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c111 Operator Manual PDF
c111 Operator Manual PDF
Operator’s Manual
Version 4.0
cobas c111
Document information
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 with software version 4.0.
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
in vitro determination of clinical chemistry and electrolyte parameters in serum,
plasma, urine or whole blood (HbA1c).
It is important that the operators read this manual thoroughly before using the
system.
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Instrument approvals The cobas c111 instrument meets the protection requirements laid down in Directive
98/79/EC of the European Parliament and of the Council of 27 October 1998 on In-
vitro Diagnostic Medical Devices. Compliance is provided by means of the
Declaration of Conformity.
Regulatory compliance is demonstrated by the following marks:
Contact address
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Table of contents
Document information 2
Contact address 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–34
Validating sample results B–51
System Description Part A Performing calibrations B–59
Performing QC B–68
1 Safety Finishing the shift B–77
Safety classification A–5 Logging off B–88
Safety information A–5 Shutting down the system and switching off the
Data security A–10 instrument B–88
License notices A–11 Using the barcode scanner B–89
Legal liability A–11
Disposal recommendation A–12 6 Special operations
Safety labels A–13 Deleting sample orders B–93
Deleting sample results B–94
2 Introduction to the instrument Calibration B–95
Overview A–17 Deleting QC results B–96
User interface A–20 Lot handling B–98
Wizards A–21 Exporting data B–104
Daily operation A–22 Importing data B–111
Maintenance A–34 Preparing a new disk B–116
System status A–35 Assigning tests to test tabs B–119
Deleting bottle sets from the Inventory list B–120
3 Hardware Refilling printer paper B–122
Covers and panels A–39 Removing condensation water from the reagent
LEDs A–41 cooler B–124
Main components A–43 Replacing the probe B–125
Hardware overview A–44 Connecting and disconnecting the external fluid
Technical specifications A–66 containers B–127
Adjusting the touchscreen B–130
4 Software Cleaning the touchscreen B–131
Introduction A–71
Screen layout A–72 7 Configuration
Display items A–73 Introduction B–135
Workflows and wizards A–74 Applications B–137
Working with the user interface A–75 Configuration B–157
Key screens A–84
Color interpretation for LEDs A–122
Buttons A–124
Maintenance Part C
8 General maintenance
Overview C–5
Maintenance actions C–8
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13 ISE operation
Troubleshooting Part D Daily operation E–17
Replacing ISE fluid bottles E–30
9 Messages and alarms Replacing electrodes E–32
About messages D–5 Cleaning the ISE tower off the instrument E–36
Message screen D–5
Acoustic signals D–6 14 ISE maintenance
Alarm monitor D–6 Introduction E–41
List of alarm messages D–10 ISE maintenance actions E–42
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Preface
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 describes the cobas c111 features and general operational concepts, and
it provides operating, maintenance, and emergency procedures.
Parts B through D describe the instrument without using an ISE unit, ISE specific informa-
tion is given in part E.
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.
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.
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Visual cues are used to help locate and interpret information in this manual quickly.
This section explains the formatting conventions used in this manual.
Safety alert
Buttons When used for identification purposes, a generic form of the buttons is used, without
color or navigation indicators.
Screenshots The screen representations shown in this publication are for illustrative purposes
only. The screens do not necessarily show valid data.
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Abbreviation Definition
Cfas Calibrator for automated systems
DIL Diluent
DM Data management
DRAM Dynamic random access memory
e.g. Exempli gratia – for example
EMC Electromagnetic compatibility
EN European standard
i.e. Id est – that is to say
IEC International Electrical Commission
ISE Ion selective electrode
LED Light-emitting diode
LIS Laboratory information system
LLD Liquid level detection
n/a Not applicable
QC Quality control
REF Reference solution for ISE unit
ROM Read only memory
SD Standard deviation
SRAM Static random access memory
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System Description A
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
2 Introduction to the instrument . . . . . . . . . . . . . . . . . . . . . . . . . A-15
3 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-37
4 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-69
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 c111
instrument.
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Table of contents
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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
Electrical safety
Electrical safety
Connect the analyzer to grounded power outlets only (IEC protection class 1). All periph-
eral 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.
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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
Instrument covers
Biohazardous materials
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Safety information
Waste
Installation
Environmental conditions
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Safety information
Power interruption
Electromagnetic devices
NOTICE Instructions for in vitro diagnostic (IVD) equipment for professional use
The IVD equipment complies with the emission and immunity requirements described in
the particular requirements for IVD medical equipment of the EN/IEC 61326-2-6 standard.
The electromagnetic environment should be evaluated prior to operation of the device.
Approved parts
Third-party software
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Safety information
Operator qualification
Spillage
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Data security
Data security
Unauthorized access and data loss due to malicious software and hacker attacks
Portable storage media can be infected with and transmit computer malware, which may
CAUTION be used to gain unauthorized access to data or cause unwanted changes to software.
The cobas c111 is not protected against malicious software and hacker attacks.
The customers are responsible for IT security of their IT infrastructure and for protecting it
against malicious software and hacker attacks. Failure to do so may result in data loss or
render the cobas c111 unusable.
Roche recommends the following precautions:
o Allow connection to authorized external devices only.
o Ensure that all external devices are protected by appropriate security software.
o Ensure that access to all external devices is protected by appropriate security equip-
ment.
o Do not copy or install any software on the cobas c111 unless it is part of the system
software or you are instructed to do so by a Roche service representative.
o If additional software is required, contact your Roche service representative to ensure
validation of the software in question.
o Do not use the USB ports to connect other storage devices unless you are instructed to
do so by official user documentation or a Roche service representative.
o Exercise utmost care when using external storage devices such as USB flash drives,
CDs, or DVDs. Do not use them on public or home computers while connecting to the
cobas c111.
o Keep all external storage devices in a secure place and ensure that they can be
accessed by authorized persons only.
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License notices
License notices
Legal liability
Roche Diagnostics Ltd. assumes only limited liability when using the cobas c111
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 c111 and the cobas c111 Development Channel
Operator’s Manual.
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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.
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 govern-
ment or local authorities.
For more information about disposal of your old products, contact your city office, waste
disposal service or your local service representative.
The instrument must be treated as biologically contaminated hazardous waste. Final dis-
posal must be organized in a way that does not endanger waste handlers. As a rule, such
WARNING equipment must be sterile before it is passed on for final disposal.
For more information contact your local service representative.
Constraint
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Safety labels
Safety labels
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 bio-
there is a danger of hazardous situations arising within the vicinity hazards within the vicinity of this label, which may result in death
of this label, which may result in death or serious injury. The rele- or serious injury.
vant 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.)
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.
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Table of contents
In this chapter, you will find basic information on the features that are relevant for
working with the cobas c111 instrument.
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Overview
Overview
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).
Only trained personnel working in a professional laboratory environment may
operate the cobas c111 instrument.
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.
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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.
L M N O
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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.
Sequence of processing For a given sample, the tests are processed in the order defined by the time required
for their processing (number of cycles), starting with the one that takes the longest.
This order can be altered manually by defining a specific process sequence list.
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.
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User interface
User interface
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).
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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-74.
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.
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.
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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
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A B C
A Reagent disk
B Reagent bottle with barcode
C Chimney
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.
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Daily operation
Volume detection For each reagent set, the number of available tests is continuously calculated.
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
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.
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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].
Day Trigger/Event Task Result used Set Cal. type Cal. Usage
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
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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.
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).
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 procedures
There are three basic procedures for performing calibration:
o Calibrating all reagent sets that will need calibrating during the forecast period
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-167.
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.
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Daily operation
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.
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Daily operation
Validating QC results Each new QC result has to be validated. If flags were generated, you must determine
their cause and decide whether to accept or ignore the result.
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-162.
If you ignore a QC result you exclude the result from further QC result calculations
such as QC History statistics.
Sample handling
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.
Sample types The cobas c111 instrument can process the following sample fluids:
o Serum
o Plasma
o Urine
o Whole blood for HbA1c
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Daily operation
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-54.
Sample barcode You can use sample tubes with or without barcode.
Removing sample tubes You can remove sample tubes as soon as pipetting is complete.
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).
Patient demographics The cobas c111 software does not support the handling of patient demographic data.
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Daily operation
Host connectivity The cobas c111 instrument can be connected to an external laboratory information
system (LIS), a host computer for downloading order information and uploading
results, or a cobas c111 Printer Tool.
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 c111 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.
e For the setup when connecting to a cobas c111 Printer Tool, see the cobas c111 Printer
Tool Operator’s Manual.
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.
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 sample 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.
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Maintenance
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.
Ratio results The user can manually define ratios. Ratio results are handled like any other sample
result, with the exception that they cannot be accepted by the user. They are
automatically accepted if all their constituent results are accepted.
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 sample 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.
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-158.
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System status
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-122.
o The colors of buttons inform you whether you need to intervene.
e See Color concept on page A-74.
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.
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.
Diagnostics A diagnostics 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
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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.
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Covers and panels
The following figure shows the removable panels and the lids that can be opened.
A B C D
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Covers and panels
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LEDs
LEDs
LEDs are placed on key positions on the cobas c111 instrument. They inform you
whether you can perform certain actions.
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LEDs
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Main components
The following figure illustrates the main components of the cobas c111 instrument.
A B C D E
G
H
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.
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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.
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
cobas c111 instrument.
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-54.
A The LED indicates that the transfer tower is approaching or that you should place a sample
tube.
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.
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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
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.)
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C
B
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.
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Hardware overview
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.
A B C
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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.
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.
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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.
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Fluid containers
The following table shows which container is used for which fluid:
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-54.
Waste containers
A
C
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)
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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-127.
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
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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.
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
e See Connecting and disconnecting the external fluid containers on page B-127.
See Checking the status of the external fluid containers on page B-15.
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Reagent bottles
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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.
Roche recommend using approved cups only. The following table lists the approved
cups.
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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
Cuvette segments
Each segment holds 10 cuvettes.
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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-28.
A Hold the segment by its handle. Make sure not to touch the cuvettes.
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.
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Rotor
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
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Reagent disk
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
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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
e See maintenance action Clean reagent disk and sample area on page C-14.
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Cuvette ring
B
A Cuvette ring B Cuvette segment
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.
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Barcode scanner
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.
A B
e For information on how to use the barcode scanner, see Using the barcode scanner on
page B-89.
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
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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)
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
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Absorbance photometer
The cobas c111 main instrument uses the absorbance photometry measuring
method.
Absorbance photometer
A 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-24.
Wavelengths for the absorbance For each cuvette, the absorbance photometer measures light intensity at 12 different
photometer wavelengths:
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Connectors
E
A F
G
H
I J K
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Fuses
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
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Technical specifications
Technical specifications
NOTICE Every effort has been made to ensure that all the information contained in these specifica-
tions 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.
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Technical specifications
Display Color touchscreen 5.7 inch active matrix (1/4 VGA, 320 x 240 pixels)
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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.
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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.
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Screen layout
Screen layout
A
B
C
The screen representations shown in this chapter and throughout this manual are for illus-
trative 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 sit-
a sequence of screens (wizard), the headline uation.
tells you where you are within this sequence. G The global action buttons represent the func-
D The working area displays the main content tions that are permanently available: Start,
of the screen. Stop, Alarm, Line Feed. The LEDs next to
them point to their status.
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Display items
Display items
The cobas c111 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.
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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.
e For details on the meaning of LED colors, see Color interpretation for LEDs on
page A-122.
e For details on the meaning of button colors, see the explanations in the relevant operation
instructions.
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
e For an overview of the navigation buttons, see Navigation functions on page A-126.
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Working with the user interface
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-130.
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.
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Working with the user interface
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 .
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
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Numeric keyboard
A Typed text
Alphanumeric keyboards
A Typed text
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A Typed text
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:
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2 Press .
A screen is displayed for selecting the filter criterion.
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].
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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:
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A The Help button is always in the top right corner of the screen.
A The Legend tab describes the buttons and B The Workflow tab provides additional
their colors. information on items on the screen or on
actions you can perform.
Figure A-44
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Messages
Message screen
Message screens are displayed automatically as soon as the message is generated.
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 when all alarm messages are confirmed.
The Alarm button is always active, even if nobody is logged on the system.
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Yellow There is at least one unconfirmed alarm message. You need to deal with it as soon as
possible.
Red There is at least one unconfirmed alarm message. You need to deal with it
immediately, processing may not be able to 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).
Alarm message A B
Figure A-47
e For details on handling alarm messages, see Reacting to alarm messages on page D-7.
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Key screens
The screen representations shown in this chapter and throughout this manual are for illus-
trative purposes only. The screens do not necessarily show valid data.
The main screen is divided into tabs. These tabs represent distinct work areas.
f 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.
End Shift Perform the necessary tasks when ending the shift.
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Fewer than 10% of tests are left for a reagent set, or its expiration date has passed.
Check the status of the cuvette segments currently loaded on the rotor.
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-95).
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
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Sample overview
B
C
1 The number in the button indicates the position on the sample area.
1
All tests are completed and their results are accepted.
1*
All tests are pipetted.
10 The number below the sample tube button indicates the estimated time to
completion. You can remove the sample tube, the time to completion disappears
when you do so.
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.
11 The number below the sample tube button indicates the estimated time to
completion.
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.
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Orders
f 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 c111 instrument is integrated in your laboratory
infrastructure (barcodes, host connection).
Identifying samples
Figure A-50
Figure A-51
e For information on how to use the keyboard screens, see Typing text on page A-76.
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Key screens
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.
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,
profiles, and ratios to them.
The tests, profiles, and ratios are sorted alphabetically. Profiles and ratios precede the
tests, and they adopt the color of their tests.
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STAT
f 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.
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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.
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Key screens
<xyz
Display detailed information on the status of this test.
Display a list of all defined tests, together with information on their status.
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.
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.)
Show the fluids that were used for generating this result, together with their lot
information.
Profiles are user defined sets of tests. They are represented like any other test.
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Key screens
Log off
f Overview > button with your user name
Log off the system.
You can log off any time, even while the system is processing orders.
Prepare
f Overview > Prepare
Start the Prepare wizard to perform the preliminary tasks at the beginning of a shift.
End shift
f Overview > End Shift
Start the End Shift wizard to perform the tasks necessary for ending the shift.
Cuvette status
f Overview > .
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:
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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.)
B The number to the left of the button indicates the number of free positions on the 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 passed.
<xyz>
Display detailed information on the status of this test.
Load a reagent set. The number to the left of the button indicates the number of free
5
positions on the disk.
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
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ISE status
This button is only active if your instrument is equipped with an ISE unit.
f Overview > .
Na, K, Cl, Ref Display detailed information on the status of the electrode.
Cal, Ref Display detailed information on the status of the ISE fluid bottle.
The fluid level in the bottle is low. (Operation will proceed until one of the sensors
detects that there is no fluid.)
Display the placement list for actions that are due, for example calibration or
electrode service.
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System status
f 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.)
Check the texts for the status of hardware items and on IDs of installed software.
o Roche strongly recommends to always use extra wash cycles with development chan-
nel applications, and also to always load extra cleaner when tests with extra wash
cycles are used.
o Roche Diagnostics Ltd. assumes only limited liability when using the cobas c111
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 c111 and the cobas c111 Develop-
ment Channel Operator’s Manual.
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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.)
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Cleaner button Press to confirm that you have exchanged the external cleaner bottle.
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.
Workplace tab
The Workplace tab leads to information on orders and the corresponding results.
QC History View QC results—on individual screens—of the current or the previous calendar
month, or those generated before the previous month.
Lot Data Define and change calibration and QC lot data by reading barcodes or typing the
values.
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Orders
f Workplace > Orders
St column Status
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.)
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Result list
f Workplace > Result Review
S column Status
!: This result has not yet been accepted.
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Delete results.
You can choose what kind of result should be deleted:
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 Selected
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QC status list
f Workplace > QC Status
S column Status
!: The result has not been accepted yet.
I: The result was ignored.
@: The result has not been transmitted yet.
Print QC results.
Delete QC results.
You can choose what kind of result should be deleted:
o All
o All Accepted
o Selected
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QC history
The QC history provides—on individual screens—information on the QC results of
the current and the previous calendar month as well as on results generated before
the previous month.
A graphic representation of the results provides a convenient way for comparing
results over a period of time.
f Workplace > 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.
Delete QC results.
You can choose what kind of result should be deleted:
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 Older than Previous Month
o Selected
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A B C
D
E
F
H
I
J
Month button Display the results of the month indicated on the button.
Old Display the results generated before the beginning of the previous month.
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Calibrations list
f Workplace > Calibrations
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.
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Lot data
f Workplace > Lot Data
Choose the kind of material for which you want to handle lot data.
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Lot list
f 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
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Loadlist
List of tests that are ready to be performed.
f Workplace > Loadlist
A B
Worklist
The worklist shows all tubes currently placed on the sample area.
f Workplace > Worklist
A B
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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.
Inventory Display information on bottle sets that are currently defined on any disk used on the
cobas c111.
Import Import application data, software updates, the complete content of a database,
certificates, extra wash cycle definitions, reagent mixing rules, or a new user interface
language.
Export Export the complete content of the database, the full results, and log files.
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Configuration
f Utilities > Configuration
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.
