focusing mechanism of the microscope, a
microscope check needs to be performed
every 4 weeks. This is done by performing a
predefined sequence of photographic
measurements of a reference cuvette.
u Checking the microscope focusing
mechanism (246)
Exchange probe When prompted to do so If the automatic probe positioning calibration
To avoid processing delays, Roche test fails or the probe is visibly damaged, e.g.
recommends to keep a replacement bent, the probe needs to be replaced.
probe on site. u To replace the probe (323)
Adjust rack and tube When a different tube type is going to be To avoid probe crashing and to ensure correct
used. and accurate pipetting, the pipetting
mechanism must be adjusted to the new tube
dimensions.
u Adjusting the probe action (307)
y Wizards on the cobas u 701 microscopy analyzer
You can always start following wizards by choosing

Monitoring > Perform maintenance.
Task name When to be performed Purpose

Create problem report As part of troubleshooting The problem report contains the most
recent 1000 messages and the most recent
10 000 entries in the audit trail, as well as
information on the installed software
versions, languages, online help, and the
current counter values.
u To create a problem report (335)
Export screenshots As part of troubleshooting Export all screenshots that were created
using the screenshot button, so they
can be viewed by the user. When you
create a screenshot, it is stored internally.
Up to 100 screenshots can be stored
internally.
u Screenshots (333)
7 Maintenance
Initialize system As part of troubleshooting or when System initialization resets the hardware
prompted to do so elements to their default positions and so
establishes a clean state from where to
proceed.
y Further guided maintenance actions
Roche Diagnostics
316 Routine maintenance

Backup database For data security, as part of troubleshooting The database backup includes all database
content, including order and result data,
user and encrypted patient demographics,
as well as all setup, definition and logging
data.
If the database backup is generated for
troubleshooting purposes, exclude the
patient demographics by selecting the
Create anonymized database backup
check box in the callout.
u To back up the database (321)
Restore database As part of troubleshooting Import a database that was generated
using the Backup database function.
Export data in CSV format As part of troubleshooting or when Export of result data.
prompted to do so u To export all results (319)
Perform wash As part of shutting down the system To remove soiling and prevent
proteinization and buildup of other
pollutants in the probe and the fluid system,
in particular the rinse station, the fluid
system needs to be washed daily.
u Washing the fluid system (224)
Unload rack In emergency situations Move the rack that is on the conveyor to
the output buffer.
y Further guided maintenance actions
The following maintenance action is started by choosing

Monitoring > Analyzer > u 701 > Perform air purge.

Perform air purge Air purge is automatically performed and To remove any possible air pockets in the
does not normally require user intervention. tubing. This is achieved by pumping system
You may also need to perform this action as water through the whole fluid system.
a result of a message in the message list or u Air purge (225)
as part of troubleshooting.
y Further maintenance actions
7 Maintenance
Roche Diagnostics
Miscellaneous maintenance actions

Some maintenance actions need to be performed
periodically, while others are performed as needed.
In this section
Cleaning the water container (317)
Managing the result storage capacity (318)
Keeping your data safe (320)
Issues with the probe (322)
If you are not going to use the analyzer for some
time (324)
Cleaning the water container

To prevent deposits inside the water container, you can
clean it with 1% NaOCl solution.
q Clean the standard water container if the analyzer

has not been used for some time.
q Clean the water container for external water supply

once a month.
Materials required • 1% NaOCl (You can use commercially available

5% NaOCl solution and dilute it 5 times with distilled
water.)
• Purified water
r To clean the water container

7 Maintenance

I Check whether there are deposits on the inside of
the water container.
2 Before you fill the container with water, rinse the

container with warm tap water several times.
I If the water container is visibly soiled, rinse it with
1% NaOCl solution.
3 Rinse the water container with purified water.
4 Fill the container with water and continue as

described in the wizard.
Roche Diagnostics
318 Miscellaneous maintenance actions
5 If the problem persists, contact your Roche Service

representative.
r To clean the water container for

external water supply
1 Turn off the external water supply.
2 Remove the water tubing adapter from the water

container.
I Keep the bottom of the tubing in the water
container until water stops running.
3 Empty the water container.
4 Rinse the water container with 1% NaOCl solution.
5 To remove any NaOCl residues, rinse the water

container with purified water.
6 Wipe the liquid level detection sensors and the float

valve with a cloth damped with 1% NaOCl solution.
7 To remove any NaOCl residues, wipe the level

detection sensors and the float valve with a cloth
damped with purified water.
8 Insert the water tubing adapter in the water container

and screw it on.
9 Turn on the external water supply.
Managing the result storage capacity

Your analyzer can be set up to automatically overwrite the
oldest data entry when the database is full or to stop
processing when the database is full.
u Managing the result storage capacity (279)
7 Maintenance
A message in the message list will inform you when the

database is getting full.
Roche Diagnostics
There are two ways of exporting results:

• You can export selected or all results contained in the
result list in PDF format to an external storage device,
and you can also export the related sediment images
in a graphics file format.
u To save results to files (result report) (182)
• You can export all results on the analyzer, including
QC and calibration results, to a file in CSV format and
then process them in a spreadsheet program.
To keep the result list manageable and to free space you

should periodically delete results.
r To export all results
1 Choose Monitoring > Perform maintenance

> Export data in CSV format.
2 If instructed to do so by your Roche Service

representative, select the Include extended data
check box to include all raw data and compress the
data in a ZIP file.
f The resulting file is password protected.
3 Choose the Yes button to export all results that are

currently stored on the analyzer.
f A callout is displayed for defining where the files
should be saved.
4 Choose a destination.

f A progress indication callout is displayed. This
action may take some time.
f A CSV file and, if you include the raw data, a ZIP
file are generated, their file names start with
RawData_.
7 Maintenance
Roche Diagnostics
r To delete results
1 CAUTION! Loss of result data due to erroneous

deletion
Choosing Delete while deletion is already in progress
may cause a further result to be deleted.
Do not choose Delete while deletion is in progress.
Always double-check your result selections before
choosing Delete.
1 Display the result list:
• Choose Routine > Manage test results.
• Choose Routine > Manage QC > Review QC
results.
2 Use the View and Search functions to display the

results you want to delete.
3 Select the results you want to delete.

