cobas c111 6 Daily operation

Performing calibrations

a To validate the calibration results

1 Choose Workplace > Calibrations
A screen is displayed that lists all tests and their currently valid calibration.

A B C D

E F G H

A Test ID. E Press to validate the result.

B Calibration use. F Press to define a new calibration order.
C Calibration type. G Press to delete the selected calibration
D Status indication. and its results.
H Press to display all or only the current
results.

Figure B-22

Interpreting the screen Item Value Interpretation

U (Use) CU Current.
The calibration results of this set are currently used.
SB Standby.
The calibration results of this set are not currently used.
(An identical set is currently in use or the set was removed
and is not empty.)
OB Obsolete.
The calibration results of this set are no longer used. (The
set was empty and removed or it was removed more than 30
days ago).
T (Type) L Lot calibration (first calibration of a lot, also applies to sub-
sequent sets of the lot).
S Set calibration (applies to calibrated set only).
Status The date indicates when the results were accepted. If flags
were generated for the result, the flag with the highest pri-
ority is displayed. In all other cases, the order status is dis-
played.

e For details on calibration types, see Calibration type on page A-27.

2 Select the result.

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Performing calibrations

3 Press to display information on the selected calibration and its results.

A B C D

F
G
H
I

J K L

A Test ID. H Flags.

B Calibration use. I Calibration results.
C Calibration type. J Press to validate the results.
D Calibration status. K Press to display result details.
E Calculation date and time. L Press to display context information of the
F Calibrator, lot, expiration date. fluids used to arrive at this result.
G Accepted by: User name. $SYS$ means
automatically accepted.

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.

Incorrect results when using Use Old

Calibrations are performed to compensate for changes over time in reagents and in the
WARNING measurement systems. Failing to perform calibrations when they are due may lead to
incorrect results.
o Roche recommend performing a QC measurement before you continue working
with the old calibration results.
o In the application definitions, choose On for QC After Cal.
(Utilities > Applications > Laboratory Parameters > Control > QC After Cal)

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Performing calibrations

Accepting calibration results

Calibration results will be used by the system only when you have accepted them.

There can be only one unaccepted calibration result for a test.

If there already exists a not accepted calibration for a test and you place another cali-
bration order for this test, the order will be blocked.

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Performing QC

QC is performed at regular intervals to check the integrity of the whole measuring

system.

Control A control is a sample that has been measured using all tests it is associated with, in
order to define the ranges and values that determine the correct functioning of the
instrument. This is typically done both for the normal and the pathological analyte
concentration.
e For an overview on QC, see Quality control (QC) on page A-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:

Default QC Default QC is an automated process for performing QC measurements in one

request. This is the ideal method if you want to perform QC on certain days or at
certain times.
This process only applies to tests whose controls are defined to be performed as part
of Default QC. Therefore, if you intend to work with Default QC, you need to
configure the tests accordingly.
e See Defining control definitions and lots on page B-149.

Performing Default QC follows a streamlined procedure whereby QC orders are

automatically defined as soon as you identify a control. An order is defined for all tests
for which this control is defined as the Default QC, provided the test is currently
active on the system.

Interval QC Interval QC is a process that is suitable both for performing a single QC measurement
and for performing all QC measurements that are due. You can select all tests that
require QC simply by pressing a button ( ). (This selection also reflects QC of the
type QC after Cal.) A wizard helps you select the controls, and a placement list
supports you in preparing and loading them.

Safety information

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.

Incorrect results due to inappropriate tube and cup placement

Inappropriate tube and cup placement may lead to inaccurate pipetting and consequently
WARNING to incorrect results.
Make sure that the primary tubes are placed centrally and perfectly vertically in the hold-
ers in the sample area and that they are inserted firmly.
Make sure that secondary tubes are placed centrally on the primary tubes and that they
rest fully on them.

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Performing QC

Short guide

The following table provides an overview of the steps that make up the QC process.

Step User action

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

Perform all interval QC mea- 1. Choose Overview > Order > or

surements that are due. Workplace > QC Status > .
2. Press .
3. Press .
4. Select a control and place the tube. Repeat until
there are no controls left on the screen.
5. Press .

Perform a single interval QC 1. Choose Workplace > QC Status.

measurement. 2. Press .
3. Select the test.
4. Press .
5. Select a control and place the tube. Repeat until
there are no controls left on the screen.
6. Press .