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Maintenance
f Utilities > Maintenance
A B
The maintenance actions are listed according to the urgency with which they need to
be performed.
This maintenance action should be performed on the next major maintenance day.
The defined maintenance interval has expired. Perform this maintenance action now.
If you interrupt the performing of a maintenance action that was due, its status will remain
due, and you need to fully re-perform the action later.
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Laboratory Parameters Handle the definitions of the installed applications and import and install new
applications.
Host Codes Display, export and import the mapping table for test IDs of the cobas c111
instrument and the laboratory information system.
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Applications
f Utilities > Applications > Laboratory Parameters
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.
Import an application.
Define a new profile or a ratio.
Install an application
Uninstall an application.
Delete a profile or uninstalled application.
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Host codes
f Utilities > Applications > Host Codes
Use the same test IDs for the cobas c111 instrument and the laboratory information
system.
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Reagent mixing
f Utilities > Applications > Reagent Mixing
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Process sequence
f Utilities > Applications > Process Sequence
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Diagnostics
f Utilities > Diagnostics
Diagnostics actions are designed for use by Roche representatives or when instructed by
them to do so. Therefore, these functions are not described in this manual.
You need at least Lab Manager user rights to perform diagnostics functions.
At the end of performing a diagnostics action (system status transition from Diagnostics
to Ready), the system checks that all modules are initialized, if they are not, initialization is
performed.
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Inventory
The inventory displays information on all bottle sets that are defined on any of the
disks used on this cobas c111 instrument, including sets that were removed from the
disk, as long as they were not empty or their expiration date had not passed yet.
(Bottle sets that have been removed from the disk and whose expiration date had
passed more than 30 days ago are automatically deleted from the Inventory list,
provided there is still a valid set for the same fluid on board. If this were not the case,
the set that was loaded last would remain in the inventory.)
f Utilities > Inventory
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Import
f Utilities > Import
EWC/Mixing Import extra wash cycle or mixing information for a particular application.
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Users
f Utilities > Users
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.
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Export
f Utilities > Export
Log Files Export the system messages, alarm logs, and possibly trace logs.
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Stopping a run
Abort When the system is in Operating status: 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.
Recover When the system is in Standby or Stopped status: Initialize all systems and modules
that are currently not ready.
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.
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Color interpretation for LEDs
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.
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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.
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.
Table A-13 Interactive buttons
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Buttons
Forecast Select all calibrations that are due within the forecast period.
Calibrations
Default QC Perform Default QC.
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Buttons
Move All Left Move all elements in the list to the list on the left.
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Operation B
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.
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Table of contents
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Introduction
Introduction
Daily operation includes the routine tasks that are required to prepare and monitor
the system, and to analyze samples.
The screen representations shown in this chapter and throughout this manual are for illus-
trative purposes only. The screens do not necessarily show valid data.
Safety information
Before you start working with the cobas c111 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.
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Introduction
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.
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Introduction
Overview
The following table gives an overview of the tasks you might need to perform during
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.
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
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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.
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.
When the system is ready to log on, the Overview tab is displayed.
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Starting the shift
User name and password are case sensitive. This means that for example User and
user are two different names.
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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.
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.
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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.
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.
3. Press to proceed to the next stage in the
Prepare wizard.
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Preparing the system
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.
A B C
Figure B-2
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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.
o Remove the tubing adapter from the white water container and place it on a
clean surface.
o Refill the bottle with purified water.
o 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.
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The waste container was last emptied more than one day ago.
You should check the waste level and empty if required.
No action is required.
The system does not monitor the filling level. It is up to the operator to empty the waste
container regularly.
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No action is required.
o Remove the tubing adapter from the cleaner bottle and place it on a clean
noncorrosive surface.
o Dispose of the bottle.
o Remove the cap from the new bottle.
o Place the new bottle on the rack.
o 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:
Choose Overview > > .
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Make sure that you have read and understood section Safety information on page C-8.
If you interrupt the performing of a maintenance action that was due, its status will remain
due, and you need to fully re-perform the action later.
A Maintenance action name. C Use the scroll bar to display the mainte-
B Due dates, in ascending order. nance actions that are currently hidden.
Figure B-3
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 per-
formed.
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Performing the maintenance 2 Select the maintenance action you want to perform.
actions
The selected line turns blue.
3 Press .
The maintenance definition screen is displayed.
e For information on how to perform individual maintenance actions, see Chapter
8 General maintenance.
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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 2 to 8°C.
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 Personal injury or damage to the analyzer due to contact with instrument mechanism on
page B-5.
When handling the reagent disk without using the Prepare wizard:
Choose Overview > .
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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.
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 Loss of sight on page B-6.
o Personal injury or damage to the analyzer due to contact with instrument mechanism on
page B-5.
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A B
A Number of tests left C R indicates that the set was removed from
B ID of reagent disk on which the set is the disk.
defined
Figure B-4
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B C
A Press to add a reagent set. C The number indicates the number of free
B Press to display the disk content in a table. positions on the disk.
Figure B-5
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A Status description
Figure B-6
Preparing reagents
During preparation, you typically replace reagents that are empty or whose
expiration date has passed, or you add new reagents.
Preparing the reagent set 2 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.)
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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.
Before you add a set, check the number to the left of the button, it indicates the
number of free positions on the disk. If this number is smaller than the number of bot-
tles in the set you need to add, remove a set first. For the number of bottles in a set
refer to the respective package insert.
A screen is displayed, asking you to place the bottle on the reagent disk.
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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.
14 Do one of the following:
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-7
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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 > .
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-55.
For information on the cuvette ring, see Cuvette ring on page A-60.
Make sure that you have read and understood section Safety information on page B-5. The
following warning messages in particular are relevant:
o Personal injury or damage to the analyzer due to contact with instrument mechanism on
page B-5.
o Infection by waste solution on page B-5.
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.)
Interpreting the screen The number in the button indicates how many cuvettes are free to be used.
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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.
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.
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At this stage, the system checks for all calibrations that are due.
e For an overview on calibration, see Calibration on page A-26.
For performing individual calibrations, see Performing calibrations on page B-59.
By default, all calibrations that are due or will be due within the forecast period are
taken into account during the Prepare phase.
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.
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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-8
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.
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A B C
D
E
A Position on the sample area where to D There are not enough empty positions, the
place the calibrator. system suggests using occupied positions.
B Lot number E Calibrator with lowest concentration
C Calibrator with highest concentration
Figure B-9
o The system first uses the free positions, if there are not enough free positions,
occupied positions are suggested. For these you would have to replace the cur-
rently loaded tubes with calibrator tubes.
o With absorbance tests that require several calibrators, the calibrators are placed
according to their concentration, starting with the highest concentration.
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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-68.
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Analyzing samples
Safety information
Make sure that you have read and understood section Safety information on page B-5. The
following warning messages in particular are relevant:
o Infection by biohazardous materials on page B-5.
o Personal injury or damage to the analyzer due to contact with instrument mechanism on
page B-5.
o Loss of sight on page B-6.
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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.
2 Select the tests, ratios and 1. Press a tab to select the test panel (if required).
profiles. 2. Press an active test, ratio or profile to select it.
This step is not required if the Press a selected item to cancel its selection.
workflow setting Working 3. Press .
Mode is Host. (Utilities > Con-
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.
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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 or to a
computer running the cobas c111 Printer Tool.
The orders are automatically defined, 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-119.
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 sample, and to let the system automatically append a
running number to the ID for each order.
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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
NOTICE Probe damage and instrument malfunction due to not removing primary tube caps
The probe is not designed to pierce tube caps. It can get damaged when trying to pierce
tube caps, which can lead to instrument malfunction.
Always remove the caps of primary tubes before placing them on the instrument.
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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 bar-
code.
You do not work with sample barcodes or if 1. Press .
the barcode could not be read for some rea- 2. Type the sample ID, then press .
son: 3. Type the order ID, then press .
Note: This step is only required if the
configuration setting Order ID = Sam-
ple ID is not selected.
A screen is displayed that shows all active tests, profiles, and ratios. Note that all
applications of a profile or ratio must be installed for it to be active.
(If the workflow setting Working Mode is Host, this screen will not be displayed.
Utilities > Configuration > Workflow.)
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-10
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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 tests are sorted alphabetically. Profiles precede the tests. Profiles display the
color of their tests.
3 Select one or several of the tests, profiles, and ratios.
You can select items from more than one tab. (An item 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 items are marked with an asterisk (*).
4 Press to confirm your selection.
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.
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.)
7 Do one of the following:
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.
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If you defined the order while the system was processing orders, new orders will
automatically be processed, without pressing .
o Roche strongly recommends to always load extra cleaner when tests with extra wash
cycles are used.
o Roche Diagnostics Ltd. assumes only limited liability when using the cobas c111
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 c111 and the cobas c111 Develop-
ment Channel Operator’s Manual.
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-55.
See Rerunning tests on page B-56.
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.
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Recognizing STAT orders on the On the Overview tab, the sample buttons for STAT orders are marked with a wide
screens edge.
In the orders list (Workplace > Orders), STAT orders are marked with an asterisk
(*).
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.
a To change an order
1 Identify the sample.
If the sample is still on the o 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.
o Press .
A screen for selecting tests is displayed.
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If the sample is still on the A message is displayed showing the position the sample is placed on.
instrument
o Press to confirm the position
The screen with details on the order and the sample is displayed again.
o Press to close the screen.
If the sample is no longer on the A message is displayed, asking you to place the sample.
instrument
o Place the sample on the sample area.
The orders list is displayed again.
4 The system reschedules the order and processes it as normal.
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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.
B
C
D
Figure B-12
All tests are pipetted. You can remove the sample tube, the
1*
time to completion disappears when
10
you do so.
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 posi-
tion.
(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
1*
started. tests, but you can add additional tests
12
The number below the sample tube to the order.
button indicates the estimated time to
completion.
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.
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B C D
Figure B-13
After deleting a running order, cuvettes and reagents that were not used are released
again for future use.
Figure B-14
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Analyzing samples
Acoustic signal
An acoustic signal informs you of the fact that all tests are finished and the system
status has changed to Standby.
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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-15
Interpreting the screen Abort When the system is in Operating status: Stop immediately all pro-
cessing activities.
Pipettings that were not finished are considered not pipetted.
Measurements that have not yielded a valid result are considered not
measured.
Recover When in Standby or Stopped status: Initialize all systems and mod-
ules that are currently not ready.
Sampling stop Finish the current pipetting action, but do not start a new one.
You can restart processing by pressing the global action but-
ton.
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 can only be performed in Standby status.
Restart Shut down the cobas c111 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.
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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 > .
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Validating sample 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.
Results must be accepted before they can be transmitted to a host or before they can be
automatically printed.
Ratio results cannot be manually accepted. They are automatically accepted if their con-
stituent results are accepted.
The effect of flagged results depends on the configuration (Utilities > Configuration
> Result Handling). The following table shows how.
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Validating sample results
A B C
D E F
A Status C Results.
!: 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.
->-: Repeated.
Figure B-16
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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. only (filter).
E Time when the order was defined.
Figure B-17
Interpreting flags e For detailed information on the flags, see List of flags on page D-28.
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-167.
See Editing the acceptable flags list on page B-162.
6 Press .
A screen is displayed for selecting your reaction.
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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 sample results of on-board samples on
page B-52.
e If the sample is no longer on board, see To validate sample results from the results list
on page B-53.
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
Figure B-18
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Validating sample results
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
1 Validate the result.
e If the sample is still on board, see To validate sample results of on-board samples on
page B-52.
e If the sample is no longer on board, see To validate sample results from the results list
on page B-53.
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
Figure B-19
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Validating sample results
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).
e See Result handling on page B-167.
See Editing the acceptable flags list on page B-162.
a To accept a result
1 Validate the result.
e If the sample is still on board, see To validate sample results of on-board samples on
page B-52.
e If the sample is no longer on board, see To validate sample results from the results list
on page B-53.
f Press Accept.
The result list is displayed again.
Ratio results cannot be manually accepted. They are automatically accepted if all their
constituent results are accepted.
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Validating sample results
a To print results:
1 Do one of the following:
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).
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Performing calibrations
Performing calibrations
Safety information
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.
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Performing calibrations
Short guide
The following table provides an overview on the steps that make up the calibration
process.
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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-30.
a To perform calibrations
1 Choose Workplace > Calibrations.
A screen is displayed that lists all tests and their currently valid calibration.
2 Press .
A screen is displayed that shows all active tests.
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-20
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Performing calibrations
If Do this
You want to perform all due 1. Press .
calibrations: All tests with due calibrations are selected. (The cur-
rently 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
D
E
A Position on the sample area where to D There are not enough empty positions, the
place the calibrator. system suggests using occupied positions.
B Lot number E Calibrator with lowest concentration
C Calibrator with highest concentration
Figure B-21
o The system first uses the free positions, if there are not enough free positions,
occupied positions are suggested. For these you would have to replace the cur-
rently loaded tubes with calibrator tubes.
o With absorbance tests that require several calibrators, the calibrators are placed
according to their concentration, starting with the highest concentration.
You can delete a running calibration order. After deleting the order, the calibration
retains the Due status if it was due before
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After deleting the order, the calibration retains the Due status if it was due before.
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Performing calibrations
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.
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A B C D
E F G H
Figure B-22
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Performing calibrations
A B C D
F
G
H
I
J K L
Figure B-23
4 Press .
A screen is displayed for selecting your decision.
5 Do one of the following:
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-27.
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.
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Performing QC
Performing QC
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-30.
For information on QC configuration, see Defining control definitions and lots on
page B-149.
There are two basic ways of performing QC on the cobas c111 instrument:
Safety information
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 Personal injury or damage to the analyzer due to contact with instrument mechanism on
page B-5.
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Short guide
The following table provides an overview of the steps that make up the QC process.
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Performing QC
Performing Default QC
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.
9 Press to close the screen.
10 Press to start processing the control orders.
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Performing QC
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-24
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).
If at this stage, the required controls are already loaded on the instrument, then the QC
orders are automatically created.
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Performing QC
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.
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A B C D
Figure B-25
2 Select a result.
3 Press to look at result details.
A B C D
Figure B-26
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Performing QC
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 .
6 Do one of the following:
o Press Accept to accept the QC results for the selected test.
o Press Ignore to exclude the result from further QC result calculations such as
QC history statistics.
When ignoring a result, the due status does not change.
In the QC results tables, ignored QC results are marked with "I".
Flags of ignored results are not inherited to dependent results.
o Press Retransmit to send the result again.
(This option is active if your instrument is connected to a host system.)
A B C
Figure B-27
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Performing QC
2 Press .
A graphic is displayed that shows either the QC results for the current or the
previous month, or those generated before the previous month.
A B C
D
E
F
G
H
I
J
K L M N O
A Calibrator change 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
O Press to display the results that were gen-
erated before the last month
Figure B-28
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A B C
Figure B-29
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-29.
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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 shut down the system and
switch off the instrument.
Safety information
Make sure that you have read and understood section Safety information on page B-5. The
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
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Finishing the shift
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 but-
ton.
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Finishing the shift
7 Check the cuvette status. Replace at least all red cuvette segments.
1. Press the cuvette button.
2. Open the main cover.
3. Replace the cuvette segments.
4. Close the main cover.
5. Press to proceed to the next stage in the
End Shift wizard.
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Finishing the shift
Results must be accepted before they can be printed or transmitted to the host.
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Finishing the shift
The easiest way of performing the end of shift tasks is by following the End Shift
wizard.
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Finishing the shift
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 a database on page B-114.
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Finishing the shift
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):
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-105.
These files can be processed with any spreadsheet program that can import csv files.
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Finishing the shift
The cobas c111 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 sample results, you delete the corresponding orders as well.
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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.
When performing maintenance actions without using the End Shift wizard:
Choose Utilities > Maintenance.
Replacing cuvettes
a To replace cuvettes
1 Follow the instructions given in To prepare the cuvettes on page B-28.
2 Press to proceed to the next stage in the End Shift wizard.
A screen is displayed that shows the status of the external fluid bottles.
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Finishing the shift
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.
Roche recommend to refill the water container whenever you empty the waste container.
When emptying the waste without using the End Shift wizard:
Choose Overview > > .
Roche recommend to empty the waste container whenever you refill the water container.
When refilling the water without using the End Shift wizard:
Choose Overview > > .
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Finishing the shift
During periods when you do not perform tests, the disk should be stored in a clean
refrigerated place at temperatures in the range of 2 to 8°C.
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 Personal injury or damage to the analyzer due to contact with instrument mechanism on
page B-5.
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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.
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).
If there is no other shift, you can now shut down the system and switch off the
main instrument.
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.
a To shut down the system and switch off the main instrument
1 Press
2 The Stop screen is displayed.
3 Press Shutdown to shut down the system.
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Using the barcode scanner
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
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.
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Using the barcode scanner
For safety reasons, the barcode scanner is set to only read barcodes that contain a check-
sum.
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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.
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Deleting sample orders
Sample orders are normally deleted as part of the daily end of shift activities. This
section describes how to proceed if you need to delete sample orders outside the
normal daily routine.
e For deleting orders at the end of a shift, see Cleaning up the database on page B-84.
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 sample orders.
2 Do one of the following:
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.