I Select individual check boxes at the beginning of
the result entries or select the check box in the
table header to select all results in the list.

I Deleting results from the result list also removes
them from the database.
Keeping your data safe

You can export your setup data and the complete
database to an external device and import these data
again as required.
In this section
About exporting and importing the setup data (320)
Backing up the database (321)
7 Maintenance
About exporting and importing the setup data

The setup data include all definitions made in System
settings and System configuration. They do not
include any order, result, user, or patient related data.
You can backup your setup data by exporting and

importing the system settings.
u Importing and exporting system settings (303)
Roche Diagnostics
Backing up the database

You can back up the database to an external device.
The backup includes all database content, including

order and result data, user and encrypted patient
demographics, as well as all setup, definition and logging
data.
You can create a backup where the patient

demographics are not included. In this case,
demographic data cannot be recovered using Database
restore. Patient demographics that are on the instrument
are deleted during the restore process.
r To back up the database
1 If you want to perform a standard database backup,

choose Monitoring > Perform maintenance
> Backup database.
2 If the database backup is generated for

troubleshooting purposes, exclude the patient
demographics by selecting the Create anonymized
database backup check box in the callout.
3 In the callout, confirm the action.
4 In the next callout, choose the destination.

I This action may take some time.
7 Maintenance
Roche Diagnostics
Issues with the probe

During initialization of the analyzer the probe positioning
is automatically calibrated and its position adjusted. The
probe needs to be replaced if during initialization the
required corrections are consistently outside the allowed
ranges. A message in the message list would alert you to
this fact.
! WARNING
Incorrect results due to touching the probe
the results.
r Do not touch the probe except for maintenance as
described in this documentation.
! CAUTION
Skin inflammation or injury caused by working
solutions
Direct contact with cleaning solutions or other working
solutions may cause skin irritation, inflammation, or
burns.
! CAUTION
Personal injury due to contact with sharp objects
r Avoid contact with the probe tip.
q To avoid processing delays, Roche recommends to

keep a replacement probe on site.
7 Maintenance
If initialization is not successful proceed as follows:
1 Repeat the initialization.

Choose Monitoring > Perform maintenance
> Initialize system.
2 If the problem persists, clean the probe bend detector.
3 If the problem persists, clean the probe.
u To clean the probe (323)
y Required tasks
Roche Diagnostics
4 If the problem persists, replace the probe.

u To replace the probe (323)
y Required tasks
r To clean the probe
1 Start the Exchange probe wizard.

indicates that the probe needs replacing, then
choose the Exchange probe button in the detail
panel.
• Choose Assistance > Wizards > Exchange
probe on u 701.
2 Follow the on-screen instructions. But instead of

removing and replacing the probe just wipe it with a
lint-free cloth.
I Carefully move the cloth from top to bottom, do not
use up and down movements.
r To replace the probe
1 Start the Exchange probe wizard.

indicates that the probe needs replacing, then
choose the Exchange probe button in the detail
panel.
• Choose Assistance > Wizards > Exchange
probe on u 701.
7 Maintenance
Roche Diagnostics
If you are not going to use the analyzer for some time
Supplies that remain on the analyzer for a long time may
deteriorate. Therefore, if you intend not to use the
analyzer for some time, Roche recommend removing
them from the analyzer.
1 Empty the solid waste.

2 Empty the water container.
u To empty the water container (324)
3 Drain all water from the fluid system.
u To drain the system water (324)
4 Empty the liquid waste.
5 Shut down the system and switch off the power.
u To shut down the analyzer (325)
y Required tasks
Location of status indicator in the global

information area
r To empty the water container
1 Choose Assistance > Wizards > Fill water

container on u 701.
2 Remove the water container and empty the system

water.
3 Install the empty water container.
4 Finish the wizard.

7 Maintenance
r To drain the system water
1 Choose Overview > analyzer illustration of the

microscopy analyzer > Perform air purge.
2 Perform the previous step several times until you

cannot see any water in the tubing.
Roche Diagnostics
r To shut down the analyzer
1 Ensure that the analyzer status in the global

information area is Idle.
2 Choose Overview > Shut down.

f A callout is displayed, asking you whether you
want to perform the daily wash maintenance
action.
3 Choose the No button.

f The software is shut down and the analyzer is
switched off.
4 Put the power switch at the rear of the analyzers in the

off position .
7 Maintenance
Roche Diagnostics
326
7 Maintenance Miscellaneous maintenance actions
Roche Diagnostics
Troubleshooting
8 Troubleshooting ....................................................................................................329
Roche Diagnostics
329
Table of contents
Troubleshooting 8
In this chapter, you find information on how to recover

from unusual situations.
In this chapter 8
Exceptional situations . . . . . . . . . . . . . . . . . . . . . . . . . . 331
Screenshots. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
Log files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334
No microscope check results can be generated . . . . 336
Detached barcode labels. . . . . . . . . . . . . . . . . . . . . . . . 337
Recovering from an irregular stop . . . . . . . . . . . . . . . . 338
Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 339
When you have accidentally pulled the waste
drawer during operation . . . . . . . . . . . . . . . . . . . . . . . . 341
Recovering from a power outage . . . . . . . . . . . . . . . . . 342
Safety interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343
Clogged inlet water filter . . . . . . . . . . . . . . . . . . . . . . . . 343
8 Troubleshooting
Blocked floats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346
Roche Diagnostics
330
Table of contents
8 Troubleshooting
Roche Diagnostics
Exceptional situations 331
Exceptional situations
The following table lists, in alphabetical order, exceptional
situations that may occur and points to ways of how to
handle them.
Keyword Situation How to handle the situation

