c111 Operators Manual V2 en

cobas c111 system
Operator’s Manual
Version 2.0
cobas c111
Document information
Revision history Manual version Software version Revision date Changes

1.0 July 2006 First publication.
2.0 2.0 December 2007 Full mode added.
Improved calibration concept.
Additional maintenance and
troubleshooting information.
Additions, improvements, and
corrections.
Language Order number

English 04901703018
French 04901703080
German 04901703001
Portuguese 04901703046
Spanish 04901703036
Edition notice The cobas c111 instrument is a continuous random-access analyzer intended for the
in vitro determination of clinical chemistry and electrolyte parameters in serum,
plasma, urine or whole blood (HbA1c). It is optimized for small throughput
workloads of approximately 30 samples per day, utilizing photometric analysis and an
optional unit for ion selective electrodes (ISE).
This manual is for users of the cobas c111 instrument.
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of printing. However, Roche Diagnostics GmbH reserves
the right to make any changes necessary without notice as part of ongoing product
development.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Software updates are done by service representatives.
Intended use The cobas c111 instrument is a continuous random-access analyzer intended for the
plasma, urine or whole blood (HbA1c).
It is important that the operators read this manual thoroughly before using the
system.
Copyrights © 2007, Roche Diagnostics GmbH. All rights reserved.
Trademarks The following trademarks are acknowledged:

COBAS, COBAS C and LIFE NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective owners.
Roche Diagnostics
2 Operator’s Manual · Version 2.0
cobas c111
Instrument approvals The cobas c111 instrument meets the protection requirements laid down in IVD
Directive 98/79/EC and the European Standard EN 591. Furthermore, our
instruments are manufactured and tested according to the following international
standards:
o EN/IEC 61010-1 2nd Edition
o EN/IEC 61010-2-101 1st Edition
The Operator’s manual meets the European Standard EN 591.
Regulatory compliance is demonstrated by the following marks:
Complies with European Union (EU) Directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the

US.
C ® US
Contact addresses
Manufacturer Roche Diagnostics Ltd.

Forrenstrasse
CH-6343 Rotkreuz
Switzerland
Distributor Roche Diagnostics GmbH

Sandhofer Strasse 116
D-68305 Mannheim
Germany
Roche Diagnostics
Operator’s Manual · Version 2.0 3
cobas c111
Roche Diagnostics
cobas c111
Table of contents
Document information 2
Contact addresses 3
Operation Part B
Table of contents 5
Preface 7 5 Daily operation
How to use this manual 7 Introduction B-5
Online Help system 7 Starting the shift B-10
Conventions used in this manual 8 Preparing the system B-12
Analyzing samples B-32
Validating patient results B-46
System Description Part A Performing calibrations B-52
Performing QC B-59
1 Safety Finishing the shift B-68
Safety classification A-5 Logging off B-78
Safety information A-5 Switching off the system B-78
License notices A-10 Using the barcode scanner B-79
Legal liability A-10
Disposal recommendation A-11 6 Special operations
Safety labels A-12 Deleting patient orders B-83
Deleting patient results B-83
2 Introduction to the instrument Calibration B-84
Overview A-15 Deleting QC results B-85
User interface A-18 Lot handling B-87
Wizards A-19 Exporting data B-92
Daily operation A-20 Importing data B-99
Maintenance A-32 Preparing a new disk B-103
System status A-32 Assigning tests to test tabs B-106
Refilling printer paper B-108
3 Hardware Removing condensation water from
Covers and panels A-37 the reagent cooler B-110
LEDs A-39 Replacing the probe B-111
Main components A-41 Connecting and disconnecting the
Hardware overview A-42 external fluid containers B-113
Technical specifications A-64 Adjusting the touchscreen B-116
Cleaning the touchscreen B-117
4 Software
Introduction A-69 7 Configuration
Screen layout A-70 Introduction B-121
Display items A-71 Applications B-123
Workflows and wizards A-72 Configuration B-137
Working with the user interface A-73
Key screens A-82
Color interpretation for LEDs A-114
Maintenance Part C
Buttons A-116
8 General maintenance
Overview C-5
Maintenance actions C-8
Roche Diagnostics
cobas c111
Troubleshooting Part D Glossary and Index Part F
9 Messages and alarms Glossary F-3

About messages D-5 Index F-11
Message screen D-5
Acoustic signals D-6
Alarm monitor D-6
Revisions Part G
List of alarm messages D-9
16 Revisions
10 Result flags
About flags D-19
Safety D-21
List of flags D-22
11 Troubleshooting
Introduction D-35
Dealing with exceptional situations D-36
Reacting to messages D-38
Detailed procedures D-40
ISE Part E
12 ISE description
Overview E-5
Hardware E-9
Basic operation E-12
Technical specifications E-13
13 ISE operation
Daily operation E-17
Replacing ISE fluid bottles E-28
Replacing electrodes E-30
Cleaning the ISE tower off the instrument E-34
14 ISE maintenance
Introduction E-39
ISE maintenance actions E-40
15 ISE troubleshooting
Introduction E-67
Safety E-68
List of ISE flags E-69
Reacting to error messages E-78
Roche Diagnostics
cobas c111
Preface
The cobas c111 instrument is a continuous random-access analyzer intended for the
This manual describes the cobas c111 features and general operational concepts,
and it provides operating, maintenance, and emergency procedures.
How to use this manual
o Keep this Operator’s Manual in a safe place to ensure that it is not damaged and
remains available for use.
o This Operator’s Manual should be easily accessible at all times.
To help you find information quickly, there is a table of contents at the beginning of
the manual and each chapter. In addition, a complete index can be found at the end.
Online Help system
The cobas c111 instrument has a context-sensitive online Help feature to aid in its
operating. “Context-sensitive” means that wherever you are located within the
cobas c111 software, choosing Help ( ) displays Help text relating to that area of
the software. The online Help offers a quick and convenient way of finding
information, such as explanations of screens and dialog boxes and on how to perform
particular tasks.
Roche Diagnostics
cobas c111
Conventions used in this manual
Visual cues are used to help locate and interpret information in this manual quickly.
This section explains the formatting conventions used in this manual.
Symbols The following symbols are used:
Symbol Used for

a Start of procedure
o List item
e Cross-reference
h Call-up (software navigation path)
Color of display item on the screen
Tip
Safety alert
Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.
The symbol denotes that the equipment must not be disposed of in
the municipal waste system.
Buttons When used for identification purposes, a generic form of the buttons is used, without
color or navigation indicators.
<> Angled brackets are used to identify buttons of the user interface.
[] Square brackets are used to identify user interface elements, for example tabs, names
of options, boxes and column headings.
Screenshots The screen representations shown in this publication are for illustrative purposes
only. The screens do not necessarily show valid data.
Roche Diagnostics
cobas c111
Abbreviations The following abbreviations are used:
Abbreviation Definition
C
Cfas Calibrator for automated systems
D
DIL Diluent
DM Data management
DRAM Dynamic random access memory
E
e.g. Exempli gratia – for example
EMC Electromagnetic compatibility
EN European standard
I
i.e. Id est – that is to say

IEC International Electrical Commission
ISE Ion selective electrode
L
LED Light-emitting diode

LIS Laboratory information system
LLD Liquid level detection
N
n/a Not applicable

Q
QC Quality control
R
REF Reference solution for ISE unit

ROM Read only memory
S
SD Standard deviation
SRAM Static random access memory
Roche Diagnostics
cobas c111
Units Abbreviation Description

°C degree centigrade
µL microliter
µm micrometer
A ampère
cm centimeter
h hour
Hz hertz
LB pound (weight)
in inch
kg kilogram
kVA kilo volt-ampere
L liter
m meter
MB megabytes
min minute
mL milliliter
mm millimeter
nm nanometer
s second
V volt
VA volt-ampère
V AC volt alternating current
V DC volt direct current
W watt
Roche Diagnostics
System Description A
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
2 Introduction to the instrument . . . . . . . . . . . . . . . . . . . . . . . . . A-13
3 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-35
4 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-67
cobas c111 1 Safety
Table of contents
Safety
Protecting yourself and the environment
In this chapter, you will find information on the safe operation of the cobas c 111
instrument.
In this chapter Chapter 1

Safety classification ...................................................................................................... A-5
Safety information ...................................................................................................... A-5
Transport ............................................................................................................... A-5
Electrical safety ...................................................................................................... A-5
Optical safety ......................................................................................................... A-6
Mechanical safety .................................................................................................. A-6
Instrument covers .................................................................................................. A-6
Operation and maintenance ................................................................................. A-6
Biohazardous materials ......................................................................................... A-6
Waste ...................................................................................................................... A-7
Reagents and other working solutions ................................................................. A-7
Installation ............................................................................................................. A-7
Environmental conditions .................................................................................... A-7
Power interruption ................................................................................................ A-8
Electromagnetic devices ........................................................................................ A-8
Approved parts ...................................................................................................... A-8
Third-party software ............................................................................................. A-8
Operator qualification ........................................................................................... A-8
Operation over an extended period of time ......................................................... A-9
Cross contamination of sample ............................................................................ A-9
Insoluble contaminants in sample ........................................................................ A-9
Spillage ................................................................................................................... A-9
License notices ........................................................................................................... A-10
Legal liability .............................................................................................................. A-10
Roche Diagnostics
Operator’s Manual · Version 2.0 A-3
1 Safety cobas c111
Table of contents
Disposal recommendation ........................................................................................ A-11

Disposal label ....................................................................................................... A-11
Disposal of external components ....................................................................... A-11
Disposal of the instrument ................................................................................. A-11
Constraint ............................................................................................................ A-11
Safety labels ................................................................................................................ A-12
Roche Diagnostics
A-4 Operator’s Manual · Version 2.0
cobas c111 1 Safety
Safety classification
Safety classification
Before you attempt to use the cobas c111 instrument, you must be fully familiar
with the following symbols and their meanings:
Warning
Indicates a hazardous situation which, if not avoided, could result in death or serious
WARNING injury.
Caution
Indicates a hazardous situation which, if not avoided, may result in minor or moderate
CAUTION injury.
NOTICE Notice
Indicates a hazardous situation which, if not avoided, may result in property damage.
Safety information
Before operating the cobas c111 instrument, it is essential that you both read and
understand the safety information listed below.
Read all Roche safety notices carefully and make sure you understand them.
Transport
Injury from heavy loads

You may injure your hands, fingers, or back when putting the analyzer in place. Carry the
WARNING analyzer according to the transport instructions.
Electrical safety
Electrical shock by electronic equipment

Do not attempt to work in any electronic compartment. Installation, service, and repair
WARNING must only be performed by authorized and qualified personnel.
Electrical safety
Connect the analyzer to grounded power outlets only (IEC protection class 1). All
peripheral devices that are connected to the cobas c111 instrument must comply with
safety standard IEC 60950 for information technology equipment, or with IEC 61010-1, UL
61010-1 for laboratory use instruments.
Roche Diagnostics
1 Safety cobas c111
Safety information
Optical safety
Loss of sight
The intense light of the LEDs may severely damage you eyes. Do not stare into the LEDs.
WARNING Scanning equipment using LED technology is covered by the international standard IEC
60825-1 LED Safety: Class 1.
Mechanical safety
Personal injury or damage to the analyzer due to contact with instrument

mechanism
WARNING Do not touch moving parts during instrument operation.
Instrument covers

mechanism
WARNING Keep all covers closed, operate them as instructed on the screen.
Operation and maintenance

mechanism
WARNING Do not touch any parts of the instrument other than those specified. During operation and
maintenance of the instrument, proceed according to the instructions.
Biohazardous materials
Infection by biohazardous materials

Contact with samples containing material of human origin may result in infection. All
WARNING materials and mechanical components associated with samples of human origin are
potentially biohazardous.
o Be sure to wear protective equipment. Take extra care when working with protective
gloves; these can easily be pierced or cut, which can lead to infection.
o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o If waste solution contacts your skin, wash it off immediately with water and apply a
disinfectant. Consult a physician.
Roche Diagnostics
cobas c111 1 Safety
Safety information
Waste
Infection by waste solution

Contact with waste solution may result in infection. All materials and mechanical
WARNING components associated with the waste systems are potentially biohazardous.
Reagents and other working solutions
Injury through reagents and other working solutions

Direct contact with reagents, cleaning solutions, or other working solutions may cause
WARNING personal injury.
When handling reagents, exercise the precautions required for handling laboratory
reagents, observe the cautions given in the package insert, and observe the information
given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning
solutions.
Skin inflammation caused by reagents

Direct contact with reagents may cause skin irritation, inflammation, or burns.
When handling reagents, be sure to wear protective equipment and observe the cautions
given in the package insert.
Installation
Incorrect results or damage to the analyzer due to wrong installation

Follow the specified installation instructions carefully.
CAUTION
Environmental conditions
Incorrect results or damage to the analyzer due to heat and humidity

Use the instrument indoor only.
CAUTION
e For details on the required environmental conditions, see Environmental conditions on

page A-64.
Roche Diagnostics
1 Safety cobas c111
Safety information
Power interruption
NOTICE Data loss or damage to the system due to voltage drop

By a power failure or momentary voltage drop the operation unit or software of this system
may get damaged or data loss may occur. Use only uninterruptible power supply.
Electromagnetic devices
NOTICE Malfunction of instrument and incorrect results due to interfering electromagnetic

fields
Devices that emit electromagnetic waves may cause the instrument to malfunction. Do not
operate the following devices in the same room where the system is installed:
o Mobile phone
o Transceiver
o Cordless phone
o Other electrical devices that generate electromagnetic waves
Approved parts
Malfunction of instrument and incorrect results due to nonapproved parts

Use of nonapproved parts or devices may result in malfunction of the instrument and may
CAUTION render the warranty null and void. Only use parts and devices approved by Roche
Diagnostics.
Third-party software
Malfunction of instrument and incorrect results due to third-party software

Installation of any third-party software that is not approved by Roche Diagnostics may
CAUTION result in incorrect behavior of the system. Do not install any nonapproved software.
Operator qualification
Incorrect results or damage to the analyzer due to wrong operation

Operators are required to have a profound knowledge of relevant guidelines and norms as
CAUTION well as the information and procedures contained in the Operator’s Manual.
o Do not carry out operation and maintenance unless you have been trained by Roche
Diagnostics.
o Carefully follow the procedures specified in the Operator’s Manual for the operation
and maintenance of the system.
o Leave maintenance that is not described in the Operator’s Manual to trained service
representatives.
o Follow standard laboratory practices, especially when working with biohazard material.
Roche Diagnostics
cobas c111 1 Safety
Safety information
Operation over an extended period of time
Fatigue due to long hours of operation

Looking at the monitor screen over an extended period of time may lead to fatigue of your
CAUTION eyes or body. Take a rest for 10 to 15 minutes every hour to relax. Avoid spending more
than 6 hours per day looking at the monitor screen.
Cross contamination of sample
Incorrect results due to carryover

Traces of analytes or reagents may be carried over one test to the next. Take adequate
CAUTION measures (e.g. sample aliquoting) to safeguard additional testing and to avoid potentially
false results.
Insoluble contaminants in sample
Incorrect results and interruption of analysis due to contaminated samples

Insoluble contaminants in samples may cause clogging or pipetting volume shortage and
CAUTION deterioration in measurement accuracy. When loading samples on the instrument, make
sure that samples contain no insoluble contaminants such as fibrin or dust.
Spillage
NOTICE Malfunction due to spilled liquid

Any liquid spilled on the instrument may result in malfunction of the instrument. If liquid
does spill on the instrument, wipe it up immediately and apply disinfectant.
Roche Diagnostics
1 Safety cobas c111
License notices
License notices
Malfunction of instrument and incorrect results due to software modifications by

the customer
CAUTION The cobas c 111 instrument uses open source software. Among other things, the holders
of the proprietary rights grant licenses under the terms of the GNU General Public Licence
(GPL edition 2 or above) as well as under the GNU Lesser General Public License (LGPL).
The cobas c 111 instrument has been designed to be operated with the unmodified
software as shipped. The user assumes full responsibility for changing any part of the open
source software, which excludes any liability of Roche Diagnostics Ltd.
This program is distributed without any warranty; without even the implied warranty of
merchantability or fitness for a particular purpose. See the GNU General Public License for
more details (www.gnu.org/copyleft/gpl.html).
The source code of the used open source software is part of MIKRAPs CPUX255LCDNET
board support package and may be obtained from SYSGO (http://www.sysgo.com/
products/board-support-packages/).
Legal liability
Roche Diagnostics Ltd. assumes only limited liability when using the cobas c 111
instrument in conjunction with the cobas c111 Development Channel
Programming Software.
For detailed information on this matter refer to the latest version of the Development
Channel Registration Form cobas c 111.
Roche Diagnostics
cobas c111 1 Safety
Disposal recommendation
Disposal recommendation
All electrical and electronic products should be disposed of separately from the
municipal waste system. Proper disposal of your old appliance prevents potential
negative consequences for the environment and human health.
Disposal label
Electrical and electronic equipment marked with this symbol are covered by the European
directive on waste electrical and electronic equipment (WEEE) 2002/96/EC.
The symbol denotes that the equipment must not be disposed of in the municipal waste
system.
Disposal of external components
External components such as the scanner and the ISE power supply, which are marked
with the crossed-out wheeled bin symbol, are covered by the European Directive 2002/96/
EC (WEEE).
These items must be disposed of via designated collection facilities appointed by
government or local authorities.
For more information about disposal of your old products, contact your city office, waste
disposal service or your local service representative.
Disposal of the instrument
The instrument must be treated as biologically contaminated hazardous waste. Final

disposal must be organized in a way that does not endanger waste handlers. As a rule,
WARNING such equipment must be sterile before it is passed on for final disposal.
For more information contact your local service representative.
Constraint
It is left to the responsible laboratory organization to determine whether control unit

components are contaminated or not. If contaminated, treat in the same way as the
instrument.
Roche Diagnostics
1 Safety cobas c111
Safety labels
Safety labels
Read all safety labels on the instrument and equipment.

The following illustration shows where on the instrument labels are displayed.
A B
A This label on the electrode block of the ISE unit indicates that B This label on the main cover indicates that there are potential
there is a danger of hazardous situations arising within the vicinity biohazards within the vicinity of this label, which may result in
of this label, which may result in death or serious injury. The death or serious injury.
relevant laboratory procedures on safe use must be observed. The relevant laboratory procedures on safe use must be observed.
(You will find this label only if an ISE unit is installed.)
Figure A-1 Safety labels on the cobas c111 instrument
In addition to safety labels on the instrument, there are safety notes in the
corresponding parts of the Operator’s Manual.
These safety notes give more detailed information about potentially hazardous
situations that may arise during daily operation or when carrying out maintenance
procedures.
When working with the instrument, be sure to observe both the safety labels on the
instrument and the safety notes in the Operator’s Manual.
Roche Diagnostics
cobas c111 2 Introduction to the instrument
Table of contents
Introduction to the instrument

What you need to know before you start
In this chapter, you will find basic information on the features that are relevant for
working with the cobas c 111 instrument.

Overview .................................................................................................................... A-15
Principles of operation ........................................................................................ A-17
User interface ............................................................................................................. A-18
Wizards ...................................................................................................................... A-19
Daily operation .......................................................................................................... A-20
Overview .............................................................................................................. A-20
Reagent and diluent handling ............................................................................. A-23
Calibration ........................................................................................................... A-24
Calibration type ............................................................................................. A-25
Calibration sequence ..................................................................................... A-26
Calibration status of a set .............................................................................. A-26
Calibration result storage .............................................................................. A-26
Validating calibration results ........................................................................ A-27
Calibration procedures .................................................................................. A-27
Quality control (QC) .......................................................................................... A-28
Sample handling .................................................................................................. A-29
Order handling .................................................................................................... A-30
Results .................................................................................................................. A-31
Maintenance .............................................................................................................. A-32
System status .............................................................................................................. A-32
Roche Diagnostics
2 Introduction to the instrument cobas c111
Table of contents
Roche Diagnostics
Overview
Overview
The cobas c111 instrument is a continuous random-access analyzer intended for the
Only trained personnel working in a professional laboratory environment may
operate the cobas c 111 instrument.

Diagnostics.
representatives.
Features As part of the cobas family of instruments, the cobas c111 instrument offers small
laboratories the following advantages:
o High analytical performance
The same bulk reagents, 12-wavelength photometer and disposable cuvettes
generate results that are highly correlated to other cobas instruments.
o Efficient operation
Cooled, exchangeable reagent disks ensure economical reagent use; disposable
cuvette segments allow for easy cuvette loading and removal.
o High reliability, low maintenance
Innovative "low impact" instrument design and software-driven preventive
maintenance improves up-time and reduces maintenance costs.
o Adaptable user interface
The built-in color touchscreen, process-driven software, and reagent and sample
barcode entry adapts to users of different skills and access levels.
o High safety standards
Built-in safety devices, such as level detection, tube bottom detection, cuvette
quality control, and ISE clot detection anticipate potential hazards during
operation.
o Flexible sampling
Eight on-board sample positions accommodate virtually any type of sample
carrier, and enable continuous sample placing and removal during operation.
o Data management
Bidirectional RS-232 and USB ports, on-board thermal printer, and drivers offer
the latest in data management capabilities.
Roche Diagnostics
Overview
Measuring principles Measurements are performed by means of an absorbance photometer and optionally
an ISE (ion selective electrode) module that uses ion selective potentiometry.
A first look at the instrument A B C D
L M N O
A Left service flap (covers wash station, ISE H Touchscreen

tower, tubing) I Fluid connectors
B Main cover (covers rotor, reagents, cuvettes, J Right service flap (covers photometer unit,
photometer unit) sample area)
C Main switch K Printer panel
D Transfer head (holds probe) L Main cover LED
E Rear service flap (covers computer boards, M Paper slot
power supply, degasser) N Release button for printer panel
F Sample area LED O USB connector (not shown)
G Sample area (space for 8 sample tubes)
Figure A-2 The cobas c 111 instrument
Roche Diagnostics
Overview
Principles of operation
The cobas c111 main instrument uses absorption photometry for determining the
amount of absorbance in a fluid. The absorbance is used to calculate the
concentration in the solution.
Loading the sample The operator identifies the sample, places it on the instrument, and defines the order.
(If you work with a host system, the order is defined automatically.)
Measuring process The measuring process for each test consists of forty regular cycles, each lasting 18
seconds. In each of these cycles, a measurement is taken, irrespective of what other
actions take place during this cycle. The application definitions determine what is
done in which cycle, and they also define which results are taken into account for the
result calculation.
With each cycle, a new test can be started.
The basic process works as follows:
1. Checking the cuvette.
A measurement is taken to check the quality of the cuvette.
2. Pipetting reagent (R1) to the cuvette.
After each pipetting action, the system performs a wash cycle to minimize carry-
over. During this cycle, the probe and tubing are flushed with water and cleaner.
3. Wait.
The fluid needs to reach the prescribed temperature. Such a phase can last several
cycles.
During the wait cycles, activities for other tests are performed.
4. Pipetting the next fluid.
Typically, this would be the sample. The details are defined in the application
definitions.
5. Wait.
6. Pipetting the next fluid.
7. Wait.
8. And so on.
Calculating the results The test result is calculated on the basis of the photometric measurement results.
During this process, various checks are performed to ensure that the whole measuring
process was technically correct. If values are above or below predefined limits, the test
result is flagged.
The results are stored on the system. This includes both the forty measurement results
(raw data) and the calculated test result.
Status of the measuring process At any stage of the measuring process, the user can check its status on the screen.
Result data management The system provides storage space for the results of one working day. For backup
purposes, the results must be exported to an external storage device once a day.
Roche Diagnostics
User interface
User interface
The cobas c111 instrument is equipped with a touchscreen, an on-screen keyboard

and four global action buttons. LEDs and acoustic signals let you know when it is safe
to add or remove samples, reagents and other fluids.
With buttons and other display items, “traffic light” color coding is used: Green
means OK, yellow: watch out, you need to do something, and red means that your
intervention is required for processing to continue.
The screens have a clear and consistent layout and are easy to use. The topics are
divided in the proven work areas: Overview for order and fluid handling, Workplace
for result handling and details on orders, and Utilities for administration tasks.
e For details on the user interface, see Chapter 4 Software.
The following is an example of a screen. It contains the full range of display items.
A F
B
C
G
D
A The status line displays the system status. F The Help button leads to concise information
B Tabs represent the major work areas. that is relevant to the current screen and
C The headline characterizes the content or situation.
function of the screen. If the screen is part of G The global action buttons represent the
a sequence of screens (wizard), the headline functions that are permanently available:
tells you where you are within this sequence. Start, Stop, Alarm, Line Feed. The LEDs next
D The working area displays the main content to them point to their status.
of the screen.
E The buttons vary depending on the content
of the working area and the screen position
within a series of steps (wizard).
Figure A-3 Example of a screen
Roche Diagnostics
Wizards
Wizards
Screens help you perform your tasks. If not all steps of a task can be performed from
one screen, the workflow is realized as a sequence of screens, a so-called wizard.
cobas c111 wizards do not usually force you to perform a task at a certain stage, they
just make your work easier.
e For details on workflows, see Workflows and wizards on page A-72.
When intervention is required On the screen, there are several methods of telling when your intervention is required:
o Buttons and texts are color coded.
Everything is fine.
To ensure smooth operation, you need to perform some task.
The current process or action has not started yet or stopped. You need to
do something for it to start or continue.
o Screens can contain instructions. For example the text may ask you to place the
sample on the sample area or to remove a reagent bottle from the reagent disk.
o Messages inform you about the status of current actions.
o A permanent alarm monitor alerts you to events you should know about.
Wizards There are three major wizards: Prepare wizard, Orders wizard, and End Shift wizard.
With most tasks that involve more than one step, such as exchanging reagent or other
fluid bottles, you are supported by wizards.
Prepare wizard The Prepare wizard guides you through the tasks that need to be performed at the
beginning of a shift. When this wizard is done, the system is ready for processing
orders.
Orders wizard The Orders wizard guides you through the process of creating and changing orders.
End Shift wizard The End Shift wizard guides you through the tasks that need to be performed at the
end of the day or to prepare the instrument for handing over to another operator.
Individual tasks can be performed outside the wizards

Most tasks that make up a workflow can be performed without using a wizard.
If you perform a task independently, you first need to navigate to the appropriate screen
and then start the task from there; whereas if you use a wizard, the appropriate screen is
displayed automatically.
Using the wizards also ensures that all necessary steps are performed and in the right
order.
Roche Diagnostics
Daily operation
Daily operation
Overview
Daily operation includes the routine tasks that are required to prepare and monitor
the system, and to analyze samples.
When you switch on the system, it performs several checks to make sure that all
preconditions are met, for example that all covers are closed or that there are cuvettes
available. It then performs self-tests to ensure that all modules function properly.
At the end of the startup phase, the screen is updated to display the current status of
the system.
The following table gives an overview of the tasks you might need to perform during
daily operation.
Task Steps Navigation

With wizard As individual steps
1 Starting the system 1. Switch on the system.
2 Logging on the system Overview > Logon
3 Preparing the system Start the Prepare wizard. Overview > Prepare
1. Check the external fluid containers. Overview > >
2. Perform the maintenance actions Utilities > Maintenance
that are due.
3. Load the reagent disk. Overview >
4. Check the reagents. Overview >
5. Check the cuvettes. Overview >
6. Perform mixing Overview > > test >
7. Perform calibrations that are due. Workplace > Calibrations > >
4 Defining orders Start the Orders wizard. Overview > Order (or Overview > STAT)
1. Identify the sample. n/a
2. Select the tests. n/a
3. Place the sample. n/a
4. Start the run.
5 Monitoring the progress n/a Overview
6 Validating results 1. View results. n/a Workplace > Result Review

2. Handle flagged results. n/a Workplace > Result Review >
... > Repeat
... > Rerun
3. Accept results. n/a Workplace > Result Review > > Accept
Table A-1 Overview of the daily operation tasks
Roche Diagnostics
Daily operation

7 Performing calibrations
Performing individual 1. Start the wizard. Workplace > Calibrations >
calibrations 2. Select the test. n/a
3. Prepare and place the calibrators. n/a
4. Start the calibration.
5. Validate the calibration results. Workplace > Calibrations >
6. Remove the calibrators.
Performing 1. Start the wizard. Workplace > Calibrations >
all due calibrations 2. Select all tests with due calibrations. n/a
or
Select all tests with calibration due
within the forecast period.
8 Performing controls
Performing 1. Start the wizard. Overview > Order >
Default QC 2. Select a control and place the tube. n/a
Repeat until there are no controls left
on the screen.
3. Start the QC measurement.
4. Validate the QC results. Workplace > QC Status >
5. Remove the controls. n/a
Performing an individual 1. Start the wizard. Workplace > QC Status >
QC measurement 2. Select a test. n/a
3. Select a control and place the tube. n/a
on the screen.
6. Remove the control.
Performing all 1. Start the wizard. Overview > Order > >
due QC measurements 2. Select a control and place the tube. n/a
on the screen.
5. Remove the controls.
Roche Diagnostics
Daily operation

9 Finishing the shift 1. Check for unfinished samples. Workplace > Orders
Choose > Not Finished
2. Check for non-validated results. Workplace > Result Review
Choose > Not Accepted
3. Check for non-transmitted results. Workplace > Result Review
(If working with a host system only.) Choose > Not Sent to Host
4. Start the End Shift wizard. Overview > End Shift
5. Perform the daily backup. Utilities > Export > Database
6. Export the full results Utilities > Export > Results
7. Clean up the database. Workplace > Orders >
Workplace > Result Review>
Workplace > QC Status >
Workplace > QC History >
Workplace > Calibrations >
that are due.
9. Replace cuvettes. Overview >
11. Remove the reagent disk (if last shift). Overview > >
12. Log off the system. Overview > button with your user name
13. Switch off the system (if last shift). n/a n/a
Roche Diagnostics
Daily operation
Reagent and diluent handling
A B C
A Reagent disk C Chimney

B Reagent bottle with barcode
Figure A-4 Equipment for reagent handling
Reagent disk On the instrument, the reagents are stored on a reagent disk. It provides space for 27
bottles, allowing up to 14 reagent sets to be installed on the disk, assuming that most
tests need two reagents. Extra diluents and cleaners are also loaded on the reagent
disk.
You can work with up to eight different reagent disks on one cobas c111
instrument.
You always load and remove bottles while the disk is on the instrument. (The system
needs to know exactly what is loaded on the disk.)
When you finished running tests, you can remove the whole reagent disk, place it in a
reagent disk container, and store it in a refrigerator.
Bottles cobas c111 reagents, diluents and extra cleaners are provided in uniform bottles.
They are supplied with two dimensional barcodes and placed on the reagent disk with
their cap removed.
Chimneys Chimneys are bottle inserts that reduce evaporation. For reagents that are especially
sensitive to concentration changes, Roche recommend using chimneys on the reagent
bottles. (See the package inserts of the tests whether you should use chimneys or not.)
To generally reduce evaporation, you may use chimneys on all reagent bottles.
Reagent set Up to three reagents can be required to perform a certain test. These reagents are
handled in reagent sets. You can define more than one reagent set for a test, but only
one can be active.
A reagent set is defined as soon as its first bottle is loaded. From this moment on,
whenever you remove or replace a reagent, you do so for all reagents of the set.
Each diluent or cleaner bottle is treated as a separate reagent set.
Roche Diagnostics
Daily operation
Volume detection For each reagent set, the number of available tests is continuously calculated.
Figure A-5 Remaining tests indication
Periodic mixing Reagents may have a mixing interval defined. This interval is checked by the system
every 30 minutes, and mixing is performed without removing the reagent bottles
from the reagent disk.
For a reagent set that contains more than one reagent for which mixing is defined, the
shortest interval of all reagents of the set is used for all reagents.
Tests are blocked if any reagent they use requires mixing.
Diluents Both, system water and dedicated diluents are used. System water is kept in the
external water container, dedicated diluents are supplied in reagent bottles and placed
on the reagent disk.
Cleaners Both, a system cleaner and dedicated cleaners can be used. The system cleaner is kept
in the external cleaner bottle, dedicated cleaners are supplied in reagent bottles and
placed on the reagent disk.
Calibration
Calibration is the process that establishes, under specified conditions, the relationship
between values indicated by the analytical instrument and the corresponding known
values of an analyte.
Periodic calibration is required because the concentration of reagents can change over
time.
Reagents are typically calibrated with a two-point calibration, measuring the
predefined value of a multicalibrator and of system water. Some reagents are
calibrated using a set of calibrators.
On the cobas c111 instrument, reagents are handled as sets of up to three reagents.
(You always load and unload all reagents of a set.) As a consequence, all reagents
(bottles) of a set are calibrated when performing calibration.
The system checks when calibration is due.
Each reagent set must have accepted calibration results to be available for use in tests.
When a calibration is due depends mainly on two definitions, the calibration type and
the calibration sequence.
Roche Diagnostics
Daily operation
Calibration type
The calibration types Set and Lot define the manner in which the system determines
whether there is a valid calibration result for a particular reagent set.
Set calibration Set calibration results are valid for the calibrated set only. They can be generated from
any reagent set.
Lot calibration Lot calibration results are valid for the reagent set they were calibrated with and for all
subsequent reagent sets of the same lot. Usually, lot calibrations are generated by
calibrating the first reagent set of a new lot. There can only be one accepted lot
calibration result for the reagents of a given lot.
Let us suppose that you place the first reagent set of a new lot and calibrate it straight
away. Let us further assume that subsequent control measurements suggest that a new
calibration is required. Within the first 24 hours of placing a set on the system, you
can recalibrate it, and possibly existing lot calibration results of this set are
superseded. When this period has elapsed you can no longer change the lot
calibration results. (To generate new lot calibration results, you would have to delete
the existing results and then calibrate a new reagent set.)
Lot calibration is relevant if you work with the calibration sequence [Each Lot and Interval].
The following table illustrates the two calibration types in an example.

Assumptions:
o Sequence: Each Lot and Interval
o Interval: 5 days.
(Note that the interval (re)starts when a set is calibrated as a result of the interval
expiring or a new lot being started.)
Day Trigger/Event Task Result Set Cal. type Cal. Usage

used
1 NA 1. Place first reagent set of new lot. Result 1 L1/1 Lot Current
2. Calibrate set L1/1.
2 Reagent empty. 1. Remove set L1/1. Result 1 L1/2 Set Current
2. Place new set L1/2. L1/1 Lot -
Reagent empty. Replace set whenever it is empty. Result 1 Set Current
5 Interval expired. Calibrate current set L1/n. Result 2 L1/n Set Current
L1/n-1 Set Obsolete
6 Reagent empty. Place new set L1/n+1. Result 1 L1/n+1 Set Current
L1/n Set Obsolete
8 Reagent empty. 1. Remove set L1/n+1. Result 3 L2/1 Lot Current
New lot. 2. Place new set, which is the first set of a new lot. L1/1 Lot Obsolete
3. Calibrate set L2/1.
L1/n+1 Set Obsolete
Reagent empty. Place new set L2/2. Result 3 L2/2 Set Current
L2/1 Lot -
10 Interval expired. Calibrate current set L2/n. Result 4 L2/n Set Current
L2/n-1 Set Obsolete
11 Reagent empty. Place new set L2/n+1. Result 3 L2/n+1 Set Current
L2/n Set Obsolete
Table A-2 Example for set change and calibration types
Roche Diagnostics
Daily operation
Calibration sequence
The calibration sequence is an application definition. It defines the manner in which
the system determines when a calibration is due.
Roche recommend not to change the calibration sequence.
The calibration interval defines the on-board stability of a reagent.

One of the following sequences applies to each reagent set:
No Interval You perform calibration whenever you think fit. Use this value if you are sure that the
reagent is stable until it is empty and you replace it with a new one. Calibration is due
whenever a new reagent set is loaded on the instrument.
Interval only You perform calibration only when the interval has expired.
Each Lot and Interval You perform calibration whenever the fist reagent of a new lot is loaded and then each
time the interval has expired.
In this case, the interval is related to the date when the lot calibration was generated,
and it (re)starts whenever you calibrate a reagent set (as a result of interval expiry or
starting a new lot).
You can turn off the interval check by defining its duration as 0 (zero).
Each Set and Interval You perform calibration whenever a new reagent is loaded and when the interval has
expired.
The interval starts again whenever you calibrate a reagent set because the interval had
expired or a new lot was started.
You can turn off the interval check by defining its duration as 0 (zero).
Calibration status of a set

Each reagent set has one of the following calibration statuses:
CU (current) denotes that the set is on board and that its calibration results are currently
used.
OB (obsolete) denotes that the set’s calibration results are no longer used.
This status applies for example to the following situations:
o The set was removed and it is empty.
o The set was removed and it is not empty. It was removed more than 30 days ago.
SB (standby) indicates that the set’s calibration results are not currently used.
This status applies for example to the following situations:
o A new set was loaded and calibrated while an identical set was still in use (pre-
calibration).
o The set was removed not more than 30 days ago and it is not empty.
Calibration result storage

The current and up to five obsolete calibration results are stored on the system. If
there are more than five obsolete calibration results, the oldest obsolete calibration
results are automatically deleted as part of the daily end of shift activities.
Roche Diagnostics
Daily operation
Validating calibration results

Applications define checks for ranges and limits. If these are exceeded, the results are
flagged.
Each new calibration result has to be validated. If flags were generated, you must
determine their cause and decide whether to accept the result, rerun the calibration or
continue using the old calibration results.
You can automatically accept unflagged results and results with flags that are
contained in a specific list of flags that should be ignored.
e See Editing the acceptable flags list on page B-142.
Calibration procedures
There are three basic procedures for performing calibration:
o Calibrating all reagent sets that need calibrating
o Calibrating all reagent sets that will need calibrating during the forecast period
o Calibrating individual reagent sets

<xyz>
Forecast period The forecast period is a configurable period of time. Calibrations that fall due within
this period will be performed collectively.
e See Calibration on page B-146.
Typically you would set this period to fit your shift length, for example 8 hours. This
would enable you to prepare the instrument before the work shift starts and so avoid
having to interrupt sample processing for performing calibrations.
Precalibration At any given time, there is only one accepted calibration result for each test. You can,
however, install and precalibrate one reserve reagent set. This is done, for example, to
ensure continuous sample processing.
Roche Diagnostics
Daily operation
Quality control (QC)
QC is performed at regular intervals to check the integrity of the whole measuring

system. For each test, up to three controls are defined. The results are compared
against predefined ranges or values and then interpreted accordingly.
Control A control is a sample that has been measured using all tests it is associated with, in
order to define the ranges and values that determine the correct functioning of the
instrument. This is typically done both for the normal and the pathological analyte
concentration.
When QC is due With regards to when it needs to be performed, QC is divided in the following types:
o QC after Cal.
The QC measurement is due after calibration of the test.
o Interval QC
QC is due whenever its interval has expired. QC measurements of this type are
performed in a batch, typically once or twice a day.
o Default QC
QC is performed at certain times during routine operation. This is done to fit in
with laboratory processes and procedures.
Ways of performing QC With regards to how QC is performed, the following methods are provided:
o Default QC
Default QC is an automated process for performing multiple QC measurements at
the time when you define the QC orders. This is the ideal method if you want to
perform QC at certain times and days.
This method only applies to tests whose controls are defined to be performed as
part of Default QC. Therefore, if you intend to work with the Default QC
function, you need to configure the tests accordingly.
Default QC follows a streamlined procedure where the necessary QC orders are
automatically defined as soon as you identify a control. An order is defined for
each test for which this control is defined, provided the test is currently active on
the system. A wizard helps you select the controls, and a placement list supports
you in preparing and loading the controls.
o Interval QC
This method applies to tests whose controls have an interval defined.
Interval QC is a process that is suitable both for performing a single QC
measurement and for performing all QC measurements that are due. You can
select all tests that require QC simply by pressing a button. (This selection also
reflects QC of the type [QC after Cal].) A wizard helps you select the controls, and
a placement list supports you in preparing and loading them.
Validating QC results Each new QC result has to be validated. If flags are generated, you must determine
their cause and decide whether to accept the result or to rerun the QC measurement.
You can automatically accept unflagged results and results with flags that are
contained in a specific list of flags that should be ignored.
Roche Diagnostics
Daily operation
Sample handling
You can place up to eight sample tubes on the sample area.
A Sample area LED. A green LED indicates that you should place a tube, a blinking yellow LED
that you should keep clear of the sample area.
Figure A-6 Sample area with sample tubes
Sample types The cobas c111 instrument can process the following sample fluids:
o Serum
o Plasma
o Urine
o Whole blood for HbA1c
Incorrect results due to inadequate sample preparation

Specimen containing clots may obstruct the probe. Specimen containing bubbles or foam
WARNING may cause level detection errors and air pipetting. Consequently, incorrect results may be
generated.
Take adequate care when preparing the samples.
Sample tubes The cobas c111 instrument can use both primary and secondary tubes (cups).
You can use any type of primary tube, as long as their dimensions lay within
prescribed limits. Roche recommend using approved cups only.
e See Tubes on page A-52.
Sample ID The sample ID is an identifier of up to 23 alphanumeric characters that is unique

within a whole organization, for example the hospital. It identifies the sample and is
also used for host communication.
Sample IDs are defined either by scanning a barcode or by typing them manually.
Because there is limited space when displaying lists on screens, Roche recommend to
limit the ID to 13 characters.
Sample barcode You can use sample tubes with or without barcode.
Dilution Pre-dilution is used when performing calibration.

Post-dilution is used when measuring samples.
(The dilution factor is part of the application definition and therefore does not need
to be defined by the operator.)
Removing sample tubes You can remove sample tubes as soon as pipetting is complete.
Roche Diagnostics
Daily operation
Order handling
Order Mode The order mode reflects the way in which you organize the tests on the test selection
screen.
Choose <Easy> if the reagents fit on one or two reagent disks and you work with one
test panel on the screen (You can fit up to 25 tests and profiles on this panel).
Choose <Full> if you distribute the reagents across several (up to eight) reagent disks
and if you predominantly work with specific groups of tests, for example for
emergency situations or for testing diabetes. You can assign up to 20 tests and profiles
to each panel (tab).
Order ID The order ID is an identifier of up to 23 alphanumeric characters that is unique

within the laboratory. The order ID identifies the order and links it to the sample.
Order and sample IDs are often identical. Using separate IDs makes sense when
working with a host system.
Order IDs are defined either by scanning a barcode or by typing them manually.
Because there is limited space when displaying lists on screens, Roche recommend to
limit the ID to 13 characters.
Patient demographics The cobas c111 software does not support the handling of patient demographic
data.
Host connectivity The cobas c111 instrument can be connected to an external laboratory information
system (LIS) or a host computer for downloading order information and uploading
results.
If the instrument is connected to a host system, the following setups can be
configured:
o Downloading order information
When you identify a sample using the barcode scanner, the appropriate order
information is automatically assigned to the order on the system. (The order
information was downloaded previously.)
o Performing host queries
When you identify a sample using the barcode scanner, a query is sent to the host,
asking for the order information of the sample in question. This information is
then downloaded to the cobas c 111 instrument and automatically assigned to
the sample on the system.
o Transmitting results
You can have results automatically transmitted to the host as soon as they are
accepted.
Routine orders Routine orders are normally defined on the [Overview] tab. The software guides you
through the process of assigning the tests to the sample and placing the sample tube
on the instrument.
STAT orders STAT (short turn around time) orders are handled in the same way as routine orders,
except that their tests are processed next, irrespective of the scheduling of routine
order tests.
Roche Diagnostics
Daily operation
Defining orders There must be at least one free sample tube position when defining an order. You are
guided by the software when ordering the tests and placing the samples.
There can be only one order for each test and sample.
Modifying orders The process for changing an order is similar to that of defining it. You first identify the
sample and then change the tests. You can change an order as long as its processing
has not yet started.
It is always possible to add a further test to an existing order.
Deleting orders At the end of a shift, you should delete all orders that are defined on the system. This
is to free storage space for the next shift. Deleting the orders is an integral part of the
End Shift wizard. (Deleting an order also deletes the corresponding patient results.)
You can export the data to a USB stick and store them on a computer.
Controlling the run Controlling the execution of test runs is done via the global action buttons.
Press to start the run.
Press to stop the run.
Results
You can check the results on the screen as soon as they are calculated.
Units Results are normally given in your lab units. The units can be configured.
Flags Result flags are test-specific. They indicate that the limit of an internal check was
exceeded or not reached.
System flags point to the status of the result within the process of analysis; for
example, they tell you that the result has not been accepted or that is has not been
transmitted to the host successfully.
Printing results You can print all or selected results on the built-in printer.
Validating results All results need to be validated (result accepted, test rerun or repeated).
Result flags help you identify critical results and point to possible actions that need to
be taken.
Each test must have accepted calibration results; tests whose associated calibration
results are not accepted cannot be performed.
Repeating and rerunning tests If a result is flagged, you may decide to run a test again. You can either perform
exactly the same test (Repeat) or perform it with a different predefined dilution
(Rerun).
Storing results The cobas c111 instrument is designed to hold the patient results of one day’s
analyzing. Therefore, you need to back up the data regularly to an external medium.
(Backing up results is an integral part of the End Shift wizard.)
The QC results of the previous and the current months are stored on the system.
Up to five calibration results are stored on the system for each test.
Roche Diagnostics
Maintenance
Maintenance
Completing maintenance actions correctly and on time helps to ensure smooth and
uninterrupted operation of your instrument.
Maintenance scheduling The cobas c111 instrument facilitates performing the maintenance actions in
bundles at the times that suit your laboratory work processes. To that purpose, you
can define in the configuration settings one day of the week as your maintenance day.
e For information on scheduling maintenance actions, see Scheduling maintenance actions
on page B-138.
All maintenance actions can be performed any time.
Interval For most maintenance actions a fixed maintenance interval is defined. (You cannot
change this interval.) This is the basis upon which the system calculates the date when
the actions need to be performed.
The interval timers and counters are reset whenever you confirm that the
maintenance action has been performed.
Maintenance actions without predefined intervals are performed whenever necessary,
or they are triggered by another maintenance action.
Due date The due date is the last possible maintenance day. This is the date you see when you
check the status of maintenance actions.
Ensuring smooth operation Performing all due maintenance actions during the daily Prepare or End Shift phase
ensures that routine operation does not have to be interrupted for performing
maintenance actions.
System status
The cobas c111 instrument provides several means of indicating the status of the
various parts and processes:
o Color coded LEDs on the instrument inform you when and when not to open
covers or place sample tubes.
e See Color interpretation for LEDs on page A-114.
o The colors of buttons inform you whether you need to intervene.
e See Color concept on page A-72.
You can check the meaning of a button using the online Help .
o Buttons on the [Overview] tab lead to detailed information on the status of
selected processes and hardware items.
o Messages on the screen provide information on individual tasks and events.
o The text in the Status line provides information on the status and activities of the
analyzer and photometer unit.
Roche Diagnostics
System status
The following system statuses are defined:
Status Comment
Standby The user and host interfaces remain active, as do the reagent
cooling system, fluid system, and the cuvette heating.
Maintenance A maintenance action is being performed. The system is not
available for performing tests.
Operating Processing is in progress.
Powerup After switching on, the system performs initialization and
functional test.
Powerdown Regular shutdown is in progress.
E-Stopped Processing has stopped. User intervention is required to allow
the system to resume regular operation.
Table A-3 System statuses
Roche Diagnostics
System status
Roche Diagnostics
cobas c111 3 Hardware
Table of contents
Hardware
The parts and how they work
In this chapter, you will find information on the main hardware components of the
cobas c111 instrument.

Covers and panels ...................................................................................................... A-37
LEDs ........................................................................................................................... A-39
Main components ..................................................................................................... A-41
Hardware overview ................................................................................................... A-42
Sample area .......................................................................................................... A-42
Fluid system ......................................................................................................... A-43
Probe and syringe .......................................................................................... A-44
Syringe assembly ............................................................................................ A-44
Wash station ................................................................................................... A-45
External fluid connectors .............................................................................. A-45
Transfer unit ........................................................................................................ A-46
Fluid containers ................................................................................................... A-48
Waste containers ............................................................................................ A-48
Water container ............................................................................................. A-49
Cleaner bottle ................................................................................................ A-50
Reagent bottles ............................................................................................... A-51
Tubes .............................................................................................................. A-52
Cuvettes .......................................................................................................... A-52
Cuvette segments ........................................................................................... A-53
Handling cuvettes .......................................................................................... A-53
Reagent handling ........................................................................................... A-54
Rotor .................................................................................................................... A-55
Reagent disk ......................................................................................................... A-56
Reagent disk container ........................................................................................ A-57
Reagent cooler ..................................................................................................... A-57
Cuvette ring ......................................................................................................... A-58
Barcode scanner ................................................................................................... A-59
Printer .................................................................................................................. A-60
Roche Diagnostics
3 Hardware cobas c111
Table of contents
Absorbance photometer ...................................................................................... A-61

Connectors ........................................................................................................... A-62
Fuses ..................................................................................................................... A-63
Technical specifications ............................................................................................. A-64
Roche Diagnostics
Covers and panels
Covers and panels
The following figure shows the removable panels and the lids that can be opened.
A B C D
A Left side panel E Rear service flap

B Left service flap F Right side panel
C Main cover G Right service flap
D Transfer head cover H Printer panel
Transfer head cover Provides access to:

o Transfer mechanism
o Probe
Switch off the system before you open this cover.
Left service flap Provides access to:

o Wash station
o Tubing
o Internal waste tank
o Initialization plate
Open this flap as instructed during maintenance actions, or switch off the system
before you remove it.
To open the flap, press its front towards the instrument and lift.
Roche Diagnostics
Covers and panels
Main cover Provides access to:

o Rotor
o Reagent disk
o Cuvettes
o Reagent bottles
o Photometer unit
You open this cover whenever you need to handle cuvettes, reagent bottles, or the
reagent disk. A green LED indicates that you should place an item, a yellow LED that
you should not open the main cover.
To open the cover, press the release button at the underside of the front of the cover.
When you should close the cover an acoustic signal is sounded and the system icon
on the System Status screen turns red.
Rear service flap Provides access to:

o Computer boards
o Power supply
o Transfer unit
o Degasser
This flap should be opened by service representatives only.
Switch off the system before you open this cover and remove the two side panels
before opening this flap.
Right side panel Provides access to:

o Syringe assembly
Remove this panel as instructed during maintenance actions or switch off the system
before you remove it.
Right service flap Provides access to:

o Photometer unit
o Sample area
o Touchscreen
o Data management computer
Open this panel as instructed during maintenance actions or switch off the system
before you open it.
Printer panel Provides access to:

o Printer paper.
You can open this flap any time as long as the printer is not printing.
To open the panel, press the release button.
Roche Diagnostics
LEDs
LEDs
LEDs are placed on key positions on the cobas c111 instrument. They inform you
whether you can perform certain actions.
A Sample area LED C Main cover LED

B Global button LEDs (from top: Start LED,
Stop LED, Alarm LED)
Interpreting the LED colors LED Color Meaning

Main cover LED Off No activities in this area. You can open the main
cover.
User intervention is required, for example you are
expected to place or remove a bottle.
The system is performing some action. Do not
handle the cover.
An acoustic signal is sounded when the cover is open while the system is
in Operating state. You can adjust the volume (Utilities > Configuration
> System > Volume).
Sample area LED Off No activities in this area. You can remove sample
tubes.
You are expected to place a sample tube.
Blinking The transfer head is approaching. Do not place
your hand or any object in the sample area.
Start LED Off You cannot start the measuring process.
You can start the measuring process.
Table A-4 LEDs and their meaning
Roche Diagnostics
LEDs
LED Color Meaning

Stop LED Off Pressing does not have any effect.
Pressing leads to the various stop options.
Alarm LED Off There are no alarm messages to be dealt with. (All
alarm messages have been acknowledged.)
There is at least one alarm message that you need
to deal with as soon as possible.
to deal with. Processing cannot continue unless
you do so.
An acoustic signal is sounded when an alarm is generated. You can
adjust the volume (Utilities > Configuration > System > Volume).
Roche Diagnostics
Main components
Main components
The following figure illustrates the main components of the cobas c111 instrument.
A B C D E
G
H
A Rotor E Degasser I Front USB port

B Transfer unit F Sample area J External fluid rack
C Photometer unit G Display K Printer
D PCB main board H Syringe assembly
Figure A-9 Main hardware components
Rotor Provides a cooled area for reagents (cooling assembly) and a heated channel for
cuvettes. It moves the containers to the correct position for loading, removal,
pipetting, and measuring.
Transfer unit Pipettes sample, reagent, and other fluids from their source to target containers such
as cuvettes or the wash station.
Photometer unit Contains the absorbance photometer used for making absorbance measurements.
PCB main board Controls the instrument hardware.
Roche Diagnostics
Hardware overview
Fluid system (not shown) Transports all fluids around the instrument, including sample, reagent, calibrator,
control, diluent, cleaner, system water, and waste.
Syringe assembly Performs the aspiration and dispensing of fluids. This includes the supply of water
and cleaner to clean the probes in the wash station after every pipetting action, which
prevents carry-over between tests.
Degasser Removes possible air bubbles from the system water.
Sample area Eight positions for holding sample tubes. This area is also used for placing calibrators,
controls, and auxiliary fluids.
Display The touchscreen provides the user interface for controlling and managing the
Front USB port This port is used for the USB stick when backing up data or loading data on the
system.
Hardware overview
Sample area
The sample area provides eight positions for placing sample tubes. You can place
primary and secondary tubes.
e See Tubes on page A-52.
A The LED indicates that the transfer tower is approaching or that you should place a sample
tube.
Figure A-10 Sample area with sample tubes
Place the samples when instructed by the system to do so. For calibrators, the system
tells you on which position to place them, with the other fluids, you can choose any
free position.
Roche Diagnostics
Hardware overview
Fluid system
The fluid system consists of all the valves, pumps, tubing, syringe, fluid sensors, water
and waste containers, the wash station, and the probe. It transports all fluids around
the instrument, including sample, reagent, calibrator, control, diluent, cleaner, system
water, and waste. The fluid system also delivers the correct amounts of fluids to the
cuvettes.
A B C
G H I
A Wash station F Internal waste tank

B Transfer head (with probe) G Cleaner bottle (red cap)
C Pumps H Water container (white)
D Degasser I Waste container (yellow)
E Syringe assembly
Figure A-11 Fluid system
NOTICE To prevent overflow of the internal waste tank when the system is in Standby status, the
waste is periodically pumped to the external waste container. (Condensation can build up
in the cooling assembly while the system is in Standby status.)
Roche Diagnostics
Hardware overview
Probe and syringe
C
B
A Fluid sensor C Syringe

B Probe
Figure A-12 Probe and syringe
The probe is connected by tubing to:

o The syringe to ensure the pipetting of the required amounts of fluid.
o The external water container and cleaner bottle to ensure supply of fresh water
and cleaner.
e See maintenance action Clean probe manually on page C-12.
See maintenance action Deproteinize probe on page C-10.
See Replacing the probe on page B-111.
Syringe assembly
The syringe assembly controls the aspiration and dispensing of fluids. It also controls
the supply of water and cleaner to clean the probes in the wash station after every
pipetting action, which prevents carry-over between tests.
Roche Diagnostics
Hardware overview
Wash station
Figure A-13 Wash station
The probe is washed after each pipetting. It is lowered in the wash station and then
cleaner is pumped through the probe to wash it in and outside. Next water is pumped
through the probe to flush away the cleaner.
The wash station is connected by tubing to the internal waste container.
External fluid connectors

The three external fluid containers must be properly connected before you switch on
the cobas c 111 instrument.
A B C
A Water connector C Waste connector

B Cleaner connector
Figure A-14 External fluid connectors
Roche Diagnostics
Hardware overview
Transfer unit
The transfer unit moves the probe to the correct positions for all pipetting and
cleaning actions.
The following figure shows the major parts of the transfer unit.
A Transfer head C Transfer X guide rail

B Probe holder carriage
Figure A-15 Major elements of the robotic transfer unit
Transfer head The transfer head moves horizontally (along the X-axis); the probe moves up and
down (Z-axis), and it performs a rotational movement for mixing the cuvette and
reagent bottle content.
Transfer head arrest When the transfer head is obstructed in its horizontal movement, it immediately
stops. All pipetting and processing actions stop.
Roche Diagnostics
Hardware overview
A Mixing motor D Probe

B Transfer Z motor E Mixer movement axis
C Probe holder
Figure A-16 Transfer head
Mixing motor The mixing motor is mounted on the carriage. When running, it generates a circular
movement of the probe. This movement is used for mixing the content of cuvettes
and reagent bottles.
Probe The probe has a flat tip. This is required for tube bottom detection. Because such a
probe cannot pierce a bottle cap, all bottles must be placed on the instrument with
their caps removed.
Level detection A sensor detects when the probe enters a fluid. On the basis of this level, the system
establishes whether there is enough fluid to perform the scheduled pipetting action.
Tube Bottom detection A physical sensor is activated as soon as the probe touches the bottom of a sample
tube.
This mechanism also works when the probe touches an object outside the tube. In
both cases, probe action stops and an appropriate alarm message is generated.
Roche Diagnostics
Hardware overview
Fluid containers
The following table shows which container is used for which fluid:
Fluid Container(s) Position

Sample Tube Sample area
Control Tube Sample area
Calibrator Tube Sample area
Diluent Reagent bottle Reagent disk
System cleaner External cleaner bottle External fluid rack
Cleaner Reagent bottle Reagent disk
Reagent Reagent bottle Reagent disk
Water Bottle External fluid rack
Waste Bottle External fluid rack
Table A-5 Fluid containers, what they are used for and where
The term tube includes all kinds of tubes, as long as their dimensions lay within prescribed
limits. It also includes secondary tubes (cups). See Tubes on page A-52.
Waste containers
A
C
A Tubing adapter C Internal waste tank

B External waste container
Figure A-17 Waste container
Internal waste tank The internal waste tank collects the waste from the wash station and the ISE unit, if
this is used. It also collects the condensation from the cooling assembly in the rotor.
The internal waste tank is connected by tubing to:
o External waste container
o Wash station
o Reagent cooler (condensation)
o ISE unit (if installed)
Roche Diagnostics
Hardware overview
External waste container The yellow external waste container is placed on the external fluid rack. It is designed
to be washed and reused.
Because the system periodically performs wash actions, an external waste container
must be connected at all times. Therefore, when you empty the waste container, you
immediately replace it with the spare container and then empty the original
container. (The instrument is supplied with a spare waste container.)
There is no active level monitoring for the external waste container, but you are
notified if the external waste container has not been emptied for more than one day.
The external waste container is connected by tubing to the internal waste tank.
e See Connecting and disconnecting the external fluid containers on page B-113.
See Checking the status of the external fluid containers on page B-15.
See maintenance action Clean the water and waste containers on page C-16.
Water container
The white water container is positioned on the external fluid rack. Attached to the cap
is a suction tube, which is equipped with a water filter.
There is no active level monitoring for the water container, but you are notified if the
water container has not been refilled for more than one day.
The water container is designed to be washed and refilled.
B
C
A Tubing C Water inlet filter

B Container
Figure A-18 Water container
The water container is connected by tubing to:

o Wash pump
o Syringe assembly
o Probe
See maintenance action Clean the water and waste containers on page C-16.
See maintenance action Replace water inlet filter on page C-19.
Roche Diagnostics
Hardware overview
Cleaner bottle
The cleaner bottle is positioned on the external fluid rack. It is designed to be replaced
when empty.
Level monitoring for the cleaner bottle is based on the number of cleaning and
pipetting actions that were performed.
A Tubing adapter B Cleaner bottle
Figure A-19 Cleaner bottle
When delivered, the bottle has a white cap. During installation, this is replaced by a
red cap with tubing attached to it (tubing adapter).
The cleaner bottle is connected by tubing to:
o Syringe assembly
o Probe
Roche Diagnostics
Hardware overview
Reagent bottles
The cobas c 111 instrument works exclusively with reagent bottles

that are equipped with a two-dimensional barcode.
Each bottle holds up to 20 mL of fluid. The actual volume depends
on the test.
Place the bottles on the reagent disk as instructed by the software.
Reagents are handled in reagent sets. A set consists of up to three
reagents. You always load and replace all bottles of a set.
Chimneys Chimneys are bottle inserts that reduce evaporation.