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Deleting sample results
Sample results are normally deleted as part of the daily end of shift activities. This
section describes how to proceed if you need to delete sample results outside the
normal daily routine.
e For deleting results at the end of a shift, see Cleaning up the database on page B-84.
Preconditions for deleting Sample results should be accepted and printed or sent to the host before deleting.
If… Do this…
You want to delete an individual sample 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 sample results: 2. Press the appropriate filter button.
3. Press to confirm the selection.
4. Press .
5. Press List [filter criterion].
The results are deleted. You cannot retrieve them any more from the system.
By deleting all sample results of an order, you delete the corresponding order as well.
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Calibration
Calibration
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-84.
a To delete a calibration
1 Choose Workplace > Calibrations.
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.
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Deleting QC results
Deleting QC results
o 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 previ-
ous and the current months.
o 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
normal daily routine.
e For deleting QC results at the end of a shift, see Cleaning up the database on page B-84.
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Deleting QC results
If… Do this…
You want to delete all QC results: 1. Choose All.
2. Press to confirm the deletion.
You want to delete all accepted QC results: 1. Choose All Accepted.
2. Press to confirm the deletion.
You want to delete the selected result: 1. Choose Selected.
The results are deleted. You cannot retrieve them any more from the system.
If… Do this…
You want to delete all results in the list: 1. Choose List.
(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:
The results are deleted. You cannot retrieve them any more from the system.
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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)
A B C
Figure B-30
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Lot handling
B
C
Figure B-31
Calibrators that were defined or changed manually are marked with an asterisk.
Reagent lots
You can view the lot number in the reagent set details.
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Lot handling
A B
A Number of tests left C R indicates that the set was removed from
B ID of reagent disk on which the set is the disk.
defined
Figure B-32
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Lot handling
For sample, calibration, and QC results, you can check to which lot the used fluids
belong (reagents, calibrators, controls).
If Do this
You want to check the context information 1. Choose Workplace > Result Overview.
of a sample 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 sample-result lot-data.)
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.
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.
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Lot handling
Preparation tasks Make sure that the controls and calibrators are assigned to the application.
e See Preparing applications on page B-140.
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.
12. Press to confirm the definitions.
The screen for handling control lot data is displayed again.
13. Perform steps 7 through 12 for all tests you want to use.
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Lot handling
If… Do this…
The lot data are 1. Scan the barcode.
available from a bar- The screen is displayed again that lists all installed calibrator lots.
code The new lot is selected.
You want to type the 1. Press .
data manually 2. Type the name (up to 10 alphanumeric characters) and press .
3. Type the material code 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.)
7. Press to confirm the definitions.
8. Press *Add new test*.
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 cali-
brator. (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 cali-
bration. (The special zero calibrator needs to be placed on the
sample area.)
15. Press to confirm the definitions.
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 c111 instru-
ment.
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6 Special operations cobas c111
Exporting data
Exporting data
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-82.
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 a database on page B-114.
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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:
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.
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6 Special operations cobas c111
Exporting data
The following tables list, for the sample, calibration, and QC result files, the column
headings of the spreadsheet and provide information on the kind of information the
columns contain.
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Exporting data
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.
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Exporting data
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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.
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Exporting data
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.
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Importing data
Importing data
Importing applications
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 .
2. Insert the USB stick.
3. Press .
4. Select the directory that contains the
application file.
You recognize the application pack-
ages by their file extension .tsb.
5. Press to confirm the selection.
The system checks whether there is already an application on the system with
identical application code and short name.
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6 Special operations cobas c111
Importing data
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.
a To install an application
1 Choose Utilities > Applications > Laboratory Parameters.
2 Select an application whose name is in square brackets.
3 Press .
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Importing data
Importing software
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Importing data
Importing a database
Compatibility o If the version of the imported database is older than the one on the target system,
the imported database will be converted to the version on the system.
o If the version of the imported database is more recent than the one on the target
system, the database cannot be imported.
3 Press .
A screen is displayed, asking you to insert the USB stick.
4 Insert the USB stick.
5 Press .
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Importing data
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 .
A screen is displayed, asking you to insert the USB stick.
3 Insert the USB stick.
4 Press .
5 Select the certificate.
You recognize a certificate by its file extension .prm.
6 Press to confirm the selection.
The certificates are installed on the system.
The screen is displayed again, that lists the currently installed certificates.
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Preparing a new disk
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B-116 Operator’s Manual · Version 4.0
cobas c111 6 Special operations
Preparing a new disk
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
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 c111 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.
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.
14 Press .
15 On the disk overview screen, press to load the next reagent. Proceed as
described in steps 10 through 15.
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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.
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Deleting bottle sets from the Inventory list
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.
To move a test from one tab to another, delete it from the original tab and assign it to the
new tab.
The Inventory list serves to gain an overview on the status of all bottle sets that are
defined on any of the reagent disks used on the cobas c111 instrument.
You can delete bottle sets from the list; this would be appropriate if you removed a set
from the disk and did not intend to use it again.
o Before you can delete a bottle set from the Inventory list you need to remove it from
the disk.
o Bottle sets that have been removed from the disk and whose expiration date had
passed more than 30 days ago are automatically deleted from the Inventory list, pro-
vided there is still a valid set for the same fluid on board. If this were not the case, the
set that was loaded last would remain in the inventory.
Removing the bottle set 1 Remove the bottle set from the disk.
e Removing a reagent set on page B-25.
If the bottle set that you want to delete is not on the currently installed disk, you
need to change the disk first.
e Removing the reagent disk on page B-87, Preparing the reagent disk on page B-21.
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Deleting bottle sets from the Inventory list
Figure B-39
It is not possible to place a bottle set on a reagent disk again, once it was deleted from the
Bottle sets list.
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Refilling printer paper
You can refill the printer paper any time, provided printing is not in progress.
Be sure to press down the release button (A) firmly before you pull the panel. The
panel should open without resistance.
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Refilling printer paper
7 Insert the paper in the slot in the printer panel and pull some through.
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Removing condensation water from the reagent cooler
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B-124 Operator’s Manual · Version 4.0
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Replacing the probe
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Replacing the probe
Figure B-40
Before switching on the system, make sure that all external fluid containers are placed
on the rack and properly connected.
A B C
Figure B-41
3 Insert the tubing adapter in the container and push it down firmly.
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Connecting and disconnecting the external fluid containers
A B C
Figure B-42
3 Insert the tubing adapter in the container and push it down firmly.
A B C
Figure B-43
3 Insert the tubing adapter in the container and push it down firmly.
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Connecting and disconnecting the external fluid containers
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) counter-
clockwise 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
Figure B-44
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Adjusting the touchscreen
If a displayed screen item does not correspond exactly with its underlaying related
hardware and software elements, pressing a certain screen item may not show the
desired effect. Adjusting the touchscreen ensures that all parts correspond.
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B-130 Operator’s Manual · Version 4.0
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Cleaning the touchscreen
Because the touchscreen gets easily soiled you should clean it regularly.
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Cleaning the touchscreen
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B-132 Operator’s Manual · Version 4.0
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
cobas c111 instrument.
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Table of contents
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B-134 Operator’s Manual · Version 4.0
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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
1 Choose Utilities > Applications > Laboratory Parameters.
2 Expand the list.
o Select a list item marked with .
o Press .
o Select a sublist item marked with .
o Press .
o Use the scrollbar, if required, to display the items you are interested in.
The definition items and their current values are displayed.
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
1 Choose Utilities > Applications > Laboratory Parameters.
2 Expand the list to display the items and their values.
3 Select an item that shows a value.
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Introduction
4 Press .
A screen is displayed where you either can type a new value or select one by
pressing its corresponding 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.
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Applications
Applications
Installing applications
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 .
2. Insert the USB stick.
3. Press .
4. Select the directory that contains the
application file.
You recognize the application pack-
ages by their file extension .tsb.
5. Press to confirm the selection.
The system checks whether there is already an application on the system with
identical application code and short name.
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7 Configuration cobas c111
Applications
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.
a To install an application
1 Choose Utilities > Applications > Laboratory Parameters.
2 Select an application whose name is in square brackets.
3 Press .
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B-138 Operator’s Manual · Version 4.0
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Applications
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.
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7 Configuration cobas c111
Applications
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-135.
a To prepare an application
1 Choose Utilities > Applications > Laboratory Parameters.
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-162.
This code is also used on the cobas c111 Printer Tool. (The codes on the cobas c111
system and on the Printer Tool must correspond.)
General definitions 3 Expand the General entry, select Short Name, and press .
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 For details, see Assigning tests to test tabs on page B-119.
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.
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B-140 Operator’s Manual · Version 4.0
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Applications
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: Performed whenever the first 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.)
13 Press to confirm the definitions.
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.
Choose Interval Only if QC should be performed whenever the reagent interval
has expired. The system automatically informs you about due QCs.
16 Define the interval in hours.
17 For each control, perform the following steps:
o Define the material code.
Unique identifier for the controls. Check the package insert of the control.
o Define whether QC should be performed after calibration of the test (QC
After Cal).
o 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.
18 Press to confirm the definitions.
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Applications
Ratio Calculation definitions 19 For applications that use a ratio, perform the following steps:
o Expand the Ratio Calculation entry, select Coefficient w, and press .
o Define one or two coefficients.
o Define the formula.
Calculation definitions 21 Expand the Calculation entry, select Factor, and press .
22 Change the factor and offset, if correlating two different methods.
23 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.
24 Define whether the lower limit is used, if required.
25 Define whether the higher limit is used, if required.
26 Change the lower limit value, if required.
27 Change the higher limit value, if required.
28 Define, for each control, whether sample results should be flagged that were
generated using a test whose QC results were marked with a flag.
29 Press to confirm the definitions.
Result Conversion definitions 30 Expand the Result Conversion entry, select Laboratory Unit, and press .
31 Change the laboratory unit if you intend to work with units that are different
from the currently specified units.
32 Type the conversion factor, if required.
This factor is required if lab units were defined.
33 Choose whether values should be displayed in standard or laboratory units.
This definition affects displays on screens as well as printouts.
34 Change the decimal position, if required.
This value corresponds to the number of digits after the decimal point that are
displayed on the screens.
35 Press to confirm the definitions.
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Applications
Uninstalling applications
Before you can uninstall an application, you need to perform some preparation tasks:
2 Delete all associated QC results, both from the QC Status list and the QC
History.
e See Deleting QC results on page B-96.
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 indi-
cate that the application is not currently installed.)
3 Press .
A confirmation screen is displayed.
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], and in the profile details, instead of the short name its
application code is displayed.
The profiles that use this application are removed from the test selection screen. If
you still want to use these profiles, you need to remove the application from them.
e See Removing tests from a profile on page B-149.
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Operator’s Manual · Version 4.0 B-143
7 Configuration cobas c111
Applications
Deleting applications
a To delete an application
1 Choose Utilities > Applications > Laboratory Parameters.
2 Select the application.
3 Press .
The following table lists possible situations and how they affect the process of
deleting.
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Applications
4 Press .
The application data are deleted.
For a given sample, the tests are processed in the order defined by the time required
to perform the tests (number of cycles), starting with the one that takes the longest.
This order can be altered manually by defining a specific process sequence list.
2 In the Default list, select a test you want to be processed with high priority.
3 Press to move it to the Priority list.
The tests are processed in the order displayed in this list. When the tests
contained in this list are processed, the rest of the tests are processed in the
normal order.
4 Perform steps 2 and 3 to move the other tests you want to process with high
priority.
5 To move a test from the Priority to the Default list, select the test in the Priority
list and press . To move all tests to the Default lists, press .
6 In the Priority list, select a test and use and to move it up and down in
the list.
7 Press to save the processing sequence.
The processing sequence defined in the Priority list applies to all tests performed on
the current cobas c111 instrument.
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Operator’s Manual · Version 4.0 B-145
7 Configuration cobas c111
Applications
The user can manually define ratio applications. Such applications yield results that
are mathematically arrived at, and are based on test results that were generated using
up to four different applications.
In the results list, both the results of the test or tests as well as the calculated ratio
result will be displayed.
The code is a number between 910 and 930 and identifies the application.
5 Type the short name and press .
The short name must be unique on the cobas c111 system and consists of up to 5
alphanumeric characters. It is used on the screens, for example on the test
selection screen or the results list.
6 Type the long name and press .
The long name must be unique on the cobas c111 system and consists of up to 30
alphanumeric characters. Use a name that is commonly known in your laboratory
environment.
7 Select the first application and press .
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Applications
14 Select whether the offset/correlation factor is going to be used or not, then press
.
17 Select whether the high range will be used or not, then press .
23 Select whether the standard or the laboratory unit will be displayed for the final
ratio result, then press .
(For the calculation of the individual results, the system uses standard units.)
24 Type how many decimal positions will be used in the displayed results.
25 Press .
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Applications
Profiles
Defining 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 a profile
1 Choose Utilities > Applications > Laboratory Parameters.
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.
8 Press to confirm the selection.
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Applications
Deleting profiles
e See Deleting applications on page B-144.
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Operator’s Manual · Version 4.0 B-149
7 Configuration cobas c111
Applications
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.
12. Press to confirm the definitions.
The screen for handling control lot data is displayed again.
13. Perform steps 7 through 12 for all tests you want to use.
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B-150 Operator’s Manual · Version 4.0
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Applications
If… Do this…
The lot data are 1. Scan the barcode.
available from a bar- The screen is displayed again that lists all installed calibrator lots.
code The new lot is selected.
You want to type the 1. Press .
data manually 2. Type the name (up to 10 alphanumeric characters) and press .
3. Type the material code 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.)
7. Press to confirm the definitions.
8. Press *Add new test*.
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 cali-
brator. (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 cali-
bration. (The special zero calibrator needs to be placed on the
sample area.)
15. Press to confirm the definitions.
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 c111 instru-
ment.
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Operator’s Manual · Version 4.0 B-151
7 Configuration cobas c111
Applications
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. If you work with a LIS you may
need to map the Roche application code with your own code. All applications,
profiles, and ratios must be identified with an application code. For profiles and
ratios, use a number between 910 and 930 for these codes.
e See Mapping the host codes on page B-162.
This code is also used on the cobas c111 Printer Tool. (The codes on the cobas c111
system and on the Printer Tool must correspond.)
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B-152 Operator’s Manual · Version 4.0
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Applications
Calibration definitions
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Operator’s Manual · Version 4.0 B-153
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Applications
Control definitions
Roche Diagnostics
B-154 Operator’s Manual · Version 4.0
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Applications
Calculation definitions
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Operator’s Manual · Version 4.0 B-155
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Applications
Roche Diagnostics
B-156 Operator’s Manual · Version 4.0
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Configuration
Configuration
NOTICE Damage to data and programs due to unauthorized access to the cobas c111
instrument
User access to the cobas c111 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.
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.
Roche Diagnostics
Operator’s Manual · Version 4.0 B-157
7 Configuration cobas c111
Configuration
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.
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.
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:
Roche Diagnostics
B-158 Operator’s Manual · Version 4.0
cobas c111 7 Configuration
Configuration
Roche Diagnostics
Operator’s Manual · Version 4.0 B-159
7 Configuration cobas c111
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 all languages except English.
Roche Diagnostics
B-160 Operator’s Manual · Version 4.0
cobas c111 7 Configuration
Configuration
User management
Defining a user
a To define a user
1 Choose Utilities > Users.
A screen is displayed that lists all currently defined users.
2 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
Operator’s Manual · Version 4.0 B-161
7 Configuration cobas c111
Configuration
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.
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.
The application, profile and ratio codes are also used on the cobas c111 Printer Tool.
(The codes on the cobas c111 system and on the Printer Tool must correspond.)
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.
Roche Diagnostics
B-162 Operator’s Manual · Version 4.0
cobas c111 7 Configuration
Configuration
Roche Diagnostics
Operator’s Manual · Version 4.0 B-163
7 Configuration cobas c111
Configuration
Workflow definitions
Roche Diagnostics
B-164 Operator’s Manual · Version 4.0
cobas c111 7 Configuration
Configuration
Host definitions
Roche Diagnostics
Operator’s Manual · Version 4.0 B-165
7 Configuration cobas c111
Configuration
Roche Diagnostics
B-166 Operator’s Manual · Version 4.0
cobas c111 7 Configuration
Configuration
Result handling
Calibration
QC
Roche Diagnostics
Operator’s Manual · Version 4.0 B-167
7 Configuration cobas c111
Configuration
System
Roche Diagnostics
B-168 Operator’s Manual · Version 4.0
cobas c111 7 Configuration
Configuration
Maintenance
Abs adjustment
The absorbance adjustment values cannot be changed.
Roche Diagnostics
Operator’s Manual · Version 4.0 B-169
7 Configuration cobas c111
Configuration
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 Pipet-
ting Type—the extra wash cycle should be performed
(action), 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.
8. Press to confirm the definitions.
The new wash cycle is listed in the Extra Wash Cycles list. Its name is made up of
the action, the short name of the trigger bottle and the pipetting type.
Roche Diagnostics
B-170 Operator’s Manual · Version 4.0
cobas c111 7 Configuration
Configuration
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 applica-
tions.
Roche strongly recommends to always use extra wash cycles with development channel
applications, and also to always load extra cleaner when tests with extra wash cycles are
used.