Barcodes Barcode cannot be read. Barcode labels u Detached barcode labels (337)
may become detached and stick to parts of
the rack transport unit or become wedged
between the rack or sample tube and the
analyzer parts.
Calibration Microscope check does not result in valid u No microscope check results can be
results. Invalid results are produced generated (336)
repeatedly.
Cover You have accidentally opened the main u To recover after accidentally opening
cover. the main cover (338)
Emergency stop All mechanical movement must be stopped u To perform an emergency stop (340)
immediately.
The analyzer is stuck in Processing or Init
status.
Filter Processing stopped due to a clogged inlet u Clogged inlet water filter (343)
water filter.
Floats A float in the water or liquid waste u Blocked floats (346)
container does not move freely or it is
blocked.
The level indications as indicated by
messages might not agree with the actual
levels.
Labels Barcode cannot be read. Barcode labels u Detached barcode labels (337)
may become detached and stick to parts of
the rack transport unit or become wedged
between the rack or sample tube and the
analyzer parts.
You may be using a type of rack that is not
recommend by Roche
Log files All activities on the analyzer are recorded in u Log files (334)
log files. You can export these files for
u To create a problem report (335)
troubleshooting purposes
Microscope check Microscope check does not result in valid u No microscope check results can be
results. Invalid results are produced generated (336)
8 Troubleshooting
repeatedly.
Power outage After power is cut, you must follow a u To recover from a power outage (342)
prescribed procedure to avoid data loss.
Problem report All activities on the analyzer are recorded in u To create a problem report (335)
log files. You can export these files for
troubleshooting purposes.
Safety interlock A message is displayed informing you that u Safety interlock (343)
safety interlock in not on.
Shut-down The screen froze completely and you had to u To recover from a forced
shut down using the On/Off switch. shutdown (339)
Screen The screen froze completely and you had to u To recover from a forced
y Exceptional situations and how to deal with them
Roche Diagnostics
332 Exceptional situations
Keyword Situation How to handle the situation

Screenshots You want to document a particular u To generate a screenshot (333)
situation for troubleshooting reasons.
Sensor (floats) A float in the water or liquid waste u Blocked floats (346)
container do not move freely any more or
that they are blocked. The level indications
as indicated by messages might not agree
with the actual levels.
Stop Processing stopped because you have u To recover after accidentally opening
accidentally opened the main cover. the main cover (338)
Processing stopped because you have u To recover after pulling the waste
accidentally pulled out the waste drawer. drawer (341)
Processing stopped due to a clogged inlet u Clogged inlet water filter (343)
water filter.
The analyzer is stuck in Processing or Init u To perform an emergency stop (340)
status.
All mechanical movement must be stopped u To perform an emergency stop (340)
immediately.
The screen froze completely and you had to u To recover from a forced
Stuck The analyzer is stuck in Processing or Init u To perform an emergency stop (340)
status.
Waste container A float in the water or liquid waste u Blocked floats (346)
container does not move freely any more or
it is blocked. The level indications as
indicated by messages might not agree
Water container A float in the water or liquid waste u Blocked floats (346)
container does not move freely any more it
is blocked. The level indications as
indicated by messages might not agree
Water filter Processing stopped due to a clogged inlet u To clean the inlet water filter (344)
water filter. To clean the inlet water filter (external
water supply) (345)
y Exceptional situations and how to deal with them
8 Troubleshooting
Roche Diagnostics
Screenshots 333
Screenshots
As part of troubleshooting, in particular if you need to
contact a Roche Service representative, it is useful to
generate screenshots to capture the exact situation at the
time of a problem occurring.
r To generate a screenshot
1 In the global information area, choose the button.

f An image of the current screen is saved in a file.
2 If you want to examine the screenshot yourself,

choose Monitoring > Perform maintenance
> Export screen shots.
I This function saves the last 100 screenshots that
were generated using the print screen function
to a location that is accessible by the user.
8 Troubleshooting
Roche Diagnostics
334 Log files
Log files
All activities on the analyzer are recorded in log files.
Message log All users can view the message log, which contains a
chronological log of all messages that were generated by
the analyzer, including the task messages.
Audit trail Users with Supervisor user rights can also view the audit
trail, which contains a chronological log of all activities
and events such as logon, logoff, order handling, sample
processing, result validation, QC, calibration,
maintenance, software updates, and remote access, as
well as those concerning configuration.
Problem report The problem report is a collection of various logs and

comprises the last 1000 messages of the message log, the
last 10 000 entries of the audit trail, counter values, and
information about the installed versions of the software
and online help.
q Problem reports do not contain PDF versions of data,

they are meant for troubleshooting purposes.
You can export the problem report to an external device,

from where it can be sent to experts for analysis.
r To view the message log
1 Choose Administration > Message log.

f The messages are displayed in chronological
order.
r To view the audit trail

8 Troubleshooting
1 Choose Administration > Audit trail.

I You need Supervisor user rights to view the audit
trail.
f The messages are displayed in chronological
order.
Roche Diagnostics
Log files 335
r To create a problem report

> Create problem report.
2 In the callout, define the target location for the report.
q Axeda is intended for direct upload to Roche

Service. Do not use this destination unless instructed
to do so by your Roche Service representative.
q For details on defining the default file locations,

see:
u Defining the look, content, and handling of reports (299).
8 Troubleshooting
Roche Diagnostics
336 No microscope check results can be generated
No microscope check results can be

generated
If no microscope check results can be generated,
proceed as follows:
m Repeat the microscope check.
m If the problem persists, check the reference cuvette
for soiling and scratches.
- If the reference cuvette is soiled, clean it using a
cotton bud moistened with isopropyl alcohol or
ethanol. Dry it with a lint-free soft cloth.
- Repeat the microscope check.
- If the reference cuvette is scratched, perform the
microscope check with a new reference cuvette.
m If the problem still persists, initialize the analyzer
(Monitoring > Perform maintenance > Initialize
system).
- Repeat the microscope check.
m If the problem still persists, wipe the underside of the

microscope lamp objective (A) using a cotton swab
moistened with isopropyl alcohol or ethanol.
Only use isopropyl alcohol or ethanol for cleaning the
microscope lamp objective, do not use any other
cleaning solution for the microscope lamp objective.
Do not touch the underside of the objective with your
fingers.
m If the problem still persists, contact your Roche
8 Troubleshooting
Roche Diagnostics
Detached barcode labels 337
Detached barcode labels

Barcode labels may become detached and stick to parts
of the rack transport unit or become wedged between the
rack or sample tube and the analyzer parts. If this
happens between the rack entry position and the barcode
reader, a message is added to the message list.
Processing stops.
r To recover from processing stop due

to detached barcode labels
1 Display the message details and consult the possible
causes.
2 Open the main cover.
3 Ensure that the affected label does not interfere with

the rack movement. If necessary remove it.
4 Close the main cover.