2 Validate the results. 1. Choose Workplace > QC Status.

2. Press to look at result details. Close the
details screen.
3. Press and press a button to validate the QC
result.
4. Remove the controls.

Table B-7 Steps for performing QC

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Performing Default QC

Performing Default QC follows a streamlined procedure whereby QC orders are

automatically defined as soon as you identify a control. An order is defined for all tests
for which this control is defined as the Default QC, provided the test is currently
active on the system.

a To perform Default QC
1 Choose Overview > Order.
2 Press .
A screen is displayed that contains a button for each of the controls that are
required.
3 Prepare the controls.
4 Press a control button.
A screen is displayed, asking you to place the selected control.
5 Place the control tube on any free position on the sample area.
The system registers the position and automatically defines an order for each test
that has this control defined as its Default QC.
The screen with the control buttons is displayed again. The button for the control
you just loaded is no longer active.
6 Press the next active control button.
A screen is displayed, asking you to place the control.
7 Place the control on a free position on the sample area.
8 Select and place the remaining controls as described in steps 6 through 7.
When all controls are placed, the screen for identifying samples is displayed.
9 Press to close the screen.
10 Press to start processing the control orders.

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Performing interval QC measurements

a To define a QC order
1 To define a new order, do one of the following:
o Choose Overview > Order > .
o Choose Workplace > QC Status > .
A a test selection screen is displayed.

A
A Press to select all tests with due QC. Press again to cancel the selection.

Figure B-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).

A QC is due or its result has not yet been accepted.

The reagent set is on board and ready for use.

The reagent set is not on board.

2 To select the tests, do one of the following:

o Press to select all tests with due QC.
This selection also applies to controls of the type QC after Cal.
o Press a test button.
3 Press .
A screen is displayed that contains a button for each of the controls that are
required.

If at this stage, the required controls are already loaded on the instrument, then the QC
orders are automatically created.

4 Prepare the controls.

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5 Press a control button.

A screen is displayed, asking you to place the selected control.
6 Place the control tube on any free position on the sample area.
The system registers the position and automatically defines an order.
If there are more controls to place, the screen with the control buttons is displayed
again. The control you just placed is no longer active.
7 Select and place the remaining controls as described in steps 5 through 6.
When all controls have been selected and placed, the Overview tab is displayed.
8 Press to start processing the control orders.

Validating QC results

Flagged QC results If flags are generated, you must determine their cause and decide whether to accept
the result or to ignore it.
The effect of flagged QC results depends on the configuration.

Configuration setting Effect

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

e See Result handling on page B-167.

See Editing the acceptable flags list on page B-162.

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a To validate the QC results

1 Choose Workplace > QC Status.
A screen is displayed that lists the most recent QC results for each test that is
installed on the system.

A B C D

A Status D Result, if no flag was generated.

!: The result has not been accepted yet. Flag with highest priority, if a flag was
I: The result was ignored. generated.
@: The result has not been transmitted yet. Order status, if the control measurement
B Test name. has not been performed yet.
C Control ID.

Figure B-25

2 Select a result.
3 Press to look at result details.

A B C D

A Test name D Result

B Control name E Calculation date and time.
C Accepted by: User name. $SYS$ means F Time when accepted.
automatically accepted. G Press to display context information of the
fluids used to perform QC for this test.

Figure B-26

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4 Press to close the screen.

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.)

Interpreting the 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 that were generated
before the previous month.
A graphic representation of the results provides a convenient way for comparing
results over a period of time.

a To interpret the QC history

1 Choose Workplace > QC History.
A screen is displayed that contains, one QC result entry for each lot of each test.

A B C

A Test name. C Date of most recent control. measure-

B Control ID. ment. If the control does not belong to
the current lot, Previous Lot is dis-
played instead of the date.

Figure B-27

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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

o The date format in the month selection buttons is always month/year.

o Ignored QC results are not displayed in the graph, but they are included in the QC
History printout. Such results are marked with "I" at the end.
o Ignored QC results are not taken into account for QC history statistics.

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3 Press to display the results in a table.