Roche Diagnostics Ltd. assumes only limited liability when using the cobas c111 instru-
ment in conjunction with the cobas c111 Development Channel Programming Software.
For detailed information on this matter refer to the latest version of the Development Chan-
nel Registration Form cobas c111 and the cobas c111 Development Channel Operator’s
Manual.
Roche Diagnostics
Operator’s Manual · Version 4.0 B-171
7 Configuration cobas c111
Configuration
Roche Diagnostics
B-172 Operator’s Manual · Version 4.0
cobas c111 7 Configuration
Configuration
You can import and delete mixing rules, but cannot change them.
e For importing reagent mixing rules, see Importing automatic mixing and extra wash cycle
definitions on page B-116.
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Operator’s Manual · Version 4.0 B-173
7 Configuration cobas c111
Configuration
Prerequisites You need Lab Manager or Administrator user rights to perform this task.
Roche Diagnostics
B-174 Operator’s Manual · Version 4.0
Maintenance C
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.
Roche Diagnostics
Operator’s Manual · Version 4.0 C-3
8 General maintenance cobas c111
Table of contents
Roche Diagnostics
C-4 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
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.
e For information on scheduling maintenance actions, see Scheduling maintenance actions
on page B-158.
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.
Roche Diagnostics
Operator’s Manual · Version 4.0 C-5
8 General maintenance cobas c111
Overview
Figure C-1
Interpreting the colors The defined maintenance interval has expired. Perform this maintenance
action now.
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.
Roche Diagnostics
C-6 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Overview
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 cor-
rect 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.
Roche Diagnostics
Operator’s Manual · Version 4.0 C-7
8 General maintenance cobas c111
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-42.
Safety information
Roche Diagnostics
C-8 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
Whenever the term "purified water" is used in this document, water of at least the quality
specified in chapter Technical specifications must be used.
Roche Diagnostics
Operator’s Manual · Version 4.0 C-9
8 General maintenance cobas c111
Maintenance actions
Make sure that you have read and understood section Safety information on page C-8.
The following warning messages in particular are relevant:
o Injury through working solutions on page C-8.
o Incorrect results due to build-up of contaminants on page C-8.
Roche Diagnostics
C-10 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
Roche Diagnostics
Operator’s Manual · Version 4.0 C-11
8 General maintenance cobas c111
Maintenance actions
Make sure that you have read and understood section Safety information on page C-8.
The following warning messages in particular are relevant:
o Injury through working solutions on page C-8.
o Incorrect results due to build-up of contaminants on page C-8.
o Infection by biohazardous materials on page C-8.
Roche Diagnostics
C-12 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
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.
Roche Diagnostics
Operator’s Manual · Version 4.0 C-13
8 General maintenance cobas c111
Maintenance actions
Make sure that you have read and understood section Safety information on page C-8.
The following warning messages in particular are relevant:
o Injury through working solutions on page C-8.
o Infection by biohazardous materials on page C-8.
o Personal injury or damage to the analyzer due to contact with instrument mechanism on
page C-8.
Roche Diagnostics
C-14 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
11 Wash the sample tray using detergent. (You can wash the tray in a dish washer.)
Roche Diagnostics
Operator’s Manual · Version 4.0 C-15
8 General maintenance cobas c111
Maintenance actions
Make sure that you have read and understood section Safety information on page C-8.
The following warning messages in particular are relevant:
o Injury through working solutions on page C-8.
o Infection by waste solution on page C-9.
o Infection by biohazardous materials on page C-8.
Roche Diagnostics
C-16 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
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.
Roche Diagnostics
Operator’s Manual · Version 4.0 C-17
8 General maintenance cobas c111
Maintenance actions
Roche Diagnostics
C-18 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
Prerequisites None
Make sure that you have read and understood section Safety information on page C-8.
The following warning messages in particular are relevant:
o Injury through working solutions on page C-8.
Roche Diagnostics
Operator’s Manual · Version 4.0 C-19
8 General maintenance cobas c111
Maintenance actions
B C
A
D
Figure C-2
o Remove the retaining ring by pulling it by its tab away from the filter casing
(A, D, E).
o Remove the filter (B) and replace it with a new one.
o 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.
A message will inform you when the maintenance action is complete.
9 Press .
Roche Diagnostics
C-20 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
Make sure that you have read and understood section Safety information on page C-8.
The following warning messages in particular are relevant:
o Injury through working solutions on page C-8.
o Infection by biohazardous materials on page C-8.
o To find out what steps are required, you can choose Utilities > Maintenance >
Clean Housing and then press . (The maintenance definition screen is dis-
played.)
o Do not press at this stage. You do this only when you have completed the main-
tenance action. Instead, press to close the screen.
Roche Diagnostics
C-22 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
Roche Diagnostics
Operator’s Manual · Version 4.0 C-23
8 General maintenance cobas c111
Maintenance actions
Make sure that you have read and understood section Safety information on page C-8.
The following warning messages in particular are relevant:
o Injury through working solutions on page C-8.
o Infection by biohazardous materials on page C-8.
o Personal injury or damage to the analyzer due to contact with instrument mechanism on
page C-8.
Preparing the instrument 4 Open the main cover and the right service flap.
5 Remove the sample tray by lifting it.
Roche Diagnostics
C-24 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
Figure C-3
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
Operator’s Manual · Version 4.0 C-25
8 General maintenance cobas c111
Maintenance actions
Roche Diagnostics
C-26 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
Prerequisites None
Roche Diagnostics
Operator’s Manual · Version 4.0 C-27
8 General maintenance cobas c111
Maintenance actions
Make sure that you have read and understood section Safety information on page C-8.
The following warning messages in particular are relevant:
o Injury through working solutions on page C-8.
o Infection by biohazardous materials on page C-8.
o Personal injury or damage to the analyzer due to contact with instrument mechanism on
page C-8.
Roche Diagnostics
C-28 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
If at this stage, you press , the results are not stored and the maintenance action is
deemed not performed.
Roche Diagnostics
Operator’s Manual · Version 4.0 C-29
8 General maintenance cobas c111
Maintenance actions
If Do this
You cannot see any air bub- 1. Continue with step 6.
bles
You can see air bubbles or the 1. Press to abort this maintenance action.
tube is empty 2. Perform the maintenance action Prime Fluid Sys-
tem.
3. Restart the maintenance action Initialize Degasser
Fluid Sensor.
Roche Diagnostics
C-30 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
Roche Diagnostics
Operator’s Manual · Version 4.0 C-31
8 General maintenance cobas c111
Maintenance actions
Make sure that you have read and understood section Safety information on page C-8.
The following warning messages in particular are relevant:
o Injury through working solutions on page C-8.
o Infection by biohazardous materials on page C-8.
Roche Diagnostics
C-32 Operator’s Manual · Version 4.0
cobas c111 8 General maintenance
Maintenance actions
Roche Diagnostics
Operator’s Manual · Version 4.0 C-33
8 General maintenance cobas c111
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
Figure C-4
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
C-34 Operator’s Manual · Version 4.0
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Maintenance actions
Cleaning the rotor 16 Rinse the cuvette ring (A) under running water.
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.
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).
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.
24 Fit the upper rotor shell.
25 Fold down the display and fasten the fixation screw.
Roche Diagnostics
Operator’s Manual · Version 4.0 C-35
8 General maintenance cobas c111
Maintenance actions
Roche Diagnostics
C-36 Operator’s Manual · Version 4.0
Troubleshooting D
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.
Roche Diagnostics
Operator’s Manual · Version 4.0 D-3
9 Messages and alarms cobas c111
Table of contents
Roche Diagnostics
D-4 Operator’s Manual · Version 4.0
cobas c111 9 Messages and alarms
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 Immediate feedback on user actions is displayed in a pop-up message screen.
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-9.
Message screen
Roche Diagnostics
Operator’s Manual · Version 4.0 D-5
9 Messages and alarms cobas c111
Acoustic signals
Acoustic signals
Alarm monitor
The alarm button is always active, even if you are not logged on the system.
Roche Diagnostics
D-6 Operator’s Manual · Version 4.0
cobas c111 9 Messages and alarms
Alarm monitor
A B
F G
Figure D-3
The alarm list can contain up to 250 messages. When this number is reached, the old-
est message is automatically deleted when a new one is generated.
3 To limit the number of messages that are contained in the list, press .
A list of filter options is displayed.
o Select Not confirmed to include in the list all alarm messages that have not yet
been confirmed by the user.
o Select Today’s alarms to include in the list all alarm messages that so far have
been generated on the current day.
o Select Complete list to include in the list all alarm messages that are stored in
the alarm database.
Roche Diagnostics
Operator’s Manual · Version 4.0 D-7
9 Messages and alarms cobas c111
Alarm monitor
4 Select the message you are interested in. Use and to display the previous
and next message respectively.
5 Do one of the following:
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-9.
6 When you have dealt with the issue, press to confirm that you have dealt
with the issue. The message is deleted from the Not confirmed list but it remains
in the other lists and the alarm messages log, which you can export.
e See Confirming alarm messages on page D-9.
When you print alarm messages, their details are included in the printout.
Roche Diagnostics
D-8 Operator’s Manual · Version 4.0
cobas c111 9 Messages and alarms
Alarm monitor
Confirming a message means that you have dealt with the issue mentioned in it.
a To confirm a message
1 Press .
2 Select the message. (Use and to display the previous and next message
respectively.)
3 Press .
A confirmation dialog box is displayed.
o Press All to remove all messages from the list.
o Press Selected to remove the currently displayed message.
The message or messages are removed from the Not confirmed list, but they
remain in the other lists and the alarm messages log, which you can export.
When all messages are confirmed the Alarm LED is turned off (not lit).
Roche Diagnostics
Operator’s Manual · Version 4.0 D-9
9 Messages and alarms cobas c111
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, id=%d!
0001 A fatal system exception software error (%d) occurred. Restart the system. If the error recurs export the log files
while the system stays in the error condition. If the error
persists call service.
0002 An internal software error (%d) occurred while updating Restart the system. If the error recurs export the log files
the configuration. while the system stays in the error condition. If the error
persists call service.
0003 A software error occurred. Order (%d, %d) could not be Delete the orders that are not processed yet. If the error
processed. recurs export the log files while the system stays in the
error condition. If the error persists call service.
0004 A software error occurred. The unit is not ready, order Restart the system. If the error recurs export the log files
(%d) rejected. with the system remaining in this error condition. If the
error persists call service.
0005 A mathematical exception arose. Repeat the order. If the error recurs export the log files
with the system remaining in this error condition. If the
error persists call service.
0006 Last calculation cycle (%d) too short. Repeat the order. If the error recurs export the log files
with the system remaining in this error condition. If the
error persists call service.
0007 Failed to calculate linear regression. Repeat the order. If the error recurs export the log files
with the system remaining in this error condition. If the
error persists call service.
0008 The cycle range (%d..%d) is not valid. Repeat the order. If the error recurs export the log files
with the system remaining in this error condition. If the
error persists call service.
0010 The reaction direction (%d) is invalid. Repeat the order. If the error recurs export the log files
with the system remaining in this error condition. If the
error persists call service.
0011 An internal communication error occurred. The received Restart the system. If the error recurs export the log files
IPC message (%d, %d) could not be interpreted. with the system remaining in this error condition. If the
error persists call service.
0012 A software error occurred. The status of an order is Delete and redefine the order. If the error recurs export
invalid (%d.%d). the log files with the system remaining in this error condi-
tion. If the error persists call service.
0017 The installed language version is out of date (%s, %s). Install the language version that belongs to the currently
installed system software version. If the error persists call
service.
0018 The current system date and time are invalid. Correct the date and time settings in Configuration. If the
error persists call service.
0019 Printer controller revision %d is not supported. Call service.
Table D-1 List of alarm messages
Roche Diagnostics
D-10 Operator’s Manual · Version 4.0
cobas c111 9 Messages and alarms
List of alarm messages
ID Message Comment
0020 This reagent set has more bottles than there is space Load another disk or remove unused reagents.
available on the disk.
0021 Disk space problem.
0022 You are about to delete results that have been printed or
sent to host!
0023 Enter the A1c part.
0024 Now enter the A1c part.
5001 Air detected in the fluid system. Water container or
cleaner bottle is empty.
5002 [%d] Air detected in the fluid system. Refill the water container. Check the filling level of the
cleaner bottle. Replace the cleaner bottle if required. Per-
form <Prime Fluid System>. If the error persists call ser-
vice.
5003 [%s] An internal software error occurred. A parameter is Restart the system. If the error persists call service.
not valid.
5004 [%s] Error syringe motor. The syringe motor could not be Restart the system. If the error persists call service.
started.
5010 [%s] Initialization of syringe failed. Switch off instrument. Remove right side panel. Check for
syringe mechanism jamming or blockage. Ensure correct
syringe installation. Restart the system. If the error per-
sists call service.
5013 [%s] Error mixer motor. The mixer motor could not be Restart the system. If the error persists call service.
started.
5019 [%s] Initialization of the mixer motor failed. Switch off the instrument. Remove the transfer head
cover. Check if the mixing mechanism is jamming or
blocked. Restart the system. If the error persists call ser-
vice.
5022 [%s] Error temperature sensor analyzer heating system. Restart the system. If the error persists call service.
The sensor does not react anymore.
5024 [%s] Error temperature sensor analyzer cooling system. Restart the system. If the error persists call service.
The sensor does not react anymore.
5026 [%s] Error temperature sensor cooling system. The heat Restart the system. If the error persists call service.
sink temperature sensor does not react anymore.
5028 [%s] Error temperature sensor instrument. The ambient Restart the system. If the error persists call service.
temperature sensor does not react anymore.
5030 [%s] Error wash pump P1. The wash pump could not be Restart the system. If the error persists call service.
started.
5032 [%s] Error waste pump P2. The waste pump could not be Restart the system. If the error persists call service.
started.
5034 [%s] Error wash valve V1. The valve does not react Restart the system. If the error persists call service.
anymore.
5036 [%s] Error cleaner valve V2. The valve does not react Restart the system. If the error persists call service.
anymore.
5038 [%s] Error analyzer heating system. The heating system Restart the system. If the error persists call service.
does not react anymore.
5040 [%s] Error cooling system. One of the Peltier elements Restart the system. If the error persists call service.
does not react anymore.
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
Operator’s Manual · Version 4.0 D-11
9 Messages and alarms cobas c111
List of alarm messages
ID Message Comment
5044 [%s] Error main board fan. The fan could not be started or Restart the system. If the error persists call service.
the fan speed is not correct.
5047 [%s] Error cooling fan. The fan could not be started. Restart the system. If the error persists call service.
5049 [%s] Error sample area fan. Switch off the instrument. Remove the right side panel and check if the fan is jam-
ming or blocked. If possible eliminate the problem.
Restart the system. If the error persists call service.
5052 [%s] Error cooling system. The cooling heat sink Ensure unrestricted cooling air circulation. Check the
overheated. cooling fan and make sure the external vent is not
blocked. Restart the system. If the error persists call ser-
vice.
5054 [%s] The analyzer heating system overheated. Switch off the instrument and wait 15 minutes to let cool
down the analyzer. Restart the system. If the error persists
call service.
5055 [%s] The analyzer temperature is outside the range. Restart the system. If the error persists call service.
5056 [%s] The calibration of the transfer head fluid sensor Ensure that the sample probe tube is correctly installed.
failed. Ensure that the syringe is correctly installed. Restart the
system. If the error persists call service.
5058 [%s] Error fluid sensor transfer head. The sensor does not Restart the system. If the problem persists, call service.
react anymore.
5060 [%s] A not specified hardware error (%d) was reported by Restart the system. If the error recurs export the log files
the Multi-Slave control. with the system remaining in this error condition. If the
error persists call service.
5061 [%d] Air detected in the fluid system. Refill the water container. Check the filling level of the
cleaner bottle. Replace the cleaner bottle if required. Per-
form <Prime Fluid System>. If the error persists call ser-
vice.
5062 The degasser fluid sensor is not initialized. Perform <Initialize Degasser Fluid Sensor>. Follow the
instructions provided on the display. If the error persists
call service.
5063 [%s] Air bleed valve error. The air bleed valve does not Restart the system. If the error persists call service.
react anymore.
5064 [%s] Error fluid sensor degasser. The sensor does not Restart the system. If the error persists call service.
react anymore.
6001 [%s] Photometer error. Signal is invalid or unstable. Switch off the instrument. Remove and clean the rotor. In
case of a recurrence perform <Replace Photometer
Lamp> and <Abs Air/Water Calibration>. If the error
persists call service.
6002 [%s] Photometer error. The photometer has a wrong Restart the system. If the error persists call service.
status because initialization has not been successfully
performed yet.
6018 [%s] A not specified photometer hardware error (%d) was Restart the system. If the error recurs export the log files
reported by the photometer. with the system remaining in this error condition. If the
error persists call service.
6019 [%s] Photometer error. The photometer signals were Restart the system. If the error persists call service.
outside the range while performing a photometer
initialization or a photometer measurement.
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
D-12 Operator’s Manual · Version 4.0
cobas c111 9 Messages and alarms
List of alarm messages
ID Message Comment
6020 [%s] Photometer lamp error. Perform <Clean Rotor and Heating Channel>. If the error
persists, replace the photometer lamp. Perform first the
maintenance action <Replace Photometer Lamp> and
then <Abs Air/Water Calibration>.