> Unload racks.
6 Remove the rack from the output buffer.
7 Replace the barcode.

• If the problem concerns a rack barcode label,
transfer the tubes to a new rack.
• If the problem concerns a sample tube barcode
label, replace the label. You can also just remove
the label and place the tube on its original position.
In this case the analyzer automatically defines a
sample ID and an order using the default test
profile.
8 Troubleshooting
8 Place the rack in the priority rack slot.
Roche Diagnostics
338 Recovering from an irregular stop
Recovering from an irregular stop

! CAUTION
Loss of data and sample due to opening the main
cover
Opening the main cover during operation interrupts the
power supply to all units, processing stops immediately
and no status information can be stored. Incomplete tests
and other activities will have to be redone.
r Do not open the main cover while the analyzer is
performing some activity. Only do so in an emergency.
! CAUTION
Loss of data and sample due to turning off the
analyzer using the on/off switch
Pressing the on/off switch for several seconds stops all
r Do not use the on/off switch to turn off the analyzer
except in an emergency, e.g. when the screen is
“frozen” and analyzer does not react to any user
action, on-screen or otherwise.
q If during operation you open the main cover, either

by accident or deliberately, all processing activities stop
immediately (power to all units is cut) and all incomplete
tests and other activities will have to be redone.
q If for example the screen is “frozen” and the analyzer

does not react to any user action on-screen or otherwise,
you may be forced to press the on/off switch for several
8 Troubleshooting
seconds to shut down the analyzer. This stops all

r To recover after accidentally opening

the main cover
1 Close all covers.
f Power is restored to the units.
Roche Diagnostics
Emergency stop 339
2 If there is a rack on the conveyor choose Monitoring

> Perform maintenance > Unload racks.

> Initialize system.
f Wait until the Overview work area is displayed
again.
5 Check the task list and deal with all red and orange
items.
6 Replenish the samples, if required.
r To recover from a forced shutdown
1 Press the on/off switch.

f The analyzer software will start automatically.
2 Wait until the Overview work area is displayed.

items.
6 Check the samples for which there are no results.

f Ensure that there is sufficient sample.
7 Place the samples in exactly the same position on the

rack where they were removed from.
8 If you work without sample barcodes, redefine the

8 Troubleshooting
orders. (u 188)
Emergency stop
Use this function if, for some reason, all activities on the
analyzer must be stopped immediately or if the analyzer is
stuck in either the Operating or Init status.
Roche Diagnostics
340 Emergency stop
r To perform an emergency stop
1 On the Overview work area, choose the E. Stop

button.
f All mechanical movement on the analyzer stops.
2 If the analyzer has gone into Standby status, do one

of the following:
• Initialize the analyzer by choosing Monitoring
> Perform maintenance > Initialize system.
• Shut down the analyzer by using the Shut down
button.
3 If the analyzer did not go into Standby status, turn off

the analyzer by using the On/Off switch.
4 If you shut down or switched off the analyzer, sort out

any hardware problems and restart the analyzer.
(u 338)

representative.
8 Troubleshooting
Roche Diagnostics
When you have accidentally pulled the waste drawer during operation 341
When you have accidentally pulled the

waste drawer during operation
! CAUTION
Loss of data and sample due to opening the waste
drawer
When you pull the waste drawer while the analyzer is
processing tests, all operation stops immediately, the
analyzer displays the Idle status.
All pipetted cuvettes are discarded and all incomplete
tests need to be performed again.
r Do not open the waste drawer while test processing is
going on.
r To recover after pulling the waste

drawer
1 Close the waste drawer.
2 Choose the Overview work area.
3 Choose the hardware graphic.
4 Choose the Initialize system button.

f This may take a while. Wait until the analyzer is in
Idle status.


8 Troubleshooting

orders. (u 188)

f New orders are generated and the test are
processed.
Roche Diagnostics
342 Recovering from a power outage
Recovering from a power outage

! CAUTION
Loss of data and sample due to power outage
Accidentally unplugging the power supply or a power
outage stops all processing and no status information can
be stored. Incomplete tests and other activities will have
to be redone.
r Ensure that the mains cables are placed safely away
from areas where personnel might pass through.
r Roche recommends using an uninterruptible power
supply.
u Uninterruptible power supply (UPS) (113)
r To recover from a power outage
1 Restore power to the analyzer.
2 Press the on/off switch.

f The analyzer software will start automatically.
3 Wait until the Overview work area is displayed.

items.


8 Troubleshooting

orders. (u 188)
Roche Diagnostics
Safety interlock 343
Safety interlock
! WARNING
Immediate processing stop due to opening the main
cover
Opening the main cover results in immediate power
interruption to all units and processing stop.
r Do not open the main cover during routine operation.
This feature can be bypassed by the Roche Service

representative for testing and troubleshooting purposes.
When this bypass is on, a message is added to the
message list.
q If a Roche Service representative did not cancel this

bypass, contact your Roche Service representative
immediately.
Clogged inlet water filter

Impurities in the water may cause clogging of the inlet
water filter in the water container. If this is the case, the
situation may occur that the analyzer does not receive
sufficient water and processing may stop.
If such a situation occurs, proceed as follows:

m Check that the water quality is of the required
standard.
m Check whether the inlet water filter is soiled or
8 Troubleshooting
clogged.
u To clean the inlet water filter (344)
supply) (345)
m Check whether the inside of the water container is
soiled or shows deposits.
u To clean the water container (317)
u To clean the water container for external water
supply (318)
Roche Diagnostics
344 Clogged inlet water filter
Water container Water container with external water supply
A
A
B B
C C
A Water tubing adapter B Water tubing

C Inlet water filter
y Water container and Water container with external water supply
r To clean the inlet water filter

I Check for discoloring and soiling of the inlet water
filter.
2 Before you fill the container with water, rinse the inlet
water filter with 1% NaOCl.
3 CAUTION! Incorrect results due to water

contamination
System water that is contaminated with cleaning
solution may lead to incorrect results.
Rinse the filter and the other tubing adapter
components thoroughly with purified water before
8 Troubleshooting
filling the container with system water.