For reagents that are especially sensitive to concentration changes,
Roche recommend using chimneys on the reagent bottles. (See the
package inserts of the tests whether you should use chimneys or
not.)
To generally reduce evaporation, you may use chimneys on all
reagent bottles.
Incorrect results due to declining reagent quality

If the application definitions (see package insert) recommend the use of chimneys, the
CAUTION corresponding calibration intervals apply to conditions when working with chimneys.
Roche recommend using chimneys whenever this is recommended on the test insert.
Roche Diagnostics
Hardware overview
Tubes
The cobas c111 instrument can use both primary and secondary tubes (cups).
You can use any type of primary tube, as long as their dimensions lay within
prescribed limits.
o Maximum height (including secondary tube): 102 mm
o Minimum height: 70 mm
o Maximum outside width: 16.3 mm
o Minimum outside width: 11.8 mm
The following table lists a few typical tubes that are suitable, and it gives the dead
volume for each of them.
Tube name Dead volume

13 x 75 mm 500 µL
13 x 100 mm 500 µL
16 x 75 mm 700 µL
16 x 100 mm 700 µL
Table A-6 Typical examples of suitable tubes
Roche recommend using approved cups only. The following table lists the approved
cups.
Cup name Dead volume Placement

Hitachi standard cup 75 µL for 2 µL sample volume Directly on sample area
Hitachi micro cup 50 µL for 2 µL sample volume Directly on sample area
Roche Diagnostics Standard 75 µL for 2 µL sample volume Directly on sample area
false bottom tube
Table A-7 Typical examples of suitable tubes
The Hitachi standard and micro cups can be placed on top of 16 x 75 mm tubes.
Cups with a rim can be placed directly on the sample area, whereas cups without rim
must be placed on top of primary tubes.
Cuvettes
All optical measurements are made using the same transparent

plastic containers, called cuvettes. Samples are automatically
transferred from a sample tube to the cuvettes on the cuvette ring.
Cuvettes are disposable to eliminate carry-over.
Roche Diagnostics
Hardware overview
Cuvette segments
Each segment holds 10 cuvettes.
A Segment handle C Cuvettes

B Cuvette segment holding individual cuvettes
Figure A-20 Cuvette segment
Handling cuvettes
Cuvettes are supplied in boxes containing cuvette sets. Each set contains a number of
cuvette segments. This way, the cuvettes can easily be handled without touching them.
Loading and removing cuvettes is guided by the system software. When handling is
required, the rotor moves the cuvette segments to the cuvette port, where you can
load or remove them. You handle one segment at a time. Cuvette segments are placed
in the cuvette ring of the rotor.
e See Preparing cuvettes on page B-27.
Incorrect results due to scratched or soiled cuvettes

Scratches and impurities on the cuvettes distort the measurements.
CAUTION Do not touch the cuvettes and make sure they do not touch other items when handling
them.
A Hold the segment by its handle. Make sure not to touch the cuvettes.
Figure A-21 Handling a cuvette segment
Roche Diagnostics
Hardware overview
Reagent handling
Loading and removing reagents is guided by the system software. When handling is
required, the rotor moves the bottles to the reagent port, where you can load or
remove them. You handle one reagent bottle at a time. Reagent bottles are placed on
the reagent disk.
e See Preparing the reagents on page B-22.
Figure A-22 Handling a reagent bottle
Roche Diagnostics
Hardware overview
Rotor
The rotor provides the following features:

o Space for up to 27 reagent bottles (on the reagent disk)
o Space for up to 60 cuvettes (in the cuvette ring)
o A cooled environment for reagents (reagent cooler)
o A temperature controlled environment for samples (cuvette ring)
o A synchronized transport mechanism to move reagent bottles and cuvettes to the
pipetting, loading, and measuring positions.
A Reagent disk C Temperature controlled cuvette ring (not

B Reagent cooler visible)
D Cuvette segment
Figure A-23 Main rotor elements
Rotational movement The bottles and cuvettes are positioned in a manner that they can be moved to the
various positions by a rotational movement. There are positions for loading and
removal (reagent and cuvette ports), pipetting, and measuring.
A A
A Pipetting positions B Reagent port
Figure A-24 Reagent port on the reagent disk
Roche Diagnostics
Hardware overview
Reagent disk
The reagent disk holds up to 27 reagent bottles. It is designed to be handled as one

unit, including the bottles. When not used on the instrument, the reagent disk is
placed in a container and stored in a refrigerated place.
Figure A-25 Reagent disk
NOTICE Damage to the reagent disk

The reagent disk is designed to handle reagents while it is loaded on the instrument. The
cover is equipped with a locking mechanism.
Always remove and load reagents while the reagent disk is on the instrument and by using
the software supported procedures.
e See Preparing the reagent disk on page B-21.
Reagent disk ID You can use up to eight different reagent disks on one cobas c111 instrument. Each
reagent disk is equipped with numbered tabs. For automatic disk identification by the
instrument, one—and only one—of these tabs is removed. The number of this
removed tab is the disk ID. When you label the disk, make sure that the number on
the label corresponds to that of the removed tab.
A
A
B
C
A Reagent disk IDs. There are eight possible C Identification tabs

IDs. D The tab has been removed for automatic
B Disk label. The number must correspond to disk recognition
the reagent disk ID.
Figure A-26 Reagent disk ID
Roche Diagnostics
Hardware overview
Reagent disk container
For storage outside the instrument, the reagent disk is placed in a container. This
reduces evaporation of reagents and prevents their contamination.
Reagent cooler
The reagent cooler holds the reagent disk with its reagent bottles. The temperature in
the cooler is kept within the range of 6 to 10°C.
A Reagent cooler
Figure A-27 Reagent cooler
e See maintenance action Clean reagent disk and sample area on page C-14.
Roche Diagnostics
Hardware overview
Cuvette ring
The cuvette ring holds up to 6 cuvette segments, each containing 10 cuvettes.
B
A Cuvette ring B Cuvette segment
Figure A-28 Cuvette ring
Cuvettes fit neatly in the cuvette ring, without touching the walls when being moved
along the ring.
e See Preparing the reagents on page B-22.
See maintenance action Clean reagent disk and sample area on page C-14.
Roche Diagnostics
Hardware overview
Barcode scanner
A hand-held barcode scanner is used for reading barcoded labels.
Loss of sight
A B
A Barcode scanner B Scanner connector on the instrument
Figure A-29 Hand-held barcode scanner
Connect to the lower COM2 port

Always connect the barcode scanner to the lower of the two serial communication
connectors (B).
e For information on how to use the barcode scanner, see Using the barcode scanner on
page B-79.
The following containers are always supplied with barcodes:

o Reagent bottles
o Diluent bottles
o Auxiliary fluids (diluents, cleaners etc.)
Sample tubes can be used with or without barcoded labels.
Reagent bottle barcode On the reagent bottles, barcode of the PDF417 format is used.
The barcode contains the following information:
o Part ID
o Lot number
o Expiration date
o Reagent volume
o Serial number of bottle
o Test data
Roche Diagnostics
Hardware overview
Sample barcode The following barcode types are supported for sample tube identification:
o Codabar
o Codabar 2 of 7
o Code 3 of 9
o Code 128
o EAN
o Interleaved 2 of 5
o UPC (A, E)
A sample barcode must include a checksum at the end.
Printer
The cobas c111 instrument has a built-in thermal printer with a 112 mm paper roll.
The printer is used for example for printing placement lists, results, maintenance
action instructions, and status information on various items such as the loaded tests.
A
B
A Panel release button C Printer panel

B Paper slot
Figure A-30 Printer
e See maintenance action Refilling printer paper on page B-108.

See To clear the paper jam on page D-40.
Roche Diagnostics
Hardware overview
Absorbance photometer
The cobas c111 main instrument uses the absorbance photometry measuring
method.
Absorbance photometer
A Photometer unit
Figure A-31 Photometer unit
The measurements are taken without removing the cuvette from the rotor.
Halogen lamp The Halogen lamp is mounted on a holder for easy replacement. The system informs
you when you need to replace the lamp.
e See maintenance action Replace photometer lamp on page C-23.
Wavelengths for the absorbance For each cuvette, the absorbance photometer measures light intensity at 12 different
photometer wavelengths:
340 nm 449 nm 520 nm 629 nm

378 nm 480 nm 552 nm 652 nm
409 nm 512 nm 583 nm 659 nm
Measurement principles e See Principles of operation on page A-17.
Roche Diagnostics
Hardware overview
Connectors
E
A F
G
H
I J K
A Power supply G Maintenance connectors (Do not remove the

B Data and communication connectors cable.)
C Fluid connectors H USB 2 connector (for troubleshooting)
D Front USB port (not shown) I Water connector
E Serial communication connector J Cleaner connector
F Barcode scanner connector K Waste connector
Figure A-32 Connectors
Roche Diagnostics
Hardware overview
Fuses
Electrical shock by electronic equipment

Do not attempt to work in any electronic compartment. Installation, service, and repair
WARNING must only be performed by authorized and qualified personnel.
The mains fuses are situated at the rear of the instrument, above the power connector;
the internal fuses are situated on the right side of the instrument, at the top of the
connector panel.
A Power connector with T6.3 A H 250 V fuse B Low voltage fuses (T3.15 A)
F1: Heating system
F2: Motors
F3: Cooling assembly
F4: Photometer unit and LEDs
Figure A-33 Fuses
e See To change the mains fuses on page D-41.

See To change a low voltage fuse on page D-43.
Roche Diagnostics
Technical specifications
NOTICE Every effort has been made to ensure that all the information contained in these
specifications is correct at the time of printing. However, Roche Diagnostics reserves the
right to make any changes necessary without notice as part of ongoing product
development.
Physical dimension Width (with ISE unit) 590 mm (720 mm)

Depth (with ISE unit) 550 mm (550 mm)
Height (with ISE unit) 480 mm (480 mm)
Weight (with ISE unit) Approximately 32 kg (35 kg)
Power requirements Line voltage 100-125 V and 200-240 V (-15%, +10%)

Line frequency 50 Hz (±5%) and 60 Hz (±5%)
Power consumption 250 VA
Insulation coordination Installation category II (IEC 61010-1)
Main fuse T6. 3 A H 250 V
Low voltage fuses T3. 15 A L 250 V
Battery Sonnenschein SL360 (3.6V, Size AA)
Power requirements ISE unit Line voltage 100-240 V (±10%)

(optional unit)
Line frequency 50 Hz (±5%) and 60 Hz (±5%)
Supply voltage 19-24 V DC, Min. 2A
Power consumption 70 VA
Insulation coordination Installation category II (IEC 61010-1)
Measurement principles Absorbance photometry (enzymes, substrates, drugs of abuse)

Potentiometry ISE (ion selective electrodes) Na+, K+, Cl-
Environmental conditions Temperature Running conditions: 15-32°C

Transport and storage: -25 to +60°C
Humidity Running conditions: 30-80% at 15-32°C, non
condensing.
Transport and storage: 10-95%, non condensing
Pollution Degree 2 (IEC 61010-1)
Altitude Max. 2000 m above sea level
Throughput Photometric 85 tests/h max.; 60 tests/h consolidated (with typical test

panel)
ISE 180 tests/h max.; 60-100 tests/h consolidated
(photometric and ISE mixed)
Samples Sample handling Manually by operator

Time to first result 5-10 min (photometric measurements)
2 min (ISE measurements)
Roche Diagnostics
Water purity Minimum requirements Electrical resistivity [MΩ*cm @ 25°C] >1

Electrical conductivity [µS/cm @ 25°C] <1
Silicate (SiO2) [mg/L] < 0.1
Particulate matter size [µm] n/a
Bacteria [CFU/mL] < 1000
Whenever the term "purified water" is used in this document, water of at least the quality
specified above must be used.
Roche recommends using Reagent Grade water.
Calibrators Roche calibrators See the package inserts of the reagents.
Reagent bottles Reagent bottles 20 mL maximum

Identification Barcode
Barcode 2-D, format PDF417
Number of tests 50-200 tests, depending on the test
Cuvettes Segments of 10 cuvettes Manual insertion and removal of segments

Single use Cuvettes are for single use only
Static incubation temperature in 37°C ±0.5°C
cuvette
Photometer Absorbance photometer 20 W halogen lamp

12 wavelengths 340-659 nm
Sensor Photosensitive diode array
ISE unit Ion-selective electrode Indirect measurement

Sample volume 15 µL; Dilution 1:6 (1 part sample, 5 parts water)
3 Electrodes Na, K, Cl
1 ISE Reference Electrode
Software data handling Operating system o LINUX

o VX Works
CPUs Intel XScale
Memory system o Flash ROM
o DRAM
o SRAM
Mass storage External USB memory stick

Internal Flash ROM
Interfaces USB1.1/2.0 For backing up data or loading data on the system

(memory stick)
USB1.1/2.0 Modem
2 x RS232 Host, barcode scanner
Display Color touchscreen 5.7 inch active matrix (1/4 VGA, 320 x 240 pixels)
Printer Internal thermal printer Paper width 112 mm
Roche Diagnostics
Roche Diagnostics
cobas c111 4 Software
Table of contents
Software
Getting the most out of the instrument
In this chapter, you will find information on how to operate the instrument by using
the touchscreen. You will find out about the concept of wizards and you are
introduced to the key screens.

Introduction .............................................................................................................. A-69
Screen layout .............................................................................................................. A-70
Display items ............................................................................................................. A-71
Color concept ...................................................................................................... A-72
Workflows and wizards ............................................................................................. A-72
Navigation ............................................................................................................ A-72
Working with the user interface ............................................................................... A-73
Adjusting the touchscreen ................................................................................... A-73
Scrolling ............................................................................................................... A-73
Expanding and collapsing lists ............................................................................ A-74
Typing text ........................................................................................................... A-74
Using the filter function ...................................................................................... A-76
Printing information ........................................................................................... A-78
Using online Help ................................................................................................ A-79
Messages ............................................................................................................... A-80
Message screen ............................................................................................... A-80
Alarm monitor ............................................................................................... A-80
Key screens ................................................................................................................. A-82
Roche Diagnostics
4 Software cobas c111
Table of contents
Overview tab ........................................................................................................ A-82

Sample overview ............................................................................................ A-84
Order .............................................................................................................. A-85
STAT ............................................................................................................... A-87
Tests ................................................................................................................ A-87
Log off ............................................................................................................ A-89
Prepare ........................................................................................................... A-89
End Shift ........................................................................................................A-89
Cuvette status ................................................................................................. A-89
Disk and reagent status ................................................................................. A-90
ISE status ........................................................................................................ A-91
System status .................................................................................................. A-92
Workplace tab ...................................................................................................... A-94
Orders ............................................................................................................ A-95
Result list ........................................................................................................ A-96
QC status list .................................................................................................. A-98
QC History ..................................................................................................... A-99
Calibration list ............................................................................................. A-101
Lot data ........................................................................................................ A-102
Lot list .......................................................................................................... A-103
Loadlist ......................................................................................................... A-104
Worklist ........................................................................................................ A-104
Utilities tab ......................................................................................................... A-105
Configuration .............................................................................................. A-106
Maintenance ................................................................................................ A-107
Import .......................................................................................................... A-108
Export ........................................................................................................... A-108
Applications ................................................................................................. A-109
Applications ................................................................................................. A-110
Host Codes ................................................................................................... A-111
Diagnostics ................................................................................................... A-111
Users ............................................................................................................. A-112
Stopping a run ................................................................................................... A-113
Color interpretation for LEDs ................................................................................ A-114
Buttons ..................................................................................................................... A-116
Roche Diagnostics
Introduction
Introduction
To operate the cobas c111 instrument, you use its touchscreen. The design and
functional concept of the touchscreen support you in the way you work.
The following table lists the major items and characteristics of a cobas c111 screen
and describes their impact on the operation of the instrument.
Screen item Impact on operation

Screen types Distinct screen types make it easy for you to find your way
around the user interface. For example, you immediately
know whether you are on a main screen or whether you are
reading a message.
Screen layout The consistent layout allows you to quickly find the required
information and to locate the various display items.
Buttons Press a button to open and close a screen or to start a
function.
Colors The color of an item on the screen points to its own status or
that of the item it represents.
The "traffic light" color scheme is used:
o Green: Everything is OK.
o Yellow: The system is working, but you need to intervene
for it to continue to do so.
o Red: This item does not work, you need to intervene.
Wizards A wizard denotes a predefined sequence of screens (steps)
that represent a certain task, for example defining an order.
By following the suggested sequence of steps you ensure the
proper execution of the tasks and functions.
With some critical tasks, you need to follow the wizard
exactly, right through to the end. In other cases, you may skip
a step and perform it later.
Table A-8 The major items and characteristics of the touchscreen
Roche Diagnostics
Screen layout
Screen layout
All screens are based on the following layout:
A
B
C
A Status area D Global action area

B Tabs E Working area
C Headline F Buttons area
Figure A-34 Basic screen layout
The screen representations shown in this chapter and throughout this manual are for
illustrative purposes only. The screens do not necessarily show valid data.
Depending on the function of a screen, some layout items may not be displayed.
The following is an example of a screen with the full range of display items.
A F
B
C
G
D
A The status line displays the system status. E The buttons vary depending on the content
B Tabs represent the major work areas. You of the working area and the screen position
can switch to any of them any time. within a series of steps (wizard).
C The headline characterizes the content or F The Help button leads to concise information
function of the screen. If the screen is part of that is relevant to the current screen and
a sequence of screens (wizard), the headline situation.
tells you where you are within this sequence. G The global action buttons represent the
D The working area displays the main content functions that are permanently available:
of the screen. Start, Stop, Alarm, Line Feed. The LEDs next
to them point to their status.
Figure A-35 Example of a screen
Roche Diagnostics
Display items
Display items
The cobas c 111 screens are made up of text areas and various kinds of display items
such as tabs and buttons.
The following table lists the major display items and describes their use.
Display item Use
1* Button Press a button to start a function. In addition, many

buttons also either open a new screen or close the
current screen.
A triangle in the top right corner of a button tells you
that a new screen will be displayed when you press
the button; a triangle in the bottom left corner that
the current screen will be closed.
Global action The global action buttons are positioned on the right
button side next to the screen. The LED next to each of the
buttons indicates whether the button is active or not.
List Press a list item to select it. (Its color turns blue.)
Use the scroll buttons to display the items that are
not visible.
Text Text usually provides information or instructions. It

can be color coded to indicate its importance level.
Tab Tabs are used to group information into units that

can be displayed on one screen.
Table A-9 Major display items
Roche Diagnostics
Workflows and wizards
Color concept
The color of buttons and other display items tells you about the status of the display
item or the item it represents.
The cobas c111 instrument uses the familiar "traffic light" color scheme.
Color Meaning for buttons
Green The element is OK.
Yellow Your intervention is required to ensure continuous operation.
Red Your immediate intervention is required. Operation has stopped.
Blue The item is selected.
Table A-10 Color concept
e For details on the meaning of LED colors, see Color interpretation for LEDs on page A-114.
e For details on the meaning of button colors, see the explanations in the relevant operation
instructions.
Workflows and wizards
Screens and sequences of screens help you perform your tasks. If not all steps of a task
can be performed from one screen, the workflow is realized as a sequence of screens, a
so-called wizard. cobas c111 wizards do not usually force you to perform a task at a
certain stage, they just make your work easier.
Navigation
Moving from screen to screen You move from screen to screen with the help of buttons.
Knowing where you are Screens on which you perform tasks provide a headline that displays the navigation
path of the current screen.
A B
A Button where you started C Headline

B Current position in the workflow
Figure A-36 Headline with navigation path
e For an overview of the navigation buttons, see Navigation functions on page A-118.
Roche Diagnostics
Working with the user interface
Adjusting the touchscreen
With a touchscreen, it is important that the point where you press the screen
corresponds exactly with its hardware equivalent. If this were not the case, pressing a
screen item such as a button might not lead to the expected result.
e See Adjusting the touchscreen on page B-116.
Scrolling
If not all text or all list elements fit on one screen or display area, use the scrolling
function to display the hidden content.
A B C
A You are on the first page. You can scroll C You are on the last page. You can scroll up.
down.
B There is text both before and after the
currently displayed text. You can scroll up
and down.
Figure A-37 Scroll bars
Scroll to the previous page.
Select the previous line and scroll if necessary.
Select the next line and scroll if necessary.
Scroll to the next page.
Roche Diagnostics
Expanding and collapsing lists
In hierarchically structured lists, you initially see only the top level entries. List items
that contain (but hide) lower levels of entries are marked with . List items that
display lower levels of entries are marked with .
Figure A-38 Hierarchically structured list
a To expand a list
1 Select a list item marked with .
2 Press again or press .
3 Use the scrollbar, if required, to display the items you are interested in.
a To collapse a list
1 Select a list item marked with .
2 Press again or press .
Typing text
There are dedicated screens for typing alphanumeric and numeric characters.
You can choose from the following screens:
o Alphanumeric upper case
o Alphanumeric lower case
o Special characters
o Numeric characters
Roche Diagnostics
Numeric keyboard
A Typed text
Figure A-39 Numeric keyboard screen
< > Delete the last character displayed in the text line.
<A-Z> Switch to the uppercase alphanumeric keyboard.
Alphanumeric keyboards
A Typed text
Figure A-40 Upper and lowercase alphanumeric keyboard screens
Switch to the lowercase keyboard.
Switch to the uppercase keyboard.
<$%> Switch to the special characters keyboard
< > Press to insert a space.

]
Roche Diagnostics
Special characters keyboard
A Typed text
Figure A-41 Special characters keyboard screen
Switch to the lowercase alphanumeric keyboard.
<A-Z> Switch to the uppercase alphanumeric keyboard.
< > Press to insert a space.

]
Using the filter function
In many lists you can apply a filter, that is, you can select predefined criteria for
generating a selection of entries.
The way to apply a filter is the same in all screens where a filter is available. Here is an
example:
a To apply a filter to a list

1 Display the list.
Figure A-42
Roche Diagnostics
2 Press .
A screen is displayed for selecting the filter criterion.
A In the status line, the screen is indicated where you pressed .

Figure A-43
3 Choose one of the filter options.

4 Press .
The list is displayed again. It now contains only the entries that comply with the
criterion you just applied by pressing its button.
After you have applied a filter, the criterion name will appear as part of the <List> button,
for example on screens for deleting data. If you used the <Not Accepted> filter criterion,
the <List> button would be called <List [Not Accepted]>.
Figure A-44 List button names
Roche Diagnostics
Printing information
On many screens, you can print the contents of the working area on the built-in
printer. In many cases, a screen is first displayed for selecting the kind of data you
want to print. In these cases, the print button is marked with a triangle in the top
right corner .
a To print information
1 Press .
If filter criteria are available, a screen is displayed for selecting what data you want
to print. For example:
A In the status line, the screen is indicated where you pressed .

Figure A-45
2 Choose one of the print options.

The appropriate data is automatically selected and printed.
Choose > to terminate the printing task, if required.
Roche Diagnostics
Using online Help
The Help button is a permanent feature of all screens.
A The Help button is always in the top right corner of the screen.
Figure A-46 Permanent Help button
a To display the Online Help

1 Press .
A The [Legend] tab describes the buttons B The [Workflow] tab provides additional
and their colors. information on items on the screen or on
actions you can perform.
Figure A-47
2 Use the scroll bar to display the hidden information.

e For details on scrolling, see Scrolling on page A-73.
Roche Diagnostics
Messages
Messages are displayed in two ways:

o Immediate feedback on user actions is displayed in a pop-up message screen.
o Information concerning a problem that occurred during operation is reported in
the alarm monitor.
Message screen
Message screens are displayed automatically as soon as the message is generated.
Figure A-48 Message screen
Read the message and press to close the screen.
Alarm monitor
Messages concerning an irregularity that occurred during operation can be viewed in
the alarm monitor. The alarm LED alerts you when such messages are generated. It is
turned off as soon as the alarm monitor is displayed.
The Alarm button is always active, even if nobody is logged on the system.
Alarm button and LED
A Alarm LED B Alarm button
Figure A-49 Alarm LED
Roche Diagnostics
Interpreting the alarm LED
No color, off There are no alarm messages to be dealt with. (All alarm messages have been
acknowledged.)
Yellow There is at least one alarm message that you need to deal with as soon as possible.
Red There is at least one alarm message that you need to deal with. Processing cannot
continue unless you do so.
Acoustic signal An acoustic signal is sounded when an alarm is generated. You can adjust the volume
(Utilities > Configuration > System > Volume).
a To display alarm messages

1 Press .
Alarm message A B
A Alarm ID D Problem description and short remedy

B Number of total messages currently not suggestion
yet dealt with. E Display the next alarm message.
C Display the previous alarm message.
Figure A-50
2 Press to display the detailed message.
Detailed alarm message
Figure A-51 Example of a detailed alarm message
Roche Diagnostics
Key screens
Key screens
The main screen is divided into tabs. These tabs represent distinct work areas.
o The Overview tab is your main work area when performing the daily routine tasks.
o Use the Workplace to gain information on orders and the corresponding results.
You can also start the lot handling functions from this tab.
o Use the Utilities tab to perform tasks that are not normally part of the routine
analysis workflow. Typically, these would be administration and maintenance
tasks.
The following sections describe the key screens of these tabs and point out the main
tasks you can perform on them.
Overview tab
The Overview tab is your main work area when performing the daily routine tasks.
A Tube icons C Buttons

B Status of current order processing
Figure A-52 [Overview] tab
Show details about the order for this sample.
<STAT> Define STAT orders.
<Order> Define routine orders.
<Tests> Check the status of the currently installed tests.
<Log off> (<Log on>) Log off or on the system.

If somebody is logged on, your user name is displayed, for example <admin>; if
nobody is logged on, <Log on>.
<Prepare> Perform the preliminary tasks at the beginning of a shift.
<End Shift> Perform the necessary tasks when ending the shift.
Roche Diagnostics
Key screens
Check the status of the reagent disk.
The reagents are OK.
Fewer than 10% of tests are left for a reagent set, or its expiration date has expired.
No or unidentified disk on board.

A reagent set is not complete or a reagent is empty.
Check the status of the cuvette segments currently loaded on the rotor.
More than one segment is available.
The last available cuvette segment is in use.
No cuvettes are available.
<System Status> The <System Status> button displays both the icon and the color of one of the
buttons of the underlying system status screen (see System status on page A-92).
The icons are first prioritized by color, first priority being red, followed by yellow and
green, and then according to the sequence in which they are listed below.
This button can show either of the following icons.
Analyzer (main cover)
Reagent cooler and cuvette ring temperature
Sample area ventilation
External fluid containers
Maintenance
Printer
Roche Diagnostics
Key screens
Sample overview
B
C
A Sample tube buttons C Results

B Open orders
Figure A-53 Sample tube status on the [Overview] tab
1 The number in the button indicates the position on the sample area.
A sample tube button with a wide edge symbolizes a STAT order.
1
All tests are completed and their results are accepted.
1*
All tests are pipetted.
1!
All tests are completed but not yet accepted.
1!
All remaining tests are blocked for one of the following reasons:
o There is not enough sample fluid.
o The sample is not identified.
1
There is no sample on this position.
1+
Tests are ordered. Processing has not yet started.
1*
Tests are ordered, processing has started.
1?
The sample is identified, but no tests were ordered yet.
If working in Order Query Mode: The order could not be obtained from the host.
Roche Diagnostics
Key screens
Order
h Overview > Order
Press <Order> to define routine orders.
The process of defining an order, and consequently which screens are displayed,
depends on how your cobas c 111 instrument is integrated in your laboratory
infrastructure (barcodes, host connection).
Identifying samples
h Overview > Order
Figure A-54
Order Interval QC.
Order Default QC.
Typing the sample ID
h Overview > Order

(If you work with barcodes, additionally press .)
Figure A-55
e For information on how to use the keyboard screens, see Typing text on page A-74.
Order Interval QC.
Order Default QC.
Roche Diagnostics
Key screens
Selecting tests
h Overview > Order > identify sample
A Easy mode test-board, all tests fit on one C Full mode test-board. The tests are grouped
screen. in tabs.
B Tabs marked with an asterisk contain
selected tests.
Figure A-56 Test selection screens
Tabs are used to group information into units that can be displayed on one screen.
The system administrator can define up to six test tabs, name them and assign tests to
them.
The tests are sorted alphabetically. Profiles precede the tests, and they adopt the color
of their tests.
The test is on board and ready for use.
The test has already been pipetted.

CA
The test is blocked.
A QC is due or its result has not been accepted.

A more recent version of the application has been imported.
For a development channel: An extra wash cycle is missing.
The test is defined but not on board.
Display a screen that contains information on the status of each test.
Roche Diagnostics
Key screens
STAT
h Overview > STAT
Press <STAT> to define urgent (short turn-around time) orders.
The process of defining a STAT (short turn around time) order is identical to that of
defining a routine order. The difference lies in the scheduling of the tasks. When a
STAT order is defined, it will be the next order to be processed, irrespective of what
routine orders already exist. Existing STAT orders are finished first.
Tests
Displaying the test overview
h Overview > Tests
Tabs The tabs are displayed if you work with the order mode Full. They represent user-
defined test panels. If you work with the order mode Easy, all tests are on one panel
and there are no tabs.
A Test selection screen in order mode Easy. B Test selection screen in order mode Full.
Figure A-57 Test selection screen
The color of a test button represents its status:
The test is blocked for one of the following reasons:

o The calibration is due or failed.
o For the reagent set, the number of available tests is 0, or a reagent bottle is missing
(incomplete reagent set).
o Initial calibration is required.
Roche Diagnostics
Key screens

The test is not on board.
<xyz>
Display detailed information on the status of this test.
Display a list of all defined tests, together with information on their status.
Handle the reagent disk that is currently on board.
Displaying test details
h Overview > Tests > test button
A Status description of the test
Figure A-58 Details on a test
The color of the text indicates whether you need to react to the information, and if so,
with which urgency you need to deal with the issue.
[Calibration] Information on the calibration status.
[Quality control] Information on the QC status.
[Tests on disk] Total number of tests that are currently available. (There might be more than one
reagent set for this test on board.)
[Tests ready to run] Number of tests that could be performed, taking into account all disks known to the
system. (The reagent sets have been calibrated and are ready for use.)
Print the test status information.
Show the fluids that were used for generating this result, together with their lot
information.
Roche Diagnostics
Key screens
Log off
h Overview > button with your user name
Log off the system.
You can log off any time, even while the system is processing orders.
Prepare
h Overview > Prepare
Start the Prepare wizard to perform the preliminary tasks at the beginning of a shift.
End Shift
h Overview > End Shift
Start the End Shift wizard to perform the tasks necessary for ending the shift.
Cuvette status
h Overview > .
A Overview of required and available cuvettes
Figure A-59 Cuvette status
The six cuvette segments are represented by buttons. The number in the button
indicates how many cuvettes are free to be used.
Press a segment button to exchange the corresponding segment.
The segment buttons are color coded:
All cuvettes are used.
Up to two cuvettes are free to be used.
More than two cuvettes are free to be used.
Roche Diagnostics
Key screens
Disk and reagent status

h Overview >
A A plus (+) indicates that there is already an active identical reagent set on board. (This icon is
displayed as soon as the first bottle of the set is loaded.)
Figure A-60 Reagent sets loaded on the reagent disk
The color of a reagent set button represents the status of the set:
The reagent set is on board, but it is blocked for one of the following reasons:
o The number of available tests is 0.
o The set is incomplete.
o The test needs calibrating.
o There is no application that uses this reagent set.
There are fewer than 10% of tests are left for this set.
The expiration date has expired.
The reagent set is on board and ready for use.
<xyz>
Display detailed information on the status of this test.
Load a reagent set.
Display a list with all tests on board, together with information on their status.
On the list, the following abbreviations are used to indicate the status of the reagent
set:
o C: Calibration missing
o E: Empty
o I: Incomplete
o N: Not used
o L: Low
o X: Expired
Handle the reagent disk.
Roche Diagnostics
Key screens
ISE status
This button is only active if your instrument is equipped with an ISE unit.
h Overview > .
Figure A-61 ISE status
<Na> <K> <Cl> <Ref> Display detailed information on the status of the electrode.
The expiration date of an electrode has expired.
The electrode is ready for use.
Calibration required. (Does not apply to the reference electrode.)

After installing a new electrode, the Electrode Service maintenance action is due.
<Cal> <Ref> Display detailed information on the status of the ISE fluid bottle.
No fluid registered by a sensor. (Operation has stopped.)

Calibration required.
The fluid level in the bottle is low. (Operation will proceed until one of the sensors
detects that there is no fluid.)
There is sufficient fluid.
Display the placement list for actions that are due, for example calibration or
electrode service.
Roche Diagnostics
Key screens
System status
h Overview > , or , or , or , or , or
The system status button on the [Overview] tab displays both the color and the icon
of one of buttons of the system status screen. (The icons are first prioritized by color,
first priority being red, followed by yellow and green, and then according to the
sequence in which they appear on the screen.)
Figure A-62 System status
Check the texts for the status of hardware items and on IDs of installed software.
Status of the instrument.
The main cover is open.
A development channel application is run without using extra wash cycles.

Roche strongly recommends to always use extra wash cycles with development
channel applications.
Temperature status for reagent cooler and cuvette ring.
The temperature is outside the acceptable range.
Status of the sample area fan.
The fan is not running.
Display information on the fill status of each of the external bottles.

The color of the underlying buttons is displayed.
e See Checking the external bottles on page A-93.
Display the maintenance actions list.

The color of the most urgent maintenance action is displayed.
e See Maintenance on page A-107.
Status of the printer paper.
The printer is out of paper.
Roche Diagnostics
Key screens
Checking the external bottles
h Overview > > .
Figure A-63 Status of external containers
Water button Press to confirm that you have refilled the external water container.
The water container was last filled up less than one day ago.
The water container was last filled up more than one day ago. (The system does not
monitor the filling level. It is up to the operator to fill up the water container
regularly.)
A fluid sensor detected that there is no water in the instrument tubing. No new tests
can be processed, started tests may have to be restarted after refill.
Waste button Press to confirm that you have emptied the external waste container.
The waste container was last emptied less than one day ago.
The waste container was last emptied more than one day ago. (The system does not
monitor the filling level. It is up to the operator to empty the waste container
regularly.)
Cleaner button Press to confirm that you have exchanged the external cleaner bottle.
The cleaner is OK.
The cleaner level is down to 10% or lower. See the % indication.
A fluid sensor detected that there is no cleaner in the instrument tubing. No new tests
can be processed, started tests may have to be restarted after replacing the bottle.
Roche Diagnostics
Key screens
Workplace tab
The [Workplace] tab leads to information on orders and the corresponding results.
Figure A-64 [Workplace] tab
<Orders> View and handle orders.
<Result Review> View and validate patient results.
<QC Status> View and validate active QC results.
<QC History> View QC results of the current and previous months. Display graphs.
<Calibrations> View, validate and delete calibration results.
<Lot Data> Define and change calibration and QC lot data by reading barcodes or typing the
values.
<Loadlist> List of sample tubes that should to be on the instrument.
<Worklist> Information on tubes currently placed on the sample area.
Roche Diagnostics
Key screens
Orders
h Workplace > Orders
Figure A-65 Orders list
[St] column Status
A Accepted B All blocked

C Created D Deleted
F All calculated N No test order
O +Order time-out P All pipetted
R Ready S Some blocked
T Rerun time-out U Unknown
blank: Done (all tests measured and results accepted)
STAT orders are marked with an asterisk (*).
[Dn] column Number of tests done for this order.
[#] column Total number of tests required for this order.
Print the content of the orders list.

You can choose one of the following options:
o List (All orders in the list with their results. If a filter was applied, the list would
contain only the results that fulfill the filter criterion, and the filter criterion would
be part of the button name.)
o Detail of Order (The currently selected order with its results.)
Change the selected order.
Define a new order.
Delete orders.
You can choose what kind of orders should be deleted:
o List (All orders in the list. If a filter was applied, the list would contain only the
orders that fulfill the filter criterion, and the filter criterion would be part of the
button name.)
o Selected (Delete the selected order with its results.)
Apply filter criteria to the orders list.
Roche Diagnostics
Key screens
Result list
h Workplace > Result Review
Reviewing patient results
Figure A-66 Result list
This line contains result information.
This line contains sample information.
This line is selected.
[S] column Status

[!]: This result has not yet been accepted.
STAT orders are marked with an asterisk (*).

The time indication represents the time when the order was defined.
Print results. You can choose one of the following options:

o List (All results in the list. If a filter was applied, the list would contain only the
results that fulfill the filter criterion, and the filter criterion would be part of the
button name.)
o Detail of Order (All results of the associated order)
Validate the results.

o Repeat (Perform the same test with identical dilution.)
o Rerun (Perform the same test with different dilution.)
o Accept
o Retransmit
Display details of the selected result.
Roche Diagnostics
Key screens
Delete results.
You can choose what kind of result should be deleted:
button name.)
o Selected
Apply filter criteria to the results list.

You can choose one of the following criteria:
o All
o Flagged
o STAT
o Not Accepted
o Not Today
o Sent to Host
Roche Diagnostics
Key screens
QC status list
h Workplace > QC Status
Figure A-67 QC status list
The entries are grouped first by test name, then by control.
[S] column Status

!: The result has not been accepted yet.
@: The result has not been transmitted yet.
[Flag/Result> column Result if no flag was generated.

Flag with highest priority, if flags were generated.
Order status if the control measurement has not been performed yet.
[Previous Lot] indicates that controls of more than one lot were used.
Print QC results.
Validate the QC results.

o Accept
o Retransmit
Display details of the selected QC result.
Define a new QC order.
Delete QC results.
o All
o All Accepted
o Selected
Roche Diagnostics
Key screens
QC History
The QC History provides information on the QC results of the current and the
previous calendar month.
A graphic representation of the results provides a convenient way for comparing
results over a period of time.
h Workplace > QC History
Figure A-68 QC History
The list contains, for each test and control, the latest QC result. The entries are
grouped first by test name, then by control.
[Last Measurement] column Date and time of the most recent result.
[Previous Lot] indicates that control was performed after a QC lot change.
Print QC results.
Display a graphic representation of the QC results.
Delete QC results.
button name.)
o Older than Previous Month
o Selected
Apply filter criteria to the QC results list.

You can choose one of the following criteria:
o All
o Current lot
o Previous lot
Roche Diagnostics
Key screens
h Workplace > QC History >
A B C
D
E
F
H
I
J
A Calibration F +2s
B Reagent set change G Mean value
C QC target value change H -2s
D +3s I -2.5s
E +2.5s J -3s
Figure A-69 QC History graphic
Print the graphic.
Display the results in a table.

The results are sorted chronologically, relevant events (QC lot change, reagent set
change, QC target value change) precede the results.
Month button Display the results of the month indicated on the button.
Roche Diagnostics
Key screens
Calibration list
h Workplace > Calibrations
Figure A-70 Calibrations list
[U] column Use of calibration

CU: Current calibration
SB: Standby calibration
OB: Obsolete calibration
[T] column Calibration type

L: Lot calibration
S: Set calibration
[Status] column The date indicates when the results were accepted. If flags were generated for the
result, the flag with the highest priority is displayed. In all other cases, the order status
is displayed.
Print calibration results.

o List (If a filter was applied, the list would contain only the results that fulfill the
filter criterion, and the filter criterion would be part of the button name.)
o Detail of Calibration.
Validate the calibration.

o Accept
o Repeat
o Use Old
Use <Use Old> to override and reset the calibration due date and to continue
using the old calibration results.
Define a new calibration order.
Delete the selected calibration result.
Display details of the selected calibration.
Roche Diagnostics
Key screens
Lot data
h Workplace > Lot Data
Figure A-71 Select lot type
Choose the kind of material for which you want to handle lot data.
<Controls> Handle control lots.
<Calibrators> Handle calibrator lots.
Roche Diagnostics
Key screens
Lot list
h Workplace > Lot Data, then choose a lot type.
The content of this list depends on the selected lot type. The following screen is an
example of calibrator lot data.
A B C
D
E
A Calibrator name. B Calibrator lot

Asterisk: The lot data were changed by the C Expiration date
operator. D Associated test
E Lot values
[not installed]: The associated application
is not installed.
Figure A-72 Calibrator lot data
Print lot data.
With a calibrator selected: Expand or collapse the list.

With a test selected: Expand or collapse the list.
With a value selected: Change the value.
With a calibrator selected: Add a lot.

With a test selected: Assign a test to the lot.
With a value selected: Not active.
With a calibrator selected: Delete the lot values of the calibrator.

With a test selected: Delete the lot values of the test.
With a value selected: Not active.
Roche Diagnostics
Key screens
Loadlist
List of all sample tubes the system expects to be loaded on the instrument.
h Workplace > Loadlist
A B
A Number of due pipettings B Number of available pipettings
Figure A-73 Loadlist
Print the loadlist.
Worklist
The worklist shows all tubes currently placed on the sample area.
h Workplace > Worklist
A B
A Position on sample area E: ISE Etcher

B Fluid type: P: ISE Deproteinizer
A: Activator Q: Control
C: Calibrator S: Sample
D: Diluent U: Unknown
Figure A-74 Worklist
Print the worklist.
Roche Diagnostics
Key screens
Utilities tab
Use the [Utilities] tab to perform tasks that are not normally part of the routine
analysis workflow. Typically, these are administration and maintenance tasks.
Figure A-75 [Utilities] tab
<Configuration> View and change configuration values.
<Maintenance> Select and perform maintenance actions.
<Import> Import application data, software updates, the complete content of a database, and
certificates.
<Export> Export the complete content of the database, the full results, and log files.
<Applications> o Handle applications and their definitions.

o Handle extra wash cycles
o Display, export and import the mapping table for test IDs of the cobas c111
instrument and the laboratory information system.
<Diagnostics> Perform diagnostics actions.
<Users> Define users and manage their user rights.
Roche Diagnostics
Key screens
Configuration
h Utilities > Configuration
Figure A-76 Configuration list
There are list items of a lower level. Select the item marked with and press
again to expand the list and display the items.
The list is expanded. Select the item marked with and press again to hide the
items.
Print configuration data.

o All
o Selected (Print the settings of the selected configuration group.)
With an item selected: configure the selected item.

With a group title selected: expand or collapse the list.
Roche Diagnostics
Key screens
Maintenance
h Utilities > Maintenance
A B
A Maintenance action name D Use the scroll bar to display the

B Due dates, in ascending order maintenance actions that are currently
C This maintenance action is selected. hidden.
Figure A-77 Maintenance action list
The maintenance actions are listed according to the urgency with which they need to
be performed.
No action is currently required.
This maintenance action should be performed on the next major maintenance day.
The defined maintenance interval has expired. Perform this maintenance action now.
Perform the selected maintenance action.
Roche Diagnostics
Key screens
Import
h Utilities > Import
Figure A-78 Importing data
<Application> Import application data.
<Software> Import software updates.
<Database> Import the complete content of the database.
<Certificate> Import certificates that authenticate reagent barcodes.
<EWC/Mixing> Import extra wash cycle or mixing information for a particular application.
Export
h Utilities > Export
Figure A-79 Exporting data
<Database> Export the complete content of the database.
<Full Results> Export the full result data.
<Log Files> Export the system messages, alarm logs, and possibly trace logs.
Roche Diagnostics
Key screens
Applications
h Utilities > Applications
Figure A-80 Applications list
<Laboratory Parameters> Handle the definitions of the installed applications and import and install new
applications.
<Extra Wash Cycles> Handle and install extra wash cycles.
<Host Codes> Display, export and import the mapping table for test IDs of the cobas c111
instrument and the laboratory information system.
Roche Diagnostics
Key screens
Applications
h Utilities > Applications > Laboratory Parameters
Figure A-81 Applications list
items.
Print the application list.
With an item selected: change the selected item.

With any other item selected: expand or collapse the list.
Define a new order profile.
Delete a order profile.
Roche Diagnostics
Key screens
Host Codes
h Utilities > Applications > Host Codes
Figure A-82 Code mapping table
Print the mapping table.
Import the mapping table.
Export the mapping table as a text file.
Use the same test IDs for the cobas c111 instrument and the laboratory information
system.
Diagnostics
h Utilities > Diagnostics
Figure A-83 Diagnostics list

o All
o Selected (Print the actions of the selected action group.)
With a topic selected: expand or select the list.

With a diagnostic action selected: Perform the selected action.
Roche Diagnostics
Key screens
Users
h Utilities > Users
Figure A-84 User administration
items.
Print the user data of the selected user.
With an item selected: change the selected item.

With any other item selected: expand or collapse the list.
Define a new user.
Delete the user.

(You cannot delete your own user data.)
Roche Diagnostics
Key screens
Stopping a run
h Global action button
Figure A-85 Stop options
<Abort> Stop immediately all processing activities.

Pipettings that were not finished are considered not pipetted.
Measurements that have not yet yielded a valid result are considered not measured.
<Sampling stop> Finish the current pipetting action, but do not start a new one.
You can restart processing by pressing .
<Stop printing> Stop the current printing task. (It may take a few moments before printing actually
stops.)
<Shutdown> Shut down the cobas c111 software and the operating system.
This option is active in Standby status only.
<Restart> Shut down the cobas c111 software and automatically restart it.
This option is active in Standby status only. It is used in cases where a configuration
change requires restarting the software for it to become effective.
Roche Diagnostics
Color interpretation for LEDs
A Sample area LED C Main cover LED

B Global button LEDs (from top: Start LED,
Stop LED, Alarm LED)
The following table lists the LEDs and explains what their colors mean.
LED Color Meaning
Main cover LED Off No activities in this area. You can open the main
cover.
User intervention is required, for example you are
expected to place or remove a bottle.
The system is performing some action. Do not
handle the cover.
An acoustic signal is sounded when the cover is open while the system is
in Operating state. You can adjust the volume (Utilities > Configuration
> System > Volume).
Sample area LED Off No activities in this area. You can remove sample
tubes.
You are expected to place a sample tube.
Blinking The transfer head is approaching. Do not place
your hand or any object in the sample area.
Start LED Off You cannot start the measuring process.
You can start the measuring process.
Stop LED Off Pressing does not have any effect.
Pressing leads to the various stop options.

Roche Diagnostics
LED Color Meaning

Alarm LED Off There are no alarm messages to be dealt with. (All
alarm messages have been acknowledged.)
to deal with as soon as possible.
to deal with. Processing cannot continue unless
you do so.
An acoustic signal is sounded when an alarm is generated. You can
adjust the volume (Utilities > Configuration > System > Volume).
Roche Diagnostics
Buttons
Buttons
The following tables list the buttons used in cobas c111 screens and describe their
use. The buttons are grouped according to the kind of function they represent.
General functions Icon Name Use

Help Display concise information that is relevant to the current
screen and situation.
Start Start processing orders.
Stop Display Stop options.
Alarm Look at alarms.
Paper Feed Advance the printer paper.
Table A-12 Global action buttons
Interactive functions Icon Name Use

Add Add or define an item.
Delete Delete the selected item.
Cancel Abort the operation.

Close the screen.
Print Print the content of the current screen’s working area.
List Display the content of the current screen’s working area in a

table.
OK Confirm the operation, save the data and close the screen.
Save
Detail Show detailed information on the selected item.
Filter Apply filter criteria to the current view.
Edit Modify the selected item.
Perform Perform the selected action.
Export Export data.
Import Import data.
Disk Status Handle the reagent disk and its reagents. Show the status of
the reagents.
Cuvette Status Show the status of the cuvette segments.
Handle cuvette segments.
ISE Status Show the status of ISE electrodes and fluids.
Exchange ISE electrodes and fluids.
System Status Show the status of the main cover.
Table A-13 Interactive buttons
Roche Diagnostics
Buttons
Icon Name Use

Container Status Show the status of the external fluid containers.
Handle the external fluid containers.
Temperature Status Show the status of the reagent cooler and cuvette ring
temperature.
Printer Status Show the printer status.
Fan Status Show whether the sample area fan is running.
Maintenance Status Display the maintenance actions list.
Keyboard Type information manually.
Exchange Reagent Handle the reagent disk.