6021 [%s] Photometer error. The lamp voltage is outside the Restart the system. If the error persists call service.
range.
6022 [%s] Photometer error. The internal photometer 15 V Restart the system. If the error persists call service.
power supply failed.
6023 [%s] Photometer error. The lamp current is outside the Perform first the maintenance action <Replace Photome-
range. ter Lamp> and then <Abs Air/Water Calibration>. Restart
the system. If the error persists call service.
6024 [%s] Photometer error. Either the lamp fan is not running Switch off the instrument. Open the main cover and check
or its speed is not correct. if the lamp fan is jamming or blocked. Restart the system.
If the error persists call service.
6025 [%s] Photometer error. Either the dark shutter motor Restart the system. If the error persists call service.
does not work or the shutter mechanism is jamming or
blocked.
6026 [%s] Photometer error. A problem caused by the internal Restart the system. If the error persists call service.
circuitry has been detected.
6027 [%s] Photometer error. The photometer signals are Restart the system. If the error persists call service.
outside the range while performing a dark measurement.
6029 [%s] Photometer error. A problem caused by the internal Restart the system. If the error persists call service.
circuitry has been detected.
6030 [%s] Initialization of the rotor failed. Switch off the instrument. Remove the rotor and clean all
rotor measurement holes. Reinstall the rotor. Restart the
system. If the error persists call service.
6031 [%s] Photometer error. The photometer dark signal is not Restart the system. If the error persists call service.
stable.
7001 [%d] An Instrument Control software exception error Restart the system. If the error recurs export the log files
occurred. with the system remaining in this error condition. If the
error persists call service.
7002 [%d] A software error occurred. Restart the system. If the error recurs export the log files
with the system remaining in this error condition. If the
error persists call service.
7004 [%d] An internal communication software error Restart the system. If the error recurs export the log files
occurred. with the system remaining in this error condition. If the
error persists call service.
7006 [%s] A not specified hardware error (%d) was reported. Restart the system. If the error recurs export the log files
with the system remaining in this error condition. If the
error persists call service.
7007 [%d] An internal communication error (%d) occurred. A Restart the system. If the error recurs export the log files
control unit could not be connected. with the system remaining in this error condition. If the
error persists call service.
7008 [%d] A software error occurred that was caused by an Restart the system. If the error recurs export the log files
unexpected system situation. with the system remaining in this error condition. If the
error persists call service.
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
Operator’s Manual · Version 4.0 D-13
9 Messages and alarms cobas c111
List of alarm messages
ID Message Comment
7009 The LAN connection to the IC software failed. Check the external Ethernet cable. Restart the system. If
the error recurs export the log files with the system
remaining in this error condition. If the error persists call
service.
7010 Instrument initialization failed. Check for previous errors. Switch off instr. Check transfer
mechanism. Restart system. If error recurs export the log
files with the system remaining in this error condition. If
the error persists call service.
7011 Failed to aspirate sample from tube on position %d. Tube Ensure that there is enough sample in the tube.
is empty or sample volume is not sufficient.
7012 Failed to identify the reagent disk. This is probably a Check for previous errors and eliminate the cause.
consequential error. Remove the reagent disk and check the ID tabs. Reinsert
the reagent disk correctly.
7013 [%s] Position error X-transfer. Switch off the instrument. Check if the X-transfer is blocked or jamming. Eliminate
the cause. Restart the system. If the error persists call ser-
vice.
7014 [%s] %s electrode is not stable during sample Perform restart. Perform <Electrode Service>. Check ISE
measurement. Ref solution tubing for obstructions. Replace electrode.
7015 [%s] %s electrode is not stable during calibrator Perform restart. Perform <Electrode Service>. Check ISE
measurement. Ref solution tubing for obstructions. Replace electrode.
7016 [%s] The ISE sample sensor could not detect ISE Check the ISE Deproteinizer level, proper electrode
Deproteinizer. mounting, tube leakages and obstructions.
7017 [%s] The ISE sample sensor could not detect ISE Etcher. Check the ISE tower and the ISE tubing for obstructions
and leaks. Ensure that the tubing is correctly inserted into
the sample sensor. If the error persists call service.
7018 [%d] The probe is not straight or not properly mounted. Check that the probe is properly mounted. Perform
<Replace Probe>.
7019 [%d] Transfer initialization failed due to a level detection Clean the transfer init plate. Ensure that the probe is not
problem. bent and installed correctly. Restart the system. If the
error persists call service.
7020 [%d] Transfer initialization failed due to an open main Ensure that all covers are closed. Restart the system.
cover.
7021 [%d] Instrument failed to initialize due to dirty init plate Perform <Clean Probe Manually> and restart the system.
or probe. If the problem persists, call service.
7022 [%s] Motor %d movement impeded. Perform restart. If the problem persists call service.
7033 [%s] Position error Z-transfer. Switch off the instrument. Check if the Z-transfer is
blocked or jamming. Eliminate the problem. Restart the
system. If the error persists call service.
7034 [%s] Either a rotor or an X-transfer or a Z-transfer motion Restart the system. If the error persists call service.
control error occurred.
7036 [%s] The level detection frequency is outside the range. Clean the probe and probe holder. Replace the water inlet
filter. Ensure that the system water meets the specifica-
tions. Restart the system. If the error persists call service.
7037 [%s] The level detection frequency is outside the range. Clean the probe and probe holder. Check the level detec-
tion cable for damage. Ensure that the cable is connected
correctly. Restart the system. If the error persists call ser-
vice.
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
D-14 Operator’s Manual · Version 4.0
cobas c111 9 Messages and alarms
List of alarm messages
ID Message Comment
7038 [%s] Motor %d error (overheated). Switch off the instrument. Check for smooth transfer
movements. Restart the system. If the problem persists
call service.
7039 [%s] Power supply error. One or more internally used Switch off the instrument. Check the fuses F1 through F4
voltages are outside the range. and replace blown fuses. Restart the system. If the error
persists call service.
7042 [%s] Fuse F1 blown. Switch off the instrument. Check fuse F1. If necessary
replace fuse F1. Restart the system. If the error persists call
service.
7043 [%s] Fuse F2 blown. Switch off the instrument. Check fuse F2. If necessary
replace fuse F2. Restart the system. If the error persists call
service.
7044 [%s] Fuse F3 blown. Switch off the instrument. Check fuse F3. If necessary
replace fuse F3. Restart the system. If the error persists call
service.
7045 [%s] Fuse F4 blown. Switch off the instrument. Check fuse F4. If necessary
replace fuse F4. Restart the system. If the error persists call
service.
7046 [%s] The initialization of the rotor failed. Switch off the instrument. Check if the rotor is jamming
or blocked. Clean the rotor initialization light barrier.
Restart the system. If the error persists call service.
7051 [%s] Error rotor motor. The motor could not be started. Restart the system. If the error persists call service.
7052 [%s] Error motor X-transfer. The motor could not be Restart the system. If the error persists call service.
started.
7053 [%s] Error motor Z-transfer. The motor could not be Restart the system. If the error persists call service.
started.
7057 [%s] The ISE sample sensor is not calibrated or no Perform <Initialize ISE Unit>. If the error persists call ser-
calibration data is available. vice.
7058 [%s] ISE sample sensor could not detect fluid. Check the ISE tower and the ISE tubing for obstructions
and leaks. Ensure that the electrodes are installed cor-
rectly. If the error persists call service.
7059 [%s] The ISE sample sensor could not detect the end of Check the ISE tower and the ISE tubing for obstructions
the transported fluid segment. and leaks. If the error persists call service.
7060 [%s] The calibration of the ISE sample sensor failed. Check the filling level of the ISE Cal bottle. Check the ISE
tubing for obstructions and leaks. Perform <Initialize ISE
Unit>. If the error persists call service.
7061 [%s] The calibration of the ISE sample sensor failed. Check the filling level of the ISE Cal bottle. Check the ISE
tubing for obstructions and leaks. Perform <Initialize ISE
Unit>. If the error persists call service.
7062 [%s] The ISE sample sensor could not detect calibrator. Check the filling level of the ISE Cal bottle. Check the ISE
tubing for obstructions and leaks. Perform <Initialize ISE
Unit>. If the error persists call service.
7063 [%s] The ISE sample sensor could not detect the end of Check the ISE tubing for obstructions and leaks. Perform
the calibrator segment. <Initialize ISE Unit>. If the error persists call service.
7064 [%s] The ISE sample sensor could not detect Activator Check the ISE tower and ISE tubing for obstructions and
during initialization. leaks. Perform <Initialize ISE Unit>. If the error persists
call service.
7065 [%s] Calibration of the ISE reference sensor failed, no Check the filling level of ISE Ref. Perform <Initialize ISE
valid calibration data are available. Reference Sensor>. If the error persists call service.
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
Operator’s Manual · Version 4.0 D-15
9 Messages and alarms cobas c111
List of alarm messages
ID Message Comment
7066 An internal control unit (%d) reported a wrong firmware Reinstall the system software.
version.
7067 An internal control unit (%d) reported a checksum or an Restart the system. If the error recurs export the log files
attach error. with the system remaining in this error condition. If the
error persists call service.
7068 [%d] Wash aborted due to open cover. Close the cover and restart the system.
7069 [%d] Transfer initialization failed due to an open main Ensure that all covers are closed. Restart the system.
cover.
7070 The available reagent bottle volume in bottle set %s is not Replace the bottle set with a new one.
sufficient. The bottle set has been marked as empty.
7071 Photometer error. Signal is invalid or unstable. Switch off the instrument. Remove and clean the rotor. If
the error recurs perform <Replace Photometer Lamp>
and <Abs Air/Water Calibration>. If the error persists call
service.
7072 [%d] The reagent mixing failed due to a level detection Check if the probe is obstructed. Check the filling level of
problem. the associated reagent bottle. If the error persists call ser-
vice.
7073 [%s] Peristaltic pump speed is outside the range. Check ISE tubing for obstructions and leaks. Ensure that
the electrode tension lever and the peristaltic pump cover
are closed. Perform <Initialize ISE Unit>. If the error per-
sists call service.
7074 [%s] The detected sample or calibrator segment is too Check the ISE tubing for obstructions and leaks. Ensure
short. that the electrodes are installed correctly. If the error per-
sists call service.
7075 [%s] A timeout error occurred while performing an ISE Restart the system and repeat the measurement. If the
measurement. error persists call service.
7076 [%s] Initialization of the ISE unit failed due to a fluid Check the ISE tower and the ISE tubing for obstructions
transport problem. and leaks. Check the electrodes. Perform <Initialize ISE
Unit>. If the error persists call service.
7083 [%s] The ISE bypass tubing is blocked. Perform <Replace ISE Unit Tubing>. Follow the instruc-
tions in the Operator's Manual. If the error persists call
service.
7084 [%s] An ISE pinch valve is probably defective. Restart the system. If the error persists call service.
7086 [%s] The ISE air pressure is outside the range. Check the air tubing underneath the ISE tower for
obstructions. If the error persists call service.
7087 [%s] ISE air pressure sensor detected that the pressure is Restart the system. If the problem persists, call service.
too low.
7088 [%s] A failure of the internal ISE power supply has been Restart the system. If the error persists call service.
detected.
7099 [%s] Weight sensors of the ISE Ref and ISE Cal bottle are In <Diagnostics> perform <Adjust ISE Ref Bottle Sensor>
not calibrated correctly. and <Adjust ISE Cal Bottle Sensor>. If the error persists
call service.
7100 A power fail has been detected and an automatic system
restart was performed.
7101 [%s] Rotor position error. Switch off the instrument. Check if the rotor is blocked or jamming. Eliminate the
cause. Restart the system. If the error persists call service.
7102 [%s] Transfer bumper init failed. Perform restart.
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
D-16 Operator’s Manual · Version 4.0
cobas c111 9 Messages and alarms
List of alarm messages
ID Message Comment
7103 [%s] Adjustment of the ISE Ref bottle or ISE Cal bottle Repeat the adjustment: In <Diagnostics> perform <Adjust
weight sensor failed. ISE Ref Bottle Sensor> and <Adjust ISE Cal Bottle Sen-
sor>. If the error persists call service.
7107 [%s] A not specified hardware error (%d) was reported by Restart the system. If the error recurs export the log files
the ISE Unit. with the system remaining in this error condition. If the
error persists call service.
7108 [%s] A not specified hardware error (%d) was reported by Restart the system. If the error recurs export the log files
the DC-Slave control. with the system remaining in this error condition. If the
error persists call service.
7109 [%d] The sample probe is bent or not properly aligned. Check the probe and replace it if necessary. Restart the
system. If the error persists call service.
7110 [%d] A timing error occurred while fluid is expelled into a Check for previous errors. Restart the system. If the error
cuvette. Probably the error was caused by a previous persists call service.
hardware problem.
7111 [%d] Transfer movement failed due to open cover. Keep covers closed while the system is in Operating status.
7112 [%s] The ISE reference sensor detected air when ISE Ref Check the ISE Ref bottle filling level. Perform <Prime ISE
solution was transported. Reference and Calib.> and check the fluid flow. If the
error persists call service.
7113 [%d] A prime cycle failed due to an open cover. Ensure that all covers are closed while the system is being
initialized, in the Operating or Maintenance status.
7114 [%d] An initialization error occurred. The X-transfer zero Check the X-transfer for obstructions. Ensure that all cov-
positions are invalid. ers are closed. Restart the system. If the error persists call
service.
7115 [%d] Dispensing into the ISE tower stopped because the Check the ISE tower waste tubing. Check the ISE tower
ISE tower was not empty. outlet for obstructions. Check the pinch valves. If the
error persists call service.
7116 [%d] The needle crashed while the system was trying to Switch off the instrument. Check if the transfer or probe
dispense fluid. movement is obstructed. Restart the system. If the error
persists call service.
7117 [%d] Consequential error caused by a previous hardware Check previous errors. Restart the system. If the error
or software problem. recurs export the log files with the system remaining in
this error condition. If the error persists call service.
7118 [%s] Rotor initialization error. The light barrier did not Switch off the instrument. Remove the rotor and clean the
react. light barrier. Reinstall the rotor. Restart the system. If the
error persists call service.
7119 [%d] Consequential error caused by a previous hardware Check previous errors. Restart the system. If the error
or software problem. recurs export the log files with the system remaining in
this error condition. If the error persists call service.
7120 [%s] Either a rotor, an X-transfer or a Z-transfer position Restart the system. If the error persists call service.
error occurred. Maybe one of these devices has been
moved manually by accident.
7121 [%d] Consequential error caused by an internal Check previous errors. Restart the system. If the error
communication problem. recurs export the log files with the system remaining in
this error condition. If the error persists call service.
7122 [%d] The Prepare action has been stopped due to an open Ensure that all covers are closed while the system is being
cover. initialized, in the Operating or Maintenance status.
7123 Extra wash cycle after reagent pipetting failed. Perform <Deproteinize Probe> before next run.
7124 Analyzer temperature outside the range.
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
Operator’s Manual · Version 4.0 D-17
9 Messages and alarms cobas c111
List of alarm messages
ID Message Comment
7125 [%s] Motion control error in rotor motor. Restart the system to correct the problem. If the error per-
sists call service.
7126 [%s] Motion control error X-transfer motor. Restart the system to correct the problem. If the error per-
sists call service.
7127 [%s] Motion control error Z-transfer motor. Restart the system. If the error persists call service.
7128 [%s] Initialization error X-transfer. Switch off the instrument. Ensure that all covers are
closed. Check if the X-transfer is blocked or jamming.
Restart the system. If the error persists call service.
7129 [%s] Initialization error Z-transfer. Switch off the instrument. Check if the Z-transfer is
blocked or jamming. Check the seating of the transfer
head cover. Restart the system. If the error persists call
service.
7130 [%s] Rotor position error. Switch off the instrument and check if the rotor is blocked
or jamming. If the error recurs call service.
7131 [%s] Position error X-transfer. Switch off the instrument and check if the X-transfer is
blocked or jamming. If the error recurs call service.
7132 [%s] Initialization error Z-transfer. Switch off the instrument. Check if the Z-transfer is
blocked or jamming. Check the seating of the transfer
head cover. Restart the system. If the error persists call
service.
7133 [%s] Rotor motor overheated. Switch off the instrument. Check if the rotor is blocked or
jamming. Restart the system. If the error persists call ser-
vice.
7134 [%s] Motor X-transfer overheated. Switch off the instrument. Check if the X-transfer is
blocked or jamming. Ensure that the X-transfer can be
moved smoothly. Restart the system. If the error persists
call service.
7135 [%s] Motor Z-transfer overheated. Switch off the instrument. Check if the Z-transfer is
blocked or jamming. Ensure that the Z-transfer can be
moved smoothly. Restart the system. If the error persists
call service.
7136 [%s] Tube bottom detector is blocked or jamming. Switch off the instrument. Remove the transfer head
cover. Check the tube bottom detector mechanism. Install
the transfer head cover. Restart the system. If the error
persists call service.
7137 [%s] Na sample measurement unstable. Check the expiry date of the Ref and Na electrodes.