3 Rinse the inlet water filter and the other tubing
adapter components thoroughly with purified water.
4 Fill the container with water and continue as

described in the wizard.

representative.
Roche Diagnostics
Clogged inlet water filter 345
r To clean the inlet water filter

(external water supply)
1 To clean the inlet water filter if an external water
supply is attached, perform the following steps:
q This procedure is not software supported, and it

may interfere with analyzer activities if the analyzer is
running.
2 Shut down the analyzer. (u 232)
3 Turn off the external water supply.
4 Remove the water tubing adapter from the water

container.
I Keep the bottom of the water tubing in the water
container until water stops running.
5 Rinse the inlet water filter with 1% NaOCl.
6 CAUTION! Incorrect results due to water

contamination
System water that is contaminated with cleaning
solution may lead to incorrect results.
Rinse the filter and the other adapter components
thoroughly with purified water before reinserting the
water tubing adapter.
6 Rinse the inlet water filter and the other tubing
adapter components with purified water.
7 Insert the water tubing adapter in the water container

and screw it on.
8 Turn on the external water supply.
8 Troubleshooting
Roche Diagnostics
346 Blocked floats
Blocked floats
It may happen that the floats in the water and liquid
waste containers do not move freely any more or that they
might be blocked. In such situations, the level indications
as indicated by messages might not agree with the actual
levels.
If such a situation occurs, loosen the floats manually.
! CAUTION
Contamination of the environment by liquid and
solid waste
The waste of the analyzer is potentially biohazardous and
must be treated in accordance with the relevant laws and
regulations.
r When disposing of any waste, do so in accordance
r Any substances contained in QC materials and other
working materials, which are legally regulated for
environmental protection, must be disposed of in
accordance with the relevant water discharge facility
regulations. For the legal regulations on water
discharge, please contact the suppliers of the
materials.
! CAUTION
Infection by liquid waste
Contact with liquid waste may result in infection. All
8 Troubleshooting

Roche Diagnostics
Blocked floats 347
r To loosen the floats in the water

container
1 Choose a message that concerns the fill level of water.
2
2 Remove the water tubing adapter (A) from the water
container and place it on a clean surface.
A
3 Hold one of the floats (B) with two fingers and gently
move it back and forth along the float assembly rod.
They should move freely.
I Observe the status of the message on screen,
depending on the position of the float it should
change its color.
Do the same with the other float.
B 4 If a float does not move freely after you have moved it

back and forth or if the massage status does not
change, contact your Roche Service representative.
B 5 Reinsert the water tubing adapter in the water

container.
6 If the problem recurs, contact your Roche Service

representative.
r To loosen the floats in the water

container for external water supply
1 Choose a message that concerns the fill level of water.
2
2 Remove the water tubing adapter (A) from the water
container and place it on a clean surface.
A
8 Troubleshooting
Roche Diagnostics
348 Blocked floats
3
move it back and forth along the float assembly rod.
B change its color.
Do the same with the other float.
4 If a float does not move freely after you have moved it

5 Install the water tubing adapter on the water

container.

B representative.
r To loosen the floats in the liquid

waste container
1 Choose a message that concerns the fill level of liquid
waste.
2 Start the Empty liquid waste container wizard and

follow its instructions.
3
3 Remove the waste tubing adapter (A) from the liquid
waste container and place it on a clean surface.
A
4 Empty the liquid waste. Dispose of it in accordance
B
B move it back and forth along the float assembly rod.
8 Troubleshooting
change its color.Do the same with the other float.
6 If a float does not move freely after you have moved it

7 Reinsert the waste tubing adapter in the liquid waste

container.

representative.
Roche Diagnostics
Glossary
9 Glossary ...................................................................................................................351
Roche Diagnostics
Glossary 351
Analyte - Work area
Glossary 9
The glossary lists terms that are used in the user Work area Part of the screen, usually a tab, that
documentation that may not be familiar to the reader groups related information and tasks for the
or that carry meaning that is specific to this analyzer convenience of the user, for example tasks relating to
environment. performing tests or to setting up the analyzer.
Analyte See Urine analyte.

Arbitrary units Result classification using 1+, 2+, 3+
classes instead of numerical concentration results.
Callout Popup window that is displayed on screen to
show information or to accept user input as part of
performing a certain task.
Cleaning solution Liquid used for cleaning and
decontamination of surfaces and parts of a system.
Priority rack Any rack that is placed on the priority
rack slot for immediate processing.
Qualitative determination The measurement of
analytes or features with descriptive (qualitative) result
classification such as negative/positive.
Quantitative determination The measurement of
analytes or features in urine yielding numeric results
such as a concentration.
In quantitative analysis, the recognized particles of all

images are counted and added up.
Radio frequency identification (RFID) tag
Electronic tag attached to Roche supplies that

contains critical information such as product ID, lot
number, production date, and a parameter file.
Roche 5-position rack Standard rack that offers
space for five tubes.
Semi-quantitative determination The
measurement of analytes or features in urine yielding
an approximation of the quantity or amount of a
substance such as negative/slightly positive/moderate
positive/strongly positive.
In semi-quantitative analysis the recognized particles

of a certain number of images are counted and the
Glossary
result is then extrapolated for the whole sample area.