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

A B C

A Date of QC measurement C Flag (if generated)

B Result or event

Figure B-29

4 Press to close the screen.

Performing reagent mixing

Reagents that contain Latex granules, for example D-Dimer, require periodic mixing.
The mixing interval is part of the application definitions and cannot be changed by
the user. The system checks every 30 minutes for reagent sets that require mixing.
e For mixing during the Prepare phase, see Performing reagent mixing on page B-29.

a To perform the mixing

1 Choose Overview > .
2 Press the button of the reagent set you want to mix.
A screen is displayed that contains details on the set.
3 Press .
(This button is available if there is a mixing interval defined for this reagent set.)
Mixing starts. A screen is displayed informing you about the progress of the
mixing action.
4 When mixing is finished, press to close the screen.
Closing the dialog box while mixing is in progress stops the mixing action. Mixing
would have to be performed anew.

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Finishing the shift

Finishing the shift

The typical end of shift activities are organized in a single wizard. By performing the
steps as suggested by this wizard, you put the instrument in a condition that allows
you to hand over operation to another operator or to switch off the instrument.

Safety information

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

Skin inflammation caused by reagents

Direct contact with reagents may cause skin irritation, inflammation, or burns.
WARNING When handling reagents, be sure to wear protective equipment and observe the cautions
given in the package insert.

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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.

3 Perform data backup. 1. Press .

2. Insert the USB stick.
3. Press .
4. Select the directory.
5. Press .
6. Press to proceed to the next stage in the
End Shift wizard.

4 Export support data 1. Press .

2. Insert the USB stick, if you have removed it.
3. Press .
4. Select the directory.
5. Press .
6. Remove the USB stick.
7. Press to proceed to the next stage in the
End Shift wizard.

5 Clean up the database. 1. Press .

2. Press to confirm the deletion.
3. Press to proceed to the next stage in the
End Shift wizard.

Table B-9 Steps for finishing the shift

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Step User action

6 Perform maintenance actions 1. Check which maintenance actions are due.
2. Perform the maintenance actions.
Perform at least all red maintenance actions.
3. Press to proceed to the next stage in the
End Shift wizard.

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.

8 Empty the waste container. 1. Empty the waste container.

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

9 Remove the reagent disk. 1. Choose Overview > .

2. Press
1. Open the main cover.
2. Lift the disk from the instrument.
3. Place the disk in its container.
4. Press .
5. Close the main cover.
6. Store the reagent disk in a cool place.

10 Finish your shift. 1. Log off the system.

2. Switch off the main instrument. (If there is no
other shift.)

Table B-9 Steps for finishing the shift

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Finishing the shift

Checking for unfinished tasks

Checking for unfinished orders

a To check for unfinished orders

1 Choose Workplace > Orders.
2 Choose > Not Finished.
3 Press .
A screen is displayed that contains all unfinished orders.
4 Do whatever is necessary to finish the orders.

Checking for not accepted sample results

Results must be accepted before they can be printed or transmitted to the host.

a To check for not accepted results

1 Choose Workplace > Result Review.
A screen is displayed that contains all sample results of the day.
2 Choose > Not Accepted.
3 Press .
A screen is displayed that contains all sample results that have not been accepted
yet.
4 Select a result.
5 Press to validate the result.
A screen is displayed for selecting your decision.
e See Accepting results on page B-57.
See Repeating tests on page B-55.
See Rerunning tests on page B-56.

6 Press one of the buttons.

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

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Checking the transmission of results

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

Results must be accepted before they can be transmitted to the host.

See also the information on Result handling on page B-167, in particular on the Auto
Accept settings.

a To check for results that were not transmitted

1 Choose Workplace > Result Review.
A screen is displayed that contains all sample results of the day.
2 Choose > Not Sent to Host.
3 Press .
A screen is displayed that contains the sample results that have not been
successfully transmitted to the host.
4 Select a result.
5 Press .
A screen for validating results is displayed.
6 Press Retransmit.
The list with the results that were not transmitted successfully is displayed again.
The result you just retransmitted should no longer be present.
7 Select and retransmit the remaining results as described in Steps 4 through 6.
8 Choose > Not sent to Host.
The list should now be empty.
9 If the results were not successfully transmitted, contact the administrator of the
host computer.