Replace expired electrodes. Check the ISE tubing for
obstructions and leaks. Perform <Electrode Service>. If
the error persists call service.
7138 [%s] Cl sample measurement unstable. Check the expiry date of the Ref and Cl electrodes.
Replace expired electrodes. Check the ISE tubing for
obstructions and leaks. Perform <Electrode Service>. If
the error persists call service.
7139 [%s] K sample measurement unstable. Check the expiry date of the Ref and K electrodes. Replace
expired electrodes. Check the ISE tubing for obstructions
and leaks. Perform <Activate Electrodes>. If the error per-
sists call service.
7140 [%s] Na calibrator measurement unstable. Perform <Electrode Service> and <Prime ISE Reference
and Calib.>. Check ISE Cal and Ref flow. Check the ISE
tubing for obstructions. If the error persists call service.
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
D-18 Operator’s Manual · Version 4.0
cobas c111 9 Messages and alarms
List of alarm messages
ID Message Comment
7141 [%s] Cl calibrator measurement unstable. Perform <Electrode Service> and <Prime ISE Reference
and Calib.>. Check ISE Cal and Ref flow. Check the ISE
tubing for obstructions. If the error persists call service.
7142 [%s] K calibrator measurement unstable. Perform <Electrode Service> and <Prime ISE Reference
and Calib.>. Check ISE Cal and Ref flow. Check the ISE
tubing for obstructions. If the error persists call service.
7143 [%d] An internal software problem (%d) occurred. The Restart the system. If the error recurs export the log files
access to the internal EEPROM failed. with the system remaining in this error condition. If the
error persists call service.
7144 [%d] The instrument battery is low or not connected. The Call service.
date and time may no longer be valid. A replacement of
the battery is probably required.
7145 [%d] The action <Clean ISE> has been stopped due to an Ensure that all covers are closed while the system is being
open cover. initialized, or in the Operating or Maintenance status.
7146 [%d] The initialization of the system has been stopped due Ensure that all covers are closed while the system is being
to an open cover. initialized, or in the Operating or Maintenance status.
7147 [%d] The initialization of the ISE Unit has been stopped Ensure that all covers are closed while the system is being
due to an open cover. initialized, or in the Operating or Maintenance status.
7148 [%d] Initialization of the ISE Unit has been stopped due to Switch off the instrument. Check if the transfer is blocked
a blocked transfer. or jamming. Ensure that all covers are closed. Restart the
system. If the error persists call service.
7149 [%d] Initialization of the rotor failed. The calculated offset Switch off the instrument. Check if the rotor is blocked or
is outside the range. jamming. Restart the system. If the error persists call ser-
vice.
7150 [%d] Initialization of the transfer failed due a level Switch off the system. Clean the probe and probe holder
detection problem. and ensure that they are installed correctly. Restart the
system. If the error persists call service.
7151 [%d] Dispensing fluid into the ISE tower failed due to an Switch off the instrument. Check if the X- transfer and Z-
incorrect X-transfer or probe position. transfer are blocked or jamming. Restart the system. If the
error persists call service.
7152 [%d] A pipetting or dispensing cycle failed due to an Switch off the instrument. Check if the X- transfer and Z-
incorrect X-transfer or probe position. transfer are blocked or jamming. Restart the system. If the
error persists call service.
7153 [%d] A reagent mixing cycle failed because the probe Switch off the instrument. Check if the probe and probe
crashed. holder are correctly installed. Replace a bent probe.
Restart the system. If the error persists call service.
7154 [%d] A probe wash cycle failed because the probe crashed. Switch off the instrument. Check if the probe and probe
holder are correctly installed. Replace a bent probe.
Restart the system. If the error persists call service.
7155 [%d] Initialization of the transfer failed because the probe Switch off the instrument. Check if the probe and probe
crashed. holder are correctly installed. Replace a bent probe.
Restart the system. If the error persists call service.
7156 [%d] A prime cycle failed because the probe crashed. Switch off the instrument. Check if the probe and probe
holder are correctly installed. Replace a bent probe.
Restart the system. If the error persists call service.
7157 [%d] Initialization of the Z-transfer failed due to a level Switch off the instrument. Check if the probe and probe
detection problem. holder are correctly installed. Clean the init plate. Restart
the system. If the error persists call service.
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
Operator’s Manual · Version 4.0 D-19
9 Messages and alarms cobas c111
List of alarm messages
ID Message Comment
7158 [%d] A tube bottom sensor problem was detected. Switch off the instrument. Check if the tube bottom sen-
sor mechanism can be moved freely. Restart the system. If
the error persists call service.
7159 [%d] Movement stopped because the probe crashed. Switch off the instrument. Check if the probe and probe
holder are correctly installed. Replace a bent probe. Check
the magnetic slider. Restart the system. If the error per-
sists call service.
7160 Sample pipetting on position %d was aborted due to an
unstable LD signal%s.
7161 Reagent pipetting of bottle set %s was aborted due to an
unstable level detection signal%s. The test is automatically
repeated.
7162 The probe crashed due to a jamming main cover slider. Check the slider and ensure that it is operating correctly.
7163 The run aborted due to a jamming main cover slider. Check the slider and ensure that it is operating correctly.
7164 An internal communication error occurred. Controller %s Restart the system. If the error persists call service.
could not be connected.
12001 The host computer did not answer the order query for Check the communication and existing orders on the
sample %s within the time limit. host.
12002 The communication port is not accessible. Check the Host Settings and compare them with the host
Communication to the host server is not possible. server settings.
12003 Sending a message to the host computer failed. Enable the host trace file in the Host Settings in order to
record HIF communication activities.
12004 Receiving or processing a message from the host Enable the host trace file in the Host Settings in order to
computer failed. record HIF communication activities.
12005 Host server could not send message to the host. Select result and perform Retransmit. If the problem
recurs enable the host trace file in the Host Settings.
Retransmit again and export the log files. If the error per-
sists call service.
12006 Changes of the host communication settings could not be Restart the system. If the error persists call service.
applied.
13001 A software error (%d) occurred. The database could not Restart the system. If the error recurs export the log files
be opened. with the system remaining in this error condition. If the
error persists call service.
13002 A software error occurred. The calculated result for the Export the log files. If the error persists call service.
order (%d) could not be stored in the database.
13003 A software error occurred. Data of the order (%d) could Export the log files. If the error persists call service.
not be retrieved from the database.
13004 A software error occurred. The required parameters for Export the log files. If the error persists call service.
application (%d) could not be found.
13005 A software error occurred. The calibration result for order Export the log files. If the error persists call service.
(%d) could not be stored in the database.
13006 A software error occurred. A required parameter set for a Export the log files. If the error persists call service.
certain application (%d) could not be found.
13007 Reagent disc %d was replaced by disc %d while the system Ensure that the information provided in <Disk Status>
was switched off. corresponds to the actually loaded reagent bottle sets.
13008 The import of the database failed. The database version
does not correspond to the currently installed software
version. An old database version was provided (detected
V %d ; expected V %d ).
Table D-1 List of alarm messages (Continued)
Roche Diagnostics
D-20 Operator’s Manual · Version 4.0
cobas c111 9 Messages and alarms
List of alarm messages
ID Message Comment
13009 A software error occurred. An invalid database entry (%d) Export the log files. If the error persists call service.
for a control was detected.
13010 A software error occurred. An invalid database entry (%d) Export the log files. If the error persists call service.
for a control was detected.
13011 Validation of Development Channels failed. The number
of installed DC applications does not match the number
of available channels. (%d DC applications found, %d
channels installed).
13012 Auxiliary reagent (%d) not found. Ensure that the reagent bottle has been loaded. If the error
recurs export the log files with the system remaining in
this error condition. If the error persists call service.
13013 Reagent bottle %d not found. Ensure that the reagent bottle has been loaded. If the error
recurs export the log files with the system remaining in
this error condition. If the error persists call service.
13014 Calibrator lot definition for application %d inconsistent.
Check number of standards used with number of
calibrator cups and Last Is Water definition.
20001 <Replace Water Inlet Filter> completed.
20002 <Clean Water and Waste> completed.
20003 <Replace Photometer Lamp> completed.
20004 <Clean Probe Manually> completed.
20005 <Prime Fluid System> completed.
20006 <Clean Housing> completed.
20007 <Deproteinize Probe> completed.
20008 <Clean Reagent Disk> completed.
20009 <Database Backup> completed.
20010 <Call Service Rep.> completed.
20011 <Clean ISE Tower Manually> completed.
20012 <Replace ISE Unit Tubing> completed.
20013 <Replace ISE Pump Tubing> completed.
20014 <Replace ISE %s Electrode> completed.
20015 <Initialize ISE Reference Sensor> completed.
20016 <Clean ISE Tower Automatically> completed.
20017 <Initialize ISE Unit> completed.
20019 <Electrode Service> completed.
20020 <Activate Electrodes> completed.
20021 <Prime ISE Reference and Calibrator> completed.
20022 <Condition ISE Tubing> completed.
20023 An unknown action %d was completed successfully.
20024 Installation completed. The intervals of the maintenance
actions were reset successfully (except daily maintenance
actions).
20025 <Abs. Air/Water Calibration> completed.
20026 The external water reservoir was refilled.
20027 The external waste container was emptied.
Table D-1 List of alarm messages (Continued)
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9 Messages and alarms cobas c111
List of alarm messages
ID Message Comment
20028 <Daily Prepare Actions> completed.
20029 Database cleanup completed.
20030 <Initialize Degaser Fluid Sensor> completed.
Table D-1 List of alarm messages (Continued)
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D-22 Operator’s Manual · Version 4.0
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.
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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.
If Do this
You want to look at sample 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. For ratio results, the flag with the highest priority of
all constituent test results 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.
4 Look up the flag in section List of flags on page D-28 for detailed information on
the flag.
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10 Result flags cobas c111
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-28.
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cobas c111 10 Result flags
Safety
Safety
Before you start troubleshooting, 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.
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 com-
pleted the previous one.
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10 Result flags cobas c111
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-71.
>
Meaning Result generated by re-performing the test with the same running parameters
(repeated).
Message ID 120
Priority 32
Message ID 121
Priority 33
Ag Excess
Message ID 6
Priority 19
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List of flags
? Cal
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).
Cal Error
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
Message ID 16
Priority 13
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10 Result flags cobas c111
List of flags
Curv Dir
Message ID 14
Priority 10
Ep Unstab
Message ID 9
Priority 8
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List of flags
High Abs
Message ID 5
Priority 1
High Act
Message ID 56
Priority 9
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10 Result flags cobas c111
List of flags
Message ID 11
Priority 11
Low Act
Message ID 56
Priority 9
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List of flags
Non Linear
Message ID 11
Priority 11
Possible cause o The slope changes between the first and last parts of the reaction curve.
Non Mono
Message ID 80
Priority 14
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
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10 Result flags cobas c111
List of flags
Out of Rng
Message ID 84
Priority 16
? QC
Message ID 111
Priority 30
Possible cause The last QC measurement before this measurement was flagged. The dependency is
derived from the time sequence.
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.
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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
>R 2(2s)
Meaning Two sequential control measurements are above the 2 standard deviation.
Message ID 29
Priority 26
<R 2(2s)
Meaning Two sequential control measurements are below the -2 standard deviation.
Message ID 29
Priority 26
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10 Result flags cobas c111
List of flags
>Reag Rng
Message ID 12
Priority 7
<Reag Rng
Message ID 12
Priority 7
Message ID 13
Priority 12
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.
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List of flags
> RR
Message ID 40
Priority 22
< RR
Message ID 41
Priority 23
Message ID 17
Priority 17
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10 Result flags cobas c111
List of flags
Message ID 26
Priority 20
Message ID 27
Priority 21
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D-38 Operator’s Manual · Version 4.0
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.
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Table of contents
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D-40 Operator’s Manual · Version 4.0
cobas c111 11 Troubleshooting
Introduction
Introduction
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:
o Immediate feedback on user actions is displayed in a pop-up message screen.
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.
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11 Troubleshooting cobas c111
Dealing with exceptional situations
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 per-
detection formed 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 connec-
need to be disconnected connectors. another location. tors, remove the side panel before removing the connec-
from the instrument. o Removing blockages. tors.
e See To disconnect a tube from the instrument on
page B-129.
A service representative Diagnostics These features are usually used Follow the instructions given by the service representa-
asks you to perform diag- features. at the request of a service repre- tive.
nostics tasks. sentative. e See Exporting diagnostics screens to USB on
page D-51.
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-47.
No printing. Printer. Printer is out of paper. Load printer paper.
e Refilling printer paper on page B-122.
Printer jam. e To clear the paper jam on page D-46.
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 sup-
ported procedures.
1. Align the bottle storage assembly in the reagent
disk.
e See Realigning the reagent disk on page D-50.
2. Insert the reagent disk in the cooler.
Figure D-4 Troubleshooting overview
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Dealing with exceptional situations
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11 Troubleshooting cobas c111
Reacting to messages
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.
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Reacting to messages
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11 Troubleshooting cobas c111
Detailed procedures
Detailed procedures
Press down the release button (A) firmly before you pull the panel. The panel should
open without resistance.
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Detailed procedures
6 Insert the paper in the slot in the printer panel and pull some through.
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11 Troubleshooting cobas c111
Detailed procedures
6 Using a screwdriver disengage the clips on both sides of the fuse box cover.
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D-48 Operator’s Manual · Version 4.0
cobas c111 11 Troubleshooting
Detailed procedures
Figure D-6
o Insert the screwdriver in the slot and turn anticlockwise until the holder
disengages.
o Remove the holder with the fuse.
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11 Troubleshooting cobas c111
Detailed procedures
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.
Figure D-7
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Detailed procedures
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, and the system must be in Standby or Stopped status.
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11 Troubleshooting cobas c111
Detailed procedures
Roche Diagnostics
D-52 Operator’s Manual · Version 4.0
ISE E
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.
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Table of contents
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E-4 Operator’s Manual · Version 4.0
cobas c111 12 ISE description
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
Abbreviation Definition
CL-I Chloride indirect
CL-U Chloride urine
F Solution 1 factor
K-I Potassium indirect
K-U Potassium urine
mV Measured voltage in millivolt
NA-I Sodium indirect
NA-U Sodium urine
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
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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.
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.
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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
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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.
Fluid stability For information on the stability of fluids see the package insert of the fluid in
question.
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Hardware
Hardware
The ISE unit is designed as an add-on unit to the cobas c111 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.
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Hardware
ISE LED
Blinking The fluid level in the ISE Reference or ISE Calibrator indirect/urine
bottle is low.
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)
Peristaltic pump A fluid pump that draws the solutions through the electrode block and then pumps it
to the internal waste tank.
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Hardware
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.
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:
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-54.
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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.
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Technical specifications
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 or after a defined interval
has expired.
e For ISE-specific maintenance actions, see Chapter 14 ISE maintenance.
Technical specifications
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Technical specifications
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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.
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Table of contents
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E-16 Operator’s Manual · Version 4.0
cobas c111 13 ISE operation
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.
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. Check the ISE status. Overview >
3. Perform Daily Prepare Actions. Utilities > Maintenance
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
Safety information
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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.
4. Press to proceed to the next stage in the
Prepare wizard.
3 Check the onboard ISE fluids. 1. Replace the ISE fluid bottles, if required.
2. Replace the electrodes, if required.
3. Press to proceed to the next stage in the
Prepare wizard.
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Daily operation
When checking external fluid containers without using the Prepare wizard:
Choose Overview > > .
Replacing electrodes
a To replace an electrode
1 Follow the instructions given in Replacing electrodes on page E-32.
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13 ISE operation cobas c111
Daily operation
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.
o After replacing an ISE fluid bottle, the Prime ISE Reference and Calib. mainte-
nance action needs to be performed. This action will be performed as part of the
maintenance procedure of the Prepare wizard.
o 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.
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Daily operation
Performing calibrations
The ISE calibrations are integrated in the Daily Prepare Actions maintenance action.
e See Daily prepare actions on page E-44.
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-38.
ISE tests are defined and requested as profiles. (There is hardly ever the need for elec-
trolytic measurements of just one electrode.)
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13 ISE operation cobas c111
Daily operation
A
A Relevant instrument status buttons
Figure E-4
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Daily operation
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.
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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-44.
For details on performing individual calibrations, see Process of performing calibrations on
page B-61.
Performing QC
a To perform QC
e Follow the instructions given in Performing QC on page B-68.
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Daily operation
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.
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 shut down the system and 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-77.
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Daily operation
Short guide
2 Start the End Shift wizard. 1. On the Overview tab, press the End Shift but-
ton.
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Daily operation
7 Check the cuvette status. 1. Press to proceed to the next stage in the
(Not relevant for ISE operation.) End Shift wizard.
If you intend not to use the ISE unit for more than one week, you should deactivate it. This
saves ISE fluids, reduces wear and tear of the tubing, and lowers the likelihood of malfunc-
tions and errors occurring. (See Deactivating the ISE unit on page E-64.)
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Replacing ISE fluid bottles
ISE fluid bottles are supplied with a barcode that contains information on their
expiration date, which is monitored by the system.
Roche recommend replacing ISE fluid bottles as soon as their expiration date has passed.
(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
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 passed.
You should replace the bottle as soon as possible.
No action is required.