Urine analyte Constituent in urine whose
concentration is to be determined.
Wash solution Liquid used for internal washing the
fluid system.
Roche Diagnostics
352
9 Glossary
Roche Diagnostics
Index
Index..........................................................................................................................355
Roche Diagnostics
Index 355
Index
A C
Abbreviations, 13 Calibrating
Accuracy, 27 – probe, 99
Activating users, 268 Callouts, 126
Adding particles, 195 Cassettes
Addresses, 5 – cuvettes, 103
Adjusting Centrifuge chamber, cleaning, 242
– See, Changing Changes in this version, 16
Adjusting probe action, 307 Changing
Administration work area, 127 – cross-check rules, 278
Air in tubing, 225 – cuvette cassette, 229
Air purge – language, 302
– warning intervals, 293 – passwords, 260
– wizard, 225 – patient demographics, 218
Alarm indications – probe, 323
– See, Data alarms – QC data, 253
Analyzer – QC test parameters, 254
– logging on, 157 – range tables, 281
– not using for some time, 324 – ranges, 283
– preparing, 158 – sample information, 201
– putting into standby, 233 – user data, 267
– shutting down, 232 Charts, QC, 137
– starting, 156 Check digit
– status, 220 – caution message, 108, 298
– switching off, 232, 234 Checking
Analyzing images, 194, 200 – analyzer status, 220
Approvals, 4 – barcode parameters, 298
Assigning particles, 195 – for tasks that need doing, 221
Assigning patients, 180 – hardware, 222
Assistance, 52, 126 – installed software, 304
Assistance work area, 127 – microscope focusing mechanism, 246
Audit trail, 334 – supplies, 223
Automatic logoff, 293 Classification, safety, 25
Cleaning
– buffers, 236
B – centrifuge chamber, 242
– fluid system, 224
Backing up the database, 321
– microscope stage area, 245
Barcode readers, 107
– pipetting stage area, 241
– safety, 32
– probe, 323
Barcodes, 108
– probe bend detector, 241
– check parameters, 298
– rack conveyors, 237
– could not be read on rack, 185
– solutions, 115
– could not be read on sample, 185
– water containers, 317
Biohazard, 31
Cleaning solutions, specifications, 115
Blocked floats, 346
Colors
Bubbles on sample, 32
– buttons, 142
Buffers
Index
– messages, 124
– input, 81
– QC results, 256
– output, 82
– results, 142
Buttons, colors, 142
Components, 69
– optional, 116
Conditions
– environmental, 112
Roche Diagnostics
356 Index
– operation, 28, 112 – order of units, 275

– storage, 112 – orders, 161
Configuration – passwords, 266
– See also, Defining – patients, 217
– system, 292 – priority racks, 305
Connectors – QC materials, 250
– keyboard, 138 – QC racks, 306
– liquids, 75 – racks, 305
– liquids external water suply, 77 – range tables, 282
– mouse, 138 – reports, 299
– overview, 72 – sample ID generation, 279
Consumables, 116 – units, 273
– See, Supplies – users, 265
Contact addresses, 5 – validation method, 276
Containers – warning limits for supplies and waste, 286
– liquid, 89 – wash racks, 305
– liquid waste, 91, 227 Deleting
– solid waste, 228 – patient demographics, 218
– system water, 226 – QC materials, 255
– water, 89 – results, 320
– water external water supply, 90 Detail panels, 126
Contamination, 37 Dimensions, analyzer, 112
Conventions used in this publication Direct water supply
– product names, 11 – water container, 90
Conversion factors and particle counts, 192 Display
Copyrights, 3 – See, Screen
Correcting Display modes, 129
– See, Changing Displaying information, 131
Covers, 70 Disposal, 45
Creating problem reports, 335 Draining water, 324
Cross-check rules, defining, 277 Drawers, pulled accidentally, 341
CSV format, 319
Cuvette cassette compartment, 104
Cuvette cassettes, 103
E
– changing, 229
Edition notice, 2
Cuvettes, 103
Effective footprint, 112
– handling, 102
Electrical safety, 30
Electromagnetic fields, 37
D Emergency stop, 338, 339, 342
Empty liquid waste, wizard, 227
Daily operation Empty solid waste, wizard, 229
– overview, 58 Emptying
– short guide, 59 – liquid waste, 227
Data alarms – solid waste, 228
– defining limits, 284 – water, 324
– importance, 223 – water container, 324
– QC results, 256 End of shift, 231
– results, 176 – maintenance activities, 234
Data security, 32 – overview, 64
Database, backing up, 321 Entering information, 135
Date and time, 295 Environmental conditions, 112
Index
Date and time format, 296 Errors while processing, 185

Deactivating users, 268 Examining
Declassifying particles, 196 – See, Analyzing
Defining Exceptional situations, 185
– cross-check rules, 277 Exchange test strip cassette, wizard, 230
– host connections, 299 Exporting
– limits for data alarms, 284 – cross-check rule definitions, 261
Roche Diagnostics
Index 357
– microscope check results, 261 – reclassifying particles, 195

– QC results, 258 – reclassifying particles by changing counts, 196
– range limit definitions, 261 – zooming, 132
– range table definitions, 261 Importing system settings, 303
– range table results, 261 Incline of table, 113
– results, 182, 183, 319 Including/excluding
– screenshots, 261 – QC test parameters, 255
– system settings, 304 Infection, 31
Exporting information Inflammation, safety, 36
– overview, 261 Information
– entering, 135
– filtering, 134
F – on RFID tags, 109
– selecting, 134
Fatigue, 37
– sorting, 134
Feedback, 4
Initializing the system, 341, 342
Fill water container, wizard, 227
Input buffer, 81
Film on sample, 32
– cleaning, 236
Filter, 343
Input connection unit, 82
Filtering information, 134
Installation, 27
Flags
Installing language, 301
– See, Data alarms
Intended use, 9
Floats,blocked, 346
Interfaces, data, 114
Fluid system, 95
Interfaces, specifications, 114
– removing air, 225
Interrupts, power, 28
– washing, 224
Intervals,defining warnings, 297
Foam on sample, 32
Focusing, 106
Focusing mechanism, 56 K
Footprint, 112
Forced shutdown, 339 Keyboard, connecting, 138
Formats, date and time, 296 Keyboard, specifications, 115, 116
Fuses, 38
L
G
Labels
Global information area, 123 – detached, 337
– stuck in transport unit, 337
Labels on analyzer, 39
H Language, 293
– changing, 302
Handling
– installing, 301
– See, Working with
Levels, QC, 290
Hardware status, 222
Limits
Heat output, 113
– defining, 284
Help, 143
– defining for warnings, 286
Host connections, defining, 299
Liquid containers, overview, 89
Humidity, 39
Liquid waste containers, overview, 91
Liquids
I – connectors, 75
List of tasks, 56
Image handling, 287 Loading
Index
Images – priority racks, 169, 170

– changing counts, 200 – racks, 164
– declassifying particles, 196 – racks with input connection unit, 166
– examining, 192 Location, 295
– handling, 287 Log files, 334
– particle configuration, 287 – viewing, 334
– particle subclasses, 288 Logging off, 231
Roche Diagnostics
358 Index
Logging on, 157 – connectors, 72