Disk
Insert Bottle Place a reagent bottle.
Remove Bottle Remove a reagent bottle.
Mix Perform reagent mixing.
Replace Cuvette Confirm replacement of the cuvette segment.
Remove Cuvette Confirm removal of the cuvette segment.
Due Calibrations Select all tests with due calibration or QC.
Forecast Select all calibrations that are due within the forecast period.
Calibrations
Default QC Perform Default QC.
Interval QC Perform Interval QC.
Related Show context information for the result. (Used fluids,

Information together with their lot information.)
Map Host Codes Use identical application codes on host and cobas c111
instrument.
Exchange ISE Exchange an ISE fluid bottle.
bottle
Remove ISE bottle Remove an ISE fluid bottle.
Remove electrode Remove an ISE electrode.
Insert electrode Insert an ISE electrode.
Table A-13 Interactive buttons
Roche Diagnostics
Buttons
Navigation functions Icon Name Use

Line Up Move one line up.
Select the previous line.
Line Down Move one line down.
Select the next line.
Page Up Move one page up.
Page Down Move one page down.
To Top Select the first item in a list.
To Bottom Select the last item in a list.
Forward Open the next screen in a wizard.

Next Step
Back Open the previous screen in a wizard.
Previous Step
Table A-14 Navigation buttons
Roche Diagnostics
Operation B
5 Daily operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

6 Special operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-81
7 Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-119
cobas c111 5 Daily operation
Table of contents
Daily operation
Performing routine tasks
In this chapter, you will find information on performing the routine tasks that are
required for processing orders and keeping the system running.

Introduction ................................................................................................................ B-5
Safety information ................................................................................................. B-5
Overview ................................................................................................................ B-7
Working with a host system .................................................................................. B-9
Starting the shift ........................................................................................................ B-10
Switching on the instrument .............................................................................. B-10
Preconditions ................................................................................................. B-10
Logging on to the system .................................................................................... B-11
Preparing the system ................................................................................................. B-12
Short guide ........................................................................................................... B-12
Starting the Prepare wizard ................................................................................. B-14
Checking the status of the external fluid containers ......................................... B-15
Performing maintenance actions ........................................................................ B-19
Preparing the reagent disk .................................................................................. B-21
Preparing the reagents ......................................................................................... B-22
Preparing cuvettes ............................................................................................... B-27
Performing reagent mixing ................................................................................. B-28
Performing the calibrations (Prepare phase) ..................................................... B-29
Analyzing samples ..................................................................................................... B-32
Safety information ............................................................................................... B-32
Short guide ........................................................................................................... B-32
System setup and order definition workflow ..................................................... B-34
Defining orders .................................................................................................... B-35
Defining routine orders ................................................................................. B-35
Defining STAT orders .................................................................................... B-38
Making changes to an order ................................................................................ B-38
Starting the run ................................................................................................... B-40
Roche Diagnostics
Operator’s Manual · Version 2.0 B-3
5 Daily operation cobas c111
Table of contents
Monitoring the analysis progress ........................................................................ B-40

Checking the sample tube status .................................................................. B-40
Checking the instrument status buttons ...................................................... B-42
Checking for alarm messages ........................................................................ B-44
Acoustic signal ............................................................................................... B-44
Stopping and restarting a run ............................................................................. B-45
Removing sample tubes ...................................................................................... B-45
Validating patient results .......................................................................................... B-46
Repeating tests ..................................................................................................... B-49
Rerunning tests .................................................................................................... B-50
Accepting results .................................................................................................. B-51
Printing patient results ........................................................................................ B-51
Performing calibrations ............................................................................................ B-52
Short guide ........................................................................................................... B-53
Process of performing calibrations ..................................................................... B-54
Validating calibration results .............................................................................. B-56
Performing QC .......................................................................................................... B-59
Short guide ........................................................................................................... B-60
Performing Default QC ....................................................................................... B-61
Performing interval QC measurements ............................................................. B-62
Validating QC results .......................................................................................... B-63
Interpreting the QC History ............................................................................... B-65
Performing reagent mixing ................................................................................. B-67
Finishing the shift ...................................................................................................... B-68
Short guide ........................................................................................................... B-68
Checking for unfinished tasks ............................................................................ B-70
Checking for unfinished orders .................................................................... B-70
Checking for not accepted patient results .................................................... B-70
Checking the transmission of results ............................................................ B-71
Starting the End Shift wizard .............................................................................. B-72
Performing the daily backup .............................................................................. B-72
Exporting the result data ..................................................................................... B-73
Cleaning up the database .................................................................................... B-74
Performing maintenance actions ........................................................................ B-75
Replacing cuvettes ............................................................................................... B-75
Dealing with the external fluid bottles ............................................................... B-76
Emptying the waste container ...................................................................... B-76
Refilling the external water bottle ................................................................. B-76
Removing the reagent disk .................................................................................. B-77
Logging off ................................................................................................................. B-78
Switching off the system ............................................................................................ B-78
Using the barcode scanner ........................................................................................ B-79
Reading reagent bottle barcodes ......................................................................... B-79
Reading barcodes from sheets ............................................................................. B-80
Reading sample tube barcodes ............................................................................ B-80
Roche Diagnostics
B-4 Operator’s Manual · Version 2.0
Introduction
Introduction
Daily operation includes the routine tasks that are required to prepare and monitor
the system, and to analyze samples.
Safety information
Before you start working with the cobas c 111 instrument, it is essential that you
both read and understand the safety information listed below.
Read carefully all safety notices given in instructions and make sure you understand
them.

solutions.

materials and mechanical components associated with samples of human origin are

components associated with the waste systems are potentially biohazardous.

mechanism
Do not touch moving parts during instrument operation.
Keep all covers closed, operate them as instructed on the screen.
Roche Diagnostics
Introduction
Loss of sight

Diagnostics.
o Start all maintenance actions on the screen. Do not perform maintenance actions
without the assistance of the user interface.
o Leave maintenance that is not described in the Operator’s Manual to a trained service
representative.
Incorrect results or damage to the analyzer due to dust and soiling

The user can leave the main cover open while the system is in Standby status or while the
instrument is shut down. This can cause dust and dirt being collected in the cuvette ring,
which in turn might decrease the quality of the cuvettes.
Keep all covers closed. Open them only to perform operation actions.
Roche Diagnostics
Introduction
Overview
daily operation. Roche recommend using the sequence of steps in the way given
below; but you may perform the tasks differently. For details on the individual steps,
see the relevant sections in this chapter.

that are due.
3. Load the reagent disk. Overview >
4. Check the reagents. Overview >
5. Check the cuvettes. Overview >
6. Perform mixing Overview > > test >
7. Perform calibrations that are due. Workplace > Calibrations > >
4. Start the run.

... > Repeat
... > Rerun
Table B-1 Overview of the daily operation tasks
Roche Diagnostics
Introduction

or
on the screen.
on the screen.
on the screen.
Roche Diagnostics
Introduction

that are due.
9. Replace cuvettes. Overview >
11. Remove the reagent disk (if last shift). Overview > >
Working with a host system
Communication with the instrument is defined during installation.

e For an overview on working with a host system, see Host connectivity on page A-30.
Roche Diagnostics
Starting the shift
Starting the shift
Starting the shift includes the tasks from switching on the instrument up to the
moment when you are logged on.
The various tasks are described in the order in which they should be performed.
Switching on the instrument
Preconditions
Before you switch on the instrument, make sure the following preconditions are met:
o All covers are closed.
o The external fluid containers are connected.
o The sample area is empty.
a To switch on the instrument

1 Press down [I] on the power toggle switch.
A Power switch
Figure B-1 Power switch
The system performs internal checks and routines.

The startup phase may take a few minutes. During this time, a splash screen is
displayed.
Do not use the screen until the system is in Standby status.
When the system is ready to log on, the [Overview] tab is displayed.
Roche Diagnostics
Starting the shift
Logging on to the system
a To log on the system

1 Press <Log On>.
A screen is displayed for typing your user name.
e For information on typing text, see Typing text on page A-74.
User name and password are case sensitive. This means that for example User and user
are two different names.
2 Type your user name.

Use characters of the alphanumeric keyboard (upper and lower case).
As soon as you type the first characters of your user name, the system looks for a
name that starts with these letters and, if it finds one, displays the complete name.
3 Press .
A screen is displayed for typing your password.
4 Type your password.
Use characters of the alphanumeric keyboard (upper and lower case).
(For security reasons, you cannot see the actual characters when typing.)
5 Press .
The [Overview] tab is displayed again.
Roche Diagnostics
Preparing the system
Before you can start analyzing samples, you need to prepare the system. Preparing the
system includes both user actions and actions performed automatically by the system,
such as heating up the cuvette ring or cooling down the reagent cooler. The process is
designed in such a manner that user intervention is mainly required at the beginning
and at the end of the Prepare phase. This way, the operator does not have to stand by
the instrument the whole time.
The easiest way of performing the daily preparation tasks is to follow the Prepare
wizard.
Preventing intervention during sample processing

Performing conscientiously all preparation steps reduces considerably the chances of you
having to intervene during routine operation.
Follow the steps suggested by the wizard

You are guided through the preparation process by the Prepare wizard. This sequence of
screens shows you which actions you should perform and in which order.
Skipping a step
You may skip a step. Before you do so, remind yourself of the consequences. In many
cases, skipping a step simply means postponing the task to a more convenient time. In
other cases, skipping a step could prevent the system from performing an analysis; for
example if you chose not to replace a reagent that is low, a test that uses this reagent may
not have enough reagent.
Short guide
The following table provides an overview of the steps that make up the preparation
process.
Step User action

1 Start the Prepare wizard. 1. On the [Overview] tab, press <Prepare>.
2 Check the status of the external 1. Refill the water container, if required, and con-
containers. firm by pressing the water button. (If you refill
the water, empty the waste as well.)
2. Empty the waste container, if required, and
confirm by pressing the waste button.
3. Replace the cleaner bottle, if required, and con-
firm by pressing the cleaner button.
4. Press to proceed to the next stage in the
Prepare wizard.
Table B-2 Steps for preparing the system
Roche Diagnostics
Step User action

3 Perform the maintenance 1. Check which maintenance actions are due.
actions that are due. 2. Perform the maintenance actions.
Perform at least all red maintenance actions.
Prepare wizard.
4 Prepare the reagent disk. 1. Open the main cover.

2. Remove the disk from its container.
3. Place the disk on the instrument.
4. Close the main cover.
A screen is displayed, showing the reagent
status.
5 Prepare the reagents. Deal with at least all red and yellow buttons.
1. Press a reagent button to check the details.
Replace the empty reagents.
2. Press .
3. Open the main cover
4. Remove the bottle.
5. Press to confirm.
6. Remove the remaining bottles of the set.
7. Press .
8. Place the new bottle.
9. Press to confirm.
10. Load the remaining bottles of the set.
Prepare wizard.
6 Prepare the cuvettes. Replace all red cuvette segments.

1. Press the cuvette button.
2. Open the main cover.
3. Replace the cuvette segment.
4. Press to confirm the replacement.
5. Replace the remaining segments that need
replacing.
Prepare wizard.
Roche Diagnostics
Step User action

7 Perform reagent mixing 1. Select the test(s).
2. Press .
8 Perform calibrations. Perform the calibrations.

1. Check the test selection.
2. Press .
3. Place the calibrators.
4. On the placement screen, press .
5. Press .
6. Validate the results.
Starting the Prepare wizard
a To start the preparation process

1 Choose Overview > Prepare.
Roche Diagnostics
Checking the status of the external fluid containers
Make sure that you have read and understood section Safety information on page B-5. The
following warning messages in particular are relevant:
o Injury through reagents and other working solutions on page B-5.
o Infection by biohazardous materials on page B-5.
o Infection by waste solution on page B-5.
o Personal injury or damage to the analyzer due to contact with instrument mechanism on
page B-5.
The external fluid containers are placed on a rack.
A B C
A Cleaner bottle (red cap) C Waste container (yellow)

B Water container (white)
Figure B-2 External fluid bottles
The status of all three containers is displayed on the same screen:
Figure B-3
Roche Diagnostics
a To check the water container

1 Check the water button.
There is no water left. (A fluid sensor detected that there is no water coming
from the water container.)
You need to refill the water now. No new tests can be processed, started tests
may have to be restarted after refill.
The water container was last filled up more than one day ago.
You should check the water level and refill if required.
No action is required.
The system does not monitor the filling level. It is up to the operator to fill up the water
container regularly.
2 Refill the water, if required.
Figure B-4
Danger of poor measurement quality due to inadequate water quality

Inadequate water quality may lead to incorrect results. Always use purified water of the
CAUTION quality specified in section Technical specifications.
a) Remove the tubing adapter from the white water container and place it on a
clean surface.
b) Refill the bottle with purified water.
c) Insert the tubing adapter. Press down firmly.
3 On the screen that shows the container status, press the water button to confirm
that you have refilled the water.
4 Roche recommend to empty the waste container whenever you refill the water
container.
e See To check the waste container on page B-17.
When refilling the water without using the Prepare wizard:

Choose Overview > > .
Roche Diagnostics
a To check the waste container

1 Check the waste button.
The waste container was last emptied more than one day ago.
You should check the waste level and empty if required.
The system does not monitor the filling level. It is up to the operator to empty the waste
container regularly.
2 Empty the waste container, if required.
Figure B-5
a) Have the spare waste container ready.

The system periodically performs wash actions. Therefore, an external waste
container must be connected at all times.
b) Remove the tubing adapter from the yellow waste container and insert it in the
spare container.
c) Remove the bottle from the rack and place it on a firm and even surface.
d) Place the spare container on the rack.
e) Check that the tubing adapter is properly inserted.
f) Empty the removed waste container. Treat the fluid as biohazardous waste.
g) Rinse the container with water and leave it to dry.
3 On the screen that shows the container status, press the waste button to confirm
that you have emptied the container.
When emptying the waste without using the Prepare wizard:

Roche Diagnostics
a To check the cleaner bottle

1 Check the cleaner button.
A fluid sensor detected that there is no cleaner in the instrument tubing.

You need to replace the cleaner bottle now. No new tests can be processed,
started tests may have to be restarted after replacing the bottle.
The cleaner level is down to 10% or lower. See the % indication.
2 Replace the cleaner bottle, if required.
Figure B-6
a) Remove the tubing adapter from the cleaner bottle and place it on a clean
noncorrosive surface.
b) Dispose of the bottle.
c) Remove the cap from the new bottle.
d) Place the new bottle on the rack.
e) Insert the tubing adapter and press it down firmly.
3 On the screen that shows the container status, press the cleaner button to confirm
that you have exchanged the cleaner bottle.
Level monitoring for the cleaner bottle is based on the number of cleaning and
pipetting actions that were performed. The counter is reset when you press the
cleaner button. Make sure you only press the button when you actually have
replaced the bottle.
4 Press to proceed to the next stage in the Prepare wizard.
When replacing the cleaner bottle without using the Prepare wizard:
Roche Diagnostics
Performing maintenance actions
Maintenance actions need to be performed periodically or after certain events.

To ensure the smooth running of the system, you should perform maintenance
actions either as part of the preparation or the end of shift activities.
on page B-138.
Make sure that you have read and understood section Safety information on page C-8.
a To perform maintenance actions
Checking what maintenance 1 Check the colors of the maintenance actions.

actions are due
A B
A Maintenance action name. C Use the scroll bar to display the

B Due dates, in ascending order. maintenance actions that are currently
hidden.
Figure B-7
The maintenance actions are sorted by the maintenance date by when they should
be performed. Use these dates for planning the maintenance actions, for example
for ordering the required materials.
Interpreting the colors The defined maintenance interval has expired. Perform this maintenance
action now. The system may not be able to operate until this action is
performed.
This maintenance action should be performed on the next major

maintenance day.
This maintenance action is selected.
Roche Diagnostics
Performing the maintenance 2 Select the maintenance action you want to perform.
actions
The selected line turns blue.
Incorrect results or processing stop due to skipping maintenance actions

Not performing maintenance actions that are due may lead to situations where the system
WARNING cannot continue processing orders, or it may lead to incorrect results. If at all possible,
perform the maintenance actions when they are due.
3 Press .
The maintenance definition screen is displayed.
e For information on how to perform individual maintenance actions, see Chapter

8 General maintenance.
4 Press to start the action.

5 Follow the instructions on the screen.
6 Perform the next maintenance action that is due.
7 When you have finished performing maintenance actions, press to proceed
to the next stage in the wizard.
When performing maintenance actions without using the Prepare wizard:

Choose Utilities > Maintenance.
Roche Diagnostics
Preparing the reagent disk
The reagent disk holds the reagent and diluent bottles. During periods when you are
not performing tests, for example at night or during holidays, the disk is placed in a
reagent disk container and stored in a refrigerated place. Reagents should be stored at
temperatures in the range of 6 to 10°C.
page B-5.
Spillage through tipping reagent disk

The reagent disk container can slip off or tip over if it is not placed on an even horizontal
CAUTION surface.
When storing the reagent disk container, make sure to place it on a firm, even, horizontal
surface that is easily accessible.
When handling the reagent disk, make sure not to tilt it.
a To load the reagent disk

1 Get the reagent disk from the refrigerator and remove it from its container.
2 Open the main cover.
A screen is displayed, asking you to insert the disk.
3 Place the reagent disk in the reagent cooler.
Make sure the reagent port faces the front and align the cut-outs with their
counterparts on the reagent cooler.
The system automatically detects that a disk was inserted.
A screen is displayed, asking you to close the main cover.
4 Close the main cover.
At this stage, the system identifies the disk.
A screen is displayed that shows the status of the reagent sets.
When handling the reagent disk without using the Prepare wizard:
Choose Overview > .
Roche Diagnostics
Preparing the reagents
Reagents are handled in sets. A set consists of up to three reagents. If for example one
reagent bottle of a set is empty, all reagents of the set need to be replaced. The system
only uses reagents of complete sets.
On the screen, each set is represented by a separate button.
Use reagents of the same lot, if possible

When replacing a new reagent set, try to use one of the same lot as the old one. This way
you avoid having to perform a calibration.
Diluent and cleaner bottles

An extra diluent or cleaner bottle is considered one set. Extra cleaners and diluents are
handled in the same type of bottles that are used for reagents. Their handling works the
same way. In the following, the process is described for reagents.
o Loss of sight on page B-6.
page B-5.
Incorrect results due to declining reagent quality

Due to the declining quality of reagents, the quality of measurement may decline. This may
WARNING cause incorrect results.
Make sure to use reagents whose expiration date has not expired.
Incorrect results due to reagent dilution through condensation

In ambient conditions of high temperature and humidity, condensation can build up inside
the reagent bottles. This leads to dilution of the reagent.
In such conditions and when not performing tests, especially if you observe condensation
on the reagent disk or in the reagent cooler, be sure to remove the reagent disk from the
instrument and place it in the reagent disk container. Close the container with its lid and
place it in a refrigerator.
Incorrect results due to condensation in the reagent cooler

In ambient conditions of high temperature and humidity, condensation can build up in the
reagent cooler. Water can spill on the analyzer unit and get into the cuvettes when
removing the reagent disk.
In ambient conditions of high temperature and humidity, be sure to periodically wipe up
the condensation water in the reagent cooler.
Roche Diagnostics
Incorrect results due to inappropriate reagent handling

Removing and loading reagents while the reagent disk is outside the instrument may lead
WARNING to inconsistencies between the recorded and the physically loaded reagents and
consequently to incorrect results.

a To prepare the reagents
Checking the status of the reagent 1 Check the colors of the reagent set buttons.
sets
A Press to add a reagent set. B Press to display the disk content in a table.
Figure B-8
Interpreting the colors

Color Meaning Possible actions
No tests can be performed with this
reagent set.
The number of available tests is 0. Replace the reagent set.
The set is incomplete. Add the missing reagent.
There is no application that uses this Add the missing application.
reagent set.
The test needs calibrating. Perform calibration.
There are fewer than 10% of tests left Load a new reagent set as soon as
for this set. possible.
The expiration date has expired.
This development channel test is run Activate the extra wash cycle.
without extra wash cycles. Roche strongly recommends to always
use extra wash cycles with
development channel applications.
Ready for use. No action is currently required.
Roche Diagnostics
Displaying detailed information 2 Press a reagent button.

on a reagent set
A screen is displayed that shows the details of the selected reagent.
A Status description
Figure B-9
Incorrect results due to impurities and carryover

Traces of analytes or reagents may be carried over one test to the next when reusing bottle
CAUTION caps.
Do not remove reagent bottles that are not empty with the purpose of loading them again
later.
Preparing the reagent set 3 Obtain the reagent sets you want do add or replace.
When replacing a reagent set, try to use one of the same lot as the old one. (This
way, if you work with the calibration sequence [Each Lot and Interval], you avoid
having to perform a calibration.)
Removing a reagent set 4 Press .

The system moves the first bottle of the set to the reagent port.
5 Wait for the main cover LED to turn green.
A message is displayed, asking you to open the main cover and remove the bottle.
6 Open the main cover and remove the bottle.
Figure B-10 Removing a bottle from the reagent disk
7 Press to confirm the removal.

The system does not check whether you have actually removed the bottle.
Roche Diagnostics
8 Do one of the following:
If Do this
There is another bottle The system moves this bottle to the reagent port. A screen
belonging to the set: is displayed, asking you to remove the bottle.
1. Remove the bottle.
2. Press to confirm the removal.
3. Start adding the new reagent set.
All bottles of the set are 1. Start adding the new reagent set.
removed:
The screen with the reagent set buttons is displayed again. The button for the
removed set is no longer present. If you did not remove all bottles of the set, the
reagent set would be disabled, its button would be red.
Adding a reagent set 9 Open the main cover if required.

10 Press .
A screen is displayed, asking you to scan the bottle barcode.
11 Scan the barcode on the bottle.
When scanning, bear this in mind:

o Scanning its barcode is the only way of identifying a reagent, diluent, and cleaner
bottle.
o If there are not enough free slots for all bottles of the set, a message will inform you.
o You cannot re-insert empty bottles that were previously removed from the system. If
you scanned such bottle, a message would inform you that you cannot do this.
A screen is displayed, asking you to place the bottle on the reagent disk.
Time limit for placing reagent bottles

The system assumes that you place the bottle that you just scanned.
You need to place the reagent bottle on the reagent disk within 15 seconds of scanning the
reagent barcode. Failing to confirm the placement within 15 seconds cancels the current
identification process. You will be asked to scan the bottle again.
Incorrect results due to not placing the identified reagent

The system assumes that the operator places the reagent that was just identified. Failing to
WARNING do so might lead to wrong results.
12 Remove the cap from the bottle and place it in the reagent bay.
13 Press to confirm the insertion.
If you confirm without placing the bottle, the system assumes that the bottle is
placed.
If you press after placing the bottle, the position is deemed empty.
When the first reagent bottle is loaded, the reagent set is defined. From this
moment on, the reagents are handled as part of the set. You no longer handle
them as individual reagents.
Roche Diagnostics
If Do this
There is another bottle A screen is displayed, asking you to scan the bottle.
belonging to the set: 1. Scan the bottle
2. Insert the bottle.
3. Press to confirm the insertion.
All bottles of the set are 1. Close the main cover.
inserted: On the screen with the reagent set buttons, the button
for the new set is now present.
15 On the screen with the reagent set buttons, press the button for the set you just
inserted.
A screen is displayed that shows details of the set.
The status description points to the action you need to take. If you just inserted a
reagent set, you may have to perform the initial calibration and QC.
A Status description
Figure B-11
16 Press .
17 When you have finished adding and replacing reagent sets, press to proceed
to the next stage in the Prepare wizard.
When handling the reagent sets without using the Prepare wizard:
Choose Overview > .
Roche Diagnostics
Preparing cuvettes
Cuvettes are supplied and handled in cuvette segments. Each segment contains ten
cuvettes. The segments are placed on the cuvette ring of the rotor.
e For information on cuvette segments, see Cuvette segments on page A-53.
For information on the cuvette ring, see Cuvette ring on page A-58.
Each segment on the cuvette ring is represented by a button on the screen.
page B-5.
a To prepare the cuvettes
Checking the cuvette status 1 Check the color of the cuvette segment buttons.
You can refresh the cuvette screen by pressing . (If there were pending orders,
this would also start their processing.)
Figure B-12
Interpreting the screen The number in the button indicates how many cuvettes are free to be used.
Icon Meaning Possible actions
All cuvettes are used. Replace the segment.
Up to two cuvettes are free to be used.
More than two cuvettes are free to be No action is currently required.

used.
Replacing cuvette segments 2 Press a segment button.

A screen is displayed, informing you that the system is ready for cuvette handling.
3 Wait for the main cover LED to turn green.
5 Remove the segment and treat it as biohazardous waste.
Roche Diagnostics
Incorrect results due to scratched or soiled cuvettes

Scratches and impurities on the cuvettes distort the measurements.
CAUTION Do not touch the cuvettes and make sure they do not touch other items when handling
them.
6 Insert a new cuvette segment.

7 Press to confirm the replacement.
(Press if you removed the segment without replacing it.)
If Do this
You want to exchange another segment: Perform steps 2 through 7.
This was the last segment you wanted to Close the main cover.
exchange:
9 When you have finished replacing cuvettes, press to proceed to the next stage
in the Prepare wizard.
When handling cuvette segments without using the Prepare wizard:

Choose Overview > . The system must be in Standby status.
Performing reagent mixing
Reagents that contain Latex granules, for example D-Dimer, require periodic mixing.
The mixing interval is part of the application definitions and cannot be changed or
deleted by the user. The system checks every 30 minutes for reagent sets that require
mixing.
Within the Prepare phase a screen is displayed that lists all reagent sets for which a
mixing interval is defined.
a To perform the mixing

1 Select the reagent sets you want to mix.
If working with the Prepare wizard, the reagent sets that need mixing are
automatically selected.
2 Press .
Mixing starts. A screen is displayed informing you about the progress of the
mixing action.
(If there is more than one bottle in the set with a mixing interval defined, it will be
mixed as well, irrespective of being due or not.)
3 When mixing is finished, press to close the screen.
4 Press to proceed to the next stage in the Prepare wizard.
When mixing reagents without using the Prepare wizard:

Choose Overview > . Press the reagent set button and then . The system must be
in Standby status.
Roche Diagnostics
Performing the calibrations (Prepare phase)
At this stage, the system checks for all calibrations that are due.
e For an overview on calibration, see Calibration on page A-24.
For performing individual calibrations, see Performing calibrations on page B-52.
By default, all calibrations that are due or will be due within the forecast period are
taken into account during the Prepare phase.

WARNING When handling reagents, be sure to wear protective equipment and observe the cautions
Incorrect results due to expired calibration

Calibrations are performed to compensate for changes over time in reagents and in the
measurement systems. Failing to perform calibrations when they are due may lead to
incorrect results.
Make sure to perform calibrations when they are due.
Incorrect results due to wrong tube placement

Be sure to place the calibrators in the specified positions.
Roche Diagnostics
a To perform the calibrations

A screen is displayed that shows all active tests.
Checking which calibrations are 1 Check the colors of the test buttons.
due
A B
A Press to cancel the selection of all tests B Press to cancel the selection of all tests
that need calibrating that need calibrating within the forecast
period.
Figure B-13
Interpreting the colors Color Meaning Possible actions

No sample tests can be measured.
Possible reasons:
Initial calibration is required. Perform the calibration.
The calibration failed. Check the flag to find out why the
calibration failed. Repeat the
calibration if necessary.
The calibration was successfully Validate the calibration results.
performed, but its results have not
been accepted yet.
QC is due. Perform QC as soon as possible.
The calibration is OK. Its results have No action is currently required.

been accepted.
The calibration is OK. It applies to a No action is currently required.
reagent set that is not active.
Modifying selections By default, all tests whose calibration is due or will be due within the forecast
period are automatically selected. You can cancel these selections by pressing ,
or a test button.
If you do not perform a calibration that is due, the affected test is blocked; you
cannot perform this test.
Performing calibrations 2 On the screen that shows the tests, press .

A screen is displayed that lists all required calibrators, and it shows on which
position to place them.
Roche Diagnostics
A B C
A Position on the sample area where to C Calibrator with highest concentration

place the calibrator. D Calibrator with lowest concentration
B Lot number
Figure B-14
With absorbance tests that require several calibrators, the calibrators are placed according
to their concentration, starting with the highest concentration.
Calibrators with several concentrations are listed according to their concentration,

starting with the one with the highest concentration. They are displayed as
follows:
Number of calibrators Displayed information

1 Position, name, lot number
2 1. Position, name, [highest]
2. Position, name, lot number
More than 2 1. Position, name, [highest]
2. Position, name, lot number
3. …
4. Position, name, [lowest]
3 Prepare the calibrators.

4 Place the calibrators on the sample area positions indicated on the placement list.
5 Press to confirm the placement.
6 Press to start the calibration.
7 Choose Workplace > Calibrations to check the status of the calibrations.
Validating the results 8 Validate the results.

e See Validating calibration results on page B-56.
When performing calibrations without using the Prepare wizard:

Choose Workplace > Calibrations > .
End of Prepare phase The instrument is now ready for analyzing samples.
You may want to perform QC before analyzing samples.
e See Performing QC on page B-59.
Roche Diagnostics
Analyzing samples
Analyzing samples
Safety information
page B-5.
o Loss of sight on page B-6.
Incorrect results due to inadequate sample preparation

Specimen containing clots may obstruct the probe. Specimen containing bubbles or foam
WARNING may cause level detection errors and air pipetting. Consequently, incorrect results may be
generated.
Take adequate care when preparing the samples.
Time limit for placing samples

The system assumes that you place the sample tube that you just identified.
You need to place the sample on the sample area within 10 seconds of confirming the test
selection. Failing to place the sample tube within 10 seconds cancels the current
identification process. You will be asked to identify the sample tube again.
Short guide
The following table gives an overview of the tasks you typically perform when
analyzing samples.
Step User action

1 Identify the sample. If working with sample barcodes:
1. Scan the barcode using the barcode scanner.
If working without sample barcodes, type the

sample ID by using the screen keyboards.
1. Press .
2. Type the ID.
3. Press .
Table B-3 Steps for analyzing samples
Roche Diagnostics
Analyzing samples
Step User action

2 Select the tests. 1. Press a tab to select the test panel (if required).
This step is not required if the 2. Press an active test to select it. Press a selected
workflow setting [Working test to cancel its selection.
Mode] is Host. (Utilities > Con- 3. Press .
figuration > Workflow.)
3 Place the sample. 1. Place the sample on any free position on the
sample area.
You need to place the sample within 10 seconds
of pressing . Failing to place the sample
tube within 10 seconds cancels the current iden-
tification process. You will again be asked to
identify the sample tube.
4 Start processing. Press .

5 Validate the results. 1. Choose Workplace > Results.
2. Validate the result (You can accept the result or
perform the test again.)
6 Remove the samples. 1. Press the [Overview] tab.

2. Check the status of the sample tube button that
corresponds to the sample you want to remove.
3. If the sample tube button is green, remove the
tube.
Table B-3 Steps for analyzing samples
Roche Diagnostics
Analyzing samples
System setup and order definition workflow
The workflow for defining orders depends on a few configuration settings:

h Utilities > Configuration > Workflow
Working Mode The [Working Mode] defines the way you select tests when defining orders.
o Use <Manual> if you use the cobas c111 instrument as a stand-alone system.
During order definition, the test selection screen is displayed, allowing you to
select the tests or to make changes to the selection.
o Use <Host> if the cobas c111 instrument is connected to a host computer.
During order definition, the tests are automatically selected, the test selection
screen is not displayed. After identifying the sample, you are asked to place the
sample.
Sample Barcode Use <On> if you exclusively work with barcoded sample tubes. When defining orders,
the screen for typing the sample ID manually is skipped.
Order Mode The order mode reflects the way in which you organize the tests on the test selection
screen.
Use <Easy> if the reagents fit on one or two reagent disks and you work with one test
panel on the screen (You can fit up to 25 tests and profiles on this panel).
Use <Full> if you distribute the reagents across several (up to eight) reagent disks and
if you predominantly work with specific groups of tests, for example for emergency
situations or for testing diabetes. You can define up to 20 tests and profiles on each
panel (tab).
e See Assigning tests to test tabs on page B-106.
Sample ID Handling The sample ID is an identifier of up to 23 alphanumeric characters that is unique

within a whole organization, for example the hospital. It cannot be changed once the
order is saved. This ID is used for communication with a laboratory information
system.
The order ID is an identifier of up to 23 alphanumeric characters that is unique within
the laboratory. In practice, this could for example be an autonumber followed by the
patient name.
Because there is limited space when displaying lists on screen, Roche recommend to limit
the IDs to 13 characters.
If you work with one ID only, the sample ID is used as the order ID as well. There
exists a fixed relation between the sample and order IDs. Make sure this ID is unique
within the cobas c111 instrument.
o Use <Order ID = Sample ID> to have the system automatically define the order
ID identical to the sample ID.
o Use <Independent IDs> to define the sample and order IDs independently of each
other.
o Use <Grouped Sample ID> to use identical order and sample IDs as a constant
part of any order for a give patient, and to let the system automatically append a
running number to the ID for each order.
Roche Diagnostics
Analyzing samples
Auto Order-ID Use <On> to automatically increment the order ID number by one whenever you
define a new order. (You only need to define the number of the first order of your
shift.)
If you use <On> for this feature, use <Off> for [Order ID = Sample ID].
Defining orders
Preconditions o All preparation tasks are complete.

o The required tests are installed on the system and ready for use (calibration and
QC performed).
o The system status is either Standby or Operating.
o At least one sample position on the sample area is free.
There can be only one order per test and sample.

Possible post-dilution is predefined in the application definition.
Incorrect results due to declining sample quality

Evaporation of sample fluid may lead to incorrect results. In ambient temperatures of more
WARNING than 25°C, be sure to start processing immediately after placing the sample and defining
the order. When processing of the order is finished, be sure to immediately remove the
sample from the sample area.
Defining routine orders
a To define an order
1 Choose Overview > Order.
A screen is displayed, asking you to identify the sample.
2 Identify the sample. Do one of the following:
If Do this
You work with sample barcodes: Use the barcode scanner to scan the
barcode.
You do not work with sample barcodes or if 1. Press .
the barcode could not be read for some 2. Type the sample ID, then press .
reason: 3. Type the order ID, then press .
Note: This step is only required if the
configuration setting [Order ID =
Sample ID] is Off.

(If the workflow setting [Working Mode] is Host, this screen will not be displayed.
Utilities > Configuration > Workflow.)
Roche Diagnostics
Analyzing samples
A Easy mode test-board, all tests fit on one C Full mode test-board. The tests are
screen. distributed across several panels (tabs).
B Tabs marked with an asterisk contain
selected tests.
Figure B-15
Interpreting the colors The test is blocked for one of the following reasons:
o The calibration failed.
o Initial calibration is required.
o For the reagent set, the number of available tests is 0, or a reagent bottle is
missing (incomplete reagent set).

The test is not on board.
The tests are sorted alphabetically. Profiles precede the tests. Profiles display the
color of their tests.
3 Select the test(s).
You can select tests from several test tabs. (A test can be contained in more than
one tab. If it is selected in one, it will automatically be selected in the others.)
Tabs with selected tests are marked with an asterisk (*).
4 Press to confirm your selection.
Roche Diagnostics
Analyzing samples
5 Wait for the Sample Area LED to turn green. (Make sure to keep clear of the
sample area while the LED is yellow and blinking.)
A screen is displayed, asking you to place the sample on the instrument.
6 Place the sample on any free position on the sample area.
Time limit for placing samples

You need to place the sample on the sample area within 10 seconds of confirming the test
selection. Failing to place the sample tube within 10 seconds cancels the current
identification process. You will be asked to identify the sample tube again.
Incorrect results due to not placing the identified sample

The system assumes that the operator places the sample that was just identified. Failing to
WARNING do so might lead to wrong results.
The system registers where you placed the sample and associates this position with
the order you just defined.
The screen for identifying samples is displayed again. You can now start defining
the next order. (If there were no free sample positions, the screen for selecting the
tests would be displayed instead.)
If Do this
There is another order to be defined: Identify the sample and repeat the order
definition process.
There are no more orders to define: Press to close the screen.
8 Press the global action button to start processing.

e See Starting the run on page B-40.
If you defined the order while the system was processing orders, new orders will
automatically be processed, without pressing .
Order of processing When you first start processing orders, the order of the sample placed on the
leftmost position on the sample area is processed first. The others follow in
sequence from left to right. Once processing is in progress, the orders are
processed according to the sequence in which they were defined.
Repeats and reruns of routine orders are performed before routine orders.
e See Repeating tests on page B-49.
See Rerunning tests on page B-50.
Roche Diagnostics
Analyzing samples
Defining STAT orders

Short turn around time (STAT) orders are defined in the same way as routine orders.
a To define a STAT order

1 On the [Overview] tab, press <STAT>.
2 Continue as if defining a routine order.
e See Defining routine orders on page B-35.
If there is no space on the sample area

Remove any sample whose tube button is green .
Order of processing When you have defined a STAT order and started the run, the system reacts as follows:
o Existing STAT orders are finished first.
o Started tests of routine orders are finished.
o Repeats and reruns of STAT orders are treated as normal STAT orders. (The order
that was defined first will be performed first.)
o Repeats and reruns of routine orders are performed before routine orders.
Recognizing STAT orders on the On the [Overview] tab, the sample buttons for STAT orders are marked with a wide
screens edge.
Figure B-16 Example of STAT order icon
In the orders list (Workplace > Orders), STAT orders are marked with an asterisk (*).
Making changes to an order
You can make changes to orders that either have not yet been processed or that are
fully processed. (You can add further tests to an order any time.)
The process of changing an order depends on whether the sample tube is still on the
instrument or not.
Making a change to an order when the sample tube is no longer on the sample area is
basically the same as defining a new order.
Roche Diagnostics
Analyzing samples
a To change an order
1 Identify the sample
If the sample is still on the a) On the [Overview] tab, press the sample tube button of the order you want to
instrument change.
A screen is displayed, that shows details on the order and the sample.
b) Press .
A screen for selecting tests is displayed.
If the sample is no longer on the a) Do one of the following:

instrument
If the Starting point was Perform these steps
Overview > Order A screen is displayed, asking you to scan the sample or
to type its ID manually.
1. Identify the sample either by scanning its barcode
or by typing the sample ID.
If the same barcode was scanned before (during the
current day) or you use the same sample ID as in
the original order, the system recognizes the origi-
nal order and displays its associated information.
2. Press .
Workplace > Orders A screen is displayed that lists all orders.
1. Select the order you want to change.
2. Press .
2 Select the tests.

o Press an available test to select it.
o Press a selected test to cancel its selection. (Tests that are already scheduled to
be performed cannot be cancelled.)
3 Press to confirm your selection.
If the sample is still on the A message is displayed showing the position the sample is placed on.
instrument
a) Press to confirm the position
The screen with details on the order and the sample is displayed again.
b) Press to close the screen.
If the sample is no longer on the A message is displayed, asking you to place the sample.
instrument
a) Place the sample on the sample area.
The orders list is displayed again.
4 The system reschedules the order and processes it as normal.
Roche Diagnostics
Analyzing samples
Starting the run
a To start processing an order

1 Press the global action button.
The system checks whether there are enough cuvettes and whether all required
reagents are on the reagent disk.
If any of this is not the case, a screen is displayed informing you of what is missing.
Order of processing When you first start processing orders, the order of the sample placed on the leftmost
position on the sample area is processed first. The others follow in sequence from left
to right. Once processing is in progress, the orders are processed according to
sequence in which they were defined.
Repeats and reruns of routine orders are performed before routine orders.
Monitoring the analysis progress
During operation, you should regularly check the following items:

o The status of the buttons on the [Overview] tab
o The Alarm Monitor LED
Checking the sample tube status
a To check the sample status

1 Press the [Overview] tab.
B
C
D
A Sample tube buttons C Information on results that are associated

B Information on tests that are associated with defined orders
with defined orders D Alarm Monitor LED
Figure B-17
Interpreting the sample tube Icon Meaning Possible action

buttons 1 The number in the button denotes n/a
the position on the sample area.
A sample tube button with a wide n/a
edge symbolizes a STAT order.
All tests are accepted. You can remove the sample tube.
1
Roche Diagnostics
Analyzing samples
Icon Meaning Possible action

All tests are pipetted. You can remove the sample tube.
1*
All tests are completed but not yet Validate the results.
1!
accepted.
All remaining tests are blocked
1!
because:
There is not enough sample fluid. 1. Remove the sample tube and add
fluid.
Do not delete the old order!
2. Scan the sample barcode or type
the same sample ID as before.
3. Reinsert the sample tube.
Processing continues where it stopped.
(Removing a sample and then placing
it again means defining a new order.
The system does not remember where
the sample was placed in the previous
order.)
The sample is not identified. 1. Remove the sample.
2. Scan the sample barcode or type
the same sample ID as before.
3. Reinsert the sample on any
position.
(Removing a sample and then placing
it again means defining a new order.
The system does not remember where
the sample was placed in the previous
order.)
There is no sample on this position. You can place a sample tube on this
1
position.
Tests are ordered. Processing has not You can still cancel ordered tests and
1+
yet started. add additional tests to the order.
Tests are ordered. Processing has You can no longer cancel ordered tests,
1* started. but you can add additional tests to the
order.
The sample is identified, but no tests This should be a temporary status. No
1? were ordered yet. action is required.
If working in Order Query Mode: The
order could not be obtained from the
host.
Roche Diagnostics
Analyzing samples
2 Press the sample tube button.

A screen is displayed that shows details about the status of the sample tube.
B C D
A Selected test C Press to add tests to the order

B Press to validate the results D Press to delete the order
Figure B-18
3 Take appropriate action.
Checking the instrument status buttons
a To check the instrument status

A Instrument status buttons
Figure B-19
Roche Diagnostics
Analyzing samples
Interpreting the instrument Icon Meaning Possible action

status buttons The reagents are OK. No action is required.
There is no disk on board. Load a disk.
Fewer than 10% of tests are left for Load a new reagent set.
a reagent set, or its expiration date
has expired.
A reagent set is not complete or a Complete the reagent set or replace
reagent is empty. it.
A reagent set is blocked because it Perform calibration or mixing.
requires calibration or mixing.
The disk could not be identified. Remove the disk and make sure
that one and only one ID tab is
removed. Reinsert the disk.
There is more than one segment No action is required.
available.
The last available segment is in use. Replace the used cuvette segments
as soon as possible.
There are no empty cuvettes Replace the cuvette segments.
available.
System The system status button displays both the icon and the color of one of the
Status buttons of the underlying system status screen. (The icons are first prioritized
by color, first priority being red, followed by yellow and green, and then
according to the sequence in which they are listed below.)
Analyzer (main cover) Press the button and, on the
System Status screen, check the
text about the status of the main
cover.
Reagent cooler and cuvette ring Press the button and, on the
temperature System Status screen, check the
text about the temperature.
Sample area ventilation Press the button and, on the
text about the ventilation status.
External fluid containers Press the button and, on the
System Status screen, press it again
to display the screen for handling
the external fluid containers.
Maintenance Press the button and, on the
System Status screen, press it again
to display the maintenance actions
list.
Printer Press the button and, on the
text about the printer status.
Roche Diagnostics
Analyzing samples
Checking for alarm messages
a To check for problems during processing

1 Observe the Alarm LED.
LED Meaning Possible action

No color There are no new alarm messages. No action is required.
(off) (All alarm messages have been
acknowledged.)
Yellow There is at least one new warning User intervention is required as
message. soon as possible. Processing can
continue for the time being.
Check the details of the message.
Red There is at least one new alarm Immediate user intervention is
message. required. Processing cannot
continue without it.
Check the details of the message.
An acoustic signal is sounded when an alarm is created. You can adjust the volume
2 Take appropriate action.

e For details on dealing with alarm messages, see Alarm monitor on page D-6.
Acoustic signal
An acoustic signal informs you of the fact that all tests are finished and the system
status has changed to Standby.
Roche Diagnostics
Analyzing samples
Stopping and restarting a run
a To stop a run
1 Press the global action button.
A screen is displayed that offers several kinds of stopping, each of them
representing a certain level of interrupt.
Figure B-20
Interpreting the screen Abort Stop immediately all processing activities.

Pipettings that were not finished are considered not pipetted.
Measurements that have not yielded a valid result are considered not
measured.
Sampling stop Finish the current pipetting action, but do not start a new one.
You can restart processing by pressing the global action button.
Stop Printing Stop the current printing task. (It may take a few moments before
printing actually stops.)
Shutdown Shut down the cobas c 111 software and the operating system.
This option can only be performed in Standby status.
Restart Shut down the cobas c 111 software and automatically restart it.
This option is available in Standby status only. It is used in cases
where a configuration change requires restarting the software for it to
become effective.
Removing sample tubes
You can remove a sample when its tube button is green .
All tests are accepted.

1
All tests are pipetted.

1*
If you remove a sample tube before the pipetting is complete, the tests that were pipetted
will be performed as normal. The order remains unfinished.
You can check the resulting order details in Workplace > Order > .
e See Checking the sample tube status on page B-40.
Roche Diagnostics
Validating patient results
The cobas c111 instrument provides several aids for validating results:
o In the results list, results that fall outside predefined technical ranges are flagged.
o You can display detailed result information that allows you to make a considered
decision.
o Non flagged results can be accepted automatically.
o You can print the results.
o You can export the results and process them on an external computer.
The following ways of dealing with results are available:
o Accept the result.
o Re-perform the identical test (Repeat).
o Re-perform the test using a predefined different dilution (Rerun).
Results must be accepted before they can be transmitted to a host or before they can
be automatically printed.
The effect of flagged results depends on the configuration (Utilities > Configuration >
Result Handling). The following table shows how.
Configuration setting Effect

Sample Auto Accept: On Results that do not contain a flag are
automatically accepted. Results with flags that
are marked in a predefined list of flags that
should be ignored are accepted as well.
Sample Auto Accept: Off All results need to be manually accepted.
Sample Accept Flags Flags that are marked in this list will be
ignored by the system.
Table B-4 Sample flag configuration and its effect
There are two main approaches to validating results:

o To validate patient results of an order whose sample is still on board, press the
tube button on the [Overview] tab.
o In all other situations, choose Workplace > Result Review.
Roche Diagnostics
a To validate patient results of on-board samples

1 On the [Overview] tab, press the sample button.
A screen is displayed that lists the results of the order that is associated with the
sample.
A B C
D E F
A Status C Results are given in lab units.

!: The result has not been accepted yet. D Press to validate the results.
@: The result has not been transmitted yet. E Press to add more tests to the order.
B Test name. F Press to delete the order and its results.
-v-: Rerun with dilution.
Figure B-21
2 Select the result, if there is more than one test.

3 Continue with Validating the results on page B-48.
Roche Diagnostics
a To validate patient results from the results list

1 Choose Workplace > Result Review.
A screen is displayed that lists the results.
B C D
G H
A Order number. F This test was performed again:
B Status ->-: Repeated.
!: The result has not been accepted yet. -v-: Rerun with dilution.
@: The result has not been transmitted yet. G Press to validate the selected result.
C Test name. H Press to display certain kinds of results
D Results are given in lab units. only (filter).
E Time when the order was defined.
Figure B-22
To check when the result was generated press .

For results, that were not generated on the current day, only their date of generation is
displayed. You can look at the results by pressing .
To display context information of the fluids used to arrive at this result, press , then on
the detail screen press .
Interpreting flags e For detailed information on the flags, see List of flags on page D-22.
Displaying details of a result 2 Select the result.

3 Press to display detailed information on the selected result.
4 Press to close the screen.
The screen with the result list is displayed again.
5 Select a result.
Validating the results The system can be set up to automatically accept results that are not flagged. In
addition, it can be set up to accept results with flags that are marked in an editable
list of flags that should be ignored, which is particularly suitable if the flags are
assessed on the host system anyway.
e See Result handling on page B-146.
See Editing the acceptable flags list on page B-142.
6 Press .
A screen is displayed for selecting your reaction.
Roche Diagnostics

o Press <Repeat> to re-perform the test using the same dilution.
e See Repeating tests on page B-49.
o Press <Rerun> to re-perform the test using a predefined (different) dilution.
e See Rerunning tests on page B-50.
o Press <Accept> to accept the result.
e See Accepting results on page B-51.
o Press <Retransmit> to send the result to the host again. Use this function if
you suspect that the result has not been stored properly on the host system, for
example because of a communication problem.
Repeating tests
Repeat Performing a repeat means reperforming the same test with identical dilution.
Typically, you perform repeats if the result is flagged and you want to confirm the
result.
a To repeat a test
1 Validate the result.
e If the sample is still on board, see To validate patient results of on-board samples on
page B-47.
e If the sample is no longer on board, see To validate patient results from the results list on
page B-48.
2 Press <Repeat>.
The system automatically creates a new order and selects the test. It then performs
the test.
In the results list, the result of the Repeat is shown on a separate line:
A
B
A First result B Repeat result (->-)
Figure B-23
Roche Diagnostics
Rerunning tests
Rerun Performing a rerun means reperforming the same test with a different predefined
dilution. Typically, you perform reruns if the result is outside the test range.
a To rerun a test
page B-47.
page B-48.
2 Press <Rerun>.
The system automatically creates a new order and selects the test. (The dilution
factor is part of the test definition and therefore automatically selected. It cannot
be changed.) It then performs the test.
In the results list, the result of the Rerun is shown on a separate line:
A
B
A First measurement B Rerun result

-v-: Rerun with dilution.
Figure B-24
Roche Diagnostics
Accepting results
Results must be accepted before they can be printed, sent to the host, or deleted.
Automatic acceptance The system can be set up to automatically accept results that are not flagged. In
addition, it can be set up to accept results with flags that are marked in an editable list
of flags that should be ignored (Utilities > Configuration > Result Handling).
a To accept a result
page B-47.
page B-48.
2 Press <Accept>.
The result list is displayed again.
Printing patient results
a To print results:
If Do this
You want to print all results of an order: Choose Workplace > Orders.
You want to print individual results: Choose Workplace > Result Review.
2 Press .
A screen is displayed for selecting which results should be printed.
3 Press one of the buttons.
Press <List> to print the items currently displayed in the list. If a filter was applied,
the list would contain only the items that fulfill the filter criterion, and the filter
criterion would be part of the button name.
Press <Detail of Order> to print all results of the associated order.
For repeated or rerun orders, all results of this order are printed, including those
that were accepted earlier.
Automatic printing You can set up the system to automatically print results as soon as all results of an
order are accepted (Configuration > Workflow > Auto Print Results).
Choose > to terminate the printing task, if required.
Roche Diagnostics
Performing calibrations
e For an overview on calibration concepts, see Calibration on page A-24.

For performing calibrations in the Prepare phase, see Performing the calibrations (Prepare
phase) on page B-29.
For information on configuring calibration, see Defining calibrator definitions and lots on
page B-132.
Tests with a due calibration are blocked.

e For validating calibration results see Validating calibration results on page B-56.
Safety information

Incorrect results due to expired calibration

measurement systems. Failing to perform calibrations when they are due may lead to
incorrect results.
Make sure to perform calibrations when they are due.
Incorrect results due to wrong tube placement

Be sure to place the calibrators in the specified positions.
Roche Diagnostics
Short guide
The following table provides an overview on the steps that make up the calibration
process.
Step User action

1 Perform the calibrations.
Perform all due calibrations. 1. Choose Workplace > Calibrations > .
2. Press to select all tests that currently need
calibrating.
3. Check and, if required, print the placement list.
4. Prepare and place the calibrators according to
the placement list.
5. Press .
Perform all calibrations that will 1. Choose Workplace > Calibrations > .
be due within the forecast 2. Press to select all tests that will require
period. calibrating within the forecast period.
the placement list.
5. Press .
Perform an individual 1. Choose Workplace > Calibrations > .
calibration. 2. Select the test.
3. If there is more than one reagent set on board
for this test, choose whether to calibrate the
current set or to precalibrate a standby set.
the placement list.
6. Press .
2 Validate the results. 1. Choose Workplace > Calibrations.
2. Select the calibration result.
3. Press to look at result details.
4. Press to validate the calibration.
Table B-5 Steps for performing calibrations
Roche Diagnostics
Process of performing calibrations
The process of defining calibration orders depends on what you want to achieve:
o Calibrating all tests that need calibrating
o Calibrating all tests that will need calibrating during the forecast period
o Calibrating individual tests
O Calibrating the current set
O Pre-calibrating a standby set
e For information on performing calibrations in the Prepare phase, see Performing the
calibrations (Prepare phase) on page B-29.
a To perform calibrations
1 Choose Workplace > Calibrations.
A screen is displayed that lists all tests and their currently valid calibration.
2 Press .
A B
A Press to select all tests that now need B Press to select all tests that need
calibrating. calibration within the forecast period.
Figure B-25
Interpreting the colors Color Meaning Possible actions

Calibration is due. Perform the calibration.
Calibration failed. Check the result flag to find out why
the calibration failed. Repeat the
calibration if necessary.
The calibration was successfully Validate the calibration results.
performed, but its result has not
been accepted yet.
Not relevant for calibration.
The calibration is OK. Its result has No action is currently required.

been accepted.
The calibration is OK. It applies to a No action is currently required.
reagent set that is not active.
Roche Diagnostics
3 To select the tests, do one of the following:
If Do this
You want to perform all due 1. Press .
calibrations: All tests with due calibrations are selected. (The
currently active lots and sets are used for the
calibration.)
2. Press .
You want to perform all 1. Press .
calibrations that fall due All tests are selected whose calibration will be due
during the forecast period: within the forecast period. (The currently active lots
and sets are used for the calibration.)
2. Press .
You want to calibrate the 1. Select the test.
current set: 2. Press .
A screen is displayed that lists the calibrators that are required for the ordered
calibrations, and it shows on which sample position to place them.
A B C
A Position on the sample area where to C Calibrator with highest concentration

place the calibrator. D Calibrator with lowest concentration
B Lot number
Figure B-26
With absorbance tests that require several calibrators, the calibrators are placed according
to their concentration, starting with the highest concentration.