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Replacing ISE fluid bottles
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.
You need to perform a main calibration before you can process orders.
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Replacing electrodes
Replacing electrodes
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.
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.
o Injury through reagents and other working solutions on page E-19.
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Replacing electrodes
a To replace an electrode
1 Check that the system is in Standby status.
2 Choose Overview > .
The ISE status is displayed.
A Electrode buttons
Figure E-5
A Tension lever
Figure E-6
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.
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Replacing electrodes
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.
At this stage, if you want to replace another electrode, press its button and continue
with step 7.
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 .
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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.
Make sure that you have read and understood section Safety information on page E-19.
The following warning messages in particular are relevant:
o Infection by biohazardous materials on page E-19.
o Injury through reagents and other working solutions on page E-19.
Removing the ISE tower 1 Make sure the system is in Standby status.
2 Shut down the system and switch off the instrument.
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
Figure E-7
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Cleaning the ISE tower off the instrument
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-8
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-9
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Cleaning the ISE tower off the instrument
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Table of contents
ISE maintenance
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Table of contents
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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.
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 cor-
rect 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.
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ISE maintenance actions
Safety information
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ISE maintenance actions
Whenever the term "purified water" is used in this document, water of at least the quality
specified in chapter Technical specifications must be used.
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ISE maintenance actions
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Injury through working solutions on page E-42.
o Incorrect results due to build-up of contaminants on page E-42.
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ISE maintenance actions
Activate electrodes
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Injury through working solutions on page E-42.
o Infection by biohazardous materials on page E-42.
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ISE maintenance actions
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Injury through working solutions on page E-42.
o Infection by biohazardous materials on page E-42.
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ISE maintenance actions
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Injury through working solutions on page E-42.
o Infection by biohazardous materials on page E-42.
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ISE maintenance actions
Electrode service
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Injury through working solutions on page E-42.
o Infection by biohazardous materials on page E-42.
You need to perform a main calibration before you can process orders.
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ISE maintenance actions
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Injury through working solutions on page E-42.
o Infection by biohazardous materials on page E-42.
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ISE maintenance actions
When the ISE tower is blocked, perform first the Clean ISE Tower Automatically mainte-
nance action (See Clean ISE tower automatically on page E-50). If this does not help, per-
form 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-36.)
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Injury through working solutions on page E-42.
o Infection by biohazardous materials on page E-42.
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ISE maintenance actions
7 Clean the inside of the ISE tower with a cotton swab to remove any residual of ISE
Deproteinizer.
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.
A message will inform you when the maintenance action is complete.
14 Remove the Activator and ISE Deproteinizer from the sample area.
15 Press .
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ISE maintenance actions
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Infection by biohazardous materials on page E-42.
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ISE maintenance actions
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Injury through working solutions on page E-42.
o Infection by biohazardous materials on page E-42.
o Infection by waste solution on page E-43.
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ISE maintenance actions
Figure E-10
A Connector plate
Figure E-11
Figure E-12
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ISE maintenance actions
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.
12 Align the tubing connector plate with the tube connectors on the ISE unit.
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ISE maintenance actions
Always replace the ISE tubing with the help of the Replace ISE Unit Tubing maintenance
action.
Make sure that you have read and understood section Safety information on page E-42.
The following warning messages in particular are relevant:
o Injury through working solutions on page E-42.
o Infection by biohazardous materials on page E-42.
o Infection by waste solution on page E-43.
o Personal injury or damage to the analyzer due to contact with instrument mechanism on
page E-42.
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ISE maintenance actions
Disconnecting the ISE solution 7 Remove the tubing adapters from ISE Calibrator indirect/urine and ISE Reference
bottles Solution bottles.
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.
Figure E-13
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.
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ISE maintenance actions
o Push the cap horizontally in the direction of the arrow, away from the cut-out.
o Lift and put it aside.
o 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
o 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.
o 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.
o 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.
o Disconnect the tubing.
Do not remove the piece of tubing at the underside of the mixing tower. It will be
changed when a service representative performs periodic maintenance.
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ISE maintenance actions
Figure E-14
A Tension lever
Figure E-15
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 17 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.
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ISE maintenance actions
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 to 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
Figure E-16
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.
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ISE maintenance actions
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.
Figure E-17
o Pull the tube through the hole that aligns with the clips.
o Insert the nozzle in the tube.
o 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.
o Fix the tube to the clips.
With the adapter that offers two clip positions, use the inner position.
o Insert the tubing adapter in the appropriate bottle.
10 Close the ISE cover, then the left service flap and the main cover.
11 Press to confirm completion of the action.
Conditioning the tubing The system now performs the maintenance action Prime ISE Reference and
Calib.
A message will inform you when the maintenance action is complete.
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.
12 Open the ISE cover.
13 Remove the tubing adapter from of the ISE Reference Solution bottle.
o Have a clean lint-free tissue ready.
o Lift the tubing adapter and place it on the tissue.
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If you intend not to use the ISE unit for more than one week, you should deactivate it.
This saves ISE fluids, reduces wear and tear of the tubing, and lowers the likelihood of
malfunctions and errors occurring
This situation may occur, for example, if you need to close the laboratory
temporarily, or if you want to relocate the cobas c111 instrument with the ISE unit.
Make sure that you have read and understood section Safety information on page E-42.
The following warning message in particular is relevant:
o Injury through working solutions on page E-42.
o Infection by biohazardous materials on page E-42
Figure E-18
A Connector plate
Figure E-19
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-58.
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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.
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Table of contents
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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-42.
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-74.
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
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Safety
Safety
Before you start troubleshooting, 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.
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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-28.
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 com-
pleted the previous one.
>
Meaning Result generated by re-performing the test with the same running parameters
(repeated).
Message ID 120
Priority 32
Air Fluid
Message ID 19
Priority 4
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List of ISE flags
Air Isecal
Message ID 91
Priority 5
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
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).
Cal Error
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.
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List of ISE flags
Calc Error
Message ID 16
Priority 13
Ise Unstab
Meaning The signal from the electrode(s) was not stable during the measurement.
Message ID 18
Priority 6
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.
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List of ISE flags
No Fluid
Meaning The ISE sample or ISE Reference Solution sensor could not detect any fluid. It takes
too long for a sample segment to reach the electrodes.
Message ID 68
Priority 2
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
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List of ISE flags
Out of Rng
Message ID 20
Priority 15
? QC
Message ID 111
Priority 30
Possible cause The last QC measurement before this measurement was flagged. The dependency is
derived from the time sequence.
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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.
R 1(3s)
Meaning One control value is above 3 standard deviation or below -3 standard deviation.
Message ID 35
Priority 27
>R 2(2s)
Meaning Two sequential control measurements are above the 2 standard deviation.
Message ID 29
Priority 26
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List of ISE flags
<R 2(2s)
Meaning Two sequential control measurements are below the -2 standard deviation.
Message ID 29
Priority 26
> RR
Message ID 40
Priority 22
< RR
Message ID 41
Priority 23
Seg Fluid
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List of ISE flags
Seg Isecal
Sol1 F Dev
Meaning The ISE Solution 1 factor was not within the expected range.
Message ID 22
Priority 18
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List of ISE flags
Message ID 26
Priority 20
Message ID 27
Priority 21
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Reacting to error messages
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Glossary and Index F
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-11
cobas c111 Glossary
2-dimensional barcode - button
Glossary
This glossary is a compendium in which to look up the analyte The constituent in the sample that is to be
meaning of technical terms used in conjunction with the determined.
cobas c111 instrument.
analytical instrument A device or a combination of
devices used to carry out an analytical process.
Numbers
analyzer unit Central analyzing unit including cooling
2-dimensional barcode A type of barcode on reagent assembly, heating channel, rotor and insulation. Does
bottles, calibrators, and control barcode sheets. These not include the photometer unit.
matrix barcodes, which use PDF417 symbology, contain
more information than traditional linear barcodes. application Chemistry and method to determine a
parameter. See also test.
A
assay 1. A specific test.
absorbance photometer A device used to make 2. The process of measuring a substance.
absorbance photometry measurements. It consists of a
halogen light source, optical groupings, a
monochromator (diffraction grating), a preamplifier, B
filters, and a diode array. See also photometer.
backup The saving of data onto supplementary storage
accuracy The absolute deviation of a result from a pre- media such as disks or tape. If such data is required again
defined target value in percent or absolute units. but is no longer available from the main storage
(instrument hard disk), it can be restored from a backup
activate The process of conditioning electrodes with copy.
fresh serum so that the correct potentials are measured.
barcode A numeric or alphanumeric code used on
Activator Serum used to coat ISE electrodes, tubing sample tubes and reagent bottles to identify the samples
and the sample probe after cleaning procedures. (The and reagents. Different barcode standards are available.
cobas c111 Activator is based on human sample See also barcode type.
material. For further details refer to the Activator
package insert.) barcode scan The process of reading barcode
information into the memory of an instrument.
alarm A visual or audible operator notification of any
system irregularity. barcode scanner The device that reads the code from
sample or reagent barcode labels.
Alarm button A button used to display the alarm
messages. barcode transfer sheet (BTS) A sheet bearing a
barcode that encodes test-related (or calibrator or
alarm level A level that identifies the source and control) information for an analytical instrument.
severity of a problem. There are two levels: warning, and
alarm. barcode type Typical sample barcode types used in
the IVD industry are Code39, NW7 (Codabar), ITF, and
alarm message A message that reports a system Code 128.
irregularity. It can be viewed in the alarm monitor
screen. See Alarm button. biohazardous A classification used to identify material
that poses a health threat, for example something
aliquot Portion of sample material pipetted into any contaminated with biological material.
secondary cup.
button A button is found on a screen or pop-up
alphanumeric sorting The listing of information, in a window. It can be touched either to initiate an action or
printout or on a screen, in a pre-defined order by letters to move to a different screen.
or numbers.
Roche Diagnostics
Operator’s Manual · Version 4.0 F-3
Glossary cobas c111
calculated result - dead volume
calibration interval A specified interval at which an CPU The Central Processing Unit of the system or
assay should be calibrated. Typically found on reagent computer.
package inserts.
CSF Abbreviation for cerebral spinal fluid. A sample
calibration type Describes the event that triggers the type for clinical analysis.
calibration, for example lot change, and interval
expiration. cup See sample cup.
conditioning The process of letting serum-type liquid DAU Drug of Abuse in Urine. The old term for DAT or
flow through the flow path before electrolyte Drugs of Abuse Testing.
measurement.
DB Abbreviation for database.
consumables A generic term for items that are used
during test processing and must be replaced on a regular DBMS Abbreviation for database management system.
basis by the operator. Examples of consumables include
printer paper and cuvette segments. dead volume The amount of residual sample material
in a sample tube or cup.
control See control material.
Roche Diagnostics
F-4 Operator’s Manual · Version 4.0
cobas c111 Glossary
default QC - ISE Reference Electrode
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 management and control of the computer network.
that 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).
expected value A value for a test result that can be installing applications Process of making the
considered as a normal result. application available for testing, as opposed to importing
the application data, which just saves the data on the
expiration date Also called the expiry date. The end of system.
a period until which Roche Diagnostics guarantees
product claims for its reagents, calibrators, and controls. interval QC A streamlined process of performing (all)
due QC measurements (for QC that needs to be
extended dynamic range The measuring range for performed periodically.)
an assay at its highest dilution.
ISE Abbreviation for ion-selective electrode.
Roche Diagnostics
Operator’s Manual · Version 4.0 F-5
Glossary cobas c111
ISE Reference Solution - operator ID
ISE Reference Solution A KCl solution pulled maintenance procedure See maintenance action.
through the ISE Reference Electrode to set the electronic
baseline to zero for ISE measurement. Also known as the manual dilution An off-system, pre-analytical step
REF or reference electrode solution. performed by laboratory staff to reduce the analyte
concentration in a sample.
IVD Abbreviation for in vitro diagnostics. A diagnostic
procedure performed outside the living body with mean The sum of values divided by the number of
specimen body fluid. values.
level detection A check for the availability of measuring range See reportable range.
sufficient liquid in a container.
message In computing, a defined set of alphanumeric
linear barcode A conventional one-dimensional data that transfers information from computer to
barcode with limited data capacity. computer or from an analytical instrument to the
operator.
liquid level detection (LLD) The ability of an
analytical instrument to sense liquid by using the probe. Microcup A secondary sample cup made by Hitachi
with a small dead (residual) volume.
log file A set of data, typically stored in the control unit,
that traces instrument-related or operator-related minimum sample volume The amount of residual
activities such as maintenance. sample material plus the volume required for assaying all
requested tests to ensure faultless sample aspiration.
log off The procedure of terminating access to a system.
Also known as log out or logoff. The reverse procedure is monochromatic Absorbance measurement at one
known as log on or log in. (primary) wavelength.
main calibration Two-point calibration of the ISE operating system A software program that controls
tests with ISE Solution 1 and 2. (As opposed to the all basic functions of a computer (for example, Windows,
calibration with ISE Calibrator indirect/urine, which is Linux, and Palm OS).
part of each ISE measurement.)
operator The person who uses and controls the
maintenance action A maintenance procedure analytical instrument or a computer system.
performed by the system or the operator; and that must See also user.
be performed on a regular basis (for example daily,
weekly, or monthly) to secure reliable operation of the operator ID An alphanumeric ID that a system uses to
analyzer. identify a particular operator.
Roche Diagnostics
F-6 Operator’s Manual · Version 4.0
cobas c111 Glossary
order - reagent disk position
order Collection of all tests that are defined to be prime The process of flushing a system, for example the
performed for a particular sample. tubing, with ISE Calibrator indirect/urine and water to
clear it of possible obstacles, traces of fluid, and of air
order ID A set of alphanumeric data that unmistakably bubbles.
identifies a particular sample order in the lab and is often
manually written on the sample label. profile A user-defined set of tests.
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.
preventive maintenance A series of actions, reagent bottle Standard plastic bottle for photometric
suggested by the system, that the operator should reagents.
perform to ensure smooth and uninterrupted operation
of the instrument (for example, emptying the waste reagent disk The removable device into which the
container or replenishing reagents). reagent bottles are placed.
primary tube The original tube containing the sample reagent disk position One of the multiple positions
that has been drawn from the patient. on the reagent disk.
See sample tube.
Roche Diagnostics
Operator’s Manual · Version 4.0 F-7
Glossary cobas c111
reagent port - STAT
reagent port Section of the analyzer unit where sample tube A glass or plastic container for liquid
reagent bottles are inserted and removed. samples to be used with the system. It may or may not
have a bar code label, which may be used for positive
reference electrode See ISE Reference Electrode. sample identification. A sample tube contains sample of
one specific specimen (sample) type.
reference range See expected range.
sample type A type of sample that can be analyzed:
reference solution See ISE Reference Solution. serum, plasma, whole blood, or urine.
repeat The performance of the same test on a sample sampling stop An alarm level that indicates a problem
again with identical dilution. with the sampling system.
See also S.Stop.
reportable range The range of results that can be
reported for the assay. It stretches from the lower scan See barcode scan.
detection limit to the high end of the calibration curve.
scroll The action of moving through text or graphics
request See order. (up, down, left, or right) to see parts of the file or list that
cannot fit on the screen.
rerun The performance of the same test on a sample
again with a different dilution. scroll arrow An arrow on either end of a scroll bar that
you use to scroll through the contents of the screen or list
result The value reported by an analytical device during box.
or after the assay of a sample or control.
scroll bar A bar that appears at the bottom or right
ROM Abbreviation for read-only memory. edge of a screen whose contents are not entirely visible.
Semiconductor memory devices used in computers.
ROM content remains when a computer is switched off. SD Abbreviation for standard deviation.
rotor Assembly consisting of cuvette ring and plastic secondary tube A sample container of variable size
frame. into which aliquots are transferred.
sample cup A small container that is used for samples specimen Generic term for a calibrator, control and
and also for calibrator and control material. A sample sample.
cup can be placed either directly on the sample area, or
on sample tubes. Compared to a sample tube, a sample standard Traceable reference material used to create
cup allows the use of smaller liquid volumes and so the master calibration curve.
reduces the dead volume.
standard deviation A statistic used as a measure of
sample ID A set of alphanumeric data that the dispersion or variation in a distribution of data.
unmistakably identifies a particular sample within a
whole organization, for example the hospital. It is used Start button A button used to start system operation
on barcodes and is the unique identifier used to (Operating status) and begin the pipetting of samples,
communicate with a laboratory information system. measurement, and the result calculation process.
sample splitting The act of making one or more STAT Abbreviation for Short Turn Around Time.
aliquots from a primary or secondary specimen. Terminology used by the medical clinical professionals
to prioritize the processing of a sample in a laboratory.
Roche Diagnostics
F-8 Operator’s Manual · Version 4.0
cobas c111 Glossary
status - worklist
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.