Logoff, automatic, 293 – daily operation, 58, 59, 153
– end of shift, 64
– fluid system, 95
M – liquid containers, 89
– liquid waste containers, 91
Main panels, 126
– microscope check of focusing mechanism, 56
Maintenance
– performing tests, 54
– cleaning centrifuge chamber, 242
– QC, 57
– cleaning microscope stage area, 245
– racks, 85
– cleaning pipetting stage area, 241
– result validation, 63
– cleaning probe bend detectors, 241
– results, 62
– cleaning rack conveyors, 237
– sample handling, 101
– cleaning the buffers, 236
– solid waste containers, 93
– cleaning water container, 317
– water containers, 89
– end of shift, 234
– water containers external water supply, 90
– routine, 314
Overview work area, 127
– washing fluid system, 224
Managing patients, 217
Measurement principles, specifications, 114 P
Message list, 124
Messages, color coding, 124 Panel splitter, 129
Method of validation, 276 Panels
Microscope check, 56 – detail, 126
– can’t be generated, 336 – main, 126
Microscope focusing mechanism, checking, 246 Particle configuration, 287
Microscope stage area, cleaning, 245 Particle counts and conversion factors, 192
Microscope, focusing mechanism, 106 Particle labels, 272
Microscopy, 105 Particle subclasses, 288
Minimum sample volumes, 114 Particles
Monitor, specifications, 115 – adding, 195
Monitoring work area, 127 – assigning, 195
Mouse , connecting, 138 – declassifying, 196
Moving parts, safety, 38 – reclassifying, 195
– reclassifying by changing counts, 196
Parts, 28
N Passwords
– changing, 260
Navigation bar, 125
– defining, 266
Non-routine situations, 185
– modes, 293
Not used for long, 29
– resetting, 268
Patient demographics, 217
O Patient information, 217
Patients
Online help, 143 – assigning, 180
Operation – changing, 218
– checking for tasks, 221 – defining, 217
– conditions, 28, 112 – deleting, 218
– principles, 53 – information, 217
– safe, 26 – managing, 217
– short guide, 59, 153 Perform wash, wizard, 224
Operator qualification, 26 Performing QC, 225, 250
Index
Optional components, 116 Performing QC with LAS, 250

Orders Performing tests
– defining, 161 – short guide, 59, 153
Output buffer, 82 Physical dimensions, 112
– cleaning, 236 Pipetting stage area, cleaning, 241
Overview Pipetting units, 98
– components, 69 Power
Roche Diagnostics
Index 359
– interrupt, 28 QC test parameters

– requirements, 113 – changing, 254
Power requirements, 113 – including, excluding, 255
Power switches, 78 Quality control
Powering on/off – See, QC
– See Switching on/off
Precision, 27
Preparing, analyzer, 158
R
Principles , operation, 53
Rack conveyors, cleaning, 237
Printing information
Rack handling, overview, 94
– overview, 261
Rack transport units, 94
Printing results, 181, 182
Rack trays, 87
Priority rack, loading, 169, 170
Racks
Priority racks, 86, 166
– barcodes could not be read, 185
– defining, 305
– defining, 305
Priority racks with input connection unit, 167
– handling, 94
Probe, 97
– loading, 164
– cleaning, 323
– loading with input connection unit, 166
– replacing, 323
– managing, 305
Probe bend detector, 99
– overview, 85
– cleaning, 241
– priority, 86, 166
Probe calibration, 99
– priority racks, 305
Problem reports, creating, 335
– priority with input connection unit, 167
Processing
– QC, 87
– resuming, 259
– QC racks, 306
– status, 171
– sample, 86
– stopping, 259
– transport units, 94
Processing errors, 185
– wash, 87
Protective equipment, 27
– wash racks, 305
Rack-transport-mode only, 295
Q Radio frequency identification
– See, RFID
QC Range tables, 280
– changing data of QC materials, 253 – changing, 281
– changing test parameters, 254 – defining new, 282
– charts, 137 Ranges
– including and excluding test parameters, 255 – changing, 283
– levels, 290 RBC
– materials, 250 – semiquantitative, 284
– overview, 57 Reclassifying particles, 195
– performing, 225, 248, 250 Recovery
– performing with LAS, 250 – accidental opening of main cover, 338
– result colors, 256 – emergency stop, 338
– result data alarms, 256 – forced shutdown, 339
– result symbols, 255 – power cut, 342
– reviewing results, 255 Refilling water, 226
– RFID reader, 252 Regional settings, 295
– tasks, 248 Replacing
QC charts, 137 – probe, 323
QC materials Reporting
– changing, 253 – See, Printing, Exporting
Index
– deleting, 255 Reports, 181, 261

QC racks, 87 – defining, 299
– defining, 306 Rerunning tests, 186
– preparing, 249 Resetting passwords, 268
QC results Results
– printing, 258 – colors, 142
– saving to file, 258 – data alarms, 176
Roche Diagnostics
360 Index
– deleting, 320 – assistance, 126

– exporting, 319 – callouts, 126
– overview, 62 – detail panel, 126
– printing, 181, 182 – displaying information, 131
– QC, 255 – global information area, 123
– QC, saving to file, 258 – key elements, 121
– questionable, 185 – main panel, 126
– saving, 319 – message list, 124
– saving to file, 182, 183 – navigation bar, 125
– status symbols, 176 – specifications, 115
– storage capacity, 279, 318 – tabs, 125, 129
– validating, 175 – task buttons, 124
– viewing, 174 – task indicator, 124
Resuming sample processing, 259 – task list, 124
RFID tags, 109 – work areas, 127
– information, 109 Screen sharing, 295
RFID, reading QC materials, 252 Screenshot disclaimer, 3
Rinse station, 100 Screenshots
Routine maintenance, 314 – exporting, 315
Routine work area, 127 – generating, 333
Screenshots, exporting, 315
Security, data, 32
S Selecting information, 134
Semi-quantitative
Safety
– RBC, 284
– ambient humidity, 39
– WBC, 284
– barcode readers, 32
Send function, 175
– biohazard, 31
Sequence number
– classification, 25
– See, Sample sequence numbers
– contamination, 37
Short guide, daily operation, 59, 153
– disposal, 45
Shutting down the analyzer, 232
– electrical, 30
Size, analyzer, 112
– electromagnetic fields, 37
Software
– fatigue, 37
– installed, 304
– fuses, 38
– third-party, 28
– infection, 31
Solid waste containers
– inflammation, 36
– overview, 93
– labels, 39
– pulled accidentally, 341
– mechanical, 36
Solutions, cleaning, 115
– moving parts, 38
Solutions, for internal wash, 114
– operator qualification, 26
Sorting information, 134
– safe operation, 26
Specifications, 111
– spillage, 38
– allowed tilt, 113
– tiredness, 37
– cleaning solutions, 115
– vibrations, 37, 39
– effective footprint, 112
– waste, 31
– environmental conditions, 112
Safety interlock, 343
– heat output, 113
Sample handling, 101
– interfaces, 114
Sample IDs, generating, 279
– keyboard, 115, 116
Sample racks, 86
– measurement principles, 114
Sample sequence numbers, 159, 160, 279
– min. sample volumes, 114
Sample volumes, minimum, 114
– monitor, 115
Index
Samples
– physical dimensions, 112
– adjust information, 201
– power requirements, 113
– barcodes could not be read, 185
– throughputs, 114
Saving results, 319
– uninterruptible power supply, 113
Saving results to files, 182, 183
– wash solution, 114
SavingQC results to files, 258
– waste containers, 115
Screen
– water container, 115
Roche Diagnostics
Index 361
– water quality, 114 U