8 Validate the calibration results.
e See Validating calibration results on page B-56.
9 Remove the calibrator tubes.
Roche Diagnostics
a To replace the current lot calibration

2 Select the test whose lot calibration want to replace.
3 Press to delete the result.
4 Press to confirm the deletion.
5 Load the new reagent set. (See Adding a reagent set on page B-25.)
You can only generate a new lot calibration result when calibrating a new reagent
set.
7 Press .
8 Select the test.
9 Press .
If a screen is displayed for selecting the calibration type, choose <Lot Master>.
Validating calibration results
For a calibration to become active, you need to accept its result.
Flagged calibration results If flags are generated, you must determine their cause and decide whether to accept
the result, continue working with the old results, or to rerun the calibration.
The effect of flagged calibration results depends on the configuration.

Cal Auto Accept: On Results that do not contain a flag are
should be ignored are also automatically
accepted.
Cal Auto Accept: Off All results need to be manually accepted.
Cal Acceptable Flags Flags that are marked in this list will be
Table B-6 Calibration flag configuration and its effect

Roche Diagnostics
a To validate the calibration results

1 Choose Workplace > Calibrations
A B C D
E F G H
A Test ID. E Press to validate the result.

B Calibration use. F Press to define a new calibration order.
C Calibration type. G Press to delete the selected calibration
D Status indication. and its results.
H Press to display all or only the current
results.
Figure B-27
Interpreting the screen Item Value Interpretation

U (Use) CU Current.
The calibration results of this set are currently used.
SB Standby.
The calibration results of this set are not currently used.
(An identical set is currently in use or the set was removed
and is not empty.)
OB Obsolete.
The calibration results of this set are no longer used. (The
set was empty and removed or it was removed more than 30
days ago).
T (Type) L Lot calibration (first calibration of a lot, also applies to
subsequent sets of the lot).
S Set calibration (applies to calibrated set only).
Status The date indicates when the results were accepted. If flags
were generated for the result, the flag with the highest
priority is displayed. In all other cases, the order status is
displayed.
e For details on calibration types, see Calibration type on page A-25.
2 Select the result.
Roche Diagnostics
3 Press to display information on the selected calibration and its results.
A B C D E
F
G
H
I J K
A Test ID. F Calibrator, lot, expiration date.
B Calibration use. G Flags.
C Accepted by: User name. $SYS$ means H Calibration results.
automatically accepted. I Press to validate the results.
D Calibration type. J Press to display result details.
E Calibration status. K Press to display context information of the
fluids used to arrive at this result.
Figure B-28
4 Press .
A screen is displayed for selecting your decision.
o Press <Accept Set> to accept the set calibration results for the selected test.
o Press <Accept Lot> to accept the lot calibration results for the selected test.
This button is only active if the calibration sequence [Each Lot and Interval] is
defined for the application and if no flags were generated for the result.
e For information on lot and set calibration, see Calibration type on page A-25.
o Press <Repeat> to have the calibration performed again.
o Press <Use Old> to discard the new result, reset the calibration due date, and
to continue using the old calibration results.
This possibility is available if you selected an accepted result. When you press
<Use Old>, a copy of the old result is made and a new entry is displayed in the
calibration results list. Note that the intervals are reset as if a new calibration
result were generated.
Incorrect results when using <Use Old>

WARNING measurement systems. Failing to perform calibrations when they are due may lead to
incorrect results.
o Roche recommend performing a QC measurement before you continue working with
the old calibration results.
o In the application definitions, choose <On> for [QC After Cal].
(Utilities > Applications > Laboratory Parameters > Control > QC After Cal)
Roche Diagnostics
Performing QC
Accepting calibration results

Calibration results will be used by the system only when you have accepted them.
There can be only one unaccepted calibration result for a test.

If there already exists a not accepted calibration for a test and you place another
calibration order for this test, the order will be blocked.
Performing QC
QC is performed at regular intervals to check the integrity of the whole measuring

system.
Control A control is a sample that has been measured using all tests it is associated with, in
order to define the ranges and values that determine the correct functioning of the
instrument. This is typically done both for the normal and the pathological analyte
concentration.
e For an overview on QC, see Quality control (QC) on page A-28.
For information on QC configuration, see Defining control definitions and lots on
page B-131.
There are two basic ways of performing QC on the cobas c111 instrument:
Default QC Default QC is an automated process for performing QC measurements in one

request. This is the ideal method if you want to perform QC on certain days or at
certain times.
This process only applies to tests whose controls are defined to be performed as part
of Default QC. Therefore, if you intend to work with Default QC, you need to
configure the tests accordingly.
e See Defining control definitions and lots on page B-131.
Performing Default QC follows a streamlined procedure whereby QC orders are

automatically defined as soon as you identify a control. An order is defined for all tests
for which this control is defined as the Default QC, provided the test is currently
active on the system.
Interval QC Interval QC is a process that is suitable both for performing a single QC measurement
and for performing all QC measurements that are due. You can select all tests that
require QC simply by pressing a button ( ). (This selection also reflects QC of the
type [QC after Cal].) A wizard helps you select the controls, and a placement list
supports you in preparing and loading them.
Safety information
page B-5.
Roche Diagnostics
Performing QC
Short guide
The following table provides an overview of the steps that make up the QC process.
Step User action

1 Perform QC
Perform Default QC. 1. Choose Overview > Order.
2. Press .
3. Select a control and place the tube. Repeat until
there are no controls left on the screen.
4. Press .
Perform all interval QC 1. Choose Overview > Order > or

measurements that are due. Workplace > QC Status> .
2. Press .
3. Press .
5. Press .
Perform a single interval QC 1. Choose Workplace > QC Status.

measurement. 2. Press .
3. Select the test.
4. Press .
6. Press .
2 Validate the results. 1. Choose Workplace > QC Status.

2. Press to look at result details. Close the
details screen.
3. Press and press a button to validate the QC
result.
Table B-7 Steps for performing QC
Roche Diagnostics
Performing QC
Performing Default QC
Performing Default QC follows a streamlined procedure whereby QC orders are

automatically defined as soon as you identify a control. An order is defined for all tests
for which this control is defined as the Default QC, provided the test is currently
active on the system.
a To perform Default QC
1 Choose Overview > Order.
2 Press .
A screen is displayed that contains a button for each of the controls that are
required.
3 Prepare the controls.
4 Press a control button.
A screen is displayed, asking you to place the selected control.
5 Place the control tube on any free position on the sample area.
The system registers the position and automatically defines an order for each test
that has this control defined as its Default QC.
The screen with the control buttons is displayed again. The button for the control
you just loaded is no longer active.
6 Press the next active control button.
A screen is displayed, asking you to place the control.
7 Place the control on a free position on the sample area.
8 Select and place the remaining controls as described in steps 6 through 7.
When all controls are placed, the screen for identifying samples is displayed.
10 Press to start processing the control orders.
Roche Diagnostics
Performing QC
Performing interval QC measurements
a To define a QC order
1 To define a new order, do one of the following:
o Choose Overview > Order > .
o Choose Workplace > QC Status > .
A a test selection screen is displayed.
A
A Press to select all tests with due QC. Press again to cancel the selection.
Figure B-29
Interpreting the display The test is blocked for one of the following reasons:
o Calibration is required.
o The calibration failed.
o For the reagent set, the number of available tests is 0, or a reagent bottle is
missing (incomplete reagent set).
A QC is due or its result has not yet been accepted.
The reagent set is on board and ready for use.
The reagent set is not on board.
2 To select the tests, do one of the following:

o Press to select all tests with due QC.
This selection also applies to controls of the type [QC after Cal].
o Press a test button.
3 Press .
A screen is displayed that contains a button for each of the controls that are
required.
If at this stage, the required controls are already loaded on the instrument, then the QC
orders are automatically created.
4 Prepare the controls.
Roche Diagnostics
Performing QC
5 Press a control button.

A screen is displayed, asking you to place the selected control.
6 Place the control tube on any free position on the sample area.
The system registers the position and automatically defines an order.
If there are more controls to place, the screen with the control buttons is displayed
again. The control you just placed is no longer active.
7 Select and place the remaining controls as described in steps 5 through 6.
When all controls have been selected and placed, the [Overview] tab is displayed.
8 Press to start processing the control orders.
Validating QC results
Flagged QC results If flags are generated, you must determine their cause and decide whether to accept
the result or to ignore it.
The effect of flagged QC results depends on the configuration.

QC Auto Accept: On Results that do not contain a flag are
should be ignored are also automatically
accepted.
QC Auto Accept: Off All results need to be manually accepted.
QC Acceptable Flags Flags that are marked in this list will be
Table B-8 QC flag configuration and its effect

Roche Diagnostics
Performing QC
a To validate the QC results

1 Choose Workplace > QC Status.
A screen is displayed that lists the most recent QC results for each test that is
installed on the system.
A B C D
A Status D Result, if no flag was generated.

!: The result has not been accepted yet. Flag with highest priority, if a flag was
@: The result has not been transmitted yet. generated.
B Test name. Order status, if the control measurement
C Control ID. has not been performed yet.
Figure B-30
2 Select a result.
3 Press to look at result details.
A B C D
A Test name D Result

B Control name E Press to display context information of the
C Accepted by: User name. $SYS$ means fluids used to perform QC for this test.
automatically accepted.
Figure B-31
If the QC result is outside the defined range, perform the QC again. If the results are still
outside the range, check for other causes. If all fails, perform a calibration.
5 Press .
Roche Diagnostics
Performing QC

o Press <Accept> to accept the QC results for the selected test.
o Press <Retransmit> to send the result again.
(This option is active if your instrument is connected to a host system.)
If you want to ignore the result, delete it. It will not be added to the QC History.
Interpreting the QC History
The QC History provides information on the QC results of the current and the
previous calendar month. (At the beginning of each month, the results of the month
that now lies two months back are automatically blocked from display.)
A graphic representation of the results provides a convenient way for comparing
results over a period of time.
a To interpret the QC history

1 Choose Workplace > QC History.
A screen is displayed that contains, one QC result entry for each lot of each test.
A B C
A Test name. C Date of most recent control.

B Control ID. measurement. If the control does not
belong to the current lot, [Previous Lot]
is displayed instead of the date.
Figure B-32
Roche Diagnostics
Performing QC
2 Press .
A graphic is displayed that shows the QC results for the current or the previous
month.
A B C
D
E
F
G
H
I
J
K L M N
A Calibration I -2.5s
B Reagent set change J -3s
C QC target value change K Press to print the graphic
D +3s L Press to display the results in a table
E +2.5s M Press to display the results of the previous
F +2s month
G Mean value N Press to display the results of the current
H -2s month
Figure B-33
3 Press to display the results in a table.

The results are sorted chronologically. An overview is followed by statistical data
for all stored results and for the results of the current month. (If a QC target value
change took place, only the results from this date onward are taken into account
for both statistics.)
A B C
A Date of QC measurement C Flag (if generated)

B Result or event
Figure B-34
Roche Diagnostics
Performing QC
Performing reagent mixing
Reagents that contain Latex granules, for example D-Dimer, require periodic mixing.
The mixing interval is part of the application definitions and cannot be changed by
the user. The system checks every 30 minutes for reagent sets that require mixing.
e For mixing during the Prepare phase, see Performing reagent mixing on page B-28.
a To perform the mixing

1 Choose Overview > .
2 Press the button of the reagent set you want to mix.
A screen is displayed that contains details on the set.
3 Press .
(This button is available if there is a mixing interval defined for this reagent set.)
Mixing starts. A screen is displayed informing you about the progress of the
mixing action.
4 When mixing is finished, press to close the screen.
Roche Diagnostics
Finishing the shift
Finishing the shift
The typical end of shift activities are organized in a single wizard. By performing the
steps as suggested by this wizard, you put the instrument in a condition that allows
you to hand over operation to another operator or to switch off the instrument.
Safety information
following safety messages in particular are relevant:
Warning messages:
o Injury through reagents and other working solutions on page B-5
o Infection by biohazardous materials on page B-5
o Injury through reagents and other working solutions on page B-5

Short guide
The following table provides an overview of the steps that make up the end of shift
process.
Step User action

1 Check for unfinished tasks. 1. Check for unfinished orders.
2. Check for nonvalidated results.
3. Check for results that were not transmitted.
2 Start the End Shift wizard. 1. On the [Overview] tab, press the <End Shift>
button.
Table B-9 Steps for finishing the shift
Roche Diagnostics
Finishing the shift
Step User action

3 Perform data backup. 1. Press .
2. Insert the USB stick.
3. Press .
4. Select the directory.
5. Press .
End Shift wizard.
4 Export support data 1. Press .

2. Insert the USB stick, if you have removed it.
3. Press .
5. Press .
6. Remove the USB stick.
End Shift wizard.
5 Clean up the database. 1. Press .

2. Press to confirm the deletion.
End Shift wizard.
6 Perform maintenance actions 1. Check which maintenance actions are due.

2. Perform the maintenance actions.
End Shift wizard.
7 Check the cuvette status. Replace at least all red cuvette segments.
1. Press the cuvette button.
3. Replace the cuvette segments.
End Shift wizard.
8 Empty the waste container. 1. Empty the waste container.

2. Press the <Waste> button to confirm.
3. Refill the water container.
4. Press the <Water> button to confirm.
Roche Diagnostics
Finishing the shift
Step User action

9 Remove the reagent disk. 1. Choose Overview > .
2. Press
2. Lift the disk from the instrument.
3. Place the disk in its container.
4. Press .
6. Store the reagent disk in a cool place.
10 Finish your shift. 1. Log off the system.

2. Switch off the main instrument. (If there is no
other shift.)
Checking for unfinished tasks
Checking for unfinished orders
a To check for unfinished orders

1 Choose Workplace > Orders.
2 Choose > Not Finished.
3 Press .
A screen is displayed that contains all unfinished orders.
4 Do whatever is necessary to finish the orders.
Checking for not accepted patient results
Results must be accepted before they can be printed or transmitted to the host.
a To check for not accepted results

A screen is displayed that contains all patient results of the day.
2 Choose > Not Accepted.
3 Press .
A screen is displayed that contains all patient results that have not been accepted
yet.
4 Select a result.
Roche Diagnostics
Finishing the shift
5 Press to validate the result.

A screen is displayed for selecting your decision.
e See Accepting results on page B-51.
See Repeating tests on page B-49.
See Rerunning tests on page B-50.
6 Press one of the buttons.

7 Select and validate the remaining results as described in Steps 4 through 6.
If you did not accept all results, deal with the not accepted ones and check for not
accepted results again.
Checking the transmission of results

This step is only relevant if you work with a host system.
Before deleting the results, you must make sure they were properly transmitted to the
host.
Results must be accepted before they can be transmitted to the host.

See also the information on Result handling on page B-146, in particular on the Auto
Accept settings.
a To check for results that were not transmitted

A screen is displayed that contains all patient results of the day.
2 Choose > Not Sent to Host.
3 Press .
A screen is displayed that contains the patient results that have not been
successfully transmitted to the host.
4 Select a result.
5 Press .
A screen for validating results is displayed.
6 Press <Retransmit>.
The list with the results that were not transmitted successfully is displayed again.
The result you just retransmitted should no longer be present.
7 Select and retransmit the remaining results as described in Steps 4 through 6.
8 Choose > Not sent to Host.
The list should now be empty.
9 If the results were not successfully transmitted, contact the administrator of the
host computer.
Roche Diagnostics
Finishing the shift
Starting the End Shift wizard
The easiest way of performing the end of shift tasks is by following the End Shift
wizard.
a To start the End Shift wizard

1 Choose Overview > End Shift.
A screen is displayed for performing daily backup.
Performing the daily backup
The cobas c111 instrument can store orders and result data for one working day. It
is therefore necessary to export to an external medium all data that you need to keep.
During a database export, the full content of the database is copied to the USB stick.
The database data can be restored to the instrument if required (Utilities > Import >
Database).
e For information on restoring the database, see Importing the database on page B-101.
a To perform the daily backup

1 Press .
A screen is displayed, asking you to insert the USB stick.
2 Insert the USB stick.
A screen is displayed showing the directory structure of the USB stick.
3 Select the directory where you want the backup file to be copied.
4 Press to confirm the selection.
The data are copied to the stick.
Database files names have the following name format: dba_yyyymmddhhss.tgz.
5 Press to proceed to the next stage in the End Shift wizard.
A screen is displayed for deleting patient results.
When performing backup without using the End Shift wizard:

Choose Utilities > Export > Database.
Roche Diagnostics
Finishing the shift
Exporting the result data
When exporting results, the full result data are exported. The following results are
copied to the USB stick (each of the sets is contained in a separate file):
Data set File name

Patient results res_yyyymmddhhss.csv
QC results qcs_yyyymmddhhss.csv
Calibration results cal_yyyymmddhhss.csv
File format Result data are exported as comma-separated value (csv) files. The entries are
separated by semicolons (;).
e For details on csv definitions, see Exporting results on page B-93.
These files can be processed with any spreadsheet program that can import csv files.
a To export the results

1 Press .
A screen is displayed showing the directory structure of the USB stick.
3 Select the directory where you want the result files to be copied.
The data are copied to the stick.
A screen is displayed for deleting patient results.
When performing backup without using the End Shift wizard:

Choose Utilities > Export > Full Results.
Roche Diagnostics
Finishing the shift
Cleaning up the database
The cobas c 111 instrument can store orders and results data for one working day. It
is therefore necessary to delete results and orders to ensure that there is enough space
on the system for the next shift.
By deleting the patient results, you delete the corresponding orders as well.
a To clean up the database

1 Press .
The following results will be deleted:
o Accepted patient results.
o QC results that were accepted are deleted from the QC Status list (they remain
in the QC History).
o QC results that were generated before the first day of the previous month are
deleted from the QC History.
o Obsolete calibration results, provided there are more than five obsolete results
for the same test.
(Results become obsolete if the empty set was removed or if the set was
removed more than 30 days ago.)
The results are deleted.
A screen for handling cuvettes is displayed.
When deleting results outside the End Shift wizard:

Outside the End Shift wizard, you can delete accepted patient and calibration results
individually only.
Choose Workplace > Result Review > .
Choose Workplace > QC Status or QC History > > All Accepted.
Choose Workplace > Calibrations > .
Roche Diagnostics
Finishing the shift
To ensure the smooth running of the system, you should perform all due
maintenance actions. Performing these actions as part of the end of shift activities
ensures that at the beginning of the next shift, when there might be many tests to be
performed, the system is ready for processing quickly.

1 Follow the instructions given in To perform maintenance actions on page B-19.
A screen is displayed that shows the status of the cuvettes.

Replacing cuvettes
a To replace cuvettes
1 Follow the instructions given in To prepare the cuvettes on page B-27.
A screen is displayed that shows the status of the external fluid bottles.
When replacing cuvettes without using the End Shift wizard:

Choose Overview > .
Roche Diagnostics
Finishing the shift
Dealing with the external fluid bottles
Emptying the waste container
To prevent unpleasant smells and contamination of the environment, you need to

empty the waste at the end of your shift.
a To empty the waste container

1 Remove the tubing adapter from the yellow waste container and insert it in the
spare container.
2 Remove the bottle from the rack and place it on a firm and even surface.
3 Place the spare container on the rack.
4 Follow the instructions given in To check the waste container on page B-17.
Roche recommend to refill the water container whenever you empty the waste container.
When emptying the waste without using the Prepare wizard:

Refilling the external water bottle

CAUTION quality specified in section Technical specifications.
a To refill the external water container

1 Remove the tubing adapter from the white water container and place it on a clean
surface.
2 Follow the instructions given in To check the water container on page B-16.
Roche recommend to empty the waste container whenever you refill the water container.
When refilling the water without using the Prepare wizard:

Roche Diagnostics
Finishing the shift
Removing the reagent disk
During periods when you do not perform tests, the disk should be stored in a clean
refrigerated place at temperatures in the range of 6 to 10°C.
page B-5.

The reagent disk container can slip off or tip over if it is not placed on an even horizontal
CAUTION surface.
When storing the reagent disk container, make sure to place it on a firm, even, horizontal
surface that is easily accessible.
a To remove the reagent disk

1 Choose Overview > > .
A screen is displayed, asking you to remove the reagent disk.
3 Remove the reagent disk.
4 Place the reagent disk in the reagent disk container.
6 Store the reagent disk container in a refrigerated place.
Roche Diagnostics
Logging off
Logging off
You should log off the system before you hand it over to another operator. (Only one
person can be logged on at any time.)
You can log off any time, even while the system is processing orders.
a To log off the system

1 Choose Overview > button with your user name.
Automatic logoff
You can configure the system to automatically log off the user after a configurable period
of inactivity (Utilities > Configuration > System > Screen Saver Wait ≠ 0; Utilities >
Configuration > System > Auto Log-off = On).
Viewing alarms while you are logged off

You can view alarms any time, even when you are logged off.
e For configuring automatic logoff, see System on page B-147.
If there is no other shift, you can now switch off the main instrument.
Switching off the system
When you switch off the system, reagent cooling stops. Therefore, you need to remove the
reagent disk and store it in a cool place before switching off the system.
Preconditions The system must be in Standby status.
a To switch off the main instrument

1 Press [O] on the toggle switch.
Roche Diagnostics
Using the barcode scanner
e For information on the barcodes, see Barcode scanner on page A-59.
Because the barcodes on reagent bottles and sample tubes are different, you use the
barcode scanner in a different way. The various procedures are described in the
following sections.
Loss of sight
WARNING Scanning equipment using LED technology is covered by the international standard
IEC 60825-1 LED Safety: Class 1.

personal injury. When handling reagents, exercise the precautions required for handling
laboratory reagents, observe the cautions given in the package insert, and observe the
information given in the Safety Data Sheets available for Roche Diagnostics reagents and
cleaning solutions.
Malfunction due to spilled liquid

Any liquid spilled on the instrument may result in malfunction of the instrument. If liquid
CAUTION does spill on the instrument, wipe it up immediately and apply disinfectant.
Make sure you do not tilt the bottle or sample tube when scanning its barcode.
Reading reagent bottle barcodes
a To use the barcode scanner for reading reagent bottle barcodes

1 When a screen is displayed, asking you to scan, use the barcode scanner and scan
the barcode.
2 Make sure not to tilt the bottle while scanning its barcode.
3 Hold the scanner at a distance of approximately 20 cm (8 in) from the barcode,
pull the trigger on the scanner and point the red light just outside the barcode.
4 Move the light slowly across the barcode.
5 Wait until you hear a beep and release the trigger.
If the reading was successful, a screen is displayed, asking you to place the bottle
on the reagent disk.
Roche Diagnostics
Reading barcodes from sheets
a To use the barcode scanner for reading barcodes from sheets

the barcode.
2 Place the barcode transfer sheet on a flat surface and smooth it out.
pull the trigger on the scanner and point the red light just outside the barcode.
4 Move the light slowly across the barcode.
5 Wait until you hear a beep and release the trigger.
If the reading was successful, a screen is displayed, asking you to place the item.
Reading sample tube barcodes
For safety reasons, the barcode scanner is set to only read barcodes that contain a
checksum.
a To use the barcode scanner for reading sample tube barcodes

the barcode.
2 Make sure not to tilt the sample tube while scanning its barcode.
pull the trigger on the scanner and point the red light at the barcode.
4 Wait until you hear a noise and release the trigger.
If the reading was successful, a screen for selecting tests is displayed.
Roche Diagnostics
cobas c111 6 Special operations
Table of contents
Special operations
The tasks you do not perform every day
In this chapter, you will find information on operator tasks that are not part of the
daily routine of analyzing samples.

Deleting patient orders ............................................................................................. B-83
Deleting patient results ............................................................................................. B-83
Calibration ................................................................................................................. B-84
Deleting calibration results ................................................................................. B-84
Setting up your calibration schedule .................................................................. B-85
Deleting QC results .................................................................................................. B-85
Lot handling .............................................................................................................. B-87
Viewing the current lot definitions .................................................................... B-87
Calibrator and QC lots .................................................................................. B-87
Reagent lots .................................................................................................... B-88
Viewing the lot details of fluids that were used ................................................. B-89
Adding a new lot .................................................................................................. B-89
Exporting data ........................................................................................................... B-92
Exporting the database ........................................................................................ B-92
Exporting results ................................................................................................. B-93
Interpreting result data ....................................................................................... B-94
Exporting log files ............................................................................................... B-98
Importing data .......................................................................................................... B-99
Importing applications ....................................................................................... B-99
Importing software ............................................................................................ B-101
Importing the database ..................................................................................... B-101
Importing certificates ........................................................................................ B-102
Importing automatic mixing and extra wash cycle definitions ...................... B-102
Preparing a new disk ............................................................................................... B-103
Assigning tests to test tabs ....................................................................................... B-106
Refilling printer paper ............................................................................................. B-108
Removing condensation water from the reagent cooler ....................................... B-110
Replacing the probe ................................................................................................. B-111
Roche Diagnostics
6 Special operations cobas c111
Table of contents
Connecting and disconnecting the external fluid containers ............................... B-113

Adjusting the touchscreen ...................................................................................... B-116
Cleaning the touchscreen ........................................................................................ B-117
Roche Diagnostics
Deleting patient orders
Deleting patient orders
Patient orders are normally deleted as part of the daily end of shift activities. This
section describes how to proceed if you need to delete patient orders outside the
normal daily routine.
e For deleting orders at the end of a shift, see Cleaning up the database on page B-74.
Preconditions for deleting The orders should be fully processed before you delete them.
a To delete orders
1 Choose Workplace > Orders.
A screen is displayed that lists all currently defined patient orders.
If Do this
You want to delete an individual order: 1. Select the order entry in the list.
2. Press .
3. Press <Selected>.
You want to delete all or a specific group of 1. Press .
orders: 2. Press the appropriate filter button.
3. Press to confirm the selection.
4. Press .
5. Press <List [filter criterion]>.
The orders are deleted. You cannot retrieve them any more from the system.
By deleting a patient order, you delete the associated results as well.
Deleting patient results
Patient results are normally deleted as part of the daily end of shift activities. This
section describes how to proceed if you need to delete patient results outside the
e For deleting results at the end of a shift, see Cleaning up the database on page B-74.
Preconditions for deleting Patient results should be accepted and printed or sent to the host before deleting.
Roche Diagnostics
Calibration
a To delete patient results

1 Choose Workplace > Result Review
A screen is displayed that lists all results.
If… Do this…
You want to delete an individual patient 1. Select the result entry in the list.
result: 2. Press .
3. Press <Selected>.
You want to delete all or a specific group 1. Press .
of patient results: 2. Press the appropriate filter button.
4. Press .
5. Press <List [filter criterion]>.
The results are deleted. You cannot retrieve them any more from the system.
By deleting all patient results of an order, you delete the corresponding order as well.
Calibration
Deleting calibration results
Obsolete calibration results are automatically deleted as part of the daily end of shift
activities if there are more than five obsolete calibration results for the test.
(Calibration results become obsolete when the empty set is removed or if it was
removed more than 30 days ago.)
This section describes how to proceed if you need to delete results outside the normal
daily routine.
e For deleting calibration results at the end of a shift, see Cleaning up the database on
page B-74.
a To delete a calibration
2 Select the calibration entry.
3 Press .
A confirmation screen is displayed.
4 Press .
The order and the results are deleted. You cannot retrieve them any more from the
system.
Roche Diagnostics
Deleting QC results
Setting up your calibration schedule
The cobas c111 instrument provides convenient software-supported procedures for

the following major calibration scenarios:
o Performing all calibrations that are currently due
o Performing all calibrations that fall due within a configurable forecast period
o Performing individual calibrations
Performing calibration as part of the Prepare wizard includes performing all
calibrations that are due and that will fall due during the forecast period.
The following table lists the configurable definitions and describes their effect.
Definition item Configuration path Effect

Forecast Hours Utilities > Period of time, starting with the current
Configuration > date, within which calibration falls due.
Calibration Defining a forecast period (value other than
zero) allows to concentrate calibration
performance to specific days.
Cal Auto Accept Utilities > If on, results that are not flagged are
Configuration > Result automatically accepted.
Handling Results with flags that are marked in a
predefined list of acceptable flags would also
be automatically accepted.
Cal Acceptable Flags Utilities > List of calibration relevant flags. Flags that
Configuration > Result are marked are automatically accepted if
Handling [Cal Auto Accept] is on.
Table B-10 Calibration definitions and their effect
Deleting QC results
QC results are displayed in the QC Status list as soon as they are generated. A copy of the
results is also placed in the QC History list. This list keeps the results of the previous and
the current months.
Deleting QC results, deletes the associated orders as well.
Accepted QC results are normally deleted from the QC Status list as part of the daily
end of shift activities, at the same time, results that were generated before the first day
of the previous month are deleted from the QC History list.
This section describes how to proceed if you need to delete QC results outside the
e For deleting QC results at the end of a shift, see Cleaning up the database on page B-74.
Roche Diagnostics
Deleting QC results
a To delete QC results from the QC Status list

1 Choose Workplace > QC Status.
2 Press .
A screen for selecting results is displayed.
If… Do this…
You want to delete all QC results: 1. Choose <All>.
You want to delete all accepted QC results: 1. Choose <All Accepted>.
You want to delete the selected result: 1. Choose <Selected>.
a To delete QC results from the QC History

1 Choose Workplace > QC History.
2 Press .
A screen for selecting results is displayed.
If… Do this…
You want to delete all results in the list: 1. Choose <List [filter criterion]>.
(If a filter was applied, this list would 2. Press to confirm the deletion.
contain only the results that fulfill the filter
criterion, and the filter criterion would be
part of the button name.)
You want to delete all results that were 1. Choose <Older than Previous Month>.
generated before the first day of the 2. Press to confirm the deletion.
previous month:
You want to delete the results of the selected 1. Choose <Selected>.

control:
Roche Diagnostics
Lot handling
Lot handling
Both the lot data and its handling depend on what item the lot refers to:
o Calibrators (calibrator lot)
o Controls (QC lot)
o Reagents, diluents (reagent lot)
Viewing the current lot definitions
Calibrator and QC lots
a To view lot data

1 Choose Workplace > Lot Data
2 Press either <Controls> or <Calibrators>.
A screen is displayed that lists all installed lots.
The following description shows an example of viewing a calibrator lot.
A B C
A Calibrator name. C Expiration date

Asterisk: The lot data were changed by the
operator.
is not installed.
B Lot ID
Figure B-35
3 Select the calibrator and expand the entry.
Roche Diagnostics
Lot handling
4 Select a test and expand the entry.
B
C
A Calibrator name C Lot values

Asterisk: The lot data were changed by the
operator.
is not installed.
B Associated test
Figure B-36
Calibrators that were defined or changed manually are marked with an asterisk.
Reagent lots
You cannot view specific reagent lot data. They are an integral part of each reagent set.
a To view the lot ID

2 Press a reagent set icon.
A screen is displayed that contains information on the selected reagent set.
Roche Diagnostics
Lot handling
Viewing the lot details of fluids that were used
For patient, calibration, and QC results, you can check to which lot the used fluids
belong (reagents, calibrators, controls).
a To check context information of a result

If Do this
You want to check the context information 1. Choose Workplace > Result Overview.
of a patient result: 2. Select a result.
3. Choose > .
You want to check the context information 1. Choose Workplace > QC Status.
of a QC result: 2. Select a result.
3. Choose > .
You want to check the context information 1. Choose Workplace > Calibrations.
of a calibration result: 2. Select a result.
3. Choose > .
A screen is displayed that lists the lot IDs for the used reagent set, calibrators, and
controls. (The following figure shows an example of patient-result lot-data.)
Figure B-37
2 Scroll to display the information, if required.

Adding a new lot
Lot data are usually contained in the barcode of the item, and you define them by
scanning the barcode. With the exception of reagent and diluent lots—they can be
defined by scanning their barcodes only—all lots can also be defined manually.
Defining lots manually requires utmost diligence

During lot definition you need to type data that are directly relevant to result generation.
You would for example define the lot data manually if you cannot read the barcode
for some reason, or in the case where you work with lab-specific controls or third-
party controls that do not include barcode transfer sheets for lot data.
Roche Diagnostics
Lot handling
Preparation tasks Make sure that the controls and calibrators are assigned to the application.
e See Preparing applications on page B-125.
a To define a control lot

1 Choose Workplace > Lot Data.
2 Press <Controls>.
A screen is displayed that lists all installed control lots.
3 Press .
A screen is displayed, asking you to scan the barcode transfer sheet or to type the
data manually.
4 Define the lot values.
Do one of the following:
If… Do this…
The lot data are 1. Scan the barcode.
available from a The screen is displayed again that lists all installed control lots.
barcode The new lot is selected.
You want to type 1. Press .
the data manually 2. Type the name and press .
3. Type the material code and press .
You find this code in Utilities > Applications > select a test >
> Control.
4. Type the Lot ID and press .
5. Type the expiration date. Use the date format as indicated on
the screen.
6. Press to confirm the definitions.
If a lot with the same ID already exists on the system, a screen is
displayed, asking you whether you want to replace the existing
lot.
Press to confirm the definitions.
7. Press [*Add new test*].
8. Press .
A screen is displayed that contains all tests that use this control
and that have not yet been assigned to this lot.
9. Select a test and press .
10. Type the value for the mean concentration and press .
11. Type the value for the standard deviation.
The screen for handling control lot data is displayed again.
13. Perform steps 7 through 12 for all tests you want to use.
a To define a calibrator lot

2 Press <Calibrators>.
A screen is displayed that lists all installed calibrator lots.
3 Press .
A screen is displayed, asking you to scan the barcode or to type the data manually.
Roche Diagnostics
Lot handling

If… Do this…
available from a The screen is displayed again that lists all installed calibrator lots.
You want to type the 1. Press .
data manually 2. Type the name (up to 10 alphanumeric characters) and press .
Refer to the package insert.
4. Type the lot ID (up to nine alphanumeric characters) and press .
5. Type the expiration date and press .
Use the date format as indicated on the screen.
6. Type the number of calibrators (cups) you need to place on the
instrument. Use the information given on the package insert.
(Exclude calibrators that use system water from this number. See
step 14.)
9. Press .
A screen is displayed that shows all tests that have this calibrator
defined for them and that are not yet assigned to this lot.
10. Press one of the test buttons.
11. Press .
12. Define the first calibration value (target value).
13. Define the next calibration value.
You can define up to six calibration values, and you must define
them in descending order.
14. Select the value for [Last is Water].
Press <On> if you want to calibrate with system water as zero
calibrator. (In this case, no cup needs to be placed on the system.
(See step 7).
Press <Off> if you want to use a special zero calibrator for the
calibration. (The special zero calibrator needs to be placed on the
sample area.)
Calibration values (target values) in method sheets may be defined in increasing order of
concentration. Always define the values in decreasing order on the cobas c 111 instrument.
Roche Diagnostics
Exporting data
Exporting data
h Utilities > Export
Exporting the database
The database is normally exported as part of the daily backup during the end of shift
activities.
e See Performing the daily backup on page B-72.
During a database export, the full content of the database is copied to the USB stick.
The database data can be restored to the instrument if required.
e See Importing the database on page B-101.
a To export the database

1 Choose Utilities > Export > Database.
3 Press .
4 Select the directory.
The data are copied to the USB stick.
Database files names have the following name format: dba_yyyymmddhhss.tgz.
Roche Diagnostics
Exporting data
Exporting results
When exporting results, the full result data are copied into an archive on the USB
stick.
The archive has the name format csv_yyyymmddhhmmss.tgz, and it contains the
following files:
Data set File name

Patient results res_yyyymmddhhss.csv
QC results qcs_yyyymmddhhss.csv
QC history results qch_yyyymmddhhss.csv
Calibration results cal_yyyymmddhhss.csv
File format Result data are exported as line-oriented comma-separated value (csv) files.
The following definitions apply:
o Character set: ISO1LATIN1 - ANSI - ISO8859-1 - ISO Latin 1, Western
o Separator: Semicolon (;)
o Element qualifier: Quote (“) (ASCII-Code 34 (0x22)
o Empty element: Two quotes (“”) (ASCII-Code 34 (0x22)
o Line terminator: Standard Win Style (CRLF) ASCII-Code 13+10 (0x0D + 0x0A)
These files can be processed with any spreadsheet program that can import csv files.
a To export the support data

1 Choose Utilities > Export > Full Results.
3 Press .
A screen is displayed for selecting a directory.
Press <*.csv> to archive files only.
Press <*.*> to display all files and directories.
The data are copied to the USB stick. The screen for exporting data is displayed
again.
Roche Diagnostics
Exporting data
Interpreting result data
The following tables list, for the patient, calibration, and QC result files, the column
headings of the spreadsheet and provide information on the kind of information the
columns contain.
res_yyyymmddhhss.csv Column Title Description

Instr Instrument ID (always 30 for cobas c111)
Msg Message Type:
7 Result for sample, control, or calibration
8 QC history result
9 Process event
Index 166 ID of the data set used
141 Related reagent set data
151 Related calibration values
App Application code
Date Date when the result was generated
Time Time when the result was calculated
SW-Version Software version installed on the instrument
Serial Serial number of the instrument
Test Short name of the application
User User name ($SYS$ if Auto Accept is on)
Sample Sample ID
Order-Time Time when the order was started
Result Results of the measurement
Unit Defined display unit
Flags Flag name
Rates Rate value calculated in Abs. (Last Calculation Point - First
Calculation Point)
Raw1 - Raw40 Absorbance value of cycle 1 through 40 in Abs. (one cycle = 18 s)
isSTAT Generated as part of a STAT order
Table 38 Explanations on test results
Roche Diagnostics
Exporting data
cal_yyyymmddhhss.csv Column Title Description

Msg Message Type:
8 QC history result
9 Process event
Index 151 Calibration data
152 Std-1 value
153 Std-2 value
154 Std-3 value
155 Std-4 value
156 Std-5 value
157 Std-6 value
Cal/Std Calibrator ID (C.f.a.s. = 401) and standard number
Lot Lot number
LS/Value Calibration type/Target value of corresponding calibrator
L Lot calibration
S Set calibration
Flags Flag name
R0/Rate Offset and factor of the calibration curve
Kc/Raw01 Kc parameter value or absorbance value of cycle 1 in Abs.
A/Raw02 A parameter value or absorbance value of cycle 2 in Abs.
B/Raw03 B parameter value or absorbance value of cycle 3 in Abs.
C/Raw04 C parameter value or absorbance value of cycle 4 in Abs.
Table 39 Explanations on calibration results
If the calibration results were accepted using Use Old, "???" is displayed as the Date and
Time values, and the corresponding values for Raw1 - Raw40 are missing.
Roche Diagnostics
Exporting data
qcs_yyyymmddhhss.csv Column Title Description

Msg Message Type:
8 QC history result
9 Process event
Index 166 ID of the data set used
151 Related calibration values
Ctrl Control ID
Lot Lot ID
Mean Mean value
Result Result value
Flags Flag name
Rate Rate value calculated in Abs. (First Calculation Point - Last
Calculation Point)
Table 40 Explanations on QC results
Roche Diagnostics
Exporting data
The following figure is an example of a test result file that was opened in a spreadsheet
tool. Rows 11 and 12 represent the raw data of a development channel application
with the short name DCBLG.
Figure 3 Example of spreadsheet representation of a test result raw data file
Roche Diagnostics
Exporting data
Exporting log files
During troubleshooting, you may be asked to export the log files and to send them to
by the service representative for examination.
The log-files contain the alarm messages and system logs.
a To export the log files

1 Choose Utilities > Export > Log Files.
Press <*.tgz> to display cobas c111system files only.
5 Press to confirm the definitions.
The data are copied to the USB stick. The screen for exporting data is displayed
again.
Roche Diagnostics
Importing data
Importing data
h Utilities > Import

You can import the following kinds of data:
o Application data (application definitions)
o Software (software updates)
o Database (as exported using Utilities > Export > Database)
o Certificates (digital records that ensure the authenticity of reagent barcodes)
o EWC/Mixing (extra wash cycle and mixing definitions)
Importing applications
Importing an application consists of two steps:

1. Importing the data to the instrument by reading a barcode or a data file. This step
stores the data on the instrument.
2. Installing the application. This step activates the application on the instrument
and so makes it available for use.
a To import application data
1 Choose Utilities > Applications > Laboratory Parameters.
2 Press .
3 Press <Import Application>.
A screen is displayed, asking you to scan the barcode or to import the data from
the USB stick.
If… Do this…
You intend to scan the barcode: 1. Scan the barcode from the barcode
sheet.
You intend to import from the USB stick: 1. Press .
3. Press .
4. Select the directory that contains the
application file.
You recognize the application packages
by their file extension .tsb.
The system checks whether there is already an application on the system with
identical application code and short name.
Roche Diagnostics
Importing data
The following table lists the basic situations.
If… This happens…

Both, the application code and The laboratory parameters, for example the short
the short name exist: name, are reteined from the existing application.
The application definitions are replaced on the system
by the new ones.
The application code exists, and The laboratory parameters of the new application are
the short name does not exist for used, for example the short name.
any application on the system: The application definitions are replaced on the system
by the new ones.
The short name exists, but the A screen is displayed for changing the short name to a
application code does not: unique short name.
If you do not change the short name, the application
is not imported.
e For detailed information on possible conflicts when importing applications, see the
section on installing and configuring development channel applications in the
cobas c111 Development Channel Operator’s Manual.
If you want to replace both the laboratory parameters and the application definitions, you
first need to uninstall and delete the existing application and then to import the new
application.
If the application you are importing is a development channel application, note

the following possible exceptional situations:
Situation Explanation and possible actions

No crypto module is installed. A message is displayed, informing the operator of this
fact.
The system does not import the application.
The maximum number of A message is displayed, informing the operator of this
development channel fact.
applications is already installed. 1. Uninstall and then delete a development channel
application.
2. Start the import process again.
The applications list (Utilities > Applications > Laboratory Parameters) is

displayed. The application name is displayed in square brackets, for example
[GLU2], to indicate that the application is not installed yet.
To make the application available for performing tests, you now need to install it.
a To install an application
2 Select an application whose name is in square brackets, for example [GLU2].
3 Press .
Roche Diagnostics
Importing data
4 Choose <Install Application>.

The system checks whether there is already an application installed on the system
with identical application code or short name.
On the applications list, the application name is displayed without brackets.
5 Prep are the application.
Importing software
This function is usually used for installing software updates.
a To import system software

1 Choose Utilities > Import > Software
3 Press .
4 Select the software package.
You recognize the software packages by their file extension .tar or .tgz.
The software is installed on the system. A message will inform you when the
installation is complete.
The system will automatically reboot.
When the import is complete, the [Overview] tab is displayed, and the system is in
Standby status.
Importing the database
This function is usually used for restoring the complete system data or for cloning an
existing system.
During the installation process, existing data will be deleted, for example orders, results
(including Abs. Air/Water Calibration), bottle and electrode definitions. The admin
password is reset to its default value.
a To import the database

1 Choose Utilities > Import > Database
2 Press .
4 Press .
Roche Diagnostics
Importing data
5 Select the database file.

Typically, the file format looks like this: dba_yyyymmddhhss.tgz
Press <*.tgz> to display cobas c111system files only.
When the data are imported, a message is displayed, asking you to restart the
system.
7 Choose > Restart to restart the system.
Importing certificates
Certificates are digital records that ensure the authenticity of reagent barcodes. On
each cobas c111 instrument there must be a certificate installed.
a To import certificates
1 Choose Utilities > Import > Certificate.
A screen is displayed, that lists the currently installed certificates.
2 Press .
4 Press .
5 Select the certificate.
You recognize a certificate by its file extension .prm.
The certificates are installed on the system.
The screen is displayed again, that lists the currently installed certificates.
Importing automatic mixing and extra wash cycle definitions
Mixing and extra wash cycle information is contained in a separate barcode on a

barcode transfer sheet.
a To import mixing and extra wash cycle information

1 Choose Utilities > Import > EWC/Mixing.
A screen is displayed, asking you to scan the barcode.
2 Scan the barcode.
The data are installed on the system. A message will inform you when the
installation is complete. The screen for importing data is displayed again.
e For information on defining extra wash cycles see Defining extra wash cycles on
page B-149.
Roche Diagnostics
Preparing a new disk

solutions.


mechanism
Contact with moving parts of the instrument may cause personal injuries, stop the
instrument from processing, and cause damage to instrument parts.
o Do not touch moving parts during instrument operation.
o Keep all covers closed, operate them as instructed on the screen.

Remove or insert bottles only when the reagent disk is loaded on the instrument and
always use the software functions to perform these tasks.
Roche Diagnostics
You can use up to eight different reagent disks on one cobas c111 instrument. Each
reagent disk is equipped with numbered tabs. For automatic disk identification by the
instrument, one—and only one—of these tabs is removed. The number of this
removed tab is the disk ID. When you label the disk, make sure that the number on
the label corresponds to that of the removed tab.
A
A
B
C
D
A Reagent disk IDs. There are eight possible C Identification tabs

IDs. D The tab has been removed for automatic
B Disk label. The number must correspond to disk recognition
the reagent disk ID.
Figure B-41 Reagent disk ID
a To prepare a new reagent disk
Defining the disk ID 1 Be sure to select an ID that is not used by any other reagent disk you intend to use
on this cobas c 111 instrument.
You can choose a number between one and eight.
2 Print the number on a label and stick the label on the disk (A).
3 Using pliers, break off the ID tab (C, D) with the same number as the one printed
on the label.
Loading the disk 4 Press .

A screen is displayed, asking you to insert the disk.
6 Place the reagent disk in the reagent cooler.
Make sure the reagent port faces the front and align the cut-outs with their
counterparts on the reagent cooler.
The system automatically detects that a disk was inserted.
A screen is displayed, asking you to close the main cover.
At this stage, the system identifies the disk.
A screen is displayed that shows the status of the reagent sets.
Loading reagent sets 8 Press .

A screen is displayed, asking you to scan the bottle barcode.
9 Scan the barcode on the bottle.
Roche Diagnostics
10 Remove the cap from the bottle and place it in the reagent bay.
If you confirm without placing the bottle, the system assumes that the bottle is
placed.
If you press after placing the bottle, the position is deemed empty.
When the first reagent bottle of a set is loaded, the reagent set is defined. From this
moment on, the reagents are handled as part of the set. You no longer handle
them as individual reagents.
If Do this
There is another bottle A screen is displayed, asking you to scan the bottle.
belonging to the set: 1. Scan the bottle
2. Insert the bottle.
3. Press to confirm the insertion.
All bottles of the set are 1. Close the main cover.
inserted: On the screen with the reagent set buttons, the button
for the new set is now present.
13 Press .
14 On the disk overview screen, press to load the next reagent. Proceed as
described in steps 9 through 14.
Roche Diagnostics
Assigning tests to test tabs
The system provides two order modes: Easy and Full. When working in Easy mode,
the test selection screen consists of one panel, if working in Full mode, the screen
contains up to six panels, each is identified by a tab.
To make a test available for selection from the test selection screen, you need to assign
it to a test tab. This is done in two steps:
1. Naming the tabs (if required).
2. Assigning the tests to the tabs.
You need Lab Manager or Administrator rights for assigning tests to tabs.
Assignment when importing When you import applications, the tests are assigned to the tabs as follows:
applications
o If you work in Easy mode, the tests are added to the Easy panel. (If the panel is full,
they will not be displayed.)
o If you work in Full mode, the tests are added to the Easy panel (if there is space)
and to the first Full mode tab. If there is not enough space on the first Full mode
tab, the test is added to the next tab that has space available.
a To name a test tab

1 Choose Utilities > Configuration > Workflow.
2 Expand the [Workflow] entry, scroll down, and select [Test Tab 1...6 Name].
3 Press .
A screen for typing text is displayed.
e For details on typing text see Typing text on page A-74.
4 Type up to four characters.

This is the name of the tab on the screen for assigning tests.
5 Press .
The tab name is now available on the screen for assigning tests. See below.
a To assign a test to a tab

2 Select the test you want to assign to a tab.
3 Press .
4 Select [General] and expand the entry.
5 Select [Test Tabs].
6 Press .
A screen is displayed that provides a button for each of the possible tabs.
The <Easy> button is always available. It is the standard panel for working in Easy
order mode. (You cannot rename it.)
Roche Diagnostics
7 Select the buttons for all the tabs where the test should be displayed.
8 Press .
The tests are now available on the corresponding tabs on the test selection screen.
a To remove a test from a tab

2 Select the test you want to remove.
3 Press .
4 Select [General] and expand the entry.
5 Select [Test Tabs].
6 Press .
7 Cancel the selection of the button of the tab to which the test is assigned to.
8 Press .
The test is no longer available from the corresponding tab on the test selection
screen.
To move a test from one tab to another, delete it from the original tab and assign it to the
new tab.
Roche Diagnostics
Refilling printer paper
You can refill the printer paper any time, provided printing is not in progress.
a To check the printer status

1 On the [Overview] tab, press the <System status> button.
The printer button is red if the printer is out of paper.
2 Scroll to display the Printer entry and read the text.
a To replace the printer paper

1 Make sure the printer is not currently printing.
2 Open the printer panel.
(Press the release button to release the panel and fold it down.)
Be sure to press down the release button firmly before you pull the panel. The panel
should open without resistance.
3 Lift the empty printer paper roll from its holder.

4 Remove the pin from the roll.
5 Insert the pin in the new roll.
6 Place the new roll on the holder.
Make sure the paper unrolls at the top and towards you.
Roche Diagnostics
7 Insert the paper in the slot in the printer panel and pull some through.
8 Close the printer panel.

The system feeds some paper.
If the system ran out of paper during printing, it will resume printing.
The printer button should now be green, and the status description should
be OK.
Roche Diagnostics
Removing condensation water from the reagent cooler
Removing condensation water from the reagent cooler
a To remove water from the reagent cooler

1 Make sure the system is in Standby status.
2 Choose Overview > > .
Be sure not to tilt it and place it on an even surface.
5 Wipe the inside of the reagent cooler with a cloth or paper to remove the water.
Figure B-42
6 Insert the reagent disk.

7 Close the cover.
Roche Diagnostics
Replacing the probe
Replacing the probe
If the probe is bent, broken, or corroded, you need to replace it.
Tools and materials required o Probe and tubing set

o Tube with ISE Deproteinizer
o Tube with Activator
o Glass beaker
Injury through working solutions

Direct contact with cleaning solutions or other working solutions may cause personal
WARNING injury. When handling such solutions, exercise the precautions required for handling them,
observe the cautions given in the package insert, and observe the information given in the
Safety Data Sheets available for Roche Diagnostics cleaning solutions.

a To remove the probe

2 Switch off the system.
3 Remove the transfer head cover.
Press the release buttons on both sides and lift.
4 Release the tube leading to the probe from all tubing clips.
Roche Diagnostics
Replacing the probe
5 Remove the sensor tubing adapter (A).
A Sensor tubing adapter D Probe holder

B Example of tubing clip E Tube fixation screw on distribution block
C Tube fixation screw on holder
Figure B-43
6 Remove the probe holder (D) from the carriage.

Press the release button on the side of the probe holder carriage and lift the probe
holder with the probe.
7 Unscrew the probe from its holder and remove it from it.
8 Place the probe in the beaker and the probe holder on a clean surface.
9 Unscrew the tubing from the distribution block (E).
10 Lift the tubing and wait until all fluid has run into the beaker.
11 Dispose of the probe assembly. Treat it as biohazardous waste.
a To install the new probe

1 Carefully insert the probe in the probe holder and fasten the screw that fixes the
tubing to the holder (C).
2 Reinstall the probe holder with the probe.
Press the release button on the side of the probe holder carriage while you insert
the probe holder. Release the button when the holder is inserted.
Push the holder firmly down until the release button latches on.
3 Reinstall the sensor tubing adapter.
Push down until the clips engage.
4 Screw the tubing to the distributor block.
5 Fix the tube to all tubing clips. Start near the probe holder.
Roche Diagnostics
Connecting and disconnecting the external fluid containers
6 Install the transfer head cover.

Push down until the release buttons latch on.
7 Switch on the system.
The startup phase may take a few minutes.
When the instrument is ready for use, the [Overview] tab is displayed, and its
status is Standby.
8 Log on the system.
9 Perform the [Deproteinize Probe] maintenance action.
e See Deproteinize probe on page C-10.
Before switching on the system, make sure that all external fluid containers are placed
on the rack and properly connected.
a To connect the water container

1 Place the white full water container on the tray. (Always use purified water of the
quality specified in section Technical specifications.)
2 Connect the water tubing to the connector on the instrument by pushing the plug
firmly in the socket.
A B C
A Water container C Water connector

B Tubing adapter
Figure B-44 Water container, tubing adapter, and connector
3 Insert the tubing adapter in the container and push it down firmly.
Roche Diagnostics
a To connect the waste container

1 Place the empty yellow waste container on the tray.
2 Connect the waste tubing by pushing the plug firmly in the socket.
A B C
A Waste container C Waste connector

B Tubing adapter
Figure B-45 Waste container, tubing adapter, and connector
a To connect the cleaner bottle

1 Place the bottle on the tray.
2 Screw the cleaner tubing to the connector on the instrument. Do not fasten the
screw too tight.
A B C
A Cleaner bottle C Cleaner connector

B Tubing adapter
Figure B-46 Cleaner bottle, tubing adapter, and connector
Roche Diagnostics
a To disconnect a tube from the instrument

1 Remove the right side panel.
If Do this
You want to disconnect the water tubing: Press down the release clamp (A) on the
connecting socket and pull the connector
away from the socket.
You want to disconnect the diluent tubing: Turn the connecting screw (B)
counterclockwise until the connector is
released.
You want to disconnect the waste tubing: Press down the release clamp (C) on the
connector and pull the connector away
from the socket.
A B C
A Release clamp on water connecting socket C Waste connector release clamp.

B Diluent connector screw
Figure B-47 Cleaner bottle, tubing adapter, and connector
Roche Diagnostics
With a touchscreen, it is important that the point where you press the screen
corresponds exactly with its hardware equivalent. If this were not the case, pressing a
screen item such as a button might not lead to the expected result.
a To adjust the touchscreen

1 Press the global button.
A screen is displayed that offers several kinds of stopping.
2 Press the global button again.
A screen for adjusting the screen is displayed.
Figure B-48 Screen for adjusting the touchscreen
3 Press exactly in the center of the black cross.