Roche Diagnostics
Operator’s Manual · Version 4.0 F-9
Glossary cobas c111
worklist - worklist
Roche Diagnostics
F-10 Operator’s Manual · Version 4.0
cobas c111 Index
Index
A applications
– importing, B–111, B–137
abbreviations, 9 – installing, B–112, B–138
abbreviations, ISE, E–5 – preparing, B–140
aborting the process, A–121 – result conversion definitions, B–156
Abs. air/water calibration, maintenance action, C–28 – screen, A–112
absorbance adjustment, definitions, B–169 – uninstalling, B–143
absorbance measurements, process, A–19 applications, screen, A–111
absorbance photometer, A–63 approvals, 3
acceptable flags list, editing, B–162 approved parts, A–8
accepting assemblies, syringe, A–46
– calibration results, B–66 auto accept
– QC results, B–74 – QC results, B–64, B–72
– sample results, B–57 – sample results, B–51
acoustic signals, A–83, D–6
Activate electrodes, maintenance action, E–45
adding lots, B–101 B
adjusting, touchscreen, B–130
air/water calibration, C–28 backup, B–82
alarm button, A–82 barcode scanner, A–61, B–89
alarm LED, A–82 barcode sheets, reading, B–90
alarm messages barcodes
– checking, A–83 – reading from reagent bottles, B–89
– confirming, D–9 – reading from sample tubes, B–90
– exporting log, D–9 – reading from sheets, B–90
– overview, A–83 – reagent bottles, A–61
– printing, D–8 – samples, A–62
– reacting to, D–7, D–44 – scanner, A–61
alarm monitor biohazardous materials, safety, A–6
– overview, A–82, D–6 bottle sets
alarms – See, reagent sets
– checking, A–83 bottles
– LED, A–82 – cleaner, A–52
– LED colors, A–83 – external cleaner, B–18
– monitor, A–82 – external fluid containers, B–15
analyzer – external waste container, B–17
– See, instrument. – external water container, B–16, B–86
analyzing – ISE fluids, E–11
– checking the progress, B–44 – reagents, A–53
– samples, B–34 – reagents, specifications, A–67
application codes, mapping, B–162 – replacing ISE, E–22, E–30
applications, B–137 bottom detection, A–49
– activating, B–139 buttons
– calculation definitions, B–155 – alarms, A–82
– calibration definitions, B–153 – global action, A–73
– control definitions, B–154 – overview, A–124
– deactivating, B–139
– definitions, B–152
– deleting, B–144
– general definitions, B–152
Roche Diagnostics
Operator’s Manual · Version 4.0 F-11
Index cobas c111
Roche Diagnostics
F-12 Operator’s Manual · Version 4.0
cobas c111 Index
configuration database
– screen, A–109 – cleaning up, C–23
– system definitions, B–168 – exporting, B–104
– viewing values, B–135 – importing, B–114
– workflow definitions, B–164 – restoring, B–114
confirming, alarm messages, D–9 date and time, definitions, B–169
connecting deactivating ISE unit, E–64
– external cleaner bottle, B–128 Default QC
– external waste container, B–128 – overview, B–68
– external water container, B–127 – performing, B–70
connectivity, host, A–33 defining
connectors – calibrator lots, B–103, B–150
– fluids, A–47 – control lot, B–102
– overview, A–64 – control lots, B–149
contact addresses, 3 – lots, B–101
Contact service representative, maintenance action, – orders, B–38
C–27 – ratios, B–146
containers – users, B–161
– fluids, A–50 definitions, applications, B–152
– reagent disks, A–59 degasser, A–44
– waste, A–50 deleting
– water, A–51 – applications, B–144
control lot, defining, B–102 – bottle sets, B–120
controls – calibration orders, B–63
– definitions, B–154 – calibration results, B–95
– placing, B–70 – mixing rules, B–174
conventions used in manual, 8 – orders, B–93
cooling, reagents, A–59 – profiles, B–149
copyrights, 2 – QC results, B–96
correlations, B–156 – results at end of shift, B–84
covers – sample results, B–94
– ISE, E–9 – users, B–161
– overview, A–39 demographics, patients, A–32
cross-contamination, A–9 Deproteinize probe, maintenance action, C–10
csv files, B–83 detection
cups, A–54 – fluid levels, A–49
cuvette ring, A–60 – tube bottom, A–49
cuvette status, screen, A–92 diagnostics data, exporting, D–51
cuvettes, A–55 diagnostics, screen, A–116
– checking the status, B–28 dilutions, A–32
– handling, A–56 dimensions, specifications, A–66
– replacing, B–29, B–85 disconnecting tubes from instrument, B–129
– ring, A–60 disinfecting housing, C–21
– segments, A–55 disk space. free, B–25, B–26
– specifications, A–67 disks,free positions, A–93, B–26
display items, A–73
disposing
D – instrument, A–12
– waste, B–86
daily backup, B–82 document information, 2
daily operation, B–3
– introduction, A–22
– overview table, A–22
Daily prepare actions, maintenance action, E–44
data security, A–10
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Operator’s Manual · Version 4.0 F-13
Index cobas c111
E fluid system
– overview, A–45
edition notice, 2 – priming, C–11
electrical safety, A–5 fluids
electrode block, E–11 – bottles, A–50
Electrode service, maintenance action, E–49 – bottles for ISE, E–11
electrodes – checking external containers, B–15
– activating, E–45 – connecting external cleaner bottle, B–128
– maintenance, E–49 – connecting waste container, B–128
– position in block, E–34 – connecting water container, B–127
– replacing, E–32 – external connectors, A–47
electromagnetic devices, safety, A–8 – ISE, E–8
emptying, waste container, B–17, B–86 – replacing ISE bottles, E–22, E–30
End of Shift short guide, B–78 forecast period, A–29
environment, specifications, A–66 free disk space, B–25, B–26
error messages, reacting to, D–44, E–80 fuses, A–65
exceptional situations – changing for mains, D–47
– ISE unit, E–80 – changing low voltage, D–49
– main instrument, D–42
exchanging reagents, B–25
expanding lists, A–76 G
export, screen, A–120
exporting global action buttons, A–73
– alarm message log, D–9
– database, B–104
– diagnostics data, D–51 H
– log files, B–110
– results, B–83, B–105 handling
external bottle status, screen, A–96 – cuvettes, A–56
external waste container, A–51 – lots, B–98
extra wash cycles – orders, A–32
– activating, B–171 – reagents, A–25, A–56
– deactivating, B–171 – results, A–34
– defining, B–170 – samples, A–31
– definitions, B–172 – software data, A–67
– deleting, B–171 hardware
– importing, B–116 – overview, A–37
– screen, A–113 – specifications, A–66
heads, transfer, A–48
heating channel, cleaning, C–10
F host
– configuration, B–165
features of instrument, A–17 – connectivity, A–33
filtering, A–78 – definitions, B–165
finishing the shift, B–77 host codes, B–162
flags – screen, A–113
– Abs. results, D–28 housing, cleaning, C–21
– ISE results, E–71
– overview, D–25
– priorities, D–26 I
– viewing details, D–25
flaps ignoring QC results, B–74
– instrument, A–39 import, screen, A–118
– ISE unit, E–9
Roche Diagnostics
F-14 Operator’s Manual · Version 4.0
cobas c111 Index
importing ISE
– applications, B–111, B–137 – main calibration, E–26
– certificates, B–115 – maintenance, E–39
– database, B–114 – measurement process, E–7
– extra wash cycles, B–116 – measuring modes, E–6
– mixing information, B–116 – monitoring status, E–24
– software, B–113 – operation, E–17
Initialize ISE reference sensor, maintenance action, E–47 – overview, E–5
Initialize ISE unit, maintenance action, E–53 – preparing system, E–20
installation, safety, A–7 – priming calibrator, E–48
installing – principles of measurement, E–7
– applications, B–112, B–138 – pump tubing, E–54
– ISE pump tubing, E–54 – replacing pump tubing, E–54
– ISE unit tubing, E–61 – replacing tubing, E–57
instrument – sensors, E–11
– approvals, 3 – solutions, E–8
– disposal, A–12 – standby, E–12
– features, A–17 – status, E–69
– introduction, A–15 – tower, E–36, E–50, E–51
– main components, A–43 – troubleshooting, E–67
– overview, A–17 – tubing, E–11, E–61
– switching on, B–10 ISE reference sensor, initializing, E–47
– where to use, A–7 ISE status, screen, A–94
intended use ISE tower, E–11
– instrument, 7 – cleaning automatically, E–50
– of operator’s manual, 2 – cleaning manually, E–51
interface – cleaning off the instrument, E–36
– See, user interface ISE unit, E–9
interfaces, specifications, A–67 – deactivating, E–64
internal waste tank, A–50 – main components, E–10
interpreting, QC History, B–74 – specifications, A–67
Interval QC
– overview, B–68
– performing, B–71 K
intervals
– ISE maintenance actions, E–41 keyboards, A–76
– maintenance actions, C–7
introduction
– See, overview. L
inventory
– checking bottle sets, B–23, B–100 laboratory correlations, B–156
– deleting bottle sets, B–120 language, B–158
– screen, A–117 – changing, B–159
ISE layout of screens, A–72
– calibration, E–12 LEDs
– calibrator, priming, E–48 – alarms, A–83
– checking status, E–21 – color table, A–41, A–122
– cleaning tower automatically, E–50 – ISE, E–10
– cleaning tower manually, E–51 – overview, A–41
– cleaning tower off the instrument, E–36 level detection, A–49
– conditioning tubing, E–46 liability, A–11
– flags, E–71 licenses, A–11
– fluid containers, E–11 lids
– installing pump tubing, E–54 – ISE, E–9
– installing tubing, E–61 – overview, A–39
– list of flags, E–71
Roche Diagnostics
Operator’s Manual · Version 4.0 F-15
Index cobas c111
Roche Diagnostics
F-16 Operator’s Manual · Version 4.0
cobas c111 Index
operators performing
– qualifications, A–9 – calibration, B–59
– regular breaks, A–9 – calibration during Prepare phase, B–30
optical safety, A–6 – Default QC, B–70
order of processing, B–44, B–145 – Interval QC, B–71
orders – maintenance actions, C–6
– changing, B–42 – QC, B–68
– changing with sample on board, B–42 – reagent mixing, B–76
– checking for unfinished, B–80 – reagent mixing during Prepare phase, B–29
– defining, B–38, B–39 – tests, B–34
– defining profiles, B–148 peristaltic pump, E–10
– deleting, B–93 photometer
– handling, A–32 – overview, A–63
– IDs, A–32 – specifications, A–67
– introduction to handling, A–32 photometer lamp, replacing, C–24
– list, A–98 positions on disk, A–93, B–26
– order of processing, B–44 power
– overview, A–32 – interruption, A–8
– STAT, B–41 – requirements, A–66
– time to completion, A–86 precalibration, A–29
– workflow setup, B–37 Prepare phase, short guide, B–13
overview Prepare wizard, B–15
– buttons, A–124 preparing
– calibration, A–26 – applications, B–140
– daily operation, A–22 – ISE unit, E–20
– flags, D–25 – new reagent disks, B–116
– instrument, A–15, A–17 – reagents, B–22, B–25
– ISE, E–5 – system, B–12
– ISE operation, E–17 Prime ISE reference and calibrator, maintenance action,
– maintenance, C–5 E–48
– messages, A–82, D–5 Prime the fluid system, maintenance action, C–11
– order handling, A–32 principles
– reagent handling, A–25 – absorbance measurements, A–19
– result handling, A–34 – calibration, A–26
– routine operation, B–7 – ISE measurements, E–7
– sample handling, A–31 – specifications, A–66
– user interface, A–20, A–71 printer
– wizards, A–21 – clearing paper jam, D–46
Overview tab, A–84 – overview, A–62
– refilling paper, B–122
– specifications, A–67
P printer status, checking, D–46
Printer Tool, B–37
panels printing
– ISE, E–9 – alarm messages, D–8
– overview, A–39 – mixing rules, B–173
– See also, test panels. – overview, A–80
paper jam, clearing, D–46 – sample results, B–58
paper, refilling, B–122 – stopping, A–80, B–58
password priority, flags, D–26
– changing, B–157 probe
– typing, B–11 – cleaning manually, C–12
– deproteinizing, C–10
– description, A–49
– hardware, A–46
– replacing, B–125
Roche Diagnostics
Operator’s Manual · Version 4.0 F-17
Index cobas c111
Roche Diagnostics
F-18 Operator’s Manual · Version 4.0
cobas c111 Index
Roche Diagnostics
Operator’s Manual · Version 4.0 F-19
Index cobas c111
screens software
– external bottle status, A–96 – importing, B–113
– extra wash cycles, A–113 – updating, B–114
– host codes, A–113 software data handling, specifications, A–67
– import, A–118 solutions, ISE, E–8
– inventory, A–117 space, free on disk, A–93, B–26
– ISE status, A–94 special characters, A–78
– keyboards, A–76 specifications, technical, A–66
– layout, A–72 spillages, safety, A–9
– Loadlist, A–107 standby, ISE status, E–12
– lot data, A–105 starting
– lot list, A–106 – a run, B–44
– maintenance, A–110 – processing, B–44
– messages, A–82, D–5 – shift, B–10
– navigation, A–74 STAT orders, B–41
– orders list, A–98 status
– QC history, A–102 – cuvettes, B–28
– QC history graph, A–103 – instrument, B–46
– QC list, A–101 – ISE unit, E–69
– QC status, A–101 – reagent sets, B–23
– reagent mixing, A–114, A–115 – sample tubes, B–44
– reagent status, A–93 – standby for ISE, E–12
– result list, A–99 – system, A–35
– sample overview, A–86 stop, screen, A–121
– scrolling, A–75 stopping
– stopping processing, A–121 – printing, A–80, B–58
– system status, A–95 – processing, B–49
– test selection, A–88 – run, B–49
– test status, A–90 storage facilities, specifications, A–67
– users, A–119 switching
– worklist, A–107 – between upper and lower-case, A–77
scrolling, A–75 – off, B–88
segments of cuvettes, A–55 – on, B–10
selecting groups of list items symbols, –8
– See, filtering. syringe
selecting, tests to be calibrated, B–62 – assembly, A–46
sensors, ISE, E–11 – hardware, A–46
sequence of processing, B–145 system
service representative, contacting, C–27 – definitions, B–168
setting up, order definition, B–37 – logging on, B–11
sheets, barcodes, B–90 – preparing, B–12
shift – preparing ISE, E–20
– finishing, B–77 – See also, instrument.
– starting, B–10 system status
short guides – overview, A–35
– analyzing samples, B–35 – screen, A–95
– calibration, B–60 systems
– End of Shift, B–78 – fluid, A–45
– ISE Prepare phase, E–20 – See also, units, assemblies.
– Prepare phase, B–13
– QC, B–69
shutting down the system, B–88
– end of shift, B–88
– stop option, A–121
Roche Diagnostics
F-20 Operator’s Manual · Version 4.0
cobas c111 Index
T units
– ISE, E–9
tabs, B–119 – laboratory, B–156
– assigning tests, B–119 – transfer, A–48
– Overview, A–84 updating software, B–114
– removing tests, B–120 upper-case letters, A–77
– Utilities, A–108 user interface language, B–158
– Workplace, A–97 – changing, B–159
technical specifications, A–66 – installing, B–159
test panels – uninstalling, B–160
– assigning tests, B–119 user interface, overview, A–20, A–71
test selection, screen, A–88 user name, typing, B–11
test status, screen, A–90 users
tests – defining, B–161
– adding to profile, B–148 – deleting, B–161
– assigning to tabs, B–119 – screen, A–119
– defining profiles, B–148 using
– performing, B–34 – manual, 7
– removing from profile, B–149 – online Help, 7, A–81
– removing from tabs, B–120 Utilities tab, A–108
– repeating, B–55
– rerunning, B–56
text, typing, A–76 V
third-party software, A–8
throughput, specifications, A–66 validating
time to finish order, A–86 – calibration results, B–64
touchscreen, adjusting, B–130 – QC results, B–72
trademarks, 2 – sample results, B–51
transfer head, A–48 viewing
transfer unit, A–48 – cal and QC lot definitions, B–98
transmission, checking of results, B–81 – configuration values, B–135
transport, safety, A–5 – flag details, D–25
troubleshooting – lot details of used fluids, B–101
– ISE, E–67 – reagent lot definitions, B–99
– main instrument, D–39
tube bottom detection, A–49
tubes, A–54 W
– disconnecting from instrument, B–129
tubing wash cycles
– conditioning, E–46 – See, extra wash cycles
– connecting to instrument, B–127 wash station, A–47
– disconnecting from instrument, B–129 waste
– installing for ISE, E–61 – checking external, B–17
– ISE, E–11 – cleaning container, C–17
– replacing of ISE, E–57 – emptying, B–17, B–86
– replacing of ISE pump, E–54 – external container, A–51
typing – internal tank, A–50
– password, B–11 – safety, A–7
– text, A–76 water
– user name, B–11 – checking external, B–16, B–86
– cleaning container, C–16
– container, A–51
U – refilling, B–16, B–86
– specifications, A–67
unfinished orders, B–80 water filter, changing, C–19
uninstalling applications, B–143 wavelengths, A–63
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Operator’s Manual · Version 4.0 F-21
Index cobas c111
wizards
– concept, A–71
– End Shift, B–81
– introduction, A–21
– orders, B–35
– Prepare, B–15
workflow, definitions, B–164
working solutions, safety, A–7
worklist, A–107
Workplace tab, A–97
Roche Diagnostics
F-22 Operator’s Manual · Version 4.0
Revisions G