Spillages, 38
Standby status, 233 Uniterruptible power supply, specifications, 113
Starting Units
– analyzer, 156 – defining, 273
– processing tests, 168 – display order, 275
Status Use
– analyzer, 55, 220 – microscopy analyzer, 9
– data alarms, 223 – not for some time, 29, 324
– hardware, 222 – of symbols in this documentation, 11
– of results, 176 – of this manual, 9
– order processing, 171 – safe, 26
– users, 266 Users
Stop sample processing, 259 – activating, 268
Storage capacity, 279 – changing data, 267
– for results, 318 – deactivating, 268
Storage conditions, 112 – defining, 265
Stuck floats, 346 – groups, 266
Supplies, 116 – status, 266
– checking, 223
– warning limits, 286
Switches, power, 78
V
Switching off the analyzer, 232, 234
Validating results, 175
Symbols
Validating results, overview, 63
– QC results, 256
Validation method, 276
– results, 176
Vibrations, 37, 39
Symbols used, 11
Viewing log files, 334
System configuration, 292
Viewing results, 174
System name, 293
Virtual keyboard, 293
System settings, 269
– exporting, 304
– importing, 303 W
Warnings
T – expiry, 297
– intervals, 297
Tabs, 125, 129
Warranty, 3
Tags, RFID, 109
Wash racks, 87
Task buttons, 124
– defining, 305
Task indicator, 55, 124
Wash solution, 114
Task list, 56, 124, 220, 221
Wash station
Tasks that need doing, 221
– See Rinse station
Tasks, QC, 248
Washing the fluid system, 224
Technical specifications, 111
Waste
Tests
– liquid, 227
– microscopy analyzer, 49
– safety, 31
– performing, 54
– solid, 228
– rerunning, 186
– warning limits, 286
– short guide, 59, 153
Waste container, specifications, 115
Throughput, 114
Water
Tilt, 113
– draining, 324
Tiredness, 37
– refilling, 226
Index
Trademarks, 3
Water containers, 226
Transport, 29
– cleaning, 317
Trays, for racks, 87
– clogged filters, 343
Troubleshooting
– empty, 324
– overview, 331
– external water supply, 90
Tubes, 84
– overview, 89
– specifications, 115
Roche Diagnostics
362 Index
Water filter, clogged, 343

Water quality, specifications, 114
WBC
– semi-quantitative, 284
Wizards, 139
– Air purge, 225
– Empty liquid waste, 227
– Empty solid waste, 229
– Exchange test strip cassette, 230
– Fill water container, 227
– Perform wash, 224
Work areas, 127
– Administration, 127
– Assistance, 127
– Monitoring, 127
– Overview, 127
– Routine, 127
Working with
– cuvettes, 102
– lists, 134
– samples, 101
– tables, 134
Zoom function, 132

Index
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cobas u 701 microscopy

Manual version Software version Revision date Change description

Edition notice This publication is intended for operators and

Every effort has been made to ensure that all the

The Operator’s Manual and the Online Help contain

The Quick Reference Guide provides you with an

Training Do not carry out operation tasks or maintenance actions

Images The screenshots and hardware images in this publication

Warranty Any customer modification to the system renders the

For conditions of warranty, contact your local sales

Always leave software updates to a Roche Service

Copyright © 2014–2020, Roche Diagnostics GmbH. All rights

Trademarks The following trademarks are acknowledged:

COBAS, COBAS U, and LIFE NEEDS ANSWERS are

All other product names and trademarks are the property

Approvals The cobas u 701 microscopy analyzer meets the

Compliance with the applicable directives is provided by

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

Eurasian Conformity. Demonstrates that the

Issued by Underwriters Laboratories, Inc. (UL) for

'Laboratory Equipment' is the product identifier as

Roche Diagnostics GmbH

Roche affiliates A list of all Roche affiliates can be found at:

eLabDoc Electronic user documentation can be downloaded using

For more information, contact your local affiliate or Roche

Document information 2 4 Software

The cobas u 701 microscopy analyzer is a fully

How to use this manual

q Keep this Operator’s Manual in a safe place to

To help you find information quickly, there is a table of

Content overview The documentation is divided into the following parts:

Symbols and abbreviations

Visual cues are used to help locate and interpret

Product name Descriptor

Symbols used in this publication The following symbols are used:

Electrical and electronic equipment marked

Label on the water container for external

y Symbols used for easy recognition of information

Symbols used on product The following symbols are used:

Global Trade Item Number.

Indicates that the equipment is suitable for

For in vitro diagnostic use.

Unique device identifier.

Complies with the provisions of the applicable

Please consult instructions for use.

Issued by Underwriters Laboratories, Inc. (UL)

y Symbols used on product

'Laboratory Equipment' is the product

y Symbols used on product

Abbreviations The following abbreviations are used:

List of available accessories and consumables

Below are lists of globally available accessories and

Image of product Product name

Water Container (External Water Supply)

Liquid Waste Container

Kit External Water Supply

Cuvette basket cobas u 701