The cross turns green and the next cross turns black.
The cross turns green and the next cross turns black.
All crosses are green.
6 Press anywhere in the screen and observe where exactly a small red square (pixel)
is displayed.
The red square should be exactly where you pressed.
If Do this
The red square is exactly where you pressed: 1. Press .
The red square is some distance from where 1. Press .
you pressed: 2. Repeat the whole procedure, make sure
that you press exactly in the center of
the crosses.
Roche Diagnostics
Cleaning the touchscreen
Because the touchscreen gets easily soiled you should clean it regularly.
Tools and materials required m 70% ethyl alcohol

m Tissues
m Protective gloves
a To clean the touchscreen

1 Pour or spray some alcoholic solution on a tissue.
2 Wipe the screen.
Exert as little pressure as possible.
3 Wipe the screen with a clean tissue.
Roche Diagnostics
Roche Diagnostics
cobas c111 7 Configuration
Table of contents
Configuration
Integrating the system in your environment
In this chapter, you will find information on how to define the way you work with the

Introduction ............................................................................................................ B-121
Viewing values ................................................................................................... B-121
Changing values ................................................................................................ B-121
Applications ............................................................................................................. B-123
Installing applications ....................................................................................... B-123
Activating and deactivating applications ......................................................... B-125
Preparing applications ...................................................................................... B-125
Uninstalling applications .................................................................................. B-128
Deleting applications ......................................................................................... B-129
Order profiles .................................................................................................... B-130
Defining order profiles ................................................................................ B-130
Adding tests to a profile .............................................................................. B-130
Deleting profiles .......................................................................................... B-130
Defining control definitions and lots .............................................................. B-131
Defining calibrator definitions and lots ........................................................... B-132
Short guide to application definitions .............................................................. B-133
Version ......................................................................................................... B-133
Code ............................................................................................................. B-133
General application definitions .................................................................. B-133
Calibration definitions ................................................................................ B-134
Control definitions ...................................................................................... B-135
Calculation definitions ................................................................................ B-136
Result conversion definitions ...................................................................... B-136
Configuration .......................................................................................................... B-137
Changing your password .................................................................................. B-137
Scheduling maintenance actions ...................................................................... B-138
Handling user interface language ..................................................................... B-138
Uninstalling a language ............................................................................... B-140
Roche Diagnostics
7 Configuration cobas c111
Table of contents
User management .............................................................................................. B-141

Defining a user ............................................................................................. B-141
Deleting a user ............................................................................................. B-141
Editing the acceptable flags list ......................................................................... B-142
Mapping the host codes .................................................................................... B-142
Short guide to configuration definitions .......................................................... B-143
Workflow definitions ................................................................................... B-143
Host definitions ........................................................................................... B-145
Result handling ............................................................................................ B-146
Calibration ................................................................................................... B-146
QC ................................................................................................................ B-147
System .......................................................................................................... B-147
Date and time .............................................................................................. B-148
Maintenance ................................................................................................ B-148
Abs adjustment ............................................................................................ B-148
Defining extra wash cycles ................................................................................ B-149
Activating, deactivating and deleting extra wash cycles .................................. B-150
Short guide to extra wash cycle definitions ...................................................... B-151
Extra wash cycle definitions ........................................................................ B-151
Roche Diagnostics
Introduction
Introduction
The process for viewing and changing configuration and application values is the
same. The following procedures use the example of a calibration value.
Viewing values
a To view values
2 Expand the list.
a) Select a list item marked with .
b) Press .
c) Select a sublist item marked with .
d) Press .
e) Use the scrollbar, if required, to display the items you are interested in.
The definition items and their current values are displayed.
Figure B-49
Changing values
If the change of a value results in one or several other values needing to be changed, a
wizard is started when you change the first value. You recognize a wizard by the
presence of the and buttons.
a To change a value
2 Expand the list to display the items and their values.
3 Select an item that shows a value.
Roche Diagnostics
Introduction
4 Press .
A screen is displayed where you either can type a new value or select one by
pressing its corresponding button.
Figure B-50
5 Type the new value or press a value button.

If Do this
You are in a wizard and want to change a 1. Press .
further value: A screen is displayed for changing the
value.
2. Type the new value or press a value
button.
3. Continue with step 6.
4. When is no longer active, press
to confirm the changes.
This was the only value you want to change: 1. Press to confirm the changes.
Roche Diagnostics
Applications
Applications
Installing applications
To make available an application on a cobas c111 instrument, you need to perform

the following steps:
1. Import the data to the instrument by reading its barcode or by reading them from
a USB stick. This step saves the data on the instrument.
It is possible to import a new version of an application with identical application
code, but you cannot install it.
e To import application data on page B-123.
2. Install the application. This step activates the application on the instrument and
so makes it available for use.
e To uninstall an application on page B-128.
3. Prepare the application. This step associates the application with lot data and
auxiliary fluids such as calibrators and controls.
e To prepare an application on page B-125.
a To import application data

2 Press .
3 Press <Import Application>.
A screen is displayed, asking you to scan the barcode or to import the data from
the USB stick.
If… Do this…
You intend to scan the barcode: 1. Scan the barcode from the barcode
sheet.
You intend to import from the USB stick: 1. Press .
3. Press .
4. Select the directory that contains the
application file.
You recognize the application packages
by their file extension .tsb.
The system checks whether there is already an application on the system with
identical application code and short name.
Roche Diagnostics
Applications
The following table lists the basic situations.
If… This happens…

Both, the application code and The laboratory parameters, for example the short
the short name exist: name, are reteined from the existing application.
The application definitions are replaced on the system
by the new ones.
The application code exists, and The laboratory parameters of the new application are
the short name does not exist for used, for example the short name.
any application on the system: The application definitions are replaced on the system
by the new ones.
The short name exists, but the A screen is displayed for changing the short name to a
application code does not: unique short name.
If you do not change the short name, the application
is not imported.
e For detailed information on possible conflicts when importing applications, see the
section on installing and configuring development channel applications in the
cobas c111 Development Channel Operator’s Manual.
If you want to replace both the laboratory parameters and the application definitions, you
first need to uninstall and delete the existing application and then to import the new
application.
If the application you are importing is a development channel application, note

the following possible exceptional situations:
Situation Explanation and possible actions

No crypto module is installed. A message is displayed, informing the operator of this
fact.
The system does not import the application.
The maximum number of A message is displayed, informing the operator of this
development channel fact.
applications is already installed. 1. Uninstall and then delete a development channel
application.
2. Start the import process again.
The applications list (Utilities > Applications > Laboratory Parameters) is

displayed. The application name is displayed in square brackets, for example
[GLU2], to indicate that the application is not installed yet.
To make the application available for performing tests, you now need to install it.
a To install an application
2 Select an application whose name is in square brackets, for example [GLU2].
3 Press .
4 Choose <Install Application>.
The system checks whether there is already an application installed on the system
with identical application code or short name.
On the applications list, the application name is displayed without brackets.
Roche Diagnostics
Applications
5 Prepare the applications.

Activating and deactivating applications
When an application is installed on the system, it is automatically activated.

e Installing applications on page B-123.
You can deactivate an application to temporarily make unavailable the test on the test
panel. All associated fluids and data remain unchanged. You can activate the
application later again and continue using the test.
a To activate or deactivate an application

2 Expand the application entry.
3 Expand the [General] entry.
4 Select [Active].
5 Press .
6 Choose <On> if you want to use the application.
Choose <Off> if you do not want to use the application.
7 Press .
Preparing applications
Perform following steps for each new application. (Use the wizards to make the
definitions.)
e For the general procedure of making changes to definitions, see To change a value on
page B-121.
a To prepare an application
2 Expand the application entry.
Code The Roche application code identifies the application. It is used for host
communication. If you work with a different code for a particular application, you
need to map the Roche application code to your own code.
e See Mapping the host codes on page B-142.
Version The version uniquely identifies a particular set of application definitions.

The version number increases whenever there is a change to the application
definitions, for example from version 1.0 to 1.1.
General definitions 3 Expand the [General] entry, select [Short Name], and press .
Roche Diagnostics
Applications
4 Change the short name (up to 5 alphanumeric characters) if required.

The short name affects the display of the test name in the user interface (for
example test buttons, or test names in the Orders and Results lists, and in all
printouts).
5 Press and change the long name (up to 30 alphanumeric characters) of the
test, if required.
The long name is a telling description of the test. It is particularly useful if the
short name is not generally familiar in the laboratory environment.
6 Press and then <On> to activate the application.
If an application is not active, its associated tests are not available for use. You
cannot select them on the test selection screen. The application definitions remain
on the system.
7 Press and select the buttons of the tabs the test should be available from.
e Fore details, see Assigning tests to test tabs on page B-106.
Calibration definitions For Roche calibrators, recommended definitions are automatically defined for each
application. You can change the sequence, interval, and the replicate value, if
required.
Roche recommend not to change the calibration definitions of Roche reagents.
9 Expand the [Calibration] entry, select [Sequence], and press .

10 Change the sequence, if required. (The sequence values define when calibration
becomes due, and the system automatically informs you about due calibrations.)
No Interval: The system does not inform you about the due status. Use this value if
the reagent is stable enough over the whole period until it is empty and you
replace it. Calibration is due whenever a new reagent set is loaded on the
instrument.
Interval only: Performed when the reagent interval has expired.
Each Lot and Interval: You perform calibration whenever the fist reagent of a new
lot is loaded and then each time the interval has expired.
Each set and Interval: Performed whenever a reagent is loaded or when the reagent
interval has expired.
11 Change the interval (number of days, hours for ISE applications), if required.
12 Change the number of replicates, if required.
Possible values: 1, 2, 3. (The default value is 2.)
Control definitions 14 Expand the [Control] entry, select Sequence, and press .
15 Define the sequence.
Choose [No Interval] for cases when, for example, you intend to perform QC as
part of standard sample testing and not as a separate task. Note that an accepted
QC result is required for a test before it can be used.
Choose [Interval Only] if QC should be performed whenever the reagent interval
has expired. The system automatically informs you about due QCs.
Roche Diagnostics
Applications
16 Define the interval in hours.

17 For each control, perform the following steps:
a) Define the material code.
Unique identifier for the controls. Check the package insert of the control.
b) Define whether QC should be performed after calibration of the test (QC after
Cal).
c) Define whether the test should have QC performed as part of the Default QC
function.
Default QC is an automated process for performing all QC measurements that
are currently due. This is the ideal method if you want to perform QC
periodically during routine operation
On: QC will be performed collectively for all tests that use a certain control.
Off: QC has to be ordered manually for each test.
Calculation definitions 19 Expand the [Calculation] entry, select [Factor], and press .
20 Change the factor and offset, if correlating two different methods.
21 Choose whether valuation (a reference range) should be employed or not.
If you choose <Reference Range>, you need to define an upper and lower limit
and decide which of them should be taken into account or whether both of them.
22 Define whether the lower limit is used, if required.
23 Define whether the higher limit is used, if required.
24 Change the lower limit value, if required.
25 Change the higher limit value, if required.
26 Define, for each control, whether patient results should be flagged that were
generated using a test whose QC results were marked with a flag.
Result Conversion definitions 28 Expand the [Result Conversion] entry, select [Laboratory Unit], and press .
29 Change the laboratory unit if you intend to work with units that are different from
the currently specified units.
30 Type the conversion factor, if required.
This factor is required if lab units were defined.
31 Choose whether values should be displayed in standard or laboratory units.
This definition affects displays on screens as well as printouts.
32 Change the decimal position, if required.
This value corresponds to the number of digits after the decimal point that are
displayed on the screens.
Roche Diagnostics
Applications
Uninstalling applications
Uninstalling an application means making the application unavailable for use in

testing.
You can reinstall an uninstalled application.
e See To install an application on page B-124.
Before you can uninstall an application, you need to perform some preparation tasks:
a To prepare uninstalling an application

1 Delete all associated patient results.
e See Deleting patient results on page B-83.
2 Delete all associated QC results, both from the QC Status list and the QC History.
e See Deleting QC results on page B-85.
a To uninstall an application
1 Choose Utilities > Applications > Laboratory Parameters
2 Select the application.
Select an application that is not in square brackets, for example ALTL. (Brackets indicate
that the application is not currently installed.)
3 Press .
4 Press to confirm the action.
All associated calibration results and lot data are deleted.
In the applications list, the application name is enclosed in square brackets, for
example [GLU2].
Roche Diagnostics
Applications
Deleting applications
Deleting an application means removing the data from the system.

The process of removing an application from the system consists of the following steps:
1. Delete all associated patient results.
e See Deleting patient results on page B-83.
2. Delete all associated QC results, both from the QC Status list and the QC History.
e See Deleting QC results on page B-85.
3. Uninstall the application. This process makes the application unavailable for use
in testing.
e See Uninstalling applications on page B-128.
4. Remove all associated reagent sets from any of the reagent disks. (The disk may be
off board, and you might need to load it in order to remove the reagents.)
e See To load the reagent disk on page B-21
See Removing a reagent set on page B-24.
5. Delete the application. This process removes the application data from the system.
a To delete an application
2 Select the application.
3 Press .
The following table lists possible situations and how they affect the process of
deleting.
Situation Proceed as follows

There is one entry for the application in the 1. Confirm to proceed with uninstalling.
list, and the application is currently 2. In the applications list, select the
installed (not in brackets). uninstalled application (it is now
contained in brackets).
3. Press .
4. Confirm to proceed with deleting the
application.
There is one entry for the application in the Confirm to proceed with deleting the
list, and the application is currently not application.
installed (in brackets).
There is a second entry for the application Confirm to proceed with deleting the
in the list. The selected application is application.
installed (not in brackets) Note: You can only delete the installed
application.
The selected item is a profile. Confirm to proceed with deleting the
profile.
There are still associated reagents on one of Remove the associated reagent set from the
the disks. disk.
(The disk may be off board, and you might
need to load it in order to remove the
reagents.)

4 Press .
The application data are deleted.
Roche Diagnostics
Applications
Order profiles
Defining order profiles

A profile is a set of tests that are frequently ordered in combination. When ordering a
profile all tests of the profile are performed.
a To define an order profile

2 Press .
3 Press <Add Profile>.
4 Type the profile code. (For customer defined profiles, use the numbers 910
through 930.)
5 Type the short name (up to 5 characters).
The short name will appear on the test selection screens.
6 Type the long name (up to 30 characters).
7 Select the tests that should be included in the profile.
Adding tests to a profile
a To add tests to a profile

2 Select the profile.
3 Expand the entry.
4 Expand the [General] entry.
5 Select [Applications].
6 Press .
A test selection screen is displayed.
7 Select the tests.
e For information on assigning a profile to tabs on the test selection screen, see Assigning
tests to test tabs on page B-106.
Deleting profiles
See Deleting applications on page B-129.
Roche Diagnostics
Applications
Defining control definitions and lots
h Workplace > Lot Data
a To define control definitions and lots

Perform the following steps for all controls.
2 Press <Controls>.
A screen is displayed that lists all installed control lots.
3 Press .
A screen is displayed, asking you to scan the barcode transfer sheet or to type the
data manually.
If… Do this…
available from a The screen is displayed again that lists all installed control lots.
You want to type 1. Press .
the data manually 2. Type the name and press .
You find this code in Utilities > Applications > select a test >
> Control.
4. Type the Lot ID and press .
5. Type the expiration date. Use the date format as indicated on
the screen.
If a lot with the same ID already exists on the system, a screen is
displayed, asking you whether you want to replace the existing
lot.
Press to confirm the definitions.
8. Press .
A screen is displayed that contains all tests that use this control
and that have not yet been assigned to this lot.
9. Select a test and press .
10. Type the value for the mean concentration and press .
11. Type the value for the standard deviation.
The screen for handling control lot data is displayed again.
13. Perform steps 7 through 12 for all tests you want to use.
Roche Diagnostics
Applications
Defining calibrator definitions and lots

You need to perform the definitions for all calibrators.
a To define a calibrator lot

2 Press <Calibrators>.
A screen is displayed that lists all installed calibrator lots.
3 Press .
A screen is displayed, asking you to scan the barcode or to type the data manually.
If… Do this…
available from a The screen is displayed again that lists all installed calibrator lots.
You want to type the 1. Press .
data manually 2. Type the name (up to 10 alphanumeric characters) and press .
Refer to the package insert.
4. Type the lot ID (up to nine alphanumeric characters) and press .
5. Type the expiration date and press .
Use the date format as indicated on the screen.
6. Type the number of calibrators (cups) you need to place on the
instrument. Use the information given on the package insert.
(Exclude calibrators that use system water from this number. See
step 14.)
9. Press .
A screen is displayed that shows all tests that have this calibrator
defined for them and that are not yet assigned to this lot.
10. Press one of the test buttons.
11. Press .
12. Define the first calibration value (target value).
13. Define the next calibration value.
You can define up to six calibration values, and you must define
them in descending order.
14. Select the value for [Last is Water].
Press <On> if you want to calibrate with system water as zero
calibrator. (In this case, no cup needs to be placed on the system.
(See step 7).
Press <Off> if you want to use a special zero calibrator for the
calibration. (The special zero calibrator needs to be placed on the
sample area.)
Calibration values (target values) in method sheets may be defined in increasing order of
concentration. Always define the values in decreasing order on the cobas c 111 instrument.
Roche Diagnostics
Applications
Short guide to application definitions
The following tables provide reference information on the meaning and use of application
definitions the user might want to change.
Version
The version uniquely identifies a particular set of application definitions.
Code
The Roche application code identifies the application. It is used for host
communication. If you work with a different code for a particular application, you
need to map the Roche application code to your own code.
e See Mapping the host codes on page B-142.
General application definitions
Item Values Comment

Short Name Up to 5 alphanumeric The short name is used on the screens, for
characters example on the test selection screen or the
results list.
Long Name Up to 30 The long name is a telling description of the test.
alphanumeric It is particularly useful if the short name is not
characters generally familiar in the laboratory
environment.
Active On, Off Tests that not active are not available for use. You
cannot see them on the screens. Their
application definitions remain on the system.
Test Tabs See Workflow Choose one or several of the buttons. The test
definitions on will be included in the corresponding test tabs.
page B-143. Choose <Easy> if you work with order mode
[Easy].
Clear all selections to prevent the test from being
selected in the test selection screens.
Table B-11 General application definitions
Roche Diagnostics
Applications
Calibration definitions
ISE applications do not have calibration definitions.
Item Values Comment

Sequence The sequence values define when calibration becomes due, and the
system automatically informs you about due calibrations.
No Interval The system does not inform you about the due
status. Use this value if the reagent is stable
enough over the whole period until it is empty
and you replace it.
Calibration is due whenever a new reagent set is
loaded on the instrument.
Interval only Due whenever the reagent interval has expired.
Each Set and Interval Due whenever a new reagent is loaded and when
the interval has expired.
The interval starts again whenever you place a
new reagent set.
You can turn off the interval check by defining
its duration as 0 (zero).
Each Lot and Interval Due whenever the fist reagent of a new lot is
loaded and then each time the interval has
expired.
The interval (re)starts whenever you calibrate a
reagent set.
You can turn off the interval check by defining
its duration as 0 (zero).
If you install a reagent set of the same lot, no
calibration is required. (The system uses the Lot
calibration result as the Set calibration result of
the new reagent set.)
Interval Number of days. Use 0 (zero) if the [Sequence] is set to [No
(For ISE, 1 day fixed.) Interval].
Replicates 1, 2 Number of times each measurement should be

repeated.
Table B-12 Calibration definitions
Roche Diagnostics
Applications
Control definitions
Item Values Comment

Sequence No interval The system does not inform you about the due
status.
Use this value if you intend to perform QC as
part of standard sample testing and not as a
separate task, and if QC should be handled by a
host computer.
Note that an accepted QC result is required for a
test before it can be used.
Interval only Due whenever the reagent interval has expired.
The system automatically informs you about due
QCs.
Interval Number of days Use 0 (zero) if the Sequence is set to [No
(hours for ISE interval].
applications)
For each of the controls:
Mat. code 0 ... 999 Unique identification of the control material.
Numbers 801 through 999 are reserved for non
Roche controls.
You need to define this initially for every
application.
QC After Cal On, Off QC needs to be performed after each calibration
of the test.
Default QC On, Off Mark the test to have QC performed as part of
the Default QC function.
Default QC is an automated process for
performing all QC measurements that are
currently due. This is the ideal method if you
want to perform QC periodically during routine
operation.
Table B-13 Control definitions
Roche Diagnostics
Applications
Calculation definitions
Item Values Comment

Factor Used for patient and control results.
Final result = (Result * Factor) + Offset
The correlation factor is used to compensate for
differences in measuring methods of different
instruments. By applying a factor, the final
results of the different instruments can be
directly compared.
Offset The offset is used to compensate for differences
in measuring methods of different instruments.
By adding the offset, the final results of the
different instruments can be directly compared.
Valuation No Valuation
Reference Range Use the limits defined as Low Limit and High
Limit.
Low Used On, Off Refers to Low Limit.
High Used On, Off Refers to High Limit.
Low Limit Results that are outside the limit are flagged.
High Limit Results that are outside the limit are flagged.
1...3:Flag QC Fail On, Off Choose [On] to ensure that all patient results are
flagged that were generated using a test whose
QC results were marked with a flag.
The initial number refers to the control that was
used for performing the QC. (See also Control
definitions.)
Table B-14 Calculation definitions
Result conversion definitions
Item Values Comment

Laboratory Unit Alphanumeric Type the unit.
characters
Factor Conversion factor for converting results from
one unit to another, for example from mg/dL to
mmol/L.
Displayed Unit Standard Unit
Laboratory Unit
Dec. Position 0 ... 4 Number of digits after decimal point that are
displayed on the screens.
Table B-15 Result conversion definitions
Roche Diagnostics
Configuration
Configuration
Changing your password
NOTICE Damage to data and programs due to unauthorized access to the cobas c 111
instrument
User access to the cobas c 111 instrument is controlled by a login name and password.
Users are administered by a system administrator.
Roche recommend to periodically change the password of the system administrator and to
store the current password in a safe place with adequate access control.
User name and password are case sensitive. This means that for example Admin and
admin are two different names.
a To change you password

If… Do this…
You are logged off: 1. Press <Log on>.
You are logged on: 1. Press the button showing your user
name.
2. Press <Log on>.
2 Type your user name.

As soon as you type the first characters of your user name, the system looks for a
name that starts with these letters and, if it finds one, displays the complete name.
3 Press .
4 Press <Change Password>.

5 Type your old password.
6 Press .
7 Type the new password

8 Press .
9 Type the new password a second time.

10 Press .
Roche Diagnostics
Configuration
Scheduling maintenance actions
The cobas c111 instrument facilitates performing the maintenance actions in

bundles at times that suit your laboratory work processes. To that purpose, you can
define one day of the week as your maintenance day.
Concept of the main The main maintenance day is the day in the week when you want to perform the
maintenance day majority of the maintenance actions.
Let us suppose that you chose Monday as your main maintenance day. On the
Maintenance screen, actions that are due on Monday or an earlier day are marked in
red, actions that will fall due between Tuesday and Sunday will be marked in yellow.
The idea is to perform on the main maintenance day all red and yellow maintenance
actions. This way, between Tuesday and Sunday, you only need to perform
maintenance that need to be performed daily.
a To define the main maintenance day

1 Choose Utilities > Configuration > Maintenance.
2 Expand the main entry and select Major Maint. Day.
3 Press .
A screen is displayed for selecting a day of the week.
4 Press one of the weekday buttons.
5 Press .
The definition of the minor maintenance day has currently no practical influence on the
maintenance scheduling, because there are no maintenance actions with intervals of
between two and six days.
Handling user interface language
You can choose from up to six languages. (You could install more than six languages,
but only the first six in the alphabetic sequence are available for selection.)
In the software and the user interface, the languages are identified by their two-letter
abbreviation (ISO 639-1). The following languages are available:
Abbreviation Language Abbreviation Language

DE German EL Greek
EN English ES Spanish
FI Finnish FR French
HU Hungarian ID Indonesian
KO Korean PL Polish
PT Portuguese TR Turkish
ZH Chinese
Table B-16 Abbreviations for user interface languages
Roche Diagnostics
Configuration
Prerequisites o Make sure that there are no pending or unfinished orders.

o The system must be in Standby status.
o You need Lab Manager or Administrator user rights.
a To install a new language

1 Copy the language file (c111_xx.tar, where xx is the language code) to the Root
directory of a USB stick.
2 Choose Utilities > Import.
3 Press <Software>.
Insert the USB stick.
4 Press .
A screen is displayed that shows the file structure on the stick.
You should now see you the c111_xx.tar file, where xx stands for the language
abbreviation, for example [c111_en.tar].
5 Select the [c111_xx.tar] file.
The software is installed on the system. A message will inform you when the
installation is complete.
7 When the installation is complete, remove the USB stick.
For the language to become active you need to restart the system.
8 Press .
9 Press <Restart>.
The system will shut down and automatically restart.
When startup is complete, the [Overview] tab is displayed, and the system is in
Standby status.
10 Wait until the system is in Standby status.
a To change the user interface language

1 Choose Utilities > Configuration > System.
2 Expand the list.
3 Select [Language].
4 Press .
A screen is displayed that contains a button for each of the currently installed
languages. The buttons are labelled with the two-letter language abbreviation.
e See Table B-16 on page B-138.
5 Press the button for the required language.

6 Press .
For a language to become active you need to restart the system.

7 Press .
Roche Diagnostics
Configuration
8 Press <Restart>.
The system will shut down and automatically restart.
When startup is complete, the [Overview] tab is displayed, and the system is in
Standby status.
9 Wait until the system is in Standby status.
Uninstalling a language
You can uninstall a all languages except English.
Prerequisites o The current user interface language must be English.

e See To change the user interface language on page B-139.
o The system must be in Standby status.
o The uninstall language file [c111_uninstall_languages.tar] has been copied to a
USB stick.
o You need Lab Manager or Administrator user rights.
a To uninstall user interface languages

1 Choose Utilities > Import.
2 Press <Software>.
Insert the USB stick.
3 Press .
A screen is displayed that shows the file structure on the stick.
4 Select the [c111_uninstall_languages.tar] file.
All languages except English are deleted from the system. A message will inform
you when uninstalling is complete.
6 When the installation is complete, remove the USB stick.
Roche Diagnostics
Configuration
User management
You need Administrator user rights to define or delete a user.
Defining a user
a To define a user
1 Choose Utilities > Users.
A screen is displayed that lists all currently defined users.
2 Press .
3 Type the user name.

Make sure it is unique within your laboratory.
4 Press .
5 Type the password.

6 Press .
7 Press the appropriate user level button.

o Press <Operator> for users who should perform routine tests.
o Press <Supervisor> for users who should perform routine tests as well as
calibration and QC.
o Press <Lab Manager> for users who should perform all test actions and who
should be able to update or add applications and perform diagnostics tasks.
o Press <Administrator> to define the administrator of the cobas c 111
instrument. The administrator can, in addition to all Lab Manager actions,
perform user administration.
8 Press .
Deleting a user
a To delete a user
1 Choose Utilities > Users.
A screen is displayed that lists all currently defined users.
2 Select the user you want to delete.
3 Press .

Roche Diagnostics
Configuration
Editing the acceptable flags list
When working with automatic accepting of results, results that are not flagged are
automatically accepted. Results with flags that are marked in an acceptable flags list
are accepted as well. There is such a list for sample, QC, and calibration results.
a To add or remove a flag from an acceptable flags list

1 Choose Utilities > Configuration > Result Handling
2 Expand the list.
3 Select one of the following entries:
o Sample Accept. Flags
o QC Acceptable Flags
o Cal Acceptable Flags
4 Press .
A list of relevant flags is displayed.

5 Press the square to the left of a flag name to select it or to cancel its selection.
A selected flag shows a check mark (l).
6 Press .
Mapping the host codes
Applications are delivered with a unique ID called code. Laboratories often use their
own codes for applications. By mapping the codes used by the laboratory (host codes)
to those defined by the application manufacturer, the laboratory can work with their
own accustomed codes. The cobas c111 instrument provides a mapping table that
can easily be edited.
Editing a mapping table involves the following steps:
1. Exporting the mapping table to an USB stick. (The table is written as a text file.)
2. Editing the file on a computer and save it as a text file to the stick.
3. Importing the file to the cobas c111 instrument.
a To export the mapping table

1 Choose Utilities > Applications > Host Codes.
2 Press .
4 Press .
5 Select the directory where you want to save the mapping file.
The file is exported as a text file of the name format hct_yyyymmddhhmmss.txt.
Roche Diagnostics
Configuration
a To re-import the mapping table

1 Choose Utilities > Host Codes.
2 Press .
4 Press .
5 Select the mapping file.
Typically, mapping files have the name format hct_yyyymmddhhmmss.txt.
Press <*.txt> to display text files only.
The file is installed on the system. The screen with the mapping table is displayed
again.
a To use the manufacturer’s application codes

1 Choose Utilities > Host Codes.
2 Press .
The host codes are set to values that are identical to the application codes.
By pressing again, you can revert to the original values.
Short guide to configuration definitions
Workflow definitions
Item Values Comment

Working Mode Defines the way in which you select tests during order
definition.
Manual Use this definition if the cobas c111 instrument is
used as a stand-alone system.
During order definition, the test selection screen is
displayed, allowing you to select the tests or to make
changes to the selection.
Host Use this definition if the cobas c111 instrument is
connected to a host computer.
During order definition, the tests are automatically
selected, the test selection screen is not displayed.
After identifying the sample, you are asked to place
the sample.
Sample Barcode On, Off You can work with or without barcodes on sample
tubes. Use Off only if you exclusively work without
barcodes.
If you use On, during order definition the option to
type the sample ID manually is skipped
Table B-17 Workflow definitions
Roche Diagnostics
Configuration
Item Values Comment

Order Mode Easy You work with one test panel on the test selection
screen, containing up to 25 tests.
Typical situation for this mode: You work with one or
two reagent disks, manual order identification,
identical sample and order IDs, possibly but not
necessarily with host connection.
Full You can work with up to six test tabs on the test
selection screen, each containing up to 20 tests.
Typical situation for this mode: You distribute the
reagents across several (up to eight) reagent disks and
you predominantly work with specific groups of tests,
for example for emergency situations or for testing
diabetes. You also work with a host connection with
automatic order identification and result upload.
Sample ID Order ID = The order ID is automatically defined when you
Handling Sample ID identify the sample.
Independent IDs You define the sample ID and order ID independently
of each other.
Grouped Sample Order and sample ID are identical.
ID For a given patient, the same sample ID is used all the
time. A three digit number is appended and
automatically increased with each new order.
Examples: 789-001 for the first order, 789-002 for the
second order, and so on.
Sample ID One This definition is used in combination with Grouped
Separator alphanumeric Sample ID. It defines the character that separates the
character sample ID from the automatically appended number.
Examples: 789-001, 789.001, 789_001.
Auto Order-ID On, Off If you use On, the system automatically increments
the order ID number by one whenever you define a
new order.
If you use On, choose Off for [Order ID = Sample
ID].
Auto Print On, Off If you use On, patient results are printed as soon as all
Results results of the order are available and accepted.
Test Tab Name Up to four Display name for the test tab 1... 6
1... 6 Name alphanumeric Test tabs are used to group tests that are usually used
characters together.
You can assign a test to more than one tab.
Test Tab Visible On, Off Use On to make available the tab on the test selection
1... 6 Visible screen.
Table B-17 Workflow definitions
Roche Diagnostics
Configuration
Host definitions
Item Values Comment

Baud Rate Data transmission rate for host interface
communication.
Select one of the predefined values.
Handshake An exchange of signals between two devices when
communication begins in order to ensure
synchronization.
Off
Hardware
XON/XOFF
Line Mode Number of bits and stop bits used during data
transmission.
Select one of the predefined values.
Parity Check On, Off An error detection technique that tests the integrity of
digital data in memory or on disk.
Communication Off Download to the cobas c111instrument is possible,
Mode but upload to host is not.
Batch Only manual upload to the host is possible.
Realtime Results and queries are sent during processing.
Checksum On, Off A value used to ensure that data are stored or
transmitted without error. It is stored with the data.
When the data are retrieved from memory or received
at the other end of a network, a new checksum is
computed and matched against the existing
checksum. A non-match indicates an error.
Order Query Query mode allows real-time communication during
Mode order definition of regular, rerun, and repeated tests.
Off No queries are sent.
Test orders have to be defined either manually or by
downloading them from the host.
Once A query is sent only when the sample is identified the
first time.
Always A query is sent every time the sample is identified.
Timeout 10 ... 300 s Period of time the system will wait for a response
from the host when working in Query Mode.
This definition applies to routine, STAT and rerun
patient tests.
Send Result Mode Off The results are sent to the host manually.
Complete The results are automatically sent to the host when all
results of the order are available and accepted.
Immediate Each result is automatically sent to the host as soon as
it has been accepted.
Send Raw Data On, Off Raw data include all measurement results made
during the measuring cycles, not just the calculated
test results.
Table B-18 Host definitions
Roche Diagnostics
Configuration
Item Values Comment

Trace On, Off The Trace function records the content of the
communication with the host in a trace file.
This is a troubleshooting function. Do not work with
it during normal daily operation.
The trace file can be exported as a log file (Utilities >
Export > Log Files; file format:
htryyyymmddhhss.log.)
System Device ID Up to 10 The ID is used on reports and for communication
alphanumeric between the cobas c111 instrument and the host.
characters.
Host Device ID Up to 10 The ID is used on reports and for communication
alphanumeric between the cobas c111 instrument and the host.
characters.
Table B-18 Host definitions
Result handling
Item Values Comment

Sample Auto On, Off Results that do not contain a flag are automatically
Accept accepted. Results with flags that are marked in a list of
acceptable flags are accepted as well.
Sample Accept. List of possible flags. Results with marked flags are
Flags automatically accepted if [Sample Auto Accept] is on.
QC Auto Accept On, Off Results that do not contain a flag are automatically
accepted. Results with flags that are marked in a list of
QC Acceptable List of possible flags. Results with marked flags are
Flags automatically accepted if [QC Auto Accept] is on.
Cal Auto Accept On, Off Results that do not contain a flag are automatically
accepted. Results with flags that are marked in a list of
Cal Acceptable List of possible flags. Results with marked flags are
Flags automatically accepted if [Cal Auto Accept] is on.
Table B-19 Result handling definitions
Calibration
Item Values Comment

Forecast Hours 0 ... 999 h Calibrations that fall due within this period will be
performed collectively.
0 means working without this feature.
The default value is 8.
Table B-20 Calibration definitions
Roche Diagnostics
Configuration
QC
Item Values Comment

Rule 1 Rule: A flag is generated if one result is outside a limit.
s : Standard deviation. The value for the standard
deviation is defined in the QC lot.
Off
2.5s
3s
Rule 2 Rule: A flag is generated if two consecutive results are
outside the same limit.
s : Standard deviation. The value for the standard
deviation is defined in the QC lot.
Off
2s
Table B-21 QC definitions
System
Item Values Comment

Language Language ID The language English is always included.
according to Choose one of the available languages. (The first five
ISO 639-1. languages in the alphabetical sequence of the installed
See Table B-16 on languages and English are displayed.)
page B-138.
Date Format dd.mm.yyyy Examples for June 14, 2006:
yyyy.mm.dd o dd.mm.yyyy: 14.06.2006
mm.dd.yyyy o mm.dd.yyyy: 06.14.2006
yyyy.mm.dd
yyyy-mm-dd
dd-mm-yyyy
Time Format 24 Hours
12 Hours
Screen Saver Wait 0 ... 120 min Time after which the screen saver feature becomes
active.
0 (zero) means that the screen saver function is off.
The screen saver time is linked to the Auto Log Off
feature. For example, if you define a Screen Saver Wait
time of 5 minutes, then after 5 minutes of inactivity,
the screen saver feature becomes active and the user is
automatically logged off, provided Auto Log-off is on.
Auto Log-off On, Off If you work with On the user is automatically logged
off after a certain number minutes of inactivity on the
instrument. This number is defined in the Screen
Saver Wait definition.
Sound Effects On, Off Acoustic signals when handling instrument items, e.g.
clicking sound when typing. (Does not affect the
acoustic signals for alarms and warnings.)
Table B-22 System definitions
Roche Diagnostics
Configuration
Item Values Comment

Volume 0 ... 100 Volume of any acoustic signal generated by the
instrument, including alarm and warning signals.
0 (zero) means silent.
Host Server On The host interface of the instrument is enabled,
allowing it to communicate with a host.
Off The host interface of the instrument is disabled.
Communication with a host computer is not possible.
Host definitions have no effect.
Table B-22 System definitions
Date and time
Item Values Comment

Date Format: Date that is used for time records, for example with
dd.mm.yyyy results. Example: 17.02.2006 for February 2, 2006.
This format is for entry purposes only. It does not
influence the format of displayed dates.
Time Format: hh:mm Time that is used for time records, for example with
results. Example: 08:32. This format is for entry
purposes only. It does not influence the format of
displayed times.
Table B-23 Date and time definitions
Maintenance
Item Values Comment

Major Maint. Day Day in the week when you usually perform
Minor Maint. This definition has currently no effect.
Day
Table B-24 Maintenance definitions
Abs adjustment
The absorbance adjustment values cannot be changed.
Item Values Comment

Adjustment Valid On, Off
H2O Signal For each wave length, the adjustment value for the
cuvette filled with water is given.
H2O Cuv Signal For each wave length, the adjustment value for the
empty cuvette is given.
Table B-25 Absorbance adjustment definitions
Roche Diagnostics
Configuration
Defining extra wash cycles
Extra wash cycles are used to minimize carry-over.

You can define an extra wash cycle either by reading a barcode or by defining the
values manually.
a To define an extra wash cycle

1 Choose Utilities > Applications > Extra Wash Cycles.
A screen is displayed that lists the currently defined extra wash cycles.
2 Select [Add new rule].
3 Press .
4 Do one of the following.
If… Do this…
The definitions are available 1. Read the barcode.
on a barcode: The definitions will be installed on the system.
You want to define the 1. Press .
values manually: 2. Choose when, in relation to the pipetting action from
the bottle defined in [Trigger Bottle Code] and
[Pipetting Type], the extra wash cycle should be
performed, then press .
3. Type the trigger-bottle code and press .
The trigger-bottle code is the reagent set code. You find
it on the barcode sheet.
4. Choose the pipetting type. This defines the individual
bottle (bottle of the set or the sample tube) whose
pipetting triggers performance of the extra wash cycle.
5. Define whether the wash cycle should be active or not.
6. Type the cleaner bottle code to define which cleaner
should be used.
7. Type the volume of cleaner in µL that will be pipetted.
The new wash cycle is listed in the extra wash cycles list. Its name is made up of the
short name of the trigger bottle and the pipetting type.
Roche Diagnostics
Configuration
Activating, deactivating and deleting extra wash cycles
You can deactivate an extra wash cycle if you do not want to use it. (The definitions
remain on the system. You can activate the extra wash cycle later again.)
To ensure the highest effectiveness of probe cleaning, extra wash cycles are performed
automatically by the cobas c111 instrument when using development channel
applications.
Roche strongly recommends to always use extra wash cycles with development channel
applications.
a To activate or deactivate an extra wash cycle

2 Select and expand the extra wash cycle entry.
3 Press .
4 Choose <On> to activate the extra wash cycle.
Choose <Off> to deactivate the extra wash cycle.
5 Press .
A screen is displayed for entering your password.

6 Type your password and confirm by pressing .
a To delete an extra wash cycle

2 Select the extra wash cycle entry.
3 Press .
A screen is displayed for entering your password.

4 Type your password and confirm by pressing .
The extra wash cycle definitions are deleted.
Roche Diagnostics
Configuration
Short guide to extra wash cycle definitions
h Utilities > Applications > Extra Wash Cycles >
Extra wash cycle definitions
Item Values Comment

Active On, Off Defines whether the extra wash cycle can be applied
or not.
Action None Defines when, in relation to the pipetting action from
Before the bottle defined in Trigger Bottle Code and
After Pipetting Type, the extra wash cycle should be
performed.
Trigger-Bottle 0 ... 999 Bottle set code of the fluid that triggers performance
Code of the extra wash cycle.
If you use the pipetting type Sample, it defines the
bottle whose fluid will be prevented from being
carried over to the sample by using the extra wash
cycle.
Pipetting Type Reagent 1 Defines the individual bottle (bottle of the set or a
Reagent 2 sample tube) whose pipetting triggers performance of
Start Reagent the extra wash cycle.
Sample
Cleaner-Bottle 0 ... 999 Material code of the cleaner.
Code
Volume µL Amount of cleaner that will be pipetted during the
extra wash cycle.
Table B-26 Extra wash cycle definitions
Roche Diagnostics
Configuration
Roche Diagnostics
Maintenance C
8 General maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

cobas c111 8 General maintenance
Table of contents
General maintenance
Keeping the instrument going
In this chapter, you will find step-by-step instructions of the maintenance actions that
you must perform to keep the instrument running smoothly and efficiently.

Overview ......................................................................................................................C-5
Performing maintenance actions ..........................................................................C-6
Maintenance actions and their intervals ..............................................................C-7
Maintenance actions ...................................................................................................C-8
Safety information .................................................................................................C-8
Deproteinize probe ..............................................................................................C-10
Prime the fluid system .........................................................................................C-11
Clean probe manually .........................................................................................C-12
Clean reagent disk and sample area ....................................................................C-14
Clean the water and waste containers ................................................................C-16
Replace water inlet filter ......................................................................................C-19
Clean and disinfect housing ................................................................................C-21
Replace photometer lamp ...................................................................................C-23
Contact service representative ............................................................................C-26
Perform air/water calibration .............................................................................C-27
Initialize degasser fluid sensor ............................................................................C-29
Clean rotor and heating channel ........................................................................C-31
Roche Diagnostics
Operator’s Manual · Version 2.0 C-3
8 General maintenance cobas c111
Table of contents
Roche Diagnostics
C-4 Operator’s Manual · Version 2.0
Overview
Overview
Completing maintenance actions correctly and on time helps to ensure smooth and
uninterrupted operation of your instrument.
Maintenance scheduling The cobas c111 instrument facilitates performing the maintenance actions in
bundles at the times that suit your laboratory work processes. To that purpose, you
can define in the configuration settings one day of the week as your maintenance day.
on page B-138.
All maintenance actions can be performed any time.
Interval For most maintenance actions a fixed maintenance interval is defined. (You cannot
change this interval.) This is the basis upon which the system calculates the date when
the actions need to be performed.
The interval timers and counters are reset whenever you confirm that the
maintenance action has been performed.
Maintenance actions without predefined intervals are performed whenever necessary,
or they are triggered by another maintenance action.
Due date The due date is the last possible maintenance day. This is the date you see when you
check the status of maintenance actions.
Ensuring smooth operation Performing all due maintenance actions during the daily Prepare or End Shift phase
ensures that routine operation does not have to be interrupted for performing
Roche Diagnostics
Overview
Checking when maintenance 1 Choose Utilities > Maintenance

actions are due
A B
A Maintenance action name. D Use the scroll bar to display the

B Due dates, in ascending order. maintenance actions that are currently
C This maintenance action is selected. hidden.
Figure C-1
Interpreting the colors The defined maintenance interval has expired. Perform this maintenance
action now.
This maintenance action should be performed on the next major

maintenance day.
This maintenance action is selected.
Preparing the maintenance The maintenance actions are sorted according to the date by when they should be
actions performed. Use these dates for planning the maintenance actions, for example for
ordering the required materials.
Performing the maintenance 2 Select the maintenance action you want to perform.
action
The selected line turns blue.
3 Press .
The first screen of the wizard for performing the selected maintenance action is
displayed. Usually, this is the maintenance description screen.
Press if you want to print the instructions before you start.
4 Follow the instructions on the screen.
A message will inform you when the maintenance action is complete. In addition,
with maintenance actions that take some time, an acoustic signal is sounded. This
allows you to do work away from the instrument while the maintenance action is
in progress.
e For information on how to perform individual maintenance actions, see Maintenance
actions on page C-8.
Roche Diagnostics
Overview
Maintenance actions and their intervals
The following table lists the maintenance actions and shows how frequently they need
to be performed.
Every effort has been made to ensure that all the information contained in this table is
correct at the time of publication. However, Roche Diagnostics GmbH reserves the right to
make any changes necessary without notice as part of ongoing product development.
Maintenance actions with no defined interval need to be performed in particular situations,

for example during troubleshooting.
Interval Maintenance action

None Prime Fluid System
None Initialize Degasser Fluid Sensor
None Abs. Water/Air Calibration
None Clean Rotor And Heating Channel
Daily Deproteinize Probe
Weekly Clean Probe Manually
Monthly Clean Reagent Disk
Three-monthly Clean Water and Waste
Three-monthly Replace Water Inlet Filter
Six-monthly Clean Housing
Six-monthly Replace Photometer Lamp
Yearly Call Service Rep.
Table C-1 Periodicity of maintenance actions
Roche Diagnostics
Maintenance actions
Maintenance actions
The following sections describe the maintenance actions of the main instrument.
e For ISE-specific maintenance actions, see ISE maintenance actions on page E-40.
Safety information


mechanism


Diagnostics.
representative.
Roche Diagnostics
Maintenance actions

CAUTION components associated with the waste systems are potentially biohazardous.
Incorrect results due to build-up of contaminants

During use, contaminants may adhere to the probe. As a result, traces of analytes or
reagents may be carried over to the next. Make sure to perform the probe maintenance
actions as soon as they are due in order to prevent potentially false results.

instrument is shut down. This can cause dust and dirt being collected in the heating
channel, which in turn might decrease the quality of the cuvettes.

cannot continue processing orders, or it may lead to incorrect results. If at all possible,

quality specified in section Technical specifications.
specified in chapter Technical specifications must be used.
Roche Diagnostics
Maintenance actions
Deproteinize probe
h Utilities > Maintenance > Deproteinize Probe

To maintain the efficiency of the instrument, you must clean and deproteinize the
probe regularly to prevent the build-up of contaminants.
Operator time Approximately 5 minutes.
Prerequisites The system must be in Standby status.
Tools and materials required m ISE Deproteinizer

m Activator
Make sure that you have read and understood section Safety information on page C-8. The
o Injury through working solutions on page C-8.
o Incorrect results due to build-up of contaminants on page C-9.
a To deproteinize the probe

1 Prepare one tube with ISE Deproteinizer and one with Activator.
2 Select the maintenance action [Deproteinize Probe].
3 Press .
4 Press .
A placement list is displayed.
5 Place the ISE Deproteinizer and Activator on the positions indicated on the
screen.
6 Press to confirm the placing.
The system first deproteinizes and then activates the probe.
A message will inform you when the maintenance action is complete.
7 Remove the tubes.
8 Press .
Roche Diagnostics
Maintenance actions
Prime the fluid system
h Utilities > Maintenance > Prime Fluid System

Priming flushes the fluid system with water to ensure the paths in the fluid system
(including pipette, tubing, and probe) are filled with fluid and are free of air bubbles.
If air bubbles are present in the fluid system, your test results will be inaccurate.
Tools and materials required m Purified water.
a To prime the fluid system

1 Check the external water and waste containers. If required, refill the water and
empty the waste container.
2 Select the maintenance action [Prime Fluid System].
3 Press .
4 Press .
The system performs the priming actions automatically.
5 Press .
Roche Diagnostics
Maintenance actions
Clean probe manually
h Utilities > Maintenance > Clean Probe Manually

You must clean the probe regularly by hand to prevent any build up of deposits that
may affect results.
Operator time Approximately 1 minute.

m Tissues
o Incorrect results due to build-up of contaminants on page C-9.
o Infection by biohazardous materials on page C-8.
a To clean the probe

1 Select the maintenance action [Clean Probe Manually]
2 Press .
3 Press .
The system deactivates the transfer motors.
Press the release buttons on both sides and lift.
5 Remove the probe with its holder.
a) Remove the tube from at least the first two tubing clips.
b) Press the release button on the side of the probe holder carriage and lift the
probe holder with the probe. Be careful not to pull the tubing.
Figure C-2
Roche Diagnostics
Maintenance actions
6 Hold the assembly by the probe holder and clean the probe using a tissue
moistened with 70% ethyl alcohol.
Wipe from top to bottom several times.
7 Wipe the side of the probe holder that faces the level detection contact. Use a
tissue moistened with 70% ethyl alcohol.
Figure C-3
8 Reinstall the probe holder with the probe.

Press the release button on the side of the probe holder carriage before you insert
the probe holder. Release the button when the holder is inserted.
Push down firmly until the release button latches on.
9 Fix the tube to the tubing clips.
10 Reinstall the transfer head cover.
Press down until the release buttons latch on.
11 Press .
The system automatically initializes the transfer head and performs the [Prime
Fluid System] maintenance action.
12 Press .
Roche Diagnostics
Maintenance actions
Clean reagent disk and sample area
h Utilities > Maintenance > Clean Reagent Disk

To remove possible spillages you must clean the reagent disk and sample area
regularly.
This maintenance action involves the following steps:
o Cleaning the reagent disk
o Cleaning the sample area
Tools and materials required m Alcoholic cleansing tissues

m Tissues
m Commercial nonabrasive detergent
page C-8.
a To clean the reagent disk

1 Select the maintenance action [Clean Reagent Disk].
2 Press .
3 Press .
6 Remove spillages and stains on the disk with alcoholic cleansing tissues.
7 Wipe the inside of the reagent cooler with a cloth dampened with soapy water.
8 Reinsert the reagent disk.
e For information on inserting the reagent disk, see Preparing the reagent disk on
page B-21.
9 Open the right service flap.
Roche Diagnostics
Maintenance actions
10 Lift the sample tray from its fixture.
Figure C-4
11 Wash the sample tray using detergent. (You can wash the tray in a dish washer.)
Do not disassemble the sample tray.
12 Leave the sample tray to dry or dry it using tissues.

13 Reinsert the sample tray.
Make sure to align the guides with the pins.
Figure C-5
Press down firmly.

14 Close the right service flap and the main cover.
15 Press to confirm that you have performed the maintenance action.
The system initializes automatically.
16 Press .
Roche Diagnostics
Maintenance actions
Clean the water and waste containers
h Utilities > Maintenance > Clean Water and Waste

You must clean the external water and fluid waste containers to prevent the build-up
of contaminants, which can affect the water quality and therefore the quality of the
results produced.
This maintenance action consists of the following steps:
o Cleaning the water container
o Cleaning the waste container
The water and waste containers are placed on the rack next to the cobas c111
instrument.
Tools and materials required m Spare waste container

m Purified water
m Hypochlorite solution (0.6%)
m Alcoholic cleansing issues
o Infection by waste solution on page C-9.
a To clean the water container

1 Select the maintenance action [Clean Water and Waste].
2 Press .
3 Press .
4 Lift the tubing adapter from the white water container.
Figure C-6
5 Place the tubing adapter on a clean surface.

Roche Diagnostics
Maintenance actions
6 Dispose of any remaining water.

7 Pour 500 mL hypochlorite solution in the water container.
8 Clean the water container with a brush.
9 Dispose of the solution.
10 Clean the interior of the water container manually using tissues. Remove any
residue.
11 Rinse the water container with tap water at least four times.
12 Rinse the water container with purified water.
13 Wipe the suction pipe with a tissue.
14 Fill the water container with purified water.
15 Reinsert the tubing adapter into the water container. Press down firmly.
a To clean the waste container

1 Have the spare waste container ready.
The system periodically performs wash actions. Therefore, an external waste
container must be connected at all times.
2 Remove the tubing adapter from the yellow waste container and insert it in the
spare container.
Figure C-7
3 Remove the bottle from the rack and place it on a firm and even surface.
4 Place the spare container on the rack.
5 Check that the tubing adapter is properly inserted.
6 Empty the removed waste container. Treat the fluid as biohazardous waste.
7 Pour 500 mL hypochlorite solution in the waste container.
8 Clean the container with a brush.
9 Dispose of the fluid. Treat it as biohazardous waste.
10 Clean the interior of the waste container manually using tissues. Remove any
residue.
11 Rinse the waste container with tap water.
12 Empty the container completely.
13 Wipe the waste inlet with a tissue.
Roche Diagnostics
Maintenance actions
14 Reinsert the tubing adapter into the waste container. Press down firmly.
15 Press .
The maintenance action [Prime Fluid System] is automatically performed.
16 Press .
Roche Diagnostics
Maintenance actions
Replace water inlet filter
h Utilities > Maintenance > Replace Water Inlet Filter

The water inlet filter in the external water container removes particulate matter from
the water supply. You must replace this filter according to the maintenance action
schedule.
The water container is placed on the rack next to the cobas c111 instrument.
Prerequisites None
Tools and materials required m Purified water

m Hypochlorite solution (0.6%)
m Tissues
m Water inlet filter
a To replace the water inlet filter

1 Select the maintenance action [Replace Water Inlet Filter].
2 Press .
3 Press .
4 Remove the tubing adapter from the water container.
Roche Diagnostics
Maintenance actions
6 Replace the water inlet filter.
B C
A
D
A Removing the retaining ring D Retaining ring

B Filter E Tab on retaining ring
C Filter casing
Figure C-8
a) Remove the retaining ring by pulling it by its tab away from the filter casing (A,
D, E).
b) Remove the filter (B) and replace it with a new one.
c) Place the retaining ring.
Press it firmly on the filter casing by placing your thumb across it an applying
equal pressure all around.
7 Reinsert the tubing adapter into the water container. Press down firmly.
8 Press .
The maintenance action [Prime Fluid System] is automatically performed.
9 Press .
Roche Diagnostics
Maintenance actions
Clean and disinfect housing
h Utilities > Maintenance > Clean Housing

You must clean the housing regularly to ensure that contaminants do not build up
and affect the efficiency of the instrument as a measuring system.
Prerequisites Instrument is switched off.
Tools and materials required m Ethyl alcohol

m Tissues
To find out what steps are required, you can choose Utilities > Maintenance > Clean
Housing and then press . (The maintenance definition screen is displayed.)
Do not press at this stage. You do this only when you have completed the
maintenance action. Instead, press to close the screen.
a To clean the housing

2 Switch off the system.
3 Wipe all the outside of the instrument with alcoholic cleansing tissues.
4 Open the main cover and the right service flap.
5 Wipe all the inside of the cover and flap with alcoholic cleansing tissues.
6 Close the right service flap and then the main cover.
7 Push the transfer head to the rightmost position.
8 Open the main cover and the left service flap.
9 Wipe all the inside of the flap with alcoholic cleansing tissues.
10 Close the left service flap and the main cover.
11 Push the transfer head to its home position.
(Press the release buttons on both sides and lift.)
13 Wipe all the inside of the cover with alcoholic cleansing tissues.
14 Reinstall the transfer head cover.
(Push down until the release buttons latch on.)
15 Remove the left and right side panels.
16 Wipe the panels with alcoholic cleansing tissues.
17 Reinstall the left and right side panels.
Roche Diagnostics
Maintenance actions
18 Switch on the system.

The startup phase may take a few minutes.
When the instrument is ready for use, the [Overview] tab is displayed, and its
status is Standby.
19 Log on the system.
20 Choose Utilities > Maintenance > Clean Housing.
21 Press .
22 Press .
A detailed maintenance definition screen is displayed.
23 Press to confirm the completion of the maintenance action.
Roche Diagnostics
Maintenance actions
Replace photometer lamp
h Utilities > Maintenance > Replace Photometer Lamp

It is essential that the photometer lamp maintains a constant intensity in successive
absorbance measurements. After a certain time of use, the intensity of the light
emitted by the lamp deteriorates, and the accuracy of the measurements may no
longer meet the required standards. Therefore, the lamp must be periodically
replaced. The system alerts you when the lamp should be replaced by changing the
maintenance action status to due (entry turns red).
Tools and materials required m Paper tissue

m Photometer lamp assembly (Lamp, socket and cable are pre-assembled.)
m Cuvette segments
m Clean cloth
page C-8.
a To replace the photometer lamp

1 Select the maintenance action [Replace Photometer Lamp].
2 Press .
3 Press .
The system switches off the lamp, and the transfer head moves to the home
position.
Preparing the instrument 4 Open the main cover and the right service flap.
5 Remove the sample tray by lifting it.
Figure C-9
Roche Diagnostics
Maintenance actions
Injury through hot parts

Direct contact with hot parts may result in injury.
CAUTION Do not touch the lamp assembly with bare hands. Let the lamp cool down for about ten
minutes before touching any part of the lamp housing.
Removing the lamp 6 Unplug the power connector (A).
A Power connector C Cover

B Assembly screw
Figure C-10
7 Lift the photometer lamp housing cover (C).

8 Unscrew (B) the lamp assembly and remove it.
Installing the new lamp 9 Insert the new lamp assembly.
Incorrect results through soiled lamp

Touching the lamp with bare fingers reduces the life of the bulb and may affect the
CAUTION consistency of measurements made with the absorbance photometer.
Hold the lamp assembly by its screw.
Figure C-11
Hold the assembly by the screw and fit the lamp socket in the guides.
10 Fasten the screw of the lamp assembly.
11 Close the photometer lamp housing cover.
12 Plug the power connector into its socket.
Roche Diagnostics
Maintenance actions
Preparing the instrument 13 Reinsert the sample tray.
Figure C-12
14 Close the right service flap and the main cover.

15 Press .
The system automatically initializes the instrument.
16 Press .
17 Perform an air/water calibration.
You cannot process orders unless you perform this action.
e See Perform air/water calibration on page C-27.
Roche Diagnostics
Maintenance actions
Contact service representative
h Utilities > Maintenance > Call Service Rep.

To ensure smooth operation of the instrument, a service representative periodically
needs to perform some preventive maintenance tasks.
The system displays a message when this maintenance action is due.

(A service representative takes about 60 minutes to perform preventive maintenance
for a system without an ISE unit, 90 minutes including the ISE unit.)
Prerequisites None
a To initiate preventive maintenance

1 A message screen reminds you that you should contact your service representative.
2 Select the maintenance action [Call Service Rep.].
3 Press .
4 Press .
An instructions screen is displayed.
5 Contact your service representative to arrange for preventive maintenance.
6 Press .
Roche Diagnostics
Maintenance actions
Perform air/water calibration
h Utilities > Maintenance > Abs. Air/Water Calibration

The absorbance photometer calibration determines the air/water correction values
that are needed for result calculation. In addition, the obtained absorbance values for
an empty cuvette at each wavelength are used as a reference for the cuvette blank
check.
Tools and materials required m 2 cuvette segments with empty cuvettes
page C-8.
a To perform an air/water calibration

1 Choose Utilities > Maintenance > Abs. Air/Water Calibration.
2 Press .
Your are asked to insert a cuvette segment with empty cuvettes.
4 If there is a segment in the cuvette ring remove it and check whether there are used
cuvettes.
If all cuvettes of this segment are empty, you can reinsert it.
5 Place a cuvette segment with empty cuvettes on the cuvette ring.
6 Press .
Your are asked to insert a second cuvette segment with empty cuvettes.
7 If there is a segment on in the cuvette ring remove it and check whether there are
used cuvettes.
If all cuvettes of this segment are empty, you can reinsert it.
8 Place the cuvette segment with empty cuvettes on the cuvette ring.
10 Press .
The system performs the calibration measurements. (It first measures all cuvettes
empty, pipettes water in the cuvettes, and measures them again.
A message will inform you when the measurements are complete.
11 Scroll to display the results, if required.
12 Check the [Outlier statistics].
Roche Diagnostics
Maintenance actions
13 Press to accept the results.
If at this stage, you press , the results are not stored and the maintenance action is
deemed not performed.
14 Remove the used cuvettes or replace them with empty ones.
Roche Diagnostics
Maintenance actions
Initialize degasser fluid sensor
h Utilities > Maintenance > Initialize Degasser Fluid Sensor

The degasser fluid sensor checks whether there is air in the water supply to the syringe
assembly. Air in the water supply may lead to inaccurate pipetting and ultimately to
incorrect results. Therefore, the sensor needs to be initialized to ensure its proper
functioning.

All covers must be closed.
Tools and materials required m Full external water container

m Clean cloth
a To initialize the degasser fluid sensor

1 Make sure that all covers on the instrument are closed.
2 Choose Utilities > Maintenance > Initialize Degasser Fluid Sensor.
An instructions screen is displayed.
3 Press .
4 Check whether the tube connecting the external water container with the
instrument is full of water or contains air bubbles.
Figure C-13
If Do this
You cannot see any air 1. Continue with step 6.
bubbles
You can see air bubbles or the 1. Press to abort this maintenance action.
tube is empty 2. Perform the maintenance action [Prime Fluid
System].
3. Restart the maintenance action [Initialize Degasser
Fluid Sensor].
Roche Diagnostics
Maintenance actions
6 Lift the tubing adapter from the white water container.
Figure C-14

Make sure the filter (A) is not obstructed and air can get to it.
8 Press to initialize the fluid sensor.
The system aspirates air through the tubing adapter and initializes the fluid sensor.
When initialization is complete, you will be asked to insert the tubing adapter.
9 Insert the tubing adapter in the water container.
10 Press .
The fluid system is primed.
11 Press .
Roche Diagnostics
Maintenance actions
Clean rotor and heating channel
Perform this maintenance action whenever a message asks you to do so.

m Lint free tissues
a To clean the rotor and heating channel

a) Choose Overview > > .
A screen is displayed, asking you to remove the reagent disk.
b) Open the main cover.
c) Remove the reagent disk.
d) Close the main cover.
2 Remove all cuvettes.
a) Choose Overview > .
b) Open the main cover.
c) Press a segment button.
d) Remove the segment.
e) Press to confirm the removal.
Remove all segments as described in steps c through e.
f) Close the main cover.
3 Switch off the instrument.
4 Move the transfer head to the sample area.
5 Open and remove the main cover and left service flap.
Figure C-15
Roche Diagnostics
Maintenance actions
6 Move the transfer head to its leftmost position.

7 Open and remove the right service flap.
8 Remove the sample tray.
Figure C-16
Removing the rotor 9 Loosen the display fixation screw (A).
Figure C-17
10 Tilt forward the display.

11 Move transfer head to its rightmost position.
12 Remove the upper rotor shell.
Roche Diagnostics
Maintenance actions
13 For each of the two rotor bearings to the right, loosen slightly one of the fixation
screws and completely unscrew the other. (Use a screw driver to loosen the screws,
if required.) Then pull away from the rotor the side of the bearing that you
completely unscrewed.
C D
A E
A Retention pin of motor D Fixed rotor bearings

B Spring-loaded rotor bearing E Photometer lens (not shown)
C Rotor motor
Figure C-18
14 From the rotor motor, slightly lift the retention pin, move the motor away from
the rotor and engage the pin to fix the motor in the removed position.
Make sure to use the hole nearer to the front of the instrument for arresting the
bearing with the pin.
15 With one hand, release the spring-loaded bearing from the rotor, and with the
other hand lift the rotor.
Roche Diagnostics
Maintenance actions
Cleaning the rotor 16 Rinse the cuvette ring (A) under running water.
Figure C-19
NOTICE Do not use any cloth to clean or dry the rotor. This could leave dust and lint on the Abs.
inspection holes and so prevent proper measurement.
17 Leave the rotor to dry.
Cleaning the heating channel 18 Clean the heating channel (B) with a lint free tissue or a cloth moistened with
ethyl alcohol.
Make sure not to touch the photometer lens (A).
Figure C-20
Reinstallation 19 With one hand, pull the spring-loaded bearing away from the rotor position, and
with the other hand insert the rotor.
20 Engage the right rotor bearings and fasten the fixation screws.
21 Move the rotor to test its smooth running.
22 Hold the spring-loaded rotor motor in position, lift the retention pin and release
the motor gently.
23 Move the transfer head to its leftmost position.
Roche Diagnostics
Maintenance actions
24 Fit the upper rotor shell.

25 Fold down the display and fasten the fixation screw.
26 Install the sample tray.
Make sure to align the guides with the pins.
Figure C-21
Press down firmly.

27 Install and close the right service flap.
28 Move the transfer head to its rightmost position.
29 Install and close the left service flap and main cover.
Finishing the maintenance 30 Switch on the instrument.

action
31 Wait for initialization to finish.
32 Log on to the system.
33 Insert the reagent disk.
e See Preparing the reagent disk on page B-21
Roche Diagnostics
Maintenance actions
Roche Diagnostics
Troubleshooting D
9 Messages and alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

10 Result flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-17
11 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-33
cobas c111 9 Messages and alarms
Table of contents
Messages and alarms

How to make the most of the available information.
In this chapter, you will find information on messages generated by the cobas c111
instrument, and on how to use them and react to them.

About messages .......................................................................................................... D-5
Message screen ............................................................................................................ D-5
Acoustic signals .......................................................................................................... D-6
Alarm monitor ........................................................................................................... D-6
Reacting to alarm messages ................................................................................. D-7
Printing alarm messages ...................................................................................... D-8
Deleting alarm messages ...................................................................................... D-8
Exporting the alarm message log ......................................................................... D-8
List of alarm messages ................................................................................................ D-9
Roche Diagnostics
Operator’s Manual · Version 2.0 D-3
9 Messages and alarms cobas c111
Table of contents
Roche Diagnostics
D-4 Operator’s Manual · Version 2.0
About messages
About messages
The system performs numerous checks. When a certain event has occurred or when
an irregularity is detected, a message is generated. Messages are displayed in two ways:
o Information concerning a problem that occurred during operation is reported as
alarm messages in the alarm monitor.
Alarm messages are stored in a log file, which you can export.
e See Exporting the alarm message log on page D-8.
Message screen
Message screens are displayed automatically as soon as the message is generated.
Figure D-1 Message screen
Read the message and press to close the screen.
Roche Diagnostics
Acoustic signals
Acoustic signals
The operator is alerted to certain events by an acoustic signal.

The following events trigger an acoustic signal.
o An alarm was generated.
o The Main cover is open while the system is in Operating status.
o A run is finished. (The system status has changed from Operating to Standby.)
o A maintenance action is complete (provided it is a longer maintenance action
where no user intervention is required).
You can adjust the volume of all generated acoustic signals (Utilities > Configuration
> System > Volume).
You can also turn on and off acoustic signals:
o Choose Utilities > Configuration > System > Sound Effects to turn on and off the
acoustic signals other than alarm and warning signals.
o Choose Utilities > Configuration > System > Volume and set the value to zero to
turn off all acoustic signals.
e System on page B-147.
Alarm monitor
Messages concerning an irregularity that occurred during operation can be viewed in

the alarm monitor. The alarm LED alerts you when such messages are generated.
Alarm button and LED
A Alarm LED B Alarm button
Figure D-2 Alarm LED
The alarm button is always active, even if you are not logged on the system.
Roche Diagnostics
Alarm monitor
Reacting to alarm messages
a To react to an alarm message

1 Observe the alarm LED.
No color There are no alarm messages to be dealt with. (All alarm messages have
Off been acknowledged.)
Yellow There is at least one alarm message that you need to deal with as soon as
possible.
Red There is at least one alarm message that you need to deal with.
Processing cannot continue unless you do so.
An acoustic signal is sounded when an alarm is generated. You can adjust the volume
2 Press the Alarm button .
A B
A Alarm ID D Problem description and short remedy

B Number of total messages currently not yet suggestion
dealt with. E Display the next alarm message.
C Display the previous alarm message. F Display additional information.
Figure D-3

o Press to display more detailed information.
(If this button is not available there is no additional information.)
o Press to print alarm messages.
o Press to export the log file.
e See Exporting the alarm message log on page D-8.
4 When you have dealt with the issue, press to delete the message from the
display. (It will still remain in the log file, which you can export.)
Roche Diagnostics
Alarm monitor
Printing alarm messages
When you print alarm messages, their details are included in the printout.
a To print alarm messages

1 Press .
2 Press .
A screen is displayed for defining which alarm messages should be printed.
o Press <All> to print all messages that have not been dealt with.
o Press <Selected> to print the current message.
Deleting alarm messages
Deleting a message means confirming that you have dealt with the issue mentioned in
it. (It will still remain in the message log.)
a To delete a message
1 Press .
2 Select the message. (Use and to display the previous and next message
respectively.)
3 Press .
The current message is deleted from the display.
Exporting the alarm message log
a To export the message log file

1 Press .
2 Press .
A screen is displayed asking you to insert a USB stick.
Press <*.tgz> to display log files only.
5 Select a directory for the error log.
The log is copied to the stick. Its file name has the format
err_yyyymmddhhmmss.tgz (year, month, day, hour, minute, second)
Roche Diagnostics
List of alarm messages
In the following table, the variables %s and %d are used, they represent text and numbers.
ID Message Comment
0000 Unknown message, nbr=%d!
0001 Fatal system exception, code=%d. Perform restart. If the problem persists, call your service
representative.
0002 Configuration update failed, code=%d
0003 Order rejected with unknown measuring mode, order
index=%d, measuring mode=%d"
0004 Unit not ready, order rejected, order index=%d
0005 A mathematical exception arose.
0006 Last calculation cycle too short, cycle index=%d
0007 Failed to calculate linear regression
0008 Invalid cycle range: %d..%d
0010 Invalid reaction direction=%d
0011 Illegal IPC message received state=%d, msgId=%d
0012 Problem with order handling in SW. Check if all requested results are available, if not, re-order
the test.
0017 The version of the installed language %s is older than the
required version %s
0018 Invalid system date! Warning: Using the system with an invalid date may lead
to incorrect results.
5001 Air in the fluid system. Water container or cleaner bottle is empty.
5002 Air detected in fluid system. Refill water container and/or replace cleaner bottle and
perform <Prime Fluid System>.
5003 Parameter outside specified values. Perform restart.
5004 Syringe motor error. Perform restart. If the problem persists, call your service
representative.
5010 Syringe assembly or initialization error. Check for mechanical blockage and perform restart.
5013 Mixing motor error. Perform restart. If the problem persists, call your service
representative.
5019 Mixing motor or initialization error. Check for mechanical blockage and perform restart.
5022 Heating channel temperature sensor error. Perform restart. If the problem persists, call your service
representative.
5024 Reagent cooler temperature sensor error. Perform restart. If the problem persists, call your service
representative.
5026 Heat sink temperature sensor error. Perform restart. If the problem persists, call your service
representative.
5028 Environment temperature sensor error. Perform restart. If the problem persists, call your service
representative.
Table D-1 List of alarm messages
Roche Diagnostics
ID Message Comment
5030 Wash pump P1 error. Perform restart. If the problem persists, call your service
representative.
5032 Waste pump P2 error. Perform restart. If the problem persists, call your service
representative.
5034 Wash valve V1 error. Perform restart. If the problem persists, call your service
representative.
5036 Cleaner valve V2 error. Perform restart. If the problem persists, call your service
representative.
5038 Heating foil error. Perform restart. If the problem persists, call your service
representative.
5040 Peltier element error. Perform restart. If the problem persists, call your service
representative.
5044 Mainboard fan error. Perform restart. If the problem persists, call your service
representative.
5047 Cooling fan error. Perform restart. If the problem persists, call your service
representative.
5049 Sample area fan error. Perform restart. If the problem persists, call your service
representative.
5052 Peltier heat sink too hot. Check the cooling fan, and check for obstructions in the
air duct.
5054 Heating channel temperature too high. Switch off instrument. As soon as the heating channel is
cooled down (15 minutes) switch on again.
5055 Heating channel temperature too low. Perform restart. If the problem persists, call your service
representative.
5056 Transfer head fluid sensor adjustment error. Check the water container and cleaner bottle, and
perform <Prime Fluid System>.
5058 Transfer head fluid sensor error. Perform restart. If the problem persists, call your service
representative.
5060 MultiSControl error with code=%d. Perform restart. If the problem persists, call your service
representative.
5061 Air detected in supply pipe. Refill water container and perform <Prime Fluid
System>.
5062 Degasser fluid sensor is not initialized. Perform <Initialize Degasser Fluid Sensor>.
5063 Degasser Valve error. Perform restart. If the problem persists, call your service
representative.
6001 Photometer lamp error. Perform Clean Rotor and Heating Channel. If problem
persists, replace the photometer lamp. See the instructions
in the Operator's Manual.
6002 Photometer error. Make sure that all covers are mounted and closed. Switch
on the instrument. If the problem persists, call service.
6018 Photometer error with code=%d. Perform restart. If the problem persists, call your service
representative.
6019 ABS Signal overflow. Possible causes: Rotor dirty, rotor light barrier defect, ABS
photometer defect. Perform Clean Rotor and Heating
Channel (see Operator's Manual for instructions), check
light barrier. If problem persists, call service.
Table D-1 List of alarm messages (continued)
Roche Diagnostics
ID Message Comment
6020 Photometer lamp error. Perform Clean Rotor and Heating Channel. If problem
persists, replace the photometer lamp. See the Operator's
Manual for instructions.
7001 The Instrument Control software encountered an Perform restart. If the problem persists, call your service
exception. representative.
7002 Software error. Export the log files. Perform restart. If the problem
persists, call your service representative.
7004 Error due to a previous hardware error. Check for hardware messages.
7006 Hardware error with code=%d. Export the log files. Perform restart. If the problem
7007 Error caused by hardware module No %d. Check all cable connectors and perform restart.
7008 code raised by IC software caused by an unexpected Perform restart, if the problem persists call service.
handling or system situation.
7009 No connection to Instrument Control. Make sure that the ethernet cable is plugged in firmly.
Perform restart, if the problem persists call service.
7010 Instrument failed to initialize. Check for previous error messages and eliminate the
cause. Switch off the instrument and check the
mechanical system. Switch on instrument. If the problem
persists call service.
7011 Failed to aspirate sample from tube on position %d. Check if there is enough sample.
7012 Failed to identify the reagent disk. Remove reagent disk and check the ID tabs. Only one tab
should be removed. Reinsert the reagent disk properly.
7013 The transfer head is blocked. Check for obstacles blocking the transfer head. Perform
restart, if the problem persists call service.
7014 %s electrode is not stable during sample measurement. Perform restart. Perform <Electrode Service>. Check
reference tubing for obstructions. Replace electrode.
7015 %s electrode is not stable during calibrator measurement. Perform restart. Perform <Electrode Service>. Check
reference tubing for obstructions. Replace electrode.
7016 The ISE sample sensor could not detect ISE Deproteinizer. Check the ISE Deproteinizer level, proper electrode
mounting, tube leakages and obstructions.
7017 The ISE sample sensor could not detect ISE Etcher. Check the ISE Etcher level, check for proper electrode
mounting, tube leakages and obstructions.
7018 The probe is not straight or not properly mounted. Check that the probe is properly mounted. Perform
<Replace Probe>.
7019 The transfer init with the probe failed due to level Check for obstructions and properly mounted probe.
detection problem. Perform restart, if the problem persists call service.
7020 The transfer initialization failed. Transfer head movement failed due to open main cover.
Close the main cover. Perform restart. If the problem
7021 Instrument failed to initialize due to dirty init plate or Perform <Clean Probe Manually> and restart. If the
probe. problem persists, call service.
7022 Rotor movement impeded. Perform Clean Rotor and Heating Channel (see the
Operator's Manual for instructions). If the problem
persists call your service representative.
7033 Z-Motor mechanically blocked. Switch off the instrument. Check for smooth movement.
Switch on again, if the problem persists call service.
Roche Diagnostics
ID Message Comment
7034 Motor error (movement). Check for blockages on rotor and transfer systems. Then
perform restart. If the problem persists, call your service
representative.
7036 Level detection error (conductivity). Use water quality according to Operator's Manual.
7037 Level detection error (connection). Check probe mounted properly, white level detection
cable, contact on the probe holder. Perform restart. If the
problem persists, call service.
7038 Motor error (overheated). Switch off the instrument. Check for smooth movements.
Switch on again, if the problem persists call service.
7039 Internal voltage failed. Perform restart. If the problem persists, call your service
representative.
7042 Check Fuse F1. Replace if necessary.
7046 Rotor error. Check for properly mounted rotor bearing motor drive.
7051 Rotor motor error (electrical). Perform restart. If the problem persists, call your service
representative.
7052 Transfer X-motor error (electrical). Perform restart. If the problem persists, call your service
representative.
7053 Transfer Z-motor error (electrical). Perform restart. If the problem persists, call your service
representative.
7057 The ISE sample sensor has no valid data. Perform <Initialize ISE unit>.
7058 The ISE sample sensor could not detect liquid. Check ISE tower, electrodes, and tubing for clogging and
leakages. Check for proper mounting. Perform restart.
7059 The ISE sample sensor could not detect the segment end. Check electrodes, ISE tubing for clogging and the
peristaltic pump for proper function. Perform restart.
7060 The ISE sample sensor could not calibrate. Check the ISE Calibrator indirect/urine bottle and the
tubing. Perform <Initialize ISE unit> maintenance action.
7061 The ISE sample sensor calibration is out of range. Check the ISE tubing for proper mounting (around
sensor) and check for leakages and clogging.
7062 The ISE sample sensor could not detect calibrator. Check the ISE Calibrator indirect/urine level. Check the
ISE tubing for leakages and clogging. Perform restart.
7063 The ISE sample sensor could not detect end of calibrator Check the electrodes and ISE tubing for leakages and
segment. clogging, and the peristaltic pump for proper functioning.
Perform restart.
7064 The ISE sample sensor did not detect liquid when Check Activator, electrodes, ISE tubing for leakages/
initializing. clogging and peristaltic pump.
7065 The ISE reference sensor did not initialize. Check level of the ISE Reference Solution, electrodes, ISE
tubing for leakages/clogging and peristaltic pump.
7066 Controller %d reports wrong software version. Download Instrument Controller software.
7067 Controller %d reports a boot, checksum or attach error. Perform restart. If the problem persists, call your service
representative.
7068 Wash aborted due to open cover. Close the cover and perform restart.
Roche Diagnostics
ID Message Comment
7069 Procedure stopped due to open cover. Keep all covers closed while the instrument is in
Operating mode or during initialization.
7070 Probe crashed or bottle set %s became unexpectedly Check for obstructions of probe movement and for filling
empty. level of reagent bottle.
7071 End of photometer lamp life reached. Perform restart. If message reoccurs, replace the
photometer lamp using the maintenance function. See the
Operator's Manual for instructions.
7072 Reagent mixing failed due to level detection problem. Check the filling level of the reagent bottle.
7073 ISE pump speed is out of range. Check the ISE pump tubing and perform <Initialize ISE
Unit>.
7074 ISE - The detected sample or calibrator segment was too Check the electrodes and the ISE tubing for leakages and
short. clogging. Perform restart.
7075 ISE measuring failure. Perform restart. If the problem persists, call your service
representative.
7076 ISE - ISE fluid transportation timing problem. Check the ISE tower and tubing for leakages and clogging.
Perform <Initialize ISE Unit>.
7083 ISE bypass tube blocked. Perform restart. Perform <Replace ISE Unit Tubing>.
Follow the instructions in the Operator's Manual.
7084 ISE valve defect. Check pinch valves and tubing for proper mounting.
Perform restart. If the problem persists, call your service
representative.
7086 ISE air pressure is outside range. Check the tubing to the air pressure sensor. Perform
restart. If the problem persists, call your service
representative.
7087 ISE air pressure sensor detected that the pressure is too Perform restart. If the problem persists, call your service
low. representative.
7088 ISE unit detected an internal power supply failure. Check the fuses. Perform restart. If the problem persists,
call your service representative.
7099 ISE bottle weight sensor not fully initialized. Perform restart. Perform completely the procedure for
initializing both bottle weight sensors.
7100 System restart after power fail.
7103 ISE bottle weight mismatch. Perform restart, then perform completely the procedure
for initializing both bottle weight sensors.
7107 ISE unit error reported by Instrument Control software, Perform restart. If the problem persists, call your service
code=%d. representative.
7108 DC controller error reported by Instrument Control Perform restart. If the problem persists, call your service
software, code=%d. representative.
7109 Sample probe is bent or not properly aligned. Check probe and/or adjust transfer head.
7110 Time scale for dispensing into cuvette exceeded. Possible reason: Preceding hardware problem. Check
previous error messages, eliminate the cause and perform
restart. If the problem persists, call service.
7111 Transfer movement failed due to open cover. Keep covers closed while the instrument is in Operating
mode.
7112 The ISE reference sensor has detected too much air during Check the level of the ISE Reference Solution, check
ISE Reference Solution transport. electrodes, ISE tubing for leakages and clogging, check
peristaltic pump. Perform restart.
7113 Prime failed due to open main cover. Keep main cover closed during operation and
maintenance.
Roche Diagnostics
ID Message Comment
7114 Problem during initialization. Possible cause: Wrong zero positions for transfer head
movement. Check for obstructions of x-movement. Make
sure that all covers, including ISE cover, are closed.
Perform restart.
7115 Dispensing into ISE Tower failed because it was not Check tubing between tower and waste pump. Check fluid
empty. movement in ISE tubing. Check tubing and electrodes for
obstructions or leakages, make sure valves work properly.
Perform restart.
7116 Probe crashed. Possible causes: Magnetic slider does not work properly,
reagent lid not removed, obstruction during pipetting
into cuvette. Restart the run and observe the probe
actions.
7117 This is consequential error. Procedure stopped due to HW Check previous error messages for HW problem,
or SW problem. eliminate the cause. Perform restart. If the problem
7118 Rough Init of rotor failed. Possible causes: Blocked rotor, defective or dirty light
barrier. Perform Clean Rotor and Heating Channel (see
the Operator's Manual for instructions). If the problem
persists call service.
7119 This is a consequential error. Procedure stopped due to HW or SW problem. Check
previous error messages for HW problem, eliminate the
cause. Perform restart.
7120 Rotor or transfer head position error. Possible reasons: Transfer head or motor has been moved
manually while it was in idle state. Perform restart and
observe the transfer head movement until system is in
Standby status.
7121 This is a consequential error in case of connection Check other messages.
problems.
7122 Prepare run failed due to open cover. Keep cover closed while instrument is starting up to
operating.
12001 Host computer did not answer the order query for sample Check communication and existing order on the host.
%s within the time limit.
12002 The communication port is not accessible,
communication with the Host Server is not possible.
12003 Sending a message to the host computer failed. Enable host tracing in the Host Settings to track
communication activities.
12004 Receiving or processing a message from the host Enable host tracing in the Host Settings to track
computer failed. communication activities.
12005 The host server could not send a message to the host. Try <Resend Result> later. If the problem persists, enable
host tracing in the Host Settings and call service.
12006 Changes of the host communication settings could not be Perform restart. if the problem persists, call your service
applied. representative.
13001 Software error. Export the log files. Perform restart. If the problem
13002 Software error with code %d. Export the log files. Perform restart. If the problem
Roche Diagnostics
ID Message Comment
13007 Reagent disc %d was replaced with disc %d while the Make sure the reagent disk information on the screen
system was switched off. agrees with the content of the reagent disk.
13008 Load or reload of the database failed. An old version was
provided. (detected V %d ; expected V %d ).
13011 DC validation failed (%d DC applications found, %d
channels installed).
20001 Replacing filter and external water container complete.
20002 Cleaning of water and waste containers complete.
20003 Replacing photometer lamp complete.
20004 Manual cleaning of probe complete.
20005 Priming of fluid system complete.
20006 Cleaning and disinfecting the housing complete.
20007 Deproteinizing the probe complete.
20008 Cleaning of reagent disc and sample area complete.
20009 Data backup complete.
20010 Service representative was called for preventive
maintenance.
20011 Manual cleaning of the ISE tower complete.
20012 Replacing the ISE unit tubing complete.
20013 Replacing the ISE pump tubing complete.
20014 %s electrode replacement complete.
20015 ISE reference sensor initialization complete.
20016 Automatic cleaning of the ISE tower complete.
20017 ISE unit initialized.
20019 Electrode service complete.
20020 Activating the electrodes complete.
20021 Priming the ISE calibrator and reference complete.
20022 Conditioning of the ISE tubing complete.
20023 Unknown action (id=%d) completed.
20024 Installation complete.
20025 Abs. Air/Water calibration complete.
20026 Water bottle refilled.
20027 Empty waste bottle done.
20028 Prepare actions done.
Roche Diagnostics
Roche Diagnostics
cobas c111 10 Result flags
Table of contents
Result flags
In this chapter, you will find a list of the flags generated by the cobas c111
instrument, their associated error messages, and the possible user actions.

About flags ................................................................................................................ D-19
Safety ......................................................................................................................... D-21
List of flags ................................................................................................................ D-22
> .......................................................................................................................... D-22
V .......................................................................................................................... D-22
^ .......................................................................................................................... D-22
AG Excess ............................................................................................................ D-23
? Cal ..................................................................................................................... D-23
Cal Due ............................................................................................................... D-23
Cal Error ............................................................................................................. D-24
Calc Error ............................................................................................................ D-24
Calc Range .......................................................................................................... D-24
Curv Dir .............................................................................................................. D-25
EP Unstab ........................................................................................................... D-25
High Abs ............................................................................................................. D-26
High Act .............................................................................................................. D-26
< Kin Read .......................................................................................................... D-27
Non Linear ......................................................................................................... D-28
Non Mono .......................................................................................................... D-28
Out of Rng .......................................................................................................... D-29
? QC ..................................................................................................................... D-29
R 1(2.5s) .............................................................................................................. D-29
R 1(3s) ................................................................................................................. D-30
R 2(2s) ................................................................................................................. D-30
Reag Rng ............................................................................................................. D-30
> Repl Dev .......................................................................................................... D-31
> RR .................................................................................................................... D-31
< RR .................................................................................................................... D-31
Roche Diagnostics
10 Result flags cobas c111
Table of contents
> Std Dev ............................................................................................................ D-32

> Test Rng ........................................................................................................... D-32
< Test Rng ........................................................................................................... D-32
Roche Diagnostics
About flags
About flags
Flags are automatically generated with results if during processing certain technical
checks were not passed or if the result exceeds or does not reach predefined limits.
Measurements that did not generate flags can be considered technically correct.
Flags are displayed and printed with the results.
a To display flag information

1 Display the result.
If Do this
You want to look at patient results: Choose Workplace > Result Review
You want to look at calibration results: Choose Workplace > Calibrations
You want to look at QC results: Choose Workplace > QC Status
A screen is displayed that lists the results. If flags were generated, the flag with the
highest priority is displayed.
2 Select the flagged result.
3 Press to display all flags that were generated for this test (A). They are sorted
according to their priority.
Figure D-4
4 Look up the flag in section List of flags on page D-22 for detailed information on
the flag.
a To display flag information with the sample still on board

1 Choose Overview > tube button.
A screen is displayed that shows the result, together with the flag of the highest
priority.
e To view all flags that were possibly generated see To display flag information on
page D-19.
Roche Diagnostics
About flags
Flags and error messages Some flags trigger error messages if they appear in consecutive measurements. Each
flag has its own counter. If one measurement does not generate the flag, the counter is
reset to zero.
Flag priority If the conditions in the cobas c111 instrument are such that multiple flags were
generated for a single measurement, only the flag with the highest priority is
displayed in the results lists.
Flags and user actions With each flag description contained in this chapter, the recommended user actions
are given.
e See List of flags on page D-22.
Roche Diagnostics
Safety
Safety
Before you start troubleshooting, it is essential that you both read and understand the
safety information listed below.
them.



mechanism

Diagnostics.
representatives.
Where a flag description gives a list of recommended actions, work through each step in
turn until you have solved the problem. Proceed to the next step only after you have
completed the previous one.
Roche Diagnostics
List of flags
List of flags
This section lists the general flags and those that concern absorbance measurements
only, and it provides information on each of the flags.
e For information on ISE-specific flags , see List of ISE flags on page E-69.
>
Meaning Result generated by re-performing the test with the same running parameters
(repeated).
Message ID 120
Priority 32
Possible cause The user initiated the repeat.
Recommended actions No action required.
Meaning A rerun result with diluted sample.
Message ID 121
Priority 33
Possible cause The user initiated the rerun.
Meaning A rerun result with concentrated sample.
Message ID 122
Priority 34
Possible cause The user initiated the rerun.
Roche Diagnostics
List of flags
AG Excess
Meaning Antigen excess.

The sample contains an excess antigen and a valid result cannot be calculated.
Message ID 6
Priority 19
Recommended actions Rerun the test with postdilution.
? Cal
Meaning A result where its calibration is flagged.
Message ID 110
Priority 29
Possible cause The calibration was in question and has been flagged, however the calibration could
be used to calculate the result (compare with CAL ERROR where the calibration did
not provide a usable result).
Recommended actions Check and redo calibration if needed.
Cal Due
Meaning A result where the calibration is due but not yet executed.
Message ID 112
Priority 31
Possible cause The user decided to delay the calibration measurement.
Recommended actions Run a calibration, unless the delay was intentional.
Roche Diagnostics
List of flags
Cal Error
Meaning No calibration data or previous calibration data used.

CAL ERROR appears on each control and patient sample for the affected test until the
problem is resolved.
Message ID 43
Priority 24
Possible cause Caused by an alarm that occurred during calibration because the calibration could
not provide a usable result.
Recommended actions Check the flags of the calibration and proceed to deal with the calibration first.
Calc Error
Meaning Calculation error.

Slope or nonlinear standard curve cannot be calculated due to a calibration error.
Message ID 16
Priority 13
Possible cause o Calibrator outdated or deteriorated.

o Misplacement of the calibrator tubes.
Recommended actions o Repeat calibration with fresh calibrators.

o If the calibrators were incorrectly positioned, replace the calibrators and repeat the
calibration.
Calc Range
Meaning Calculation out of range.

The absorbance of a sample is equal or greater than the maximum theoretical
concentration. The result field will be left blank on the report and the Result Review
screen. This blank result is transmitted to the Host, together with the alarm code “>”.
Message ID 46
Priority 25
Possible cause The concentration of the sample is outside the calibration curve.
Recommended actions Rerun the sample with post-dilution.
Roche Diagnostics
List of flags
Curv Dir
Meaning Curve direction.

The direction of the calibration curve is incorrect or not as expected.
Message ID 14
Priority 10
Possible cause Misplacement of calibrator tubes
Recommended actions 1. Check the details of the calibration.

2. If the calibrators were incorrectly positioned, replace the calibrators correctly and
rerun the calibration.
EP Unstab
Meaning End point unstable.

The absorbance values near the endpoint show unacceptable fluctuation.
Message ID 9
Priority 8
Recommended actions CAL

1. Repeat with fresh calibrators if only calibration is flagged.
2. If the flag is on controls and samples also, or repeats on calibration, replace
cassette.
CNTL
1. If only one control is flagged, repeat with fresh control.
2. If more than one control and sample result is flagged, replace cassette.
TEST
1. Rerun diluted.
2. If only one sample result is flagged, repeat with fresh sample.
3. If more than one sample result is flagged, or repeats, replace cassette.
4. If a serum protein test result is flagged, repeat with dilution.
Roche Diagnostics
List of flags
High Abs
Meaning Excessive absorbance.

The absorbance value to be used for calculation and checks is > 2.0 Abs.
Message ID 5
Priority 1

o Repeat with fresh calibrator.
CNTL
o If a single control is flagged, rerun with a fresh control.
o If more than one control is flagged, perform a calibration.
TEST
o If a single sample result is flagged, rerun with dilution.
o If the problem persists, replace the reagent set.
High Act
Meaning High activity.

o The Absorbance change during measurement is above or below the accepted limit,
i.e. the reaction has taken off too fast or to slowly. Possibility of substrate
exhaustion.
o The absorbance change during the measurement is lower than the defined limit.
Message ID 56
Priority 9

1. Check if correct calibrators are placed on the calibrator rack.
2. Repeat with fresh calibrators.
CNTL
1. Check control. Repeat with fresh control.
TEST
1. Rerun with dilution.
Roche Diagnostics
List of flags
< Kin Read
Meaning Abnormal linearity.
Message ID 11
Priority 11
Possible cause o The first and last parts of the reaction curve have different slopes.
o Not enough kinetic readings.
o Insufficient absorbance readings were found in the linear part of the reaction to be
able to calculate a rate.
o Not enough readings in kinetic range for calc mode Kinetic.

1. Check reaction plot.
2. Repeat with fresh calibrator.
CNTL
2. Repeat with fresh control.
TEST
2. Rerun with dilution or concentration if necessary.
Roche Diagnostics
List of flags
Non Linear
Meaning Abnormal linearity.
Message ID 11
Priority 11
Possible cause o The first and last parts of the reaction curve have different slopes.
o Not enough kinetic readings.
o Insufficient absorbance readings were found in the linear part of the reaction to be
able to calculate a rate.
o Not enough readings in kinetic range for calc mode Kinetic.

2. Repeat with fresh calibrator.
CNTL
2. Repeat with fresh control.
TEST
2. Rerun with dilution or concentration if necessary.
Non Mono
Meaning Curve not monotonic.

No calibration curve could be calculated because the rates of the calibrators were non-
monotonic.
Message ID 80
Priority 14
Possible cause Misplacement of a series of calibrators, automatic dilution series failed.
Recommended actions 1. If the calibrators were incorrectly positioned, re-place the calibrators correctly and
rerun the calibration.
2. Check the fluid system
3. Repeat the calibration
Roche Diagnostics
List of flags
Out of Rng
Meaning Curve out of range.

The calibration curve is outside the acceptable/ programmed range.
Message ID 84
Priority 16
Possible cause Deteriorated or outdated calibrator or reagent.
Recommended actions 1. Repeat with fresh calibrators.

2. If the calibrators were incorrectly positioned, re-place the calibrators correctly and
repeat the calibration.
3. If flag reoccurs, repeat with fresh reagent.
? QC
Meaning A result where the quality control measurement is flagged.
Message ID 111
Priority 30
Possible cause The last QC measurement before this measurement was flagged. The dependency is
derived from the time sequence.
Recommended actions Check QC measurement.
R 1(2.5s)
Meaning One control value is above 2.5 standard deviation or below -2.5 standard deviation.
Message ID 36
Priority 28
Possible cause o The reagent has deteriorated (linearity of working curve degraded).
o One control is concentrated or has deteriorated.
Recommended actions 1. Repeat with fresh control.

2. Check that the correct control material has been used.
3. If the flag reappears, check the calibration and reagent status. Repeat with fresh
reagent.
Roche Diagnostics
List of flags
R 1(3s)
Meaning One control value is above 3 standard deviation or below -3 standard deviation.
Message ID 35
Priority 27
Possible cause o Improper control is set.

o Proper control values (mean value, standard deviation) are not specified.

reagent.
R 2(2s)
Meaning Two sequential control measurements are above 2 standard deviation or below -2
standard deviation.
Message ID 29
Priority 26
Possible cause o The controls are not properly prepared.

o The controls are not properly positioned on the instrument.

reagent.
Reag Rng
Meaning During calibration, the absorbance value of the lowest calibrator is below the lower
defined range or above the upper defined range.
Message ID 12
Priority 7
Possible cause Deteriorated or outdated calibrator or reagent.
Recommended actions 1. Check the calibration and reagent expiry dates.

2. Repeat with fresh lowest calibrator.
3. If the flag reappears, replace reagent set (a reagent may be contaminated).
Roche Diagnostics
List of flags
> Repl Dev
Meaning Greater than replicate deviation.

Deviation between replicates exceed programmed limit. One or more replicates are
erroneous.
Message ID 13
Priority 12
Possible cause Problems in air/water system, air bubbles, clogged probe.
Recommended actions 1. Check the calibrators for air bubbles and repeat the calibration.
2. If the flag reappears, repeat with fresh calibrators.
3. Check the probe.
4. Check the fluid system.
> RR
Meaning Above reference range.

For patient samples, the calculated concentration is greater than the upper limit of the
expected value range.
nnnnn is the actual value that was checked against.
Message ID 40
Priority 22
< RR
Meaning Below reference range.

For patient samples, the calculated concentration is less than the lower limit of the
Message ID 41
Priority 23
Roche Diagnostics
List of flags
> Std Dev
Meaning Greater than standard deviation.

A point in the calibration fell outside the defined limits.
Message ID 17
Priority 17
Recommended actions 1. Check calibration curve.

2. Repeat with fresh calibrators.
3. If the calibrators were incorrectly positioned, replace the calibrators correctly.
> Test Rng
Meaning PANIC value over (upper) Technical Limit.

The result is higher than the upper limit for the test.
Message ID 26
Priority 20
< Test Rng
Meaning PANIC value below (lower) Technical Limit.

The result is lower than the lowest limit for the test.
Message ID 27
Priority 21
Roche Diagnostics
cobas c111 11 Troubleshooting
Table of contents
Troubleshooting
Dealing with exceptional situations
In this chapter, you will find information on how to deal with selected exceptional
situations.

Introduction ............................................................................................................. D-35
Dealing with exceptional situations ........................................................................ D-36
Reacting to messages ................................................................................................ D-38
Detailed procedures ................................................................................................. D-40
Checking the printer status ................................................................................ D-40
Clearing a paper jam .......................................................................................... D-40
Changing the mains fuses .................................................................................. D-41
Changing the low voltage fuses .......................................................................... D-43
Realigning the reagent disk ................................................................................ D-44
Exporting diagnostics screens to USB ............................................................... D-44
Roche Diagnostics
11 Troubleshooting cobas c111
Table of contents
Roche Diagnostics
Introduction
Introduction
Effective troubleshooting requires a good understanding of all basic operating

procedures for the cobas c 111 instrument and the system software.
Preventive maintenance You can avoid most unforeseen situations if you observe the recommended
procedures at all times and if the operating environment is effectively controlled by
performing all maintenance actions when they become due in the manner described
in the Operator’s Manual.
e See Maintenance actions on page C-8.
Information about the status of The system performs numerous checks. When a certain event has occurred or when
the system an irregularity is detected, a message is generated. Messages are displayed in two ways:
e See Message screen on page D-5.
o Information concerning a problem that occurred during operation is reported as
alarm messages in the alarm monitor.
e See Alarm monitor on page D-6.
Roche Diagnostics
The following table list possible exceptional situations, provides information on the
possible causes, and suggests ways of remedying the situation. (Subsequent sections
contain detailed procedures for selected remedies.)
Situation Affected Possible causes Comments

items
Measuring whole blood. Tube bottom Use of unsuitable tubes. With whole blood samples, pipetting is always
detection performed from near the tube bottom of the tube.
To ensure proper pipetting, only use primary tubes.
With other tubes, the bottom detector might register
and pipetting would stop.
The fluid connectors External fluid o Moving the instrument to To get easier access to the release clamps on the
need to be disconnected connectors. another location. connectors, remove the side panel before removing the
from the instrument. o Removing blockages. connectors.
e See To disconnect a tube from the instrument on
page B-115.
A service representative Diagnostics These features are usually used Follow the instructions given by the service
asks you to perform features. at the request of a service representative.
diagnostics tasks. representative. e See Exporting diagnostics screens to USB on
page D-44.
The system does not Instrument. No electricity. 1. Check that the instrument is connected to the mains
work or does not switch power supply.
on and the power switch 2. If the instrument is properly connected replace the
light is off. mains fuses.
e See Changing the mains fuses on page D-41.
No printing. Printer. Printer is out of paper. Load printer paper.
e Refilling printer paper on page B-108.
Printer jam. e To clear the paper jam on page D-40.
Reagent disk cannot be Reagent disk. The bottle storage assembly in The reagent disk is designed to handle reagents while it
inserted in the reagent the reagent disk was moved is loaded on the instrument. The cover is equipped with
cooler. while the latter was outside the a locking mechanism.
instrument. Always remove and load reagents while the reagent disk
is on the instrument and by using the software
supported procedures.
1. Align the bottle storage assembly in the reagent disk.
e See Realigning the reagent disk on page D-44.
2. Insert the reagent disk in the cooler.
Figure D-5 Troubleshooting overview
Roche Diagnostics
Situation Affected Possible causes Comments

items
The system does not go System status There are not enough free Load empty cuvette segments.
to Operating status. cuvettes on the instrument. e See Preparing cuvettes on page B-27.
Air/water calibration is Perform [Abs. Air/Water Calibration] maintenance
required. action.
e See Perform air/water calibration on page C-27.
In the corresponding calibrator The Last Is Water definition defines what is used as the
lot definitions of at least one of zero calibrator. It is either system water (On) or a
the tests you want to perform, standard, usually water (Off), which would be placed in
the value for Last Is Water is a tube like any other calibrator.
Off. With some tests, calibration does not work with special
zero calibrators, they need the Last Is Water definition
on.
Possible remedies:
1. Delete the current calibration order and redefine it.
2. If the Last Is Water definition is off, make sure to
place a special zero calibrator on the instrument
when calibrating. (This is usually water.)
If this does not help change the Last Is Water value to
On. (Calibration for this test does not work with a
special zero calibrator.)
1. Choose Workplace > Lot Data > Calibrators.
2. Select the entry for the test and expand the entry.
3. Select the [Last Is Water] entry and press .
4. Press <On>.
5. Press .
6. Delete the current calibration order and redefine it.
A hardware error had occurred. Some hardware conditions prevent the system from
performing tests.
1. Press to check the alarm messages.
2. Follow the advise given in the messages.
3. Choose > Restart to restart the system.
Figure D-5 Troubleshooting overview (continued)
Roche Diagnostics
Reacting to messages
A cobas c111 error message starts with a message ID, which consists of a number
followed by the date and time, for example:
7009.19.19.32.1402 [25.08.2006 8:53]
Providing information to service Whenever you are asked to provide message information to a service representative,
representatives provide the error codes contained in the explanatory text, not the message ID of the
first line. If there are no error codes in the text, supply the complete message text.
Also keep in mind that an event may trigger several messages, therefore it is important
to provide the information for all messages that were generated within about one
minute.
Basically there are three kinds of error message texts:
o Messages that contain text only.
o Messages that contain an error code of the format a.bbb.xxx, for example
[3.000.121].
o Messages that contain a nine digit error code, for example [104000551].
The following table lists selected messages and provides more detailed information on
how to react to them.
In the "Message or error code" column of the following table, the most relevant
information is the number, the texts may be different on the actual instrument.
Message or error code Affected items Possible causes Comments

o
1.xxx.81 Instrument. Fuse F1, F2, or F4 is defective. Replace the low voltage fuse that is mentioned in
1.xxx.82 the alarm message.
1.xxx.84 e See Changing the low voltage fuses on
page D-43.
[109000572] code raised by Instrument. The probe is bent or the 1. Check that the probe is mounted properly
IC software caused by an transfer head is poorly adjusted. and replace it if necessary.
unexpected handling or e See Replacing the probe on page B-111.
system situation.
2. If the problem persists, contact your service
representative.
No connection to Instrument Instrument. Fuse F3 is defective. Check the LED of fuse F3. Replace the fuse if
Control. necessary. (If the fuse has blown, the LED is off.)
e See Changing the low voltage fuses on
page D-43.
The LAN cable is not or not Check that the LAN cable is properly connected:
properly connected. 1. Switch off the instrument.
2. If the cable was not connected, connect it.
If the cable was connected, remove it at both
ends and reconnect it.
3. Start the instrument.
Electronic problem If the above measures are not successful, contact
your service representative.
Figure D-6 Troubleshooting with the help of messages
Roche Diagnostics

[1.xxx.73] Level detection Level detection. o Poor water quality. 1. Make sure you use the correct water quality.
error (conductivity). o Contamination with e See Technical specifications on
cleaner (valve is leaking) page A-64.
2. Perform the [Prime Fluid System]
maintenance action.
e See Prime the fluid system on page C-11.
3. If the problem persists, contact your service
representative.
[4.xxx.41] through [4.xxx.44] Photometer. o Lamp defective. Do not attempt to clean the photometer lenses.
Various texts related to o Photometer lens soiled. 1. Replace the photometer lamp.
photometer Gc-0166807. 2. If the problem persists, contact your service
representative.
Figure D-6 Troubleshooting with the help of messages (continued)
Roche Diagnostics
Detailed procedures
Detailed procedures
Checking the printer status
a To check the printer status

The printer button is red.
2 Scroll to display the Printer entry.
Clearing a paper jam
a To clear the paper jam

1 Choose > Stop Printing, if required.
2 Open the printer panel.
Press down the release button (A) firmly before you pull the panel. The panel should open
without resistance.
3 Lift the printer paper roll from its holder.

4 Remove all loose paper. (Cut or tear it off).
5 Place the roll back on the holder.
Make sure the paper unrolls at the top and towards you.
Roche Diagnostics
Detailed procedures
6 Insert the paper in the slot in the printer panel and pull some through.
7 Close the printer panel.

The system feeds some paper and then automatically resumes printing.
9 The printer button should now be green, and the status description should be OK.
Changing the mains fuses
a To change the mains fuses

1 Press [O] on the main toggle switch to switch off the instrument.
2 Disconnect the mains cable from the instrument.
3 Using a screwdriver disengage the clips on both sides of the fuse box cover.
Roche Diagnostics
Detailed procedures
4 Remove the holder.
5 Remove the two fuses from the holder.
6 Replace both fuses.
NOTICE Damage to the analyzer due to use of wrong fuses

Always replace fuses with new ones of the same type and specifications.
See Technical specifications on page A-64.
7 Insert the fuse holder in the fuse box.

Press it in firmly until the clips engage.
8 Connect the mains cable to the instrument.
9 The instrument switch should be illuminated.
Roche Diagnostics
Detailed procedures
Changing the low voltage fuses
a To change a low voltage fuse

2 Using a screwdriver size 2 or 3, remove the fuse indicated in the alarm message.
A Low voltage fuses B Slot in low voltage fuse holder
a) Insert the screwdriver in the slot and turn anticlockwise until the holder
disengages.
b) Remove the holder with the fuse.
3 Remove the fuse from its holder.

4 Insert the new fuse in the holder.
NOTICE Damage to the analyzer due to use of wrong fuses

Always replace fuses with new ones of the same type and specifications.
See Technical specifications on page A-64.
5 Insert the holder in the socket.

6 Using the screwdriver, lock the holder in position by pressing it in and turning the
screwdriver clockwise until the slot is vertical.
7 Switch on the instrument.
Roche Diagnostics
Detailed procedures
Realigning the reagent disk
a To realign the reagent disk

1 Insert your fingers in the holes in the reagent disk cover an lift the reagent disk.

CAUTION
2 Insert a pencil in the opening in the center of the underside of the reagent disk.
3 Turn the reagent disk until the arrows of the reagent disk and the cover face each
other.
A B
A Incorrect position: The two arrows do not B Correct position: The two arrows face each
face each other. other.
Exporting diagnostics screens to USB
When performing diagnostics actions you can export the content of the screen to the
USB stick.
Prerequisites You need Lab Administrator or Administrator user rights to perform diagnostics
actions.
a To export the content of the screen

1 Press to start the diagnostics action.
2 Press .
3 Press <Send to File>.
As screen is displayed, asking you to insert the USB stick.
5 Press .
The data are copied to the USB stick. (File name format:
prt_yyyymmddhhmmss.txt.)
Roche Diagnostics
ISE E
12 ISE description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

13 ISE operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-15
14 ISE maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-37
15 ISE troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-65
cobas c111 12 ISE description
Table of contents
ISE description
Overview of the ISE unit
In this chapter, you will find a general overview of the cobas c111 ISE unit. You also
will find a description of the main components and their principle operation.

Overview ...................................................................................................................... E-5
Abbreviations ......................................................................................................... E-5
Measuring modes .................................................................................................. E-6
Principles of operation .......................................................................................... E-7
ISE solutions .......................................................................................................... E-8
Hardware ..................................................................................................................... E-9
Panels ............................................................................................................... E-9
ISE LED .......................................................................................................... E-10
Main components .......................................................................................... E-10
Fluid containers ............................................................................................. E-11
Basic operation .......................................................................................................... E-12
Samples ................................................................................................................ E-12
Calibration ........................................................................................................... E-12
ISE Standby .......................................................................................................... E-12
Maintenance actions ........................................................................................... E-13
Technical specifications ............................................................................................. E-13
Roche Diagnostics
Operator’s Manual · Version 2.0 E-3
12 ISE description cobas c111
Table of contents
Roche Diagnostics
E-4 Operator’s Manual · Version 2.0
Overview
Overview
The Ion-Selective Electrode (ISE) module is a measurement system for electrolytes that
runs independently of the main instrument. The ISE unit uses the same samples and
sample tubes that are used for photometric measurements, and the samples are
transferred using the same probe. The ISE unit uses specific solutions, some of which
are kept in bottles on the ISE unit itself, the others are transferred to sample tubes and
placed on the sample area.
Abbreviations
The following ISE specific abbreviations are used:
Abbreviation Definition
C
CL-I Chloride indirect
CL-U Chloride urine
F
F Solution 1 factor
K
K-I Potassium indirect
K-U Potassium urine
FM
mV Measured voltage in milivolt

N
NA-I Sodium indirect

NA-U Sodium urine
S
S Slope in mV/dec
Std 1/1 First measurement of ISE Solution 1
Std 1/2 Second measurement of ISE Solution 1
Std 2 Measurement of ISE Solution 2
Roche Diagnostics
Overview
Measuring modes
The ISE unit makes, in serum, plasma and urine, quantitative determinations of the
following electrolytes:
o Sodium (Na+)
o Potassium (K+)
o Chloride (Cl -)
Measurements are done using indirect mode. The samples, controls, and standard
solutions are diluted with system water 1:6 (1+5). The dilution and mixing are
performed automatically in the ISE tower.
Pipetting volumes Sample: 15 µL

Diluent (H2O): 75 µL
ISE measurements ISE measurements and photometric measurements can be carried out at the same
time and are independent of each other. (ISE measurements do not use cuvettes, the
reagent rotor, or the photometer.) All requested ISE measurements on a specific
sample, control, or standard solution are performed in parallel, that is, measurements
are made at each electrode at the same time.
Roche Diagnostics
Overview
Principles of operation
The ISE unit uses flow-through ion-selective electrodes and a reference electrode with
an open liquid junction. Each electrode has a membrane that is sensitive to a
particular type of ion.
Measuring process 1. The ISE maintenance and standard solutions (ISE Deproteinizer, ISE Etcher,
Activator, and ISE Solution 1 and 2) are pipetted from sample tubes on the sample
area to the ISE tower as required.
2. The sample is pipetted from the sample tube (located on the sample area) into the
ISE tower. The sample is diluted with system water. Mixing is performed with four
air jets arranged in a circle. These jets blow air into the tower to produce a
homogenous mixture.
3. The sample is divided into segments with the aid of a special arrangement of
valves. The first (shorter) segments are used for cleaning, these are followed by a
longer segment, on which the measurements are made.
4. The sample is passed to the ion-selective electrodes by the action of the peristaltic
pump.
The exact positioning of segments is ensured by the ISE sample sensor.
5. In the meantime, the ISE tower is washed with distilled water and dried.
6. ISE Reference Solution is passed through the ISE Reference Electrode and into the
measuring channel downstream of the electrodes. The ISE Reference Solution
completes the electrical circuits for each electrode so that measurements can be
made. While the measurements are made, the sample and ISE Reference Solution are
stationary.
7. A one-point calibration is performed after each sample measurement using the
ISE Calibrator indirect/urine, which is located on ISE unit.
8. The electrolyte concentration of the sample is calculated.
A B
F
Ref Na Cl K
G H I J K
A ISE Reference Electrode F ISE Calibrator indirect/urine

B ISE Reference Solution sensor G Peristaltic pump
C ISE tower H Measuring channel
D Samples, controls, ISE Solution 1 and 2, I Ion-selective electrodes
Activator, ISE Etcher, and ISE Deproteinizer J Electrode block
E ISE Reference Solution K ISE sample sensor
Figure E-1 Main parts of the ISE measuring system
Roche Diagnostics
Overview
ISE solutions
The ISE unit requires several specific solutions for performing the analyses and
maintaining the system. They are listed in the following table.
Solution summary Solution Location Use

ISE Solution 1 Sample Used in the two-point calibration of sodium, chloride, and
area potassium.
ISE Solution 2 Sample Used in the two-point calibration of sodium, chloride, and
area potassium.
ISE Calibrator ISE unit Used in the one-point calibration after each measurement. It
indirect/urine is also used during ISE initialization and standby, and for
maintenance purposes.
ISE Reference ISE unit Used in all ISE measurements of sodium, potassium, and
Solution chloride.
Also used during ISE standby.
ISE Etcher Sample Used as a cleaning solution for cleaning the ISE Sodium
area Electrode during ISE maintenance.
ISE Sample Used as a cleaning solution for cleaning the probe, ion-
Deproteinizer area selective electrodes, ISE tower, and tubing during ISE
maintenance.
Activator Sample Activates the electrodes, tubing, and the ISE tower during ISE
area maintenance. It is also used for the initialization of the ISE
unit and for activating the probe.
Roche recommend using their Activator on the cobas c111
instrument. (For details see the package insert of the
Activator.)
Water External Used for diluting the samples, controls, and standard
water solutions, and for cleaning purposes. It is also used during ISE
container initialization.
Sample Sample Sample tubes are placed on the sample area of the main
area instrument and pipetted by the main instrument probe.
Waste Internal The waste is first pumped into the internal waste tank of the
waste tank main instrument and then to the external waste container.
Table E-1 Solutions used with ISE analysis
Fluid stability For information on the stability of fluids see the package insert of the fluid in
question.
Incorrect results due to changes in fluids

The chemical composition of ISE fluids changes over time. The assigned on-board stability
WARNING is the interval within which the quality of the fluid remains within the prescribed tolerances.
Using fluids whose interval has expired may lead to incorrect results.
Always exchange the fluids when an interval has expired. Follow the instructions given on
the screen.
Roche Diagnostics
Hardware
Hardware
The ISE unit is designed as an add-on unit to the cobas c 111 main instrument. (It
will be installed by your service representative.)
Panels
The ISE cover has two joints. The front cover provides access to the parts you may
need to handle during daily operation. Opening the back cover as well provides access
to the peristaltic pump and its tubing.
A ISE cover B ISE LED
Figure E-2 ISE cover
Left side panel Provides access to:

o ISE power supply
o ISE connectors
Switch off the instrument before you open this cover.
ISE cover Provides access to:

o Electrodes
o ISE unit tubing
o ISE fluid bottles
Do not open this cover when the system is in Operating status.
Left service flap Provides access to:

o ISE tower
Remove this flap as instructed during maintenance actions, or switch off the
instrument before you remove it.
Roche Diagnostics
Hardware
ISE LED
The ISE LED is color coded.
Power off (e.g. power supply disconnected.)
The ISE unit is OK and ready for use.
Blinking The fluid level in the ISE Reference or ISE Calibrator indirect/urine
bottle is low.
Error, processing stopped.
Main components
A B
C
D
G H I J K
A Electrode block with ISE Sodium, Potassium, G Peristaltic pump with pump tubing
Chloride, and Reference Electrode H Exit-valve plate
B ISE Reference Solution sensor I Measuring channel
C ISE tower J ISE sample sensor
D Input-valve plate K Entry-valve plate with tubing
E ISE Reference Solution bottle (red label)
F ISE Calibrator indirect/urine bottle (blue
label)
Figure E-3 Main components of the ISE unit
Peristaltic pump A fluid pump that draws the solutions through the electrode block and then pumps it
to the internal waste tank.
Input-valve plate A set of valves to create cleaning segments and to control the flow of waste fluids.
Entry-valve plate A set of valves to control and monitor the flow of fluids.
Exit-valve plate A set of valves to control the aspiration action of the peristaltic pump.
Electrode block A block that contains the electrodes.
Roche Diagnostics
Hardware
ISE tower A hollow, transparent cylinder with multiple inlets and outlets for air and solutions.
In the ISE tower, samples and diluents are mixed using an air stream.
Tubing Tubing is used for transporting the fluids. It connects the ISE unit with the water and
waste system, and also with the ISE Reference Solution and ISE Calibrator indirect/
urine bottles, which are placed on the ISE unit.
Sensors The ISE sample sensor detects the presence of liquid (sample, control, standard
solution, or ISE Calibrator indirect/urine) or air and enables the correct placing of
segments for measurement and cleaning.
The ISE Reference Solution sensor detects the presence of ISE Reference Solution.
ISE fluid bottles Two bottles are placed on the ISE unit:
o ISE Calibrator indirect/urine bottle (blue label)
o ISE Reference Solution bottle (red label)
Level monitoring is performed on the basis of weight, the bottles are placed on scales.
Fluid containers
The following table shows which container is used for which fluid:
Fluid Container(s) Position

Samples Tube Sample area
Controls Tube Sample area
ISE Solution 1 and 2 Tube Sample area
Cleaner External cleaner bottle External fluid rack
ISE Deproteinizer Tube Sample area
Activator Tube Sample area
ISE Etcher Tube Sample area
ISE Reference Solution Bottle ISE unit
ISE Calibrator indirect/urine Bottle ISE unit
Water External water container External fluid rack
Waste External waste container External fluid rack
Table E-2 Fluids, containers, and where they are used
The term tube includes all kinds of tubes, as long as their dimensions lay within prescribed
limits. It also includes secondary tubes (cups). See Tubes on page A-52.
Roche Diagnostics
Basic operation
Basic operation
Operation of the ISE unit is integrated in the operation of the main instrument.
The following sections contain some ISE specific information on operation-related
issues.
e For general information on operating the main instrument, see the corresponding
sections in Chapter 2 Introduction to the instrument and Chapter 5 Daily operation.
For ISE-specific tasks, see Chapter 13 ISE operation.
Samples
The sample tubes are placed on the sample area of the main instrument.
Calibration
The ISE unit requires frequent calibration to ensure the accuracy of the test results
obtained.
Main calibration The electrodes are calibrated with a two-point calibration using ISE Solution 1 and 2.
The main calibration is typically performed during the Prepare phase.
One-point calibration The electrodes are calibrated after each ISE measurement using the on-board ISE
Calibrator indirect/urine. This calibration is an integral part of each ISE
measurement and is performed automatically.
ISE Standby
If there is no measurement for more than three minutes, the ISE unit switches to
Standby status. In this status, ISE Calibrator indirect/urine and ISE Reference
Solution are pumped into the measuring channel and moved a short distance at
regular intervals. Also, every two hours the ISE tubing is primed with ISE Calibrator
indirect/urine and ISE Reference Solution. This is done to prevent the following
problems:
o Flow of ISE Reference Solution backwards into the measuring channel, which can
damage the electrodes because of the high ion concentration of the ISE Reference
Solution.
o Crystallization of salts in the tubing, causing blockages.
The ISE unit has a separate power supply. Therefore, the Standby status is maintained
even if the main instrument is switched off.
NOTICE Damage to electrodes and possible tubing blockage

Do not unplug or switch off the ISE power supply. Periodic flow of solutions must be
performed at all times.
NOTICE If you intend not to use the ISE unit for more than one week, you should deactivate it. This
saves ISE fluids and reduces wear and tear of the tubing. (See Deactivating the ISE unit on
page E-62.)
Roche Diagnostics
Maintenance actions
Maintenance of the ISE unit is integrated in the maintenance of the main instrument.
The system software guides you through the maintenance procedures.
Maintenance actions are performed after a certain event, after a defined interval has
expired, or when a counter has reached a certain value.
e For ISE-specific maintenance actions, see Chapter 14 ISE maintenance.
e See Technical specifications on page A-64.
Roche Diagnostics
Roche Diagnostics
cobas c111 13 ISE operation
Table of contents
ISE operation
In this chapter, you will find information on performing the routine tasks that are
required for processing tests using the ISE unit.

Daily operation .......................................................................................................... E-17
Safety information ............................................................................................... E-19
Preparing the system ........................................................................................... E-20
Short guide ..................................................................................................... E-20
Starting the Prepare wizard ........................................................................... E-20
Checking the status of the external fluid containers .................................... E-21
Checking the ISE status ................................................................................. E-21
Performing maintenance actions .................................................................. E-22
Completing the preparation tasks ................................................................ E-22
Performing calibrations ................................................................................ E-22
Defining orders .................................................................................................... E-23
Monitoring the progress ..................................................................................... E-23
Validating patient results ..................................................................................... E-24
Main calibration .................................................................................................. E-25
Performing QC .................................................................................................... E-25
Finishing the shift ................................................................................................ E-25
Short guide ..................................................................................................... E-26
Replacing ISE fluid bottles ........................................................................................ E-28
Replacing electrodes .................................................................................................. E-30
Cleaning the ISE tower off the instrument .............................................................. E-34
Roche Diagnostics
13 ISE operation cobas c111
Table of contents
Roche Diagnostics
Daily operation
Daily operation
Daily operation of the ISE unit is integrated in the daily operation of the main
instrument.
e See Chapter 5 Daily operation.
daily operation.

2. Check the ISE status. Overview >
3. Perform [Daily Prepare Actions]. Utilities > Maintenance
4. Start the run.

... > Repeat
... > Rerun
or
Table E-3 Overview of the daily operation tasks
Roche Diagnostics
Daily operation

on the screen.
on the screen.
on the screen.
that are due.
Table E-3 Overview of the daily operation tasks
The following sections describe the ISE-specific operation tasks.
Roche Diagnostics
Daily operation
Safety information

solutions.


mechanism
Do not touch any parts of the instrument other than those specified. During operation and
Keep all covers closed, operate them as instructed on the screen.

Diagnostics.
o Leave maintenance that is not described in the Operator’s Manual to trained Roche
support representative personnel.
Roche Diagnostics
Daily operation
Short guide
The following table provides an overview on the steps that make up the preparation
process.
Step User action

1 Start the Prepare wizard. 1. On the [Overview] tab, press <Prepare>.
2 Check the status of the external 1. Refill the water container, if required, and con-
containers. firm by pressing the water button. (If you refill
the water, empty the waste as well.)
2. Empty the waste container, if required, and
confirm by pressing the waste button.
3. Replace the cleaner bottle, if required, and con-
firm by pressing the cleaner button.
Prepare wizard.
3 Check the onboard ISE fluids. 1. Replace the ISE fluid bottles, if required.
2. Replace the electrodes, if required.
Prepare wizard.
4 Perform the maintenance 1. Perform the [Daily Prepare Actions]

actions that are due. maintenance action.
2. Perform the other ISE maintenance actions that
are due.
Table E-4 Steps for preparing the system
e For non-ISE-specific tasks, see Preparing the system on page B-12.
Starting the Prepare wizard
a To start the preparation process

1 Choose Overview > Prepare.
Roche Diagnostics
Daily operation
Checking the status of the external fluid containers
a To check the status of the external fluid containers

1 Follow the instructions given in Checking the status of the external fluid containers
on page B-15.
2 When you have finished with the fluid containers, press to proceed to the
next stage in the Prepare wizard.
A screen is displayed that shows the status of the electrodes and the on-board ISE
fluids.
When checking external fluid containers without using the Prepare wizard:
Checking the ISE status

WARNING injury.
When handling such solutions, exercise the precautions required for handling them,
Replacing electrodes
a To replace an electrode
1 Follow the instructions given in Replacing electrodes on page E-30 .
After replacing an electrode, the [Electrode Service] maintenance action needs to be

performed. This action will be performed as part of the maintenance procedure of the
Prepare wizard.
After replacing an electrode, a main calibration needs to be performed. This action will be
performed as part of the [Daily Prepare Actions] maintenance action.
Replacing ISE fluid bottles A bottle with a blue label for ISE Calibrator indirect/urine and a bottle with a red
label for ISE Reference Solution are located on the ISE unit. The procedure for
exchanging these bottles is the same.
a To replace an on-board ISE fluid bottle

1 Follow the instructions given in Replacing ISE fluid bottles on page E-28.
After replacing an ISE fluid bottle, the [Prime ISE Reference and Calib.] maintenance
action needs to be performed. This action will be performed as part of the maintenance
procedure of the Prepare wizard.
After replacing an ISE fluid bottle, a main calibration needs to be performed. This action
will be performed as part of the [Daily Prepare Actions].
2 When you have finished replacing electrodes and ISE fluid bottles, press to
proceed to the next stage in the Prepare wizard.
A screen is displayed that lists the maintenance actions.
Roche Diagnostics
Daily operation

The routine maintenance actions that are relevant for working with the ISE unit are
integrated in one single maintenance action: [Daily Prepare Actions].
e For general information on performing maintenance actions, see Performing maintenance
actions on page B-19.
For details on how to perform individual ISE maintenance actions, see ISE maintenance
actions on page E-40.

1 Select [Daily Prepare Actions].
2 Press .
3 Follow the instructions given on the screen.
e See Daily prepare actions on page E-42.
4 Perform the non-routine ISE maintenance actions.

Follow the instructions given on the screen.

Completing the preparation tasks

1 When you have finished performing maintenance actions, press to proceed
to the next stage in the Prepare wizard.
A screen is displayed that shows the status of the reagents on the reagent disk. This
is not relevant for ISE operation.
2 Press .
A screen is displayed that shows the status of the cuvettes that are on board. This is
not relevant for ISE operation.
3 Press .
A screen is displayed that shows the tests that need calibrating. Because the
calibrations have already been performed as part of the [Daily Prepare Actions]
maintenance action, this step is not relevant for ISE operation.
4 Press .
The [Overview] tab is displayed. The preparation tasks are completed.
The ISE calibrations are integrated in the [Daily Prepare Actions] maintenance
action.
e See Daily prepare actions on page E-42.
Roche Diagnostics
Daily operation
Defining orders
ISE sample analysis is integrated in the operation of the main instrument. The process
of defining orders is the same.
a To define orders
1 Follow the instructions given in Defining orders on page B-35.
ISE tests are defined and requested as profiles. (There is hardly ever the need for
electrolytic measurements of just one electrode.)
Monitoring the progress
a To monitor the progress

1 Follow the instructions given in Monitoring the analysis progress on page B-40.
a To check the instrument status

A
A Relevant instrument status buttons
Figure E-4
Interpreting the instrument Icon Meaning Possible action

status buttons The ISE unit is in standby. No action is required.
The expiration date of an electrode 1. Check the details on the
has passed or an on-board ISE dedicated system status screen.
fluid level is low. 2. Replace the electrode or ISE
fluid bottle as soon as possible.
The ISE unit is blocked. 1. Check the details on the
dedicated ISE status screen.
2. Act accordingly.
Roche Diagnostics
Daily operation
Icon Meaning Possible action

<System The <System Status> button displays both the icon and the color of one of the
Status> buttons of the underlying system status screen. (The icons are first prioritized
by color, first priority being red, followed by yellow and green, and then
according to the sequence in which they are listed below.)
Analyzer (main cover) Press the button and on the System
Status screen check the text about
the status of the main cover.
Reagent cooler and cuvette ring Press the button and on the System
temperature Status screen check the text about
the temperature.
Sample area ventilation Press the button and on the System
the ventilation status.
External fluid containers Press the button and on the System
Status press it again to display the
screen for handling the external
fluid containers.
Maintenance Press the button and on the System
Status press it again to display the
maintenance actions list.
Printer Press the button and on the System
the printer status.
Acoustic signal An acoustic signal informs you of the fact that all tests are finished and the system
status has changed to Standby.
ISE result handling is integrated in the operation of the main instrument. The process
of reviewing results is the same.
a To validate patient results

1 Follow the instructions given in Validating patient results on page B-46.
e For information on ISE flags, see List of ISE flags on page E-69.
Roche Diagnostics
Daily operation
Main calibration
The main calibration of the electrodes must be performed periodically. It also needs
to be performed after certain maintenance actions.
For the indirect method, the sodium (NA-I), potassium (K-I), and chloride (CL-I)
tests are calibrated with a two-point calibration using ISE Solution 1 and 2.
For urine, the sodium (NA-U), potassium (K-U), and chloride (CL-U) tests are
calibrated with a two-point calibration using ISE Solution 1 and 2.
The main calibration is typically performed during the Prepare phase and, if there
follows a second shift, at the end of a shift. It is integrated in the [Daily Prepare
Actions] maintenance action.
e For details on performing the [Daily Prepare Actions] maintenance action, see Daily
prepare actions on page E-42.
For details on performing individual calibrations, see Process of performing calibrations on
page B-54.
Performing QC
ISE QC handling is integrated in the operation of the main instrument.
a To perform QC
e Follow the instructions given in Performing QC on page B-59.
Finishing the shift
ISE Standby status If there is no measurement for more than three minutes, the ISE unit switches to
Standby status. In this status, ISE Calibrator indirect/urine and ISE Reference
Solution are pumped into the measuring channel and moved a short distance at
regular intervals. Also, every two hours, the ISE tubing is primed with ISE Calibrator
indirect/urine and ISE Reference Solution. This is done to prevent the following:
o Flow of ISE Reference Solution backwards into the measuring channel, which can
damage the electrodes because of the high ion concentration of the ISE Reference
Solution.
o Crystallization of salts in the tubing, which can cause blockages.
The ISE unit has a separate power supply. Therefore, the Standby status is maintained
even if the main instrument is switched off.
NOTICE Damage to electrodes and possible tubing blockage

Do not unplug or switch off the ISE power supply. Periodic flow of solutions must be
performed at all times.
End Shift wizard The end of shift activities are organized in a single wizard. By performing the steps as
suggested by this wizard, you put the system in a condition that allows you to hand
over operation to another operator or to switch off the instrument.
The following table provides an overview on the steps that make up the end of shift
process.
e For details on performing the individual tasks, see the instructions in Finishing the shift on
page B-68.
Roche Diagnostics
Daily operation
Short guide
Step User action

1 Check for unfinished tasks. 1. Check for unfinished orders.
2. Check for nonvalidated results.
3. Check for results that were not transmitted.
2 Start the End Shift wizard. 1. On the [Overview] tab, press the <End Shift>
button.
3 Perform data backup. 1. Press .

3. Press .
5. Press .
End Shift wizard.
4 Export support data 1. Press .

2. Insert the USB stick, if you have removed it.
3. Press .
5. Press .
6. Remove the USB stick.
End Shift wizard.
5 Clean up the database. 1. Press .

End Shift wizard.
Table E-5 Steps for finishing the shift
Roche Diagnostics
Daily operation
Step User action

6 Perform maintenance actions 1. Check which maintenance actions are due.
2. Perform the maintenance actions.
End Shift wizard.
7 Check the cuvette status. 1. Press to proceed to the next stage in the
(Not relevant for ISE operation.) End Shift wizard.
8 Empty the waste container. 1. Empty the waste container.

2. Press the <Waste> button to confirm.
3. Refill the water container.
4. Press the <Water> button to confirm.

(Not relevant for ISE operation.)
10 Finish your shift. 1. Log off the system.

2. Switch off the main instrument. (If there is no
other shift.)
Table E-5 Steps for finishing the shift
If you intend not to use the ISE unit for more than one week, you should deactivate it. This
saves ISE fluids and reduces wear and tear of the tubing. (See Deactivating the ISE unit on
page E-62.)
Roche Diagnostics
Replacing ISE fluid bottles
ISE fluid bottles are supplied with a barcode that contains information on their expiry
date, which is monitored by the system.
Roche recommend replacing ISE fluid bottles as soon as their expiry date has elapsed.
(Their icon on the screen turns yellow.)
For information on the stability of fluids, see their package inserts.
Tools and materials required o ISE Calibrator indirect/urine or ISE Reference Solution bottle
o Tissues

WARNING injury.
When handling such solutions, exercise the precautions required for handling them,
a To replace an on-board ISE fluid bottle

1 Check that the system is in Standby status.
3 Check the status of the ISE bottles (A).
Figure E-5
Interpreting the bottle status No fluid registered by an ISE fluid sensor. (Operation has stopped.)
screen You need to replace the bottle now.
The fluid level in the bottle is low. (Operation will proceed until one of the
sensors detects that there is no fluid.)
The fluid’s expiration date has expired.
You should replace the bottle as soon as possible.
4 Press <Cal> or <Ref>.

A screen is displayed that shows details about the bottle status.
Roche Diagnostics
5 Press .
A screen is displayed, asking you to scan the bottle barcode or to type it manually.
6 Scan the bottle barcode.
7 Press .
8 Observe the messages on screen and react accordingly.
If the barcode cannot be read, type it manually.
When the scanning process is finished, a message is displayed, asking you to
replace the bottle.
9 Open the ISE cover.
10 Remove the tubing adapter by lifting it and placing it on a clean lint-free tissue.
11 Remove the bottle.
12 Remove the cap of the new bottle.
13 Place the new bottle.
14 Insert the tubing adapter.
15 Close the ISE cover.
16 On the screen, press to confirm the placement.
The system performs the [Prime ISE Reference and Calib.] maintenance action.
17 Press to close the screen for reading barcodes.
You need to perform a main calibration before you can process orders.
18 On the ISE status screen, press .

A placement list is displayed, telling you where to place ISE Solution 1 and 2.
19 Place ISE Solution 1 and ISE Solution 2 on the positions indicated on the screen.
20 Press .
The [Overview] tab is displayed.
21 Press to perform the main calibration.
22 When the system is in Standby status, remove ISE Solution 1, and ISE Solution 2
from the sample area.
23 Press .
Roche Diagnostics
Roche recommend replacing electrodes when their expiration date is reached.

For information on the stability of the electrodes, see their package inserts.
There are up to three ion-selective electrodes and one ISE Reference Electrode on the
ISE unit. The replacement procedure is the same for all of them.
As part of replacing electrodes, the [Electrode Service] maintenance action and a
main calibration need to be performed.
Replacing an electrode takes about 15 minutes.
Tools and materials required o ISE Calibrator indirect/urine (on board)

o ISE Reference Solution (on board)
o ISE Deproteinizer
o ISE Etcher
o Activator
o ISE Solution 1
o ISE Solution 2
o ISE Sodium Electrode (if you intend to replace this type of electrode)
o ISE Potassium Electrode (if you intend to replace this type of electrode)
o ISE Chloride Electrode (if you intend to replace this type of electrode)
o ISE Reference Electrode (if you intend to replace this type of electrode)
o ISE Dummy Electrode (if you intend to replace this type of electrode or if you no
longer intend to use one of the ion-selective electrodes)
Make sure that you have read and understood section Safety information on page E-19.
The following warning messages in particular are relevant:
o Injury through reagents and other working solutions on page E-19.
Roche Diagnostics
a To replace an electrode
1 Check that the system is in Standby status.
The ISE status is displayed.
A Electrode buttons
Figure E-6
3 Press the button of the electrode you want to replace.

Details of the electrode status are displayed.
4 Press to start the exchange wizard.
The system rinses the electrodes with ISE Calibrator indirect/urine to remove any
sample residue and then drains all electrodes.
You are asked to remove the electrode. (Make sure to remove the electrode that is
marked on the screen.)
6 Open the electrode block lid.
7 Release the tension lever (A).
A Tension lever
Figure E-7
Turning the tension lever releases the electrodes. You may have to push the
anchoring piece towards the tension lever to create enough space for removing the
electrodes.
Roche Diagnostics
8 Remove the electrode.

Lift it at the front to disengage, then remove it.
Figure E-8
9 On the screen, press the electrode button to confirm that you have removed the
electrode.
You are asked to scan the barcode of the new electrode or to type its ID manually.
10 Scan the electrode barcode on the package insert or type the ID manually.
(If you want to install a dummy electrode scan its barcode.)
You are asked to insert the new electrode.
Fixed electrode positions

Always replace an electrode with the same type or with an ISE Dummy Electrode. (The ISE
Reference Electrode must always be replaced with another ISE Reference Electrode. ISE
Dummy Electrode is not allowed on this position.)
11 Insert the new electrode.

Push it back towards the contacts and press it down until it clicks into place.
12 Fasten the tension lever.
13 Close the electrode block lid.
14 On the screen, press the electrode button to confirm that you inserted the
electrode.
(If you inserted a dummy electrode, press the button of the electrode you replaced
with a dummy electrode.)
A screen is displayed that shows detailed information on the electrode.
15 Press .
At this stage, if you want to replace another electrode, press its button and continue with
step 7.

17 On the ISE status screen, press to continue the process.
Roche Diagnostics
18 Place the Activator, ISE Deproteinizer, ISE Etcher, ISE Solution 1, and ISE
Solution 2 on the sample area positions indicated on the screen.
19 Press to confirm the placement and to start the action.
The system performs the [Electrode Service] maintenance action.
20 Press to perform the main calibration.
A message will inform you when the action is complete.
21 When the system is in Standby status, remove the Activator, ISE Deproteinizer, ISE
Etcher, ISE Solution 1, and ISE Solution 2 from the sample area.
22 Press .
Roche Diagnostics
Cleaning the ISE tower off the instrument
If performing the [Clean ISE Tower Manually] maintenance action did not lead to the
desired results, you need to remove the ISE tower to clean it.
Cleaning the ISE tower off the instrument consists of the following steps:
1. Removing the ISE tower
2. Soaking the ISE tower in ISE Deproteinizer
3. Cleaning and drying the ISE tower
4. Installing the ISE tower
5. Performing the maintenance action [Clean ISE Tower Automatically].
Tools and materials required o Cotton swabs

o ISE Deproteinizer
o Small glass beaker
o Infection by biohazardous materials on page E-19.
a To clean the ISE tower
Removing the ISE tower 1 Make sure the system is in Standby status.
3 Move the transfer head to its rightmost position.
4 Open the main cover and the left service flap.
5 Remove the ISE overflow collector by pulling it upwards and turning it from side
to side as you do so.
B
C
A ISE tower C Locking ring

B ISE overflow collector
Figure E-9
Place the collector behind the wash station.
Roche Diagnostics
6 Remove the locking ring from the base of the ISE tower by turning it counter-
clockwise one quarter of a turn and then lifting it over the ISE tower.
7 Lift the ISE tower and carefully disconnect the tubing.
Check whether any O-ring is stuck to the ISE tower. If so, remove it and place it
back in its position on the ISE tower base.
A O-ring positions
Figure E-10
Cleaning the ISE tower 8 Clean the inside of the ISE tower with a cotton swab to remove any visible clots.
9 Pour ISE Deproteinizer in the beaker.
10 Soak the ISE tower in the ISE Deproteinizer for about 5 minutes.
(If there are clots in the tower, you can extend the soaking time to 30 minutes.)
11 Rinse the ISE tower with deionized water and leave it to dry.
Reinstalling the ISE tower 12 Reconnect the tubing to the ISE tower.
13 Make sure that both O-rings are present and seated on the tower base.
14 Place the ISE tower on its base.
Align the two pins on the base with the two holes in the ISE tower.
A Alignment pins
Figure E-11
15 Reinstall the locking ring.

Make sure it is properly engaged and turn it firmly clockwise.
16 Reinstall the overflow collector.
17 Close the left service flap and the main cover.
Roche Diagnostics
Finishing the task 18 Switch on the instrument.

19 Wait for initialization to finish.
20 Log on to the system.
21 Perform the maintenance action [Clean ISE Tower Automatically].
e See Clean ISE tower automatically on page E-48.
Roche Diagnostics
cobas c111 14 ISE maintenance
Table of contents
ISE maintenance
In this chapter, you will find step-by-step instructions of the ISE-specific maintenance
actions that you must perform to keep the instrument running smoothly and
efficiently.

Introduction .............................................................................................................. E-39
ISE maintenance actions and their intervals ...................................................... E-39
ISE maintenance actions ........................................................................................... E-40
Safety information ............................................................................................... E-40
Daily prepare actions ........................................................................................... E-42
Activate electrodes ............................................................................................... E-43
Condition ISE tubing .......................................................................................... E-44
Initialize ISE Reference Solution sensor ............................................................. E-45
Prime ISE reference and calibrator ..................................................................... E-46
Electrode service .................................................................................................. E-47
Clean ISE tower automatically ............................................................................ E-48
Clean ISE tower manually ................................................................................... E-49
Initialize ISE unit ................................................................................................. E-51
Replace ISE pump tubing .................................................................................... E-52
Replace ISE unit tubing ....................................................................................... E-55
Deactivating the ISE unit .................................................................................... E-62
Roche Diagnostics
14 ISE maintenance cobas c111
Table of contents
Roche Diagnostics
Introduction
Introduction
The maintenance actions of the ISE unit are integrated in the maintenance actions of
the main instrument.
e For general information on performing maintenance actions, see Overview on page C-5.
This chapter describes the ISE-specific maintenance actions.
ISE maintenance actions and their intervals
The following table lists the ISE maintenance actions and shows how frequently they
need to be performed.
Every effort has been made to ensure that all the information contained in this table is
correct at the time of publication. However, Roche Diagnostics GmbH reserves the right to
make any changes necessary without notice as part of ongoing product development.
Maintenance actions with no defined interval need to be performed in particular situations,

for example during troubleshooting.
Interval Maintenance action

None Activate Electrodes
None Condition ISE Tubing
None Initialize ISE Reference Sensor
None Prime ISE Reference and Calib.
Daily Daily Prepare Actions
Daily Electrode Service
Weekly Clean ISE Tower Automatically
Monthly Clean ISE Tower Manually
Monthly Initialize ISE Unit
Six-monthly Replace ISE Unit Tubing
Six-monthly Replace ISE Pump Tubing
Table E-6 Periodicity of maintenance actions
For the expiration dates of electrodes, see their package inserts.
Roche Diagnostics
ISE maintenance actions
Safety information


mechanism


Diagnostics.
representative.

components associated with the waste systems are potentially biohazardous.
Roche Diagnostics
Incorrect results due to build-up of contaminants

During use, contaminants may adhere to the probe. As a result, traces of analytes or
CAUTION reagents may be carried over to the next. Make sure to perform the probe maintenance
actions as soon as they are due in order to prevent potentially false results.

instrument is shut down. This can cause dust and dirt being collected in the heating
channel, which in turn might decrease the quality of the cuvettes.

cannot continue processing orders, or it may lead to incorrect results. If at all possible,

quality specified in section Technical specifications.
specified in chapter Technical specifications must be used.
Roche Diagnostics
Daily prepare actions
h Utilities > Maintenance > Daily Prepare Actions

To make it easier and more efficient for the operator, some daily maintenance actions
that may take quite some time are grouped into one maintenance action. This way the
operator does not have to remain near the instrument while the actions are
performed.
The following maintenance actions are included if due:
o Initialize ISE Unit
o Electrode Service
o Clean ISE Tower Automatically
o Deproteinize Probe
In addition, a main calibration is performed.

m Activator
m ISE Etcher
m ISE Solution 1
m ISE Solution 2
o Injury through working solutions on page E-40.
o Incorrect results due to build-up of contaminants on page E-41.
a To perform the daily prepare actions

1 Prepare a tube with ISE Deproteinizer, ISE Etcher, Activator, ISE Solution 1, and
ISE Solution 2 each.
2 Select the maintenance action [Daily Prepare Actions].
3 Press .
4 Press .
5 Place the fluids on the positions indicated on the screen.
6 Press to confirm the placing.
The system performs the maintenance actions.
7 When the system is in Standby status, remove the tubes.
8 Press .
Roche Diagnostics
Activate electrodes
h Utilities > Maintenance > Activate Electrodes

The electrode surfaces must be activated with fresh serum so that the correct
potentials are measured. Electrodes may be damaged if they are deprived of regular
contact with serum.
Tools and materials required m Activator
a To activate the electrodes

1 Select the maintenance action [Activate Electrodes].
2 Press .
4 Place the Activator on the sample area position indicated on the screen.
6 Remove the Activator from the sample area.
7 Press .
Roche Diagnostics
Condition ISE tubing
h Utilities > Maintenance > Condition ISE Tubing

Conditioning the tubing with Activator ensures the proper flow of fluids.
a To condition the ISE tubing

1 Select the maintenance action [Condition ISE Tubing].
2 Press .
7 Press .
Roche Diagnostics
Initialize ISE Reference Solution sensor
h Utilities > Maintenance > Initialize ISE Reference Sensor

Initializing the ISE Reference Solution sensor ensures proper detection of possible air
in the ISE tubing.
This maintenance action forms part of the [Replace ISE Unit Tubing] maintenance
action.
Tools and materials required m Tissues
a To initialize the ISE Reference Solution sensor

1 Select the maintenance action [Initialize ISE Reference Sensor].
2 Press .
The instrument pumps ISE Reference Solution through the ISE tubing.
You are asked to remove the tubing adapter from the ISE Reference Solution
bottle.
5 Remove the tubing adapter from of the ISE Reference Solution bottle.
a) Have a clean lint-free tissue ready.
b) Lift the tubing adapter and place it on the tissue.
6 Press to confirm completion of the action.
The system now starts to initialize the ISE Reference Solution sensor.
You are asked to insert the tubing adapter in the ISE Reference Solution bottle and
to close the ISE cover.
7 Insert the tubing adapter in the ISE Reference Solution bottle.
9 Press .
The instrument pumps ISE Reference Solution through the ISE tubing.
10 Press .
Roche Diagnostics
Prime ISE reference and calibrator
h Utilities > Maintenance > Prime ISE Reference and Calib.

This maintenance action ensures that no traces of a previous ISE Calibrator indirect/
urine and ISE Reference Solution are left in the tubing and so prevents drift in the
results.
Tools and materials required None
Hazards and precautions None
a To prime the ISE calibrator and ISE Reference Solution

1 Select the maintenance action [Prime ISE Reference and Calib.].
2 Press .
The instrument pumps first ISE Reference Solution and then ISE Calibrator
indirect/urine through the ISE tubing and past the electrodes.
4 Press .
Roche Diagnostics
Electrode service
h Utilities > Maintenance > Electrode Service

The electrodes must be cleaned regularly to prevent the buildup of deposits and so to
maintain the efficiency of the ISE unit.
During this action, the ISE Sodium Electrode is etched and all electrodes are
deproteinized and activated, and the tubing is conditioned.
Tools and materials required m ISE Etcher

m Activator
m ISE Deproteinizer
a To perform electrode service

1 Select the maintenance action [Electrode Service].
2 Press .
4 Place the Activator, ISE Deproteinizer, and ISE Etcher on the sample area
positions indicated on the screen.
6 Remove the Activator, ISE Deproteinizer, and ISE Etcher from the sample area.
7 Press .
You need to perform a main calibration before you can process orders.
Roche Diagnostics
Clean ISE tower automatically
h Utilities > Maintenance > Clean ISE Tower Automatically

The ISE tower must be cleaned regularly to ensure the proper functioning of the ISE
unit. Cleaning includes deproteinizing and activating the ISE tower.

m ISE Deproteinizer
a To clean the ISE tower automatically

1 Select the maintenance action [Clean ISE Tower Automatically].
2 Press .
4 Place the Activator and the ISE Deproteinizer on the sample area positions
indicated on the screen.
6 Remove the Activator and ISE Deproteinizer from the sample area.
7 Press .
Roche Diagnostics
Clean ISE tower manually
h Utilities > Maintenance > Clean ISE Tower Manually
When the ISE tower is blocked, perform first the [Clean ISE Tower Automatically]
maintenance action (See Clean ISE tower automatically on page E-48). If this does not help,
perform the [Clean ISE Tower Manually] maintenance action. If the ISE tower is still
blocked, clean the ISE tower off the instrument. (See Cleaning the ISE tower off the
instrument on page E-34.)

m Activator
m Cotton swabs
a To clean the ISE tower

1 Select the maintenance action [Clean ISE Tower Manually].
2 Press .
4 Place the Activator and ISE Deproteinizer on the sample area positions indicated
on the screen.
The ISE tower is first washed.
The transfer head moves to the right side of the instrument.
You are asked to clean the ISE tower.
6 Open the main cover and then the left service flap.
Roche Diagnostics
7 Clean the inside of the ISE tower with a cotton swab to remove any residual of ISE
Deproteinizer.
Figure E-12
8 Close the left service flap and then the main cover.
9 Press to confirm the cleaning of the ISE tower.
The ISE tower is first washed.
The transfer head moves to the right side of the instrument.
You are asked to clean the ISE tower.
10 Open the main cover and then the left service flap.
11 Clean the inside of the ISE tower with a cotton swab to remove any residual water.
12 Close the left service flap and then the main cover.
13 Press to confirm the cleaning of the ISE tower.
The ISE tower is first washed and dried and then conditioned with Activator.
14 Remove the Activator and ISE Deproteinizer from the sample area.
15 Press .
Roche Diagnostics
Initialize ISE unit
h Utilities > Maintenance > Initialize ISE Unit

Initializing the ISE unit uses Activator to condition the electrodes and to adjust the
sensors and the pump action. This ensures proper transportation of fluids through
the ISE tubing.
a To initialize the ISE unit

1 Select the maintenance action [Initialize ISE Unit].
2 Press .
4 Place the Activator on the sample area positions indicated on the screen.
7 Press .
Roche Diagnostics
Replace ISE pump tubing
h Utilities > Maintenance > Replace ISE Pump Tubing

Replacing the pump tubing ensures proper ISE pump action.
During the [Replace ISE Pump Tubing] maintenance action, the following
maintenance actions are automatically performed:
o Prime ISE Reference and Calib.

m Roche approved ISE pump tubing set
o Infection by waste solution on page E-40.
a To replace the ISE pump tubing

1 Select the maintenance action [Replace ISE Pump Tubing].
2 Press .
The placement screen is displayed.
The tubing is emptied.
Your are asked to remove the tubing.
Roche Diagnostics
Removing the tubing 7 Open the cover of the peristaltic pump.
A Cover of peristaltic pump
Figure E-13
8 Push the pump towards the back of the instrument.

9 Disengage the tube connector plate.
A Connector plate
Figure E-14
10 Remove the ISE pump tubing set.
A ISE pump tubing set
Figure E-15
Installing the tubing Install the tubing in the reverse order of removing it.
11 Pull the new tubing set over the pump head, with the connector plate facing the
electrode block.
Roche Diagnostics
12 Align the tubing connector plate with the tube connectors on the ISE unit.
Figure E-16
13 Carefully close the peristaltic pump lid.

The tube connector plate is automatically pushed into the tube connectors of the
ISE unit.
The system first performs the [Prime ISE Reference and Calib.] maintenance
action, then [Initialize ISE Unit].
A message will inform you when the maintenance actions are complete.
17 Press .
Roche Diagnostics
Replace ISE unit tubing
h Utilities > Maintenance > Replace ISE Unit Tubing

Due to the abrasion by the ISE valve action, the ISE tubing needs to be replaced
periodically. Replacing the ISE tubing ensures the proper functioning of the ISE unit.
During the [Replace ISE Unit Tubing] maintenance action, the following
maintenance actions are automatically performed:
o Prime ISE Reference and Calib.
o Initialize ISE Reference Sensor
o Condition ISE Tubing
Always replace the ISE tubing with the help of the [Replace ISE Unit Tubing] maintenance
action.

m Roche approved ISE unit tubing set
m Tissues
o Infection by waste solution on page E-40.
page E-40.
a To remove the ISE unit tubing

1 Select the maintenance action [Replace ISE Unit Tubing].
2 Press .
The placement screen is displayed.
The tubing is emptied.
Your are asked to open the covers.
6 Open the main cover, then the left service flap and the ISE cover.
Disconnecting the ISE solution Your are asked to remove the tubing adapters from the ISE solution bottles.
bottles
7 Remove the tubing adapters from ISE Calibrator indirect/urine and ISE Reference
Solution bottles.
Roche Diagnostics
8 Press to confirm the removal.

The tubing is drained.
9 Remove the tubing from the adapters.
The two tubing adapters are slightly different, but the process of removing the
tube is the same.
A ISE Reference Solution tubing adapter B ISE Calibrator indirect/urine tubing

adapter
Figure E-17
a) Have a tissue ready.

b) Remove the tubing adapter by lifting it and place it on the clean lint-free tissue.
c) Remove the tube from its clips.
d) Remove the nozzle from the tube by pulling it off.
e) Pull through the tube from the top of the adapter.
Place the adapter together with its nozzle on the tissue.
Removing the pinch valve caps 10 Remove the pinch valve caps and clamps of the input (B), entry (C), and exit (A)
and clamps valve-plates.
Figure E-18
Roche Diagnostics
To remove a pinch valve cap and clamp:
Figure E-19
a) Push the cap horizontally in the direction of the arrow, away from the cut-out.
b) Lift and put it aside.
c) Lift the valve clamp and put it aside.
Disconnecting the tubing from 11 Disconnect the tubing from the ISE tower
ISE tower
A
B
C
Figure E-20
a) Remove the ISE overflow collector (B) by pulling it upwards and turning it
from side to side as you do so.
Place the collector behind the wash station.
b) Remove the locking ring (C) from the base of the ISE tower by turning it
counter-clockwise one quarter of a turn and then lifting it over the ISE tower.
c) Lift the ISE tower (A). Check whether any O-ring is stuck to the ISE tower. If
so, remove it and place it back in its position on the ISE tower base.
d) Disconnect the tubing.
Roche Diagnostics
12 Slide off the lid of the fluid distributor.
A Lid of fluid distributor
Figure E-21
13 Disconnect the tubing from the electrode block.
A Tension lever
Figure E-22
a) Open the electrode block lid.

b) Release the tension lever.
c) Lift the connector on the side of the K electrode.
d) Disconnect the tube on the side of the tension lever.
e) Lift the connector to the ISE Reference Electrode and disconnect the tube
leading to the ISE Reference Solution bottle.
14 Disconnect the tubing connecting to the peristaltic pump.
Removing the tubing 15 Lift the tubing from its routing, follow carefully the individual tubes.
16 Dispose of the tubing. Treat it as biohazardous waste.
Installing the new tubing Install and connect the tubing in the order recommended on the illustration on the
ISE tubing set cover.
When installing the single items, perform the individual steps in reverse order of
removing the items.
Roche Diagnostics
a To install the new ISE unit tubing

1 Remove the new tubing set from its packaging.
Make sure to keep the piece of tubing designed to fit at the underside of the mixing tower.
It will be required when a service representative performs periodic maintenance.
2 Place the tubing roughly in position on the ISE unit. Refer to the illustration on
the ISE tubing set cover.
Take care not cut the tubing, avoid any sharp objects.
3 Press the tubes into their routing.
Take care not to compress the tubes or to kink them.
Make sure to press the tubing firmly in its routing around the ISE Reference
Solution sensor.
4 Connect the tubing to the ISE tower and then install the tower.
5 After connecting the tubing to the electrode block, make sure the electrodes are
properly mounted when closing the tension lever. Close the electrode block cover.
6 When connecting the tubing to the peristaltic pump connector block, take care
not to introduce sharp angles in the tubing. (Sharp angles may lead to flow
problems.)
Always insert the tubing connectors in the lower set of holes in the pump
connector block, and make sure to fully insert the tubing in the connectors.
A B
A Peristaltic pump block C There are no sharp angles in the tubing.

B Upper set of sockets. D Lower set of sockets.
Figure E-23
7 Install all clamps and pinch valve caps. Be sure to place the clamps in the correct
position, covering the tubing.
8 Install the lid of the fluid distributor.
Roche Diagnostics
9 Install the tubing on the tubing adapters of the ISE Calibrator indirect/urine and
ISE Reference Solution bottles.
The two tubing adapters are slightly different, but the process of installing the tube
is the same.
A ISE Reference Solution tubing adapter B ISE Calibrator indirect/urine tubing

adapter
Figure E-24
a) Pull the tube through the hole that aligns with the clips.
b) Insert the nozzle in the tube.
c) At the top of the adapter, pull through the tube until the nozzle is flush with
the end of the adapter. There should be no slack.
d) Fix the tube to the clips.
With the adapter that offers two clip positions, use the inner position.
e) Insert the tubing adapter in the appropriate bottle.
10 Close the ISE cover, then the left service flap and the main cover.
Conditioning the tubing The system now performs the maintenance action [Prime ISE Reference and
Calib.].
The system now performs the maintenance action [Initialize ISE Reference
Sensor].
You are asked to remove the tubing adapter from of the ISE Reference Solution
bottle.
13 Remove the tubing adapter from of the ISE Reference Solution bottle.
a) Have a clean lint-free tissue ready.
b) Lift the tubing adapter and place it on the tissue.
Roche Diagnostics

The system now starts to initialize the ISE Reference Solution sensor.
You are asked to insert the tubing adapter in the ISE Reference Solution bottle and
to close the ISE cover.
15 Insert the tubing adapter in the ISE Reference Solution bottle.
17 Press .
The system first pumps ISE Reference Solution through the ISE tubing. Then it
performs the [Condition ISE Tubing] maintenance action, and finally [Initialize
ISE Unit].
19 Press .
Roche Diagnostics
Deactivating the ISE unit
If you intend not to use the ISE unit for more than one week, you should deactivate it.
This saves ISE fluids and reduces wear and tear of the tubing.
This situation may occur, for example, if you need close the laboratory temporarily,
or if you want to relocate the cobas c111 instrument with the ISE unit.
Tools and materials required o Glass beaker

o Deionized water
o Tissues
The following warning message in particular is relevant:
o Infection by biohazardous materials on page E-40
a To prepare the ISE data

1 Delete all ISE patient, calibration, and control results.
e See Deleting patient results on page B-83, Deleting calibration results on page B-84,
Deleting QC results on page B-85.
2 Disable all ISE applications.

e See Activating and deactivating applications on page B-125.
3 Delete the ISE lot data.

e See Lot handling on page B-87.
a To deactivate the ISE unit

2 Remove the tubing adapters from the ISE solution bottles.
3 Place the adapters in a beaker filled with deionized water.
4 Remove bottles and screw on their lids.
5 Place the beaker in the position where your removed the ISE solution bottles
from.
6 Choose Utilities > Maintenance > Prime ISE Reference and Calib.
7 Press .
The ISE unit tubing is primed with water.
9 Repeat steps 6 through 8.
10 Remove the adapters from the beaker and place them on a lint-free tissue.
11 Repeat steps 6 through 8.
The water is drained from the ISE unit tubing.
Roche Diagnostics
12 Open the cover of the peristaltic pump.
A Cover of peristaltic pump
Figure E-25
13 Push the pump towards the back of the instrument.

14 Disengage the tube connector plate.
A Connector plate
Figure E-26
15 Remove all pinch valve caps and clamps, store them in secure place.
e See Removing the pinch valve caps and clamps on page E-56.

17 Switch off instrument.
18 Disconnect the ISE power supply from the wall socket.
19 Switch on instrument.
On the [Overview] tab, the ISE icon is deactivated (grey).
Roche Diagnostics
Roche Diagnostics
cobas c111 15 ISE troubleshooting
Table of contents
ISE troubleshooting
How to deal with exceptional ISE situations
In this chapter, you will find information on the result flags that may be generated
with ISE measurements, and also guidance for general troubleshooting procedures
and on how to deal with error messages.

Introduction .............................................................................................................. E-67
Information about the ISE unit status ............................................................... E-67
Messages ............................................................................................................... E-67
Safety .......................................................................................................................... E-68
List of ISE flags .......................................................................................................... E-69
> ........................................................................................................................... E-69
Air Fluid ............................................................................................................... E-69
Air Isecal .............................................................................................................. E-70
? Cal ...................................................................................................................... E-70
Cal Error .............................................................................................................. E-70
Calc Error ............................................................................................................. E-71
Ise Unstab ............................................................................................................. E-71
No Fluid ............................................................................................................... E-72
No Isecal ............................................................................................................... E-72
Out of Rng ........................................................................................................... E-73
? QC ...................................................................................................................... E-73
R 1(2.5s) ............................................................................................................... E-74
R 1(3s) .................................................................................................................. E-74
R 2(2s) .................................................................................................................. E-74
> RR ..................................................................................................................... E-75
< RR ..................................................................................................................... E-75
Seg Fluid ............................................................................................................... E-75
Seg Isecal .............................................................................................................. E-75
Sol1 F Dev ............................................................................................................ E-76
> Test Rng ............................................................................................................ E-77
< Test Rng ............................................................................................................ E-77
Reacting to error messages ........................................................................................ E-78
Roche Diagnostics
15 ISE troubleshooting cobas c111
Table of contents
Roche Diagnostics
Introduction
Introduction
Effective troubleshooting on the ISE unit requires a good understanding of all basic
operating procedures. However, you can avoid most of the common problems if you
observe the recommended procedures at all times and if the operating environment is
effectively controlled.
e For information on ISE maintenance, see ISE maintenance actions on page E-40.
Information about the ISE unit status
The user interface keeps you informed about the status of the ISE unit as a whole, and
about particular hardware, software, and chemistry events as they arise. It does this in
the following ways:
o Color coded LEDs on the instrument inform you when to open covers or place
sample tubes.
e See Color concept on page A-72.
o The colors of buttons tell you whether you need to intervene.
You can check the meaning of a button and its color using the Online Help .
o Buttons on the [Overview] tab lead to detailed information on the status of
selected processes and hardware items.
o Messages on the screen provide information on individual tasks and events.
o The text in the Status line provides information on the status and activities of the
analyzer unit.
o Flags with results from samples, calibrations, and controls are automatically
generated if during processing certain technical checks were not passed or if the
result exceeds or does not reach predefined limits.
Messages
The system performs numerous checks. When an irregularity is detected, an alarm

message is generated. Alarm messages are displayed in two ways:
o Information concerning a problem that occurred during operation is reported in
the Alarm Monitor.
e For details on alarm messages, see Alarm monitor on page D-6.
For details on instrument messages, see Message screen on page D-5.
Roche Diagnostics
Safety
Safety
Before you start troubleshooting, it is essential that you both read and understand the
safety information listed below.
them.


Injury or damage to the analyzer due to contact with instrument mechanism

Do not touch any parts of the instrument other than those specified. During operation and

Diagnostics.
o Leave maintenance that is not described in the Operator’s Manual to trained Roche
Technical Support personnel.
Roche Diagnostics
List of ISE flags
List of ISE flags
This section lists the general and ISE-specific flags in alphabetic order and provides
information on each of the flags.
e For information on flags that concern absorbance measurements only, see List of flags on
page D-22.
Where a flag description gives a list of recommended actions, work through each step in
turn until you have solved the problem. Proceed to the next step only after you have
completed the previous one.
>
Meaning Result generated by re-performing the test with the same running parameters
(repeated).
Message ID 120
Priority 32
Possible cause The user initiated the repeat.
Air Fluid
Meaning o The length of the sample segment was too short.

o The end of the sample segment was not detected.
o It takes too long for a sample segment to reach the electrodes.
Message ID 19
Priority 4
Possible cause o Air bubbles are present.

o The ISE tower is clogged.
o The dosing from the sample probes is inaccurate.
o The ISE tubing is leaking, blocked, or not conditioned.
o Mixing is too vigorous.
Recommended actions o Check the quality of the sample.

o Check the sample tubes.
o Check the ISE tower and ISE tubing for leaks and blockages.
o Repeat the measurement.
Roche Diagnostics
List of ISE flags
Air Isecal
Meaning o The length of the calibrator segment was too short.

o The end of the calibrator segment was not detected.
o It takes too long for a calibrator segment to reach the electrodes.
Message ID 91
Priority 5
Possible cause o Air bubbles are present.

o The ISE tubing is leaking or blocked.
Recommended actions o Ensure that the ISE Calibrator indirect/urine on the ISE unit is available and check
the level of fluid; replace if necessary.
o Repeat the measurement.
o Check the ISE tubing for leaks and blockages.
? Cal
Meaning A result where its calibration is flagged.
Message ID 110
Priority 29
Possible cause The calibration was in question and has been flagged, however the calibration could
be used to calculate the result (compare with CAL ERROR where the calibration did
not provide a usable result).
Recommended actions Check and redo calibration if needed.
Cal Error
Meaning No calibration data or previous calibration data used.

CAL ERROR appears on each control and patient sample for the affected test until the
problem is resolved.
Message ID 43
Priority 24
Possible cause Caused by an alarm that occurred during calibration because the calibration could
not provide a usable result.
Recommended actions Check the flags of the calibration and proceed to deal with the calibration first.
Roche Diagnostics
List of ISE flags
Calc Error
Meaning Calculation error.

Slope or nonlinear standard curve cannot be calculated due to a calibration error.
Message ID 16
Priority 13
Possible cause o Calibrator outdated or deteriorated.

o Misplacement of the calibrator tubes.
Recommended actions o Repeat calibration with fresh calibrators.

o If the calibrators were incorrectly positioned, replace the calibrators and repeat the
calibration.
Ise Unstab
Meaning The signal from the electrode(s) was not stable during the measurement.
Message ID 18
Priority 6
Possible cause o There are air bubbles in the measuring segment.

o The concentration of sample is too low (for example, dialyzed samples).
o The ISE Reference Solution tubing is blocked or leaking.
o The pH of the sample is too low (for example, pH < 5.5).
o One or more O-rings are missing or damaged.
o There are salt deposits or there is an obstruction at the adapter of the ISE
Reference Solution bottle.
o The electrodes have not been serviced.
o The expiration date of the electrode has expired or the electrode is damaged.
o The electrodes and/or the electrode block is not dry.
o The preamplifier is defective.
Recommended actions 1. Perform the maintenance action [Electrode Service] and repeat the measurement.
2. Repeat the measurement with a suitable sample (where pH > 5.5 and sample
concentration within the test range) to establish that the ISE module is OK.
3. Check the position and condition of the O-rings and replace if necessary.
4. Check the adapter of the ISE Reference Solution bottle for salt deposits and
obstruction.
Roche Diagnostics
List of ISE flags
No Fluid
Meaning The ISE sample sensor could not detect any liquid. It takes too long for a sample
segment to reach the electrodes.
Message ID 68
Priority 2
Possible cause o The liquid was not pipetted.

o The ISE tower is clogged.
o The ISE tubing is blocked or leaking.
o The ISE sample sensor is defective.
o The ISE Electrodes are blocked or not properly mounted.
Recommended actions 1. Repeat the measurement.

2. Check the sample tubing for clots.
3. Check ISE Electrodes and O-Rings for proper mounting.
4. Check the ISE tower and ISE tubing for leaks and blockages.
5. Ensure that the ISE bottles on the ISE unit are available and check the level of
fluid; replace if necessary.
No Isecal
Meaning The ISE sample sensor could not detect any calibrator. It takes too long for a
calibrator segment to reach the electrodes.
Message ID 90
Priority 3
Possible cause o ISE Calibrator indirect/urine bottle is not available.

o The ISE tubing is leaking or blocked.
o The ISE sample sensor is defect.
Recommended actions 1. Repeat the measurement.

2. Ensure that the ISE Calibrator indirect/urine on the ISE unit is available and check
the level of liquid; replace if necessary
Roche Diagnostics
List of ISE flags
Out of Rng
Meaning Slope out of range.

The slope for the specified electrode is outside the acceptable range.
Message ID 20
Priority 15
Possible cause This flag appears with calibrations because:

o There are problems with the ISE solutions on the instrument.
o There are problems with the electrodes or the ISE unit was not properly serviced.
o The ISE Reference Solution tubing is blocked or leaking.
o The dosing from the sample probe is not accurate.
o The preamplifier is not working properly.
Recommended actions If only one calibration is flagged:

1. Repeat the calibration.
2. Repeat the calibration with fresh ISE Solutions 1 and 2, and check visually the
correct flow of all ISE solutions and the ISE Reference Solution.
If successive calibrations are flagged:
1. Repeat the calibration with fresh ISE Solutions 1 and 2, and check visually the
correct flow of all ISE solutions and the ISE Reference Solution.
2. Check whether the electrode expiration date has expired. Replace the electrodes, if
necessary.
3. Perform the maintenance action [Electrode Service].
4. Perform the maintenance action [Deproteinize Probes].
5. Check ISE Reference Solution tubing for leaks and blockages.
6. If the slopes of all electrodes are zero, replace the ISE Reference Electrode.
7. Contact your service representative.
? QC
Meaning A result where the quality control measurement is flagged.
Message ID 111
Priority 30
Possible cause The last QC measurement before this measurement was flagged. The dependency is
derived from the time sequence.
Recommended actions Check QC measurement.
Roche Diagnostics
List of ISE flags
R 1(2.5s)
Meaning One control value is above 2.5 standard deviation or below -2.5 standard deviation.
Message ID 36
Priority 28
Possible cause o The reagent has deteriorated (linearity of working curve degraded).
o One control is concentrated or has deteriorated.

reagent.
R 1(3s)
Meaning One control value is above 3 standard deviation or below -3 standard deviation.
Message ID 35
Priority 27
Possible cause o Improper control is set.

o Proper control values (mean value, standard deviation) are not specified.

reagent.
R 2(2s)
Meaning Two sequential control measurements are above 2 standard deviation or below -2
standard deviation.
Message ID 29
Priority 26
Possible cause o The controls are not properly prepared.

o The controls are not properly positioned on the instrument.

reagent.
Roche Diagnostics
List of ISE flags
> RR
Meaning Above reference range.

For patient samples, the calculated concentration is greater than the upper limit of the
Message ID 40
Priority 22
< RR
Meaning Below reference range.

For patient samples, the calculated concentration is less than the lower limit of the
Message ID 41
Priority 23
Seg Fluid
e See Air Fluid.
Seg Isecal
e See Air Isecal.
Roche Diagnostics
List of ISE flags
Sol1 F Dev
Meaning The ISE Solution 1 factor determined during a main calibration was outside the check
limits.
Message ID 22
Priority 18
Possible cause This flag occurs with calibrations because:

o The dosing from the sample probe is not accurate.
o The ISE tower is blocked or the mixing was not sufficient.
o There may be problems with the ISE unit tubing, the electrodes, or the ISE unit
was not serviced properly.
o The ISE Calibrator indirect/urine has expired.
o ISE Solution 1 has expired.
Recommended actions If only one calibration is flagged:

o Repeat the calibration.
If successive calibrations are flagged:
o Check whether the ISE Calibrator indirect/urine is in the correct position.
o Check whether the ISE Calibrator indirect/urine has expired.
o Check whether the ISE Solution 1 has expired.
o Perform the maintenance action [Clean ISE Tower Automatically].
o Perform the maintenance action [Activate Electrodes].
o Perform the maintenance action [Deproteinize Probe].
o Perform the maintenance action [Prime ISE Calibrator & Reference].
o Check whether the electrode expiration date has passed. Replace the expired
electrode, if necessary, and perform the maintenance action [Electrode Service].
o Check the ISE unit tubing for leaks and blockages.
o Contact your service representative.
Roche Diagnostics
List of ISE flags
> Test Rng
Meaning PANIC value over (upper) Technical Limit.

The result is higher than the upper limit for the test.
Message ID 26
Priority 20
< Test Rng
Meaning PANIC value below (lower) Technical Limit.

The result is lower than the lowest limit for the test.
Message ID 27
Priority 21
Roche Diagnostics
Reacting to error messages
Reacting to error messages
For general information on error messages and troubleshooting, see Reacting to

messages on page D-38.
The following table lists selected messages and provides more detailed information on
how to react to them.

[8.xxx.56] The ISE reference ISE unit. ISE Reference Solution is Replace the ISE Reference Solution bottle.
sensor has detected too much empty. e See Replacing ISE fluid bottles on page E-28.
air during ISE Reference
Solution transport. Leakage in the tubing or at o Check that the ISE unit tubing is properly
electrodes. connected.
o Check the ISE unit tubing for leakages and
blockages.
e See Replace ISE unit tubing on
page E-55.
o Check that the electrodes are mounted
properly.
e See Replacing electrodes on page E-30.
The cover of the peristaltic Close the cover.
pump is open or not properly
closed.
The tubing around the ISE Make sure that the tubing is properly pressed
Reference Solution sensor is not into the groves and that the tubing itself is not
properly installed. compressed.
[109000567] code raised by ISE unit. This is a flow problem within Perform the following checks:
IC software caused by an the ISE unit, the ISE tower is o Check that the ISE unit tubing is properly
unexpected handling or not empty. The system checks connected.
system situation. whether the tower is empty o Check the ISE unit tubing for leakages and
before dispensing. blockages.
o Check that the electrodes are mounted
properly.
o Check that the pinch valve caps and clamps
are properly installed.
o Check that the peristaltic pump cover is
properly closed.
e See Replace ISE unit tubing on page E-55.
Figure E-27 ISE troubleshooting with the help of messages
Roche Diagnostics
Glossary and Index F
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-11
cobas c111 Glossary
2-dimensional barcode - barcode type
Glossary
This glossary is a compendium in which to look up the alphanumeric sorting The listing of information, in a
meaning of technical terms used in conjunction with the printout or on a screen, in a pre-defined order by letters
cobas c111 instrument. or numbers.
analyte The constituent in the sample that is to be

Numbers determined.
2-dimensional barcode A type of barcode on reagent analytical instrument A device or a combination of

bottles, calibrators, and control barcode sheets. These devices used to carry out an analytical process.
matrix barcodes, which use PDF417 symbology, contain
more information than traditional linear barcodes. analyzer unit Central analyzing unit including cooling
assembly, heating channel, rotor and insulation. Does not
include the photometer unit.
A
application Chemistry and method to determine a
absorbance photometer A device used to make parameter. See also test.
absorbance photometry measurements. It consists of a
halogen light source, optical groupings, a assay 1. A specific test.
monochromator (diffraction grating), a preamplifier, 2. The process of measuring a substance.
filters, and a diode array. See also photometer.
accuracy The absolute deviation of a result from a pre- B

defined target value in percent or absolute units.
backup The saving of data onto supplementary storage
activate The process of conditioning electrodes with media such as disks or tape. If such data is required again
fresh serum so that the correct potentials are measured. but is no longer available from the main storage
(instrument hard disk), it can be restored from a backup
Activator Serum used to coat ISE electrodes, tubing copy.
and the sample probe after cleaning procedures. (The
cobas c111 Activator is based on human sample barcode A numeric or alphanumeric code used on
material. For further details refer to the Activator package sample tubes and reagent bottles to identify the samples
insert.) and reagents. Different barcode standards are available.
See also barcode type.
alarm A visual or audible operator notification of any
system irregularity. barcode scan The process of reading barcode
information into the memory of an instrument.
Alarm button A button used to display the alarm
messages. barcode scanner The device that reads the code from
sample or reagent barcode labels.
alarm level A level that identifies the source and
severity of a problem. There are two levels: warning, and barcode transfer sheet (BTS) A sheet bearing a
alarm. barcode that encodes test-related (or calibrator or
control) information for an analytical instrument.
alarm message A message that reports a system
irregularity. It can be viewed in the alarm monitor screen. barcode type Typical sample barcode types used in the
See Alarm button. IVD industry are Code39, NW7 (Codabar), ITF, and
Code 128.
aliquot Portion of sample material pipetted into any
secondary cup.
Roche Diagnostics
Operator’s Manual · Version 2.0 F-3
Glossary cobas c111
biohazardous - database
biohazardous A classification used to identify material conditioning The process of letting serum-type liquid
that poses a health threat, for example something flow through the flow path before electrolyte
contaminated with biological material. measurement.
button A button is found on a screen or pop-up consumables A generic term for items that are used
window. It can be touched either to initiate an action or during test processing and must be replaced on a regular
to move to a different screen. basis by the operator. Examples of consumables include
printer paper and cuvette segments.
C control See control material.
calculated result A test result calculated from control ID The abbreviated name for a control
different individual analytical methods with a given material. Control IDs are used on screens where limited
formula such as ratio A/B. space prevents the use of longer names.
calibration The set of operations that establish, under control material A material used to assess the
specified conditions, the relationship between values performance of an analytical procedure or part of an
indicated by the analytical instrument and the analytical procedure. Also called the control sample.
corresponding known values of an analyte.
control name The name of a control material, for
calibration interval A specified interval at which an example PreciControl Universal.
assay should be calibrated. Typically found on reagent
package inserts. CPU The Central Processing Unit of the system or
computer.
calibration type Describes the event that triggers the
calibration, for example lot change, and interval CSF Abbreviation for cerebral spinal fluid. A sample
expiration. type for clinical analysis.
calibrator 1. A material of known composition or cup See sample cup.

properties that can be presented to the analytical
instrument for calibration purposes. cup-on-tube The placement of a smaller secondary
2. The test portion or test solution used for calibration of sample container (for example a Hitachi Cup) on top of a
an analytical procedure. primary sample tube.
carryover A process by which materials are carried into cuvette Disposable plastic container into which sample,
a reaction mixture where they do not belong. reagents, diluent, and water is pipetted, and where the
sample pre-dilution and reaction takes place.
check digit A verification number used in barcodes
and software. cuvette port Section of the analyzer unit where cuvette
segments are inserted and removed.
check sum The result of a mathematical procedure to
validate the integrity of a set of data. cuvette segment Cuvette holder containing 10
cuvettes.
cleaner A solution used to wash the probe.
cycle The instrument time interval during which
clot detection 1. A device built into the pipetting pipetting or measurement can be carried out.
system to detect clots and to avoid false pipetting.
2. The procedure of detecting a clot.
D
cobas A modular range of in vitro diagnostics systems
from Roche Diagnostics/Hitachi High-Technologies. DAT Abbreviation for Drugs of Abuse Testing. The
abbreviation DAU is also used.
communication The exchange of data between
different computers. database A defined section of the computer memory
where all instrument, assay, and patient-relevant data are
processed and stored.
Roche Diagnostics
F-4 Operator’s Manual · Version 2.0
cobas c111 Glossary
DAU - ISE
DAU Drug of Abuse in Urine. The old term for DAT or F

Drugs of Abuse Testing.
filter A process that sorts data for viewing,
DB Abbreviation for database. documenting, or printing according to pre-defined
criteria
DBMS Abbreviation for database management system.
flag An identifier used to call an operator's attention to
dead volume The amount of residual sample material a result.
in a sample tube or cup.
default QC An automated process for performing G

multiple QC measurements at the time when you define
the QC orders. global action button See global button.
default value A set value registered in advance (initial global button A button that allows access to the global
setting). software screens and that can be used at any time. For
example, <Start>, <Stop>, or <Alarm>.
demographics Patient-related data such as name, date
of birth, and gender.
H
diluent (DIL) A liquid agent used to reduce the
concentration of a sample. home position The position to which a certain part of
the instrument returns on reset. The start position of a
dilution factor A preset dilution ratio that is used by mechanism.
the analyzer to perform a requested dilution.
host computer 1. A computer used for overall
disposable Typically a plastic tip, vessel, or cuvette that management and control of the computer network.
is discarded after a single use. 2. A clinical laboratory computer that stores and
processes patient requests and results. A host is able to
dynamic range The reportable range of an assay. This communicate with analytical instruments.
range extends from the lower detection limit to the limit
of linearity. host communication Data exchange with a clinical
laboratory information system (LIS).
E host interface protocol A technical description that

defines data transfer between a host computer and an
E-stopped A status indicating that the system has analytical system.
performed an emergency stop. This could be due to
hardware failure or because any of the safety devices have
requested an emergency stop. I
expected range The pre-defined range of test result Initialization Also known as Initializing. The
values expected for a defined group of healthy patients or operational mode of an analyzer that occurs immediately
materials. Also known as normal range or reference range. after power on and during which the instrument prepares
itself for operation.
expected value A value for a test result that can be
considered as a normal result. installing applications Process of making the
application available for testing, as opposed to importing
expiration date Also called the expiry date. The end of the application data, which just saves the data on the
a period until which Roche Diagnostics guarantees system.
product claims for its reagents, calibrators, and controls.
interval QC A streamlined process of performing (all)
extended dynamic range The measuring range for due QC measurements (for QC that needs to be
an assay at its highest dilution. performed periodically.)
ISE Abbreviation for ion-selective electrode.
Roche Diagnostics
Glossary cobas c111
ISE Reference Electrode - operating system
ISE Reference Electrode The electrode through maintenance action A maintenance procedure
which the ISE Reference Solution flows to set the performed by the system or the operator; and that must
electronic baseline to zero for ISE measurement. be performed on a regular basis (for example daily,
weekly, or monthly) to secure reliable operation of the
ISE Reference Solution A KCl solution pulled analyzer.
through the ISE Reference Electrode to set the electronic
baseline to zero for ISE measurement. Also known as the maintenance procedure See maintenance action.
REF or reference electrode solution.
manual dilution An off-system, pre-analytical step
IVD Abbreviation for in vitro diagnostics. A diagnostic performed by laboratory staff to reduce the analyte
procedure performed outside the living body with concentration in a sample.
specimen body fluid.
mean The sum of values divided by the number of
values.
L measure point Time at which absorbance reading is
level detection A check for the availability of sufficient taken and used to calculate results.
liquid in a container.
measuring range See reportable range.
linear barcode A conventional one-dimensional
barcode with limited data capacity. message In computing, a defined set of alphanumeric
data that transfers information from computer to
liquid level detection (LLD) The ability of an computer or from an analytical instrument to the
analytical instrument to sense liquid by using the probe. operator.
log file A set of data, typically stored in the control unit, Microcup A secondary sample cup made by Hitachi
that traces instrument-related or operator-related with a small dead (residual) volume.
activities such as maintenance.
minimum sample volume The amount of residual
log off The procedure of terminating access to a system. sample material plus the volume required for assaying all
Also known as log out or logoff. The reverse procedure is requested tests to ensure faultless sample aspiration.
known as log on or log in.
monochromatic Absorbance measurement at one
Log off button A button used to terminate access to a (primary) wavelength.
system. See also log off.
multi-wavelength spectrophotometer A
log on The procedure of gaining access to a system by spectrophotometer in which detectors are placed at
entering a user name and, if required, a password. Also multi-wavelength positions to enable simultaneous light
known as log in or logon. The reverse procedure is reception.
known as log off or log out.
Log on button A button used to gain access to a O

system. See also log on.
on-board 1. A technical device or function that is part
lot calibration A mandatory calibration when a new lot of the analytical instrument and can be used by the
of reagents is introduced to an analytical instrument. instrument at any time.
2. The availability of reagents and consumables on an
analytical instrument for use at any time.
M
online help On-screen documentation that a user can
main calibration Two-point calibration of the ISE tests request in a context-sensitive manner.
with ISE Solution 1 and 2. (As opposed to the calibration
with ISE Calibrator indirect/urine, which is part of each operating system A software program that controls all
ISE measurement.) basic functions of a computer (for example, Windows,
Linux, and Palm OS).
Roche Diagnostics
cobas c111 Glossary
operator - reagent bottle
operator The person who uses and controls the preventive maintenance A series of actions,
analytical instrument or a computer system. suggested by the system, that the operator should
See also user. perform to ensure smooth and uninterrupted operation
of the instrument (for example, emptying the waste
operator ID An alphanumeric ID that a system uses to container or replenishing reagents).
identify a particular operator.
primary tube The original tube containing the sample
order Collection of all tests that are defined to be that has been drawn from the patient.
performed for a particular sample. See sample tube.
order ID A set of alphanumeric data that unmistakably prime The process of flushing a system, for example the
identifies a particular sample order in the lab and is often tubing, with ISE Calibrator indirect/urine and water to
manually written on the sample label. clear it of possible obstacles, traces of fluid, and of air
bubbles.
profile A user-defined set of tests.

P
parameters A set of criteria or definitions used to protocol 1. A convention or standard that controls or
establish how an assay is performed. Examples of enables the connection, communication, and data
parameters include sample and reagent volumes and transfer between two computing end points. Protocols
incubation times and temperatures. Such information is can be implemented by hardware, software, or a
typically contained in the application definitions and combination of the two.
cannot be changed by the operator. 2. A set of rules that guides how an activity should be
performed.
password A form of authentication that uses secret
data to control access to a resource.
Q
photometer A device that measures the intensity of
light. QC Abbreviation for quality control. The operational
techniques and activities that are used to fulfill
photometer unit Complete photometer assembly, requirements for quality.
including optical components, power supply,
preamplifyer and absorbance controller. QC measurement The process of performing a test
with control material.
pipette (to …) The process of aspirating and
dispensing sample and reagents, performed by an query download A communication process between
appropriate probe. instrument PC and LIS by which a pre-defined data set is
transmitted upon request of the analytical instrument.
pop-up screen A screen that contains additional
information or additional options required for making
entries or decisions. R
potentiometric assay An assay in which analytes (for RAM Abbreviation for random access memory.
example Na, K, or Cl) are measured by ion-selective Semiconductor memory devices used in computers.
electrodes. RAM content is lost when a computer is switched off.
precision The closeness of agreement between raw data The unprocessed values obtained during the
independent test results obtained under prescribed analytical process on an instrument (for example mVolt
conditions. or absorbance).
pre-dilution A dilution step performed before samples reagent A composition of chemicals used to determine
are analytically processed on the analyzer. the concentration of substances in body fluid.
reagent bottle Standard plastic bottle for photometric

reagents.
Roche Diagnostics
Glossary cobas c111
reagent disk - STAT
reagent disk The removable device into which the sample splitting The act of making one or more
reagent bottles are placed. aliquots from a primary or secondary specimen.
reagent disk position One of the multiple positions sample tube A glass or plastic container for liquid
on the reagent disk. samples to be used with the system. It may or may not
have a bar code label, which may be used for positive
reagent port Section of the analyzer unit where reagent sample identification. A sample tube contains sample of
bottles are inserted and removed. one specific specimen (sample) type.
reference electrode See ISE Reference Electrode. sample type A type of sample that can be analyzed:
serum, plasma, whole blood, or urine.
reference range See expected range.
sampling stop An alarm level that indicates a problem
reference solution See ISE Reference Solution. with the sampling system.
See also S.Stop.
repeat The performance of the same test on a sample
again with identical dilution. scan See barcode scan.
reportable range The range of results that can be scroll The action of moving through text or graphics
reported for the assay. It stretches from the lower (up, down, left, or right) to see parts of the file or list that
detection limit to the high end of the calibration curve. cannot fit on the screen.
request See order. scroll arrow An arrow on either end of a scroll bar that
you use to scroll through the contents of the screen or list
rerun The performance of the same test on a sample box.
again with a different dilution.
scroll bar A bar that appears at the bottom or right
result The value reported by an analytical device during edge of a screen whose contents are not entirely visible.
or after the assay of a sample or control.
SD Abbreviation for standard deviation.
ROM Abbreviation for read-only memory.
Semiconductor memory devices used in computers. secondary tube A sample container of variable size
ROM content remains when a computer is switched off. into which aliquots are transferred.
rotor Assembly consisting of cuvette ring and plastic shutdown The process of powering off an instrument.
frame.
software A computer-operated program that processes
data in a defined manner. Software is usually intellectual
S property of the software supplier or its licensee.
sample area Area on the instrument where sample specimen Generic term for a calibrator, control and
tubes are placed. sample.
sample cup A small container that is used for samples standard Traceable reference material used to create the
and also for calibrator and control material. A sample master calibration curve.
cup can be placed either directly on the sample area, or
on sample tubes. Compared to a sample tube, a sample standard deviation A statistic used as a measure of the
cup allows the use of smaller liquid volumes and so dispersion or variation in a distribution of data.
reduces the dead volume.
Start button A button used to start system operation
sample ID A set of alphanumeric data that (Operating status) and begin the pipetting of samples,
unmistakably identifies a particular sample within a measurement, and the result calculation process.
whole organization, for example the hospital. It is used
on barcodes and is the unique identifier used to STAT Abbreviation for Short Turn Around Time.
communicate with a laboratory information system. Terminology used by the medical clinical professionals to
prioritize the processing of a sample in a laboratory.
Roche Diagnostics
cobas c111 Glossary
status - worklist
status A general term used to refer to the current status U

of the system. Explicit terminology may be used to
address sub-parts of the system status (such as analyzer unit A chosen reference quantity of an analyte used to
status and printer status). compare quantities of the same dimension (for example,
mol/L, g/L, or U/L).
Stop button A button used to display options for
different kinds of processing stop. user The person who operates and controls the
analytical instrument or a computer system.
SW Abbreviation for software. See also operator.
user interface The part of a system exposed to a user.

In a computer system, the user typically interacts with an
T operating system or with application software. With
target range The allowed range of recovery for an these the user interacts by using menus, icons, keystrokes,
analyte in a control material. mouse clicks, and similar means.
target value The mean of all participant responses

after removal of outlying values. V
TAS Abbreviation for Test Application Software. validation The process of checking results or data
against defined rules or ranges in clinical laboratories.
TDM Abbreviation for Therapeutic Drug Monitoring. Validation can be against technical or clinical criteria.
test Running an analysis of a specific parameter for a

sample. See also application. W
test ID The abbreviated name for a test. This code is waste Anything discarded by the analyzer; waste can be
displayed on test buttons shown on screens. liquid or solid.
test sheet A document that lists all the information worklist A report generated by an analytical
necessary to perform a specific assay or test on an instrument. A worklist aids a user by listing calibrators,
instrument. controls, and samples currently loaded on the sample
area.
touchscreen An input device that allows the user to
interact with the computer by touching the display
screen.
turn-around-time 1. The time between the decision to

perform a test and the time when the doctor receives the
result and can act on it.
2. Inside the laboratory (Lab-TAT): Time between
receiving a sample and sending out the validated result.
Roche Diagnostics
Glossary cobas c111
worklist - worklist
Roche Diagnostics
cobas c111 Index
Index
A applications, B-123
– activating, B-125
abbreviations, 9 – calculation definitions, B-136
abbreviations, ISE, E-5 – calibration definitions, B-134
aborting the process, A-113 – control definitions, B-135
Abs. air/water calibration, maintenance action, C-27 – deactivating, B-125
absorbance adjustment, definitions, B-148 – definitions, B-133
absorbance measurements, process, A-17 – deleting, B-129
absorbance photometer, A-61 – general definitions, B-133
acceptable flags list, editing, B-142 – importing, B-99, B-123
accepting – installing, B-100, B-124
– calibration results, B-58 – preparing, B-125
– patient results, B-51 – result conversion definitions, B-136
– QC results, B-65 – screen, A-110
acoustic signals, A-81, D-6 – uninstalling, B-128
Activate electrodes, maintenance action, E-43 approvals, 3
adding lots, B-89 approved parts, A-8
adjusting, touchscreen, B-116 assemblies, syringe, A-44
air/water calibration, C-27 auto accept
alarm button, A-80 – patient results, B-46
alarm LED, A-80 – QC results, B-56, B-63
alarm messages
– deleting, D-8
– exporting log, D-8 B
– overview, A-81
– printing, D-8 backup, B-72
– reacting to, D-7, D-38 barcode scanner, A-59, B-79
alarm monitor barcode sheets, reading, B-80
– overview, A-80, D-6 barcodes
alarms – reading from reagent bottles, B-79
– LED, A-80 – reading from sample tubes, B-80
– LED colors, A-81 – reading from sheets, B-80
– monitor, A-80 – reagent bottles, A-59
analyzer – samples, A-60
– See, instrument. – scanner, A-59
analyzing biohazardous materials, safety, A-6
– checking the progress, B-40 bottles
– samples, B-32 – cleaner, A-50
application codes, mapping, B-142 – external cleaner, B-18
– external fluid containers, B-15
– external waste container, B-17
– external water container, B-16, B-76
– ISE fluids, E-11
– reagents, A-51
– reagents, specifications, A-65
– replacing ISE, E-21, E-28
bottom detection, A-47
buttons
– alarms, A-80
– global action, A-71
– overview, A-116
Roche Diagnostics
Index cobas c111
C Clean rotor and heating channel,

maintenance action, C-10
calculation, B-136 Clean the water and waste containers,
calibration maintenance action, C-16
– checking if due, B-30 cleaner
– definitions, B-134, B-146 – checking external bottle, B-18
– deleting results, B-84 – replacing bottle, B-18
– during Prepare phase, B-29 cleaner bottle, A-50
– forecast period, A-27 cleaning
– introduction, A-24 – ISE tower off the instrument, E-34
– ISE, E-12, E-25 – ISE tower on the instrument, E-49
– main ISE calibration, E-12 – waste container, C-17
– overview, A-24 – water container, C-16
– performing, B-52 cleaning up, results, B-74
– reserve, A-27 clearing paper jam, D-40
– schedule, B-85 collapsing lists, A-74
– selecting tests, B-55 colors
– short guide, B-53 – alarm LED, A-81, B-44
– validating results, B-56, B-57 – cleaner button, B-18
calibration list, screen, A-101 – concept, A-69, A-72
calibration results – cuvette buttons, B-27
– auto accept, B-56 – instrument buttons, B-43
– obsolete, A-26 – ISE bottle buttons, E-28
calibrator lot, defining, B-90 – ISE LED, E-10
calibrators – LEDs, A-39, A-114
– placing, B-31, B-55, B-56 – maintenance actions, B-19
– specifications, A-65 – reagent buttons, B-24
certificates, importing, B-102 – sample buttons, B-40
changing – test buttons, B-30
– configuration values, B-121 – waste button, B-17
– low voltage fuses, D-43 – water button, B-16
– mains fuses, D-41 components
– orders, B-38 – disposal, A-11
– password, B-137 – instrument, A-41
– user definitions, B-141 – ISE unit, E-10
– user interface language, B-138 concepts
characters, special, A-76 – calibration, A-24
checking – colors in screens, A-69, A-72
– alarm messages, B-44 – wizards, A-69
– cleaner, B-18 condensation, removing from the reagent cooler, B-110
– external fluid containers, B-15 Condition ISE tubing, maintenance action, E-44
– instrument status, B-42 configuration, B-119, B-137
– ISE status, E-21 – Abs. adjustment, B-148
– printer status, D-40 – calibration definitions, B-146
– sample status, B-40 – changing values, B-121
– waste, B-17 – date and time, B-148
– water, B-16, B-76 – extra wash definitions, B-149, B-150, B-151
classification of safety notices, A-5 – host definitions, B-145
Clean and disinfect housing, maintenance action, C-21 – maintenance days, B-148
Clean ISE tower automatically, – QC definitions, B-147
maintenance action, E-48 – result handling, B-146
Clean ISE tower manually, maintenance action, E-49 – screen, A-106
Clean probe manually, maintenance action, C-12 – system definitions, B-147
Clean reagent disk and sample area, – viewing values, B-121
maintenance action, C-14 – workflow definitions, B-143
Roche Diagnostics
cobas c111 Index
connecting defining
– external cleaner bottle, B-114 – calibrator lots, B-90, B-132
– external waste container, B-114 – control lot, B-90
– external water container, B-113 – control lots, B-131
connectivity, host, A-30 – lots, B-89
connectors – orders, B-35
– fluids, A-45 – users, B-141
– overview, A-62 definitions, applications, B-133
contact addresses, 3 degasser, A-42
Contact service representative, deleting
maintenance action, C-26 – alarm messages, D-8
containers – applications, B-129
– fluids, A-48 – calibration results, B-84
– reagent disks, A-57 – orders, B-83
– waste, A-48 – patient results, B-83
– water, A-49 – profiles, B-130
control lot, defining, B-90 – QC results, B-85
controls – results at end of shift, B-74
– definitions, B-135 – users, B-141
– placing, B-61 demographics, patients, A-30
conventions used in manual, 8 Deproteinize probe, maintenance action, C-10
cooling, reagents, A-57 detection
copyrights, 2 – fluid levels, A-47
covers – tube bottom, A-47
– ISE, E-9 diagnostics data, exporting, D-44
– overview, A-37 diagnostics, screen, A-111
cross-contamination, A-9 dilutions, A-29
csv files, B-73 dimensions, specifications, A-64
cups, A-52 disconnecting tubes from instrument, B-115
cuvette ring, A-58 disinfecting housing, C-21
cuvette status, screen, A-89 display items, A-71
cuvettes, A-52 disposing
– checking the status, B-27 – instrument, A-11
– handling, A-53 – waste, B-76
– replacing, B-27, B-75 document information, 2
– ring, A-58
– segments, A-53
– specifications, A-65 E
edition notice, 2
D electrical safety, A-5
electrode block, E-10
daily backup, B-72 Electrode service, maintenance action, E-47
daily operation, B-3 electrodes
– introduction, A-20 – activating, E-43
– overview table, A-20 – maintenance, E-47
Daily prepare actions, maintenance action, E-42 – position in block, E-32
database – replacing, E-30
– exporting, B-92 electromagnetic devices, safety, A-8
– importing, B-101 emptying, waste container, B-17, B-76
– restoring, B-101 End of Shift short guide, B-68
date and time, definitions, B-148 environment, specifications, A-64
deactivating ISE unit, E-62 error messages, reacting to, D-38, E-78
Default QC exceptional situations
– overview, B-59 – ISE unit, E-78
– performing, B-61 – main instrument, D-36
Roche Diagnostics
Index cobas c111
exchanging reagents, B-24 H

expanding lists, A-74
export, screen, A-108 handling
exporting – cuvettes, A-53
– alarm message log, D-8 – lots, B-87
– database, B-92 – orders, A-30
– diagnostics data, D-44 – reagents, A-23, A-54
– log files, B-98 – results, A-31
– results, B-73, B-93 – samples, A-29
external bottle status, screen, A-93 – software data, A-65
external waste container, A-49 hardware
extra wash cycles – overview, A-35
– activating, B-150 – specifications, A-64
– deactivating, B-150 heads, transfer, A-46
– defining, B-149 heating channel, cleaning, C-10
– definitions, B-151 host
– deleting, B-150 – configuration, B-145
– importing, B-102 – connectivity, A-30
– definitions, B-145
host codes, B-142
F – screen, A-111
housing, cleaning, C-21
features of instrument, A-15
filtering, A-76
finishing the shift, B-68 I
flags
– Abs. results, D-22 import, screen, A-108
– ISE results, E-69 importing
– overview, D-19 – application data, B-99
– priorities, D-20 – applications, B-99, B-123
– viewing details, D-19 – certificates, B-102
flaps – database, B-101
– instrument, A-37 – extra wash cycles, B-102
– ISE unit, E-9 – mixing information, B-102
fluid system – software, B-101
– overview, A-43 Initialize ISE reference sensor, maintenance action, E-45
– priming, C-11 Initialize ISE unit, maintenance action, E-51
fluids installation, safety, A-7
– bottles, A-48 installing
– bottles for ISE, E-11 – applications, B-100, B-124
– checking external containers, B-15 – ISE pump tubing, E-52
– connecting external cleaner bottle, B-114 – ISE unit tubing, E-59
– connecting waste container, B-114 instrument
– connecting water container, B-113 – approvals, 3
– external connectors, A-45 – disposal, A-11
– ISE, E-8 – features, A-15
– replacing ISE bottles, E-21, E-28 – introduction, A-13
forecast period, A-27 – main components, A-41
fuses, A-63 – overview, A-15
– changing for mains, D-41 – switching on, B-10
– changing low voltage, D-43 – where to use, A-7
intended use
– instrument, 7
G – of operator’s manual, 2
interface
global action buttons, A-71 – See, user interface
Roche Diagnostics
cobas c111 Index
interfaces, specifications, A-65 K

internal waste tank, A-48
interpreting, QC History, B-65 keyboards, A-74
Interval QC
– overview, B-59
– performing, B-62 L
intervals
– ISE maintenance actions, E-39 language, B-138
– maintenance actions, C-7 layout of screens, A-70
introduction LEDs
– See, overview. – alarms, A-81
ISE – color table, A-39, A-114
– calibration, E-12 – ISE, E-10
– calibrator, priming, E-46 – overview, A-39
– checking status, E-21 level detection, A-47
– cleaning tower automatically, E-48 lids
– cleaning tower manually, E-49 – ISE, E-9
– cleaning tower off the instrument, E-34 – overview, A-37
– conditioning tubing, E-44 lists
– flags, E-69 – Abs. flags, D-22
– fluid containers, E-11 – alarm messages, D-9
– installing pump tubing, E-52 – expanding and collapsing, A-74
– installing tubing, E-59 – ISE flags, E-69
– list of flags, E-69 – lots, A-103
– main calibration, E-25 – orders, A-95
– maintenance, E-37 loading
– measurement process, E-7 – reagent disk, B-21, D-44
– measuring modes, E-6 – reagents, B-25
– monitoring status, E-23 loadlist, screen, A-104
– operation, E-17 log files, exporting, B-98
– overview, E-5 logging off, B-78
– preparing system, E-20 logging on, B-11
– priming calibrator, E-46 logs, alarm messages, D-8
– principles of measurement, E-7 lot data, screen, A-102
– pump tubing, E-52 lot list, A-103
– replacing pump tubing, E-52 lots
– replacing tubing, E-55 – adding, B-89
– sensors, E-11 – defining, B-89
– solutions, E-8 – defining for calibrators, B-132
– standby, E-12 – defining for controls, B-131
– status, E-67 – handling, B-87
– tower, E-34, E-48, E-49 – list, A-103
– troubleshooting, E-65 – viewing definitions, B-87
– tubing, E-11, E-59 – viewing details of used fluids, B-89
ISE reference sensor, initializing, E-45 lower-case letters, A-75
ISE status, screen, A-91
ISE tower, E-11
– cleaning automatically, E-48 M
– cleaning manually, E-49
– cleaning off the instrument, E-34 main calibration, E-12, E-25
ISE unit, E-9 maintenance
– deactivating, E-62 – instrument, C-5
– main components, E-10 – ISE, E-37
– specifications, A-65 – overview, C-5
– screen, A-107
Roche Diagnostics
Index cobas c111
maintenance actions O
– Abs. air/water calibration, C-27
– Activate electrodes, E-43 obsolete calibration, A-26
– Clean housing, C-21 online Help, using, 7, A-79
– Clean ISE tower automatically, E-48 operation
– Clean ISE tower manually, E-49 – overview, B-7
– Clean probe manually, C-12 – principles, A-17
– Clean reagent disk, C-14 – routine, B-3
– Clean rotor and heating channel, C-10 – routine ISE, E-17
– Clean rotor heating channel, C-31 – safety, A-6
– Clean water and waste, C-16 operators
– colors of entries, B-19 – qualifications, A-8
– Condition ISE tubing, E-44 – regular breaks, A-9
– Contact service representative, C-26 optical safety, A-6
– Daily prepare actions, E-42 order of processing, B-40
– Deproteinize probe, C-10 order profiles, B-130
– Electrode service, E-47 orders
– Initialize ISE reference sensor, E-45 – changing, B-38
– Initialize ISE unit, E-51 – changing with sample on board, B-38
– intervals, C-7 – checking for unfinished, B-70
– intervals for ISE, E-39 – defining, B-35
– performing, C-6 – defining profiles, B-130
– performing during End Shift phase, B-75 – deleting, B-83
– performing during Prepare phase, B-19 – handling, A-30
– Prime fluid system, C-11 – IDs, A-30
– Prime ISE calibrator and reference, E-46 – introduction to handling, A-30
– Replace ISE pump tubing, E-52 – list, A-95
– Replace ISE unit tubing, E-55 – order of processing, B-40
– Replace photometer lamp, C-23 – overview, A-30
– Replace water inlet filter, C-19 – STAT, B-38
maintenance days, B-148 – workflow setup, B-34
manual, how to use, 7 overview
mapping, application codes, B-142 – buttons, A-116
measurements, specifications, A-64 – calibration, A-24
measuring modes, ISE, E-6 – daily operation, A-20
messages – flags, D-19
– alarms, A-81, D-9 – instrument, A-13, A-15
– list, D-9 – ISE, E-5
– overview, A-80, D-5 – ISE operation, E-17
– screen, A-80, D-5 – maintenance, C-5
mixing information, importing, B-102 – messages, A-80, D-5
mixing motor, A-47 – order handling, A-30
mixing reagents, B-67 – reagent handling, A-23
– during Prepare phase, B-28 – result handling, A-31
monitor – routine operation, B-7
– See, alarm monitor. – sample handling, A-29
monitoring – user interface, A-18, A-69
– analysis process, B-40 – wizards, A-19
– ISE status, E-23 Overview tab, A-82
navigation, through screens, A-72
Roche Diagnostics
cobas c111 Index
P printer
– clearing paper jam, D-40
panels – overview, A-60
– ISE, E-9 – refilling paper, B-108
– overview, A-37 – specifications, A-65
– See also, test panels. printer status, checking, D-40
paper jam, clearing, D-40 printing
paper, refilling, B-108 – alarm messages, D-8
password – overview, A-78
– changing, B-137 – patient results, B-51
– typing, B-11 – stopping, A-78, B-51
patient results priority, flags, D-20
– accepting, B-51 probe
– auto accept, B-46 – cleaning manually, C-12
– checking for not accepted, B-70 – deproteinizing, C-10
– deleting, B-83 – description, A-47
– printing, B-51 – hardware, A-44
– validating, B-46 – replacing, B-111
– validating if sample on board, B-47 processing, stop, B-45
– validating if sample removed, B-48 profiles, B-130
performing – adding tests, B-130
– calibration, B-52 – deleting, B-130
– calibration during Prepare phase, B-29 pumps, ISE, E-10
– Default QC, B-61
– Interval QC, B-62
– maintenance actions, C-6 Q
– QC, B-59
– reagent mixing, B-67 QC
– reagent mixing during Prepare phase, B-28 – Default QC, B-59
– tests, B-32 – definitions, B-147
peristaltic pump, E-10 – interpreting history, B-65
photometer – Interval QC, B-59
– overview, A-61 – list, A-98
– specifications, A-65 – overview, A-28
photometer lamp, replacing, C-23 – performing, B-59
power – performing Default QC, B-61
– interruption, A-8 – performing Interval QC, B-62
– requirements, A-64 – short guide, B-60
precalibration, A-27 – status list, A-98
Prepare phase, short guide, B-12 – when due, A-28
Prepare wizard, B-14 QC history
preparing – graph, B-66
– applications, B-125 – interpreting, B-65
– ISE unit, E-20 – screen, A-99
– new reagent disks, B-103 QC history graph, screen, A-100
– reagents, B-22 QC results
– system, B-12 – auto accept, B-63
Prime ISE reference and calibrator, – deleting, B-85
maintenance action, E-46 – validating, B-63
Prime the fluid system, maintenance action, C-11 QC status list, screen, A-98
principles qualifications, of operators, A-8
– absorbance measurements, A-17 quality control
– calibration, A-24 – See, QC.
– ISE measurements, E-7
– specifications, A-64
Roche Diagnostics
Index cobas c111
R result handling
– definitions, B-146
reagent bottles, A-51 – overview, A-31
– reading barcodes, B-79 result list, screen, A-96
– specifications, A-65 results
reagent cooler, removing condensation, B-110 – calibration, B-57
reagent disks – checking for not accepted patient results, B-70
– cleaning, C-14 – checking for transmission, B-71
– ID, A-56 – cleaning up at end of shift, B-74
– loading, B-21 – deleting of calibration, B-84
– overview, A-56 – deleting of patients, B-83
– preparing, B-103 – deleting of QC, B-85
– realigning, D-44 – exporting, B-73, B-93
– removing, B-77 – flags, D-17
– storage container, A-57 – handling, A-31
reagent handling, overview, A-23 – introduction to handling, A-31
reagent sets, A-23 – list, A-96
reagent status, screen, A-90 – patients, B-46
reagents – patients, if sample on board, B-47
– barcodes, A-59 – patients, if sample removed, B-48
– bottles, A-51 – printing of patients, B-51
– cooling, A-57 – validating for QC, B-63
– exchanging, B-24 – validating of patients, B-46
– handling, A-54 revision history, 2
– introduction to handling, A-23 rotor
– loading, B-25 – cleaning, C-10
– preparing, B-22 – overview, A-55
– removing, B-24
– replacing, B-24
– safety, A-7 S
– sets, A-23
refilling safety, A-3
– printer paper, B-108 – approved parts, A-8
– water container, B-16, B-76 – biohazardous materials, A-6
removing, B-45 – calibration, B-52
– reagent disk, B-77 – classification, A-5
– reagents, B-24 – cross-contamination, A-9
– sample tubes, B-45 – disposal of instrument, A-11
repeating, tests, B-49 – during End of Shift phase, B-68
Replace ISE pump tubing, maintenance action, E-52 – during Prepare phase, B-12
Replace ISE unit tubing, maintenance action, E-55 – during routine operation, B-5
Replace photometer lamp, maintenance action, C-23 – electrical, A-5
Replace water inlet filter, maintenance action, C-19 – electromagnetic devices, A-8
replacing – insoluble contaminants, A-9
– cleaner bottle, B-18 – installation, A-7
– cuvettes, B-27, B-75 – instrument covers, A-6
– electrodes, E-30 – ISE operation, E-19
– ISE bottles, E-21, E-28 – operation and maintenance, A-6
– printer paper, B-108 – operator breaks, A-9
– probe, B-111 – operator qualifications, A-8
– reagents, B-24 – optical, A-6
– water container, B-16, B-76 – performing ISE maintenance, E-40
rerunning, tests, B-50 – performing QC, B-59
restarting the system, A-113 – power supply, A-8
restoring database, B-101 – reagents and working solutions, A-7
result conversion, B-136 – spillages, A-9
Roche Diagnostics
cobas c111 Index
safety screens
– third-party software, A-8 – QC history, A-99
– transport, A-5 – QC history graph, A-100
– waste, A-7 – QC list, A-98
– when analyzing samples, B-32 – QC status, A-98
– when exchanging external bottles, B-15 – reagent status, A-90
– when handling cuvettes, B-27 – result list, A-96
– when handling external bottles, B-15 – sample overview, A-84
– when handling reagents, B-22 – scrolling, A-73
– when removing reagent disk, B-77 – stopping processing, A-113
– when troubleshooting ISE, E-68 – system status, A-92
– when using the barcode scanner, B-79 – test selection, A-86
– with flags, D-21 – test status, A-87
– with maintenance actions, C-8 – users, A-112
sample area – worklist, A-104
– cleaning, C-14 scrolling, A-73
– overview, A-42 segments of cuvettes, A-53
sample handling, overview, A-29 selecting groups of list items
sample ID, A-29 – See, filtering.
sample overview, screen, A-84 selecting, tests to be calibrated, B-55
samples sensors, ISE, E-11
– analyzing, B-32 service representative, contacting, C-26
– barcodes, A-60 setting up, order definition, B-34
– checking the status, B-40 sheets, barcodes, B-80
– handling, A-29 shift
– introduction to handling, A-29 – finishing, B-68
– overview, B-45 – starting, B-10
– reading barcodes, B-80 short guides
– short guide, B-32 – analyzing samples, B-32
– specifications, A-64 – calibration, B-53
sampling stop, A-113 – End of Shift, B-68
scanners, A-59 – ISE Prepare phase, E-20
scheduling, calibration, B-85 – Prepare phase, B-12
screens – QC, B-60
– alarms, A-80 shutting down the system
– applications, A-110 – end of shift, B-78
– calibration list, A-101 – stop option, A-113
– configuration, A-106 software
– cuvette status, A-89 – importing, B-101
– diagnostics, A-111 – updating, B-101
– display items, overview, A-71 software data handling, specifications, A-65
– expanding and collapsing lists, A-74 solutions, ISE, E-8
– export, A-108 special characters, A-76
– external bottle status, A-93 specifications, technical, A-64
– host codes, A-111 spillages, safety, A-9
– import, A-108 standby, ISE status, E-12
– ISE status, A-91 starting
– keyboards, A-74 – a run, B-40
– layout, A-70 – processing, B-40
– Loadlist, A-104 – shift, B-10
– lot data, A-102 STAT orders, B-38
– lot list, A-103
– maintenance, A-107
– messages, A-80, D-5
– navigation, A-72
– orders list, A-95
Roche Diagnostics
Index cobas c111
status text, typing, A-74

– cuvettes, B-27 third-party software, A-8
– instrument, B-42 throughput, specifications, A-64
– ISE unit, E-67 touchscreen, adjusting, B-116
– sample tubes, B-40 trademarks, 2
– standby for ISE, E-12 transfer head, A-46
– system, A-32 transfer unit, A-46
stop, screen, A-113 transmission, checking of results, B-71
stopping transport, safety, A-5
– printing, A-78, B-51 troubleshooting
– processing, B-45 – ISE, E-65
– run, B-45 – main instrument, D-33
storage facilities, specifications, A-65 tube bottom detection, A-47
switching tubes, A-52
– between upper and lower-case, A-75 – disconnecting from instrument, B-115
– off, B-78 tubing
– on, B-10 – conditioning, E-44
symbols, A-8 – connecting to instrument, B-113
syringe – disconnecting from instrument, B-115
– assembly, A-44 – installing for ISE, E-59
– hardware, A-44 – ISE, E-11
system – replacing of ISE, E-55
– definitions, B-147 – replacing of ISE pump, E-52
– logging on, B-11 typing
– preparing, B-12 – password, B-11
– preparing ISE, E-20 – text, A-74
– See also, instrument. – user name, B-11
system status
– overview, A-32
– screen, A-92 U
systems
– fluid, A-43 unfinished orders, B-70
– See also, units, assemblies. uninstalling applications, B-128
units
– ISE, E-9
T – laboratory, B-136
– transfer, A-46
tabs, B-106 updating software, B-101
– assigning tests, B-106 upper-case letters, A-75
– Overview, A-82 user interface language, B-138
– removing tests, B-107 – changing, B-139
– Utilities, A-105 – installing, B-139
– Workplace, A-94 – uninstalling, B-140
technical specifications, A-64 user interface, overview, A-18, A-69
test panels user name, typing, B-11
– assigning tests, B-106 users
test selection, screen, A-86 – defining, B-141
test status, screen, A-87 – deleting, B-141
tests – screen, A-112
– adding to profile, B-130 using
– assigning to tabs, B-106 – manual, 7
– defining profiles, B-130 – online Help, 7, A-79
– performing, B-32 Utilities tab, A-105
– removing from tabs, B-107
– repeating, B-49
– rerunning, B-50
Roche Diagnostics
cobas c111 Index
V W
validating wash station, A-45

– calibration results, B-56 waste
– patient results, B-46 – checking external, B-17
– QC results, B-63 – cleaning container, C-17
viewing – emptying, B-17, B-76
– configuration values, B-121 – external container, A-49
– flag details, D-19 – internal tank, A-48
– lot definitions, B-87 – safety, A-7
– lot details of used fluids, B-89 water
– checking external, B-16, B-76
– cleaning container, C-16
– container, A-49
– refilling, B-16, B-76
– specifications, A-65
water filter, changing, C-19
wavelengths, A-61
wizards
– concept, A-69
– End Shift, B-72
– introduction, A-19
– orders, B-32
– Prepare, B-14
workflow, definitions, B-143
working solutions, safety, A-7
worklist, A-104
Workplace tab, A-94
Roche Diagnostics
Index cobas c111
Roche Diagnostics
Revisions G
cobas c111 Revisions
Revisions
Roche Diagnostics
Operator’s Manual · Version 2.0 G-3
Revisions cobas c111
Roche Diagnostics
G-4 Operator’s Manual · Version 2.0

c111 Operators Manual V2 en

Uploaded by

Copyright:

Available Formats

c111 Operators Manual V2 en

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

c111 Operators Manual V2 en

Uploaded by

Copyright:

Available Formats

What is the intended use of the cobas c111 instrument?

What is the intended use of the cobas c111 instrument?

What international standards are used in manufacturing and testing the cobas c111 instrument?

What international standards are used in manufacturing and testing the cobas c111 instrument?

cobas c111 system

Revision history Manual version Software version Revision date Changes

Language Order number

Copyrights © 2007, Roche Diagnostics GmbH. All rights reserved.

Trademarks The following trademarks are acknowledged:

Complies with European Union (EU) Directive 98/79/EC.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the

Manufacturer Roche Diagnostics Ltd.

Distributor Roche Diagnostics GmbH

Troubleshooting Part D Glossary and Index Part F

9 Messages and alarms Glossary F-3

How to use this manual

Online Help system

Conventions used in this manual

Symbols The following symbols are used:

Symbol Used for

Electrical and electronic equipment marked with this symbol are

Abbreviations The following abbreviations are used:

i.e. Id est – that is to say

LED Light-emitting diode

n/a Not applicable

REF Reference solution for ISE unit

Units Abbreviation Description

In this chapter Chapter 1

Disposal recommendation ........................................................................................ A-11

Injury from heavy loads

Electrical shock by electronic equipment

Personal injury or damage to the analyzer due to contact with instrument

Personal injury or damage to the analyzer due to contact with instrument

Operation and maintenance

Personal injury or damage to the analyzer due to contact with instrument

Infection by biohazardous materials

Infection by waste solution

Reagents and other working solutions

Injury through reagents and other working solutions

Skin inflammation caused by reagents

Incorrect results or damage to the analyzer due to wrong installation

Incorrect results or damage to the analyzer due to heat and humidity

e For details on the required environmental conditions, see Environmental conditions on

NOTICE Data loss or damage to the system due to voltage drop

NOTICE Malfunction of instrument and incorrect results due to interfering electromagnetic

Malfunction of instrument and incorrect results due to nonapproved parts

Malfunction of instrument and incorrect results due to third-party software

Incorrect results or damage to the analyzer due to wrong operation

Operation over an extended period of time

Fatigue due to long hours of operation

Cross contamination of sample

Incorrect results due to carryover

Insoluble contaminants in sample

Incorrect results and interruption of analysis due to contaminated samples

NOTICE Malfunction due to spilled liquid

Malfunction of instrument and incorrect results due to software modifications by

Disposal of external components

Disposal of the instrument

The instrument must be treated as biologically contaminated hazardous waste. Final