Starting the End Shift wizard

The easiest way of performing the end of shift tasks is by following the End Shift
wizard.

a To start the End Shift wizard

1 Choose Overview > End Shift.
A screen is displayed for performing daily backup.

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Performing the daily backup

The cobas c111 instrument can store orders and result data for one working day. It is
therefore necessary to export to an external medium all data that you need to keep.
During a database export, the full content of the database is copied to the USB stick.
The database data can be restored to the instrument if required (Utilities > Import >
Database).
e For information on restoring the database, see Importing a database on page B-114.

a To perform the daily backup

1 Press .
A screen is displayed, asking you to insert the USB stick.
2 Insert the USB stick.
A screen is displayed showing the directory structure of the USB stick.
3 Select the directory where you want the backup file to be copied.
4 Press to confirm the selection.
The data are copied to the stick.
Database files names have the following name format:
dba_yyyymmddhhmmss.tgz.
5 Press to proceed to the next stage in the End Shift wizard.
A screen is displayed for deleting sample results.

When performing backup without using the End Shift wizard:

Choose Utilities > Export > Database.

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Exporting the result data

When exporting results, the full result data are exported. The following results are
copied to the USB stick (each of the sets is contained in a separate file):

Data set File name

Sample results res_yyyymmddhhmmss.csv
QC results qcs_yyyymmddhhmmss.csv
QC history results qch_yyyymmddhhmmss.csv
Calibration results cal_yyyymmddhhmmss.csv
Process event log pev_yyyymmddhhmmss.csv

File format Result data are exported as comma-separated value (csv) files. The entries are
separated by semicolons (;).
e For details on csv definitions, see Exporting results on page B-105.

These files can be processed with any spreadsheet program that can import csv files.

a To export the results

1 Press .
A screen is displayed, asking you to insert the USB stick.
2 Insert the USB stick.
A screen is displayed showing the directory structure of the USB stick.
3 Select the directory where you want the result files to be copied.
4 Press to confirm the selection.
The data are copied to the stick.
5 Press to proceed to the next stage in the End Shift wizard.
A screen is displayed for deleting sample results.

When performing backup without using the End Shift wizard:

Choose Utilities > Export > Full Results.

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Finishing the shift

Cleaning up the database

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.

a To clean up the database

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

When deleting results outside the End Shift wizard:

You can delete accepted sample results, calibrations, orders, and accepted and ignored
QC results by pressing in the respective result lists.
e To delete orders on page B-93
e To delete sample results on page B-94
e To delete a calibration on page B-95
e To delete QC results from the QC Status list on page B-97
e To delete QC results from the QC History on page B-97

Maintenance action Cleanup Database

The maintenance action Cleanup Database is intended for situations where the system
does not work efficiently any more, it is not intended to clear up the data at the end of a
shift.

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Performing maintenance actions

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.

a To perform maintenance actions

1 Follow the instructions given in To perform maintenance actions on page B-19.
2 Press to proceed to the next stage in the End Shift wizard.
A screen is displayed that shows the status of the cuvettes.

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.

When replacing cuvettes without using the End Shift wizard:

Choose Overview > .

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Dealing with the external fluid bottles

Emptying the waste container

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.

To prevent unpleasant smells and contamination of the environment, you need to

empty the waste at the end of your shift.

a To empty the waste container

1 Remove the tubing adapter from the yellow waste container and insert it in the
spare container.
2 Remove the bottle from the rack and place it on a firm and even surface.
3 Place the spare container on the rack.
4 Follow the instructions given in To check the waste container on page B-17.

Roche recommend to refill the water container whenever you empty the waste container.

When emptying the waste without using the End Shift wizard:
Choose Overview > > .

Refilling the external water bottle

Danger of poor measurement quality due to inadequate water quality

Inadequate water quality may lead to incorrect results. Always use purified water of the
WARNING quality specified in section Technical specifications.

a To refill the external water container

1 Remove the tubing adapter from the white water container and place it on a clean
surface.
2 Follow the instructions given in To check the water container on page B-16.

Roche recommend to empty the waste container whenever you refill the water container.

When refilling the water without using the End Shift wizard:
Choose Overview > > .

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Removing the reagent disk

During periods when you do not perform tests, the disk should be stored in a clean
refrigerated place at temperatures in the range of 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.

Spillage through tipping reagent disk

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

a To remove the reagent disk

1 Choose Overview > > .
A screen is displayed, asking you to remove the reagent disk.
2 Open the main cover.
3 Remove the reagent disk.
4 Place the reagent disk in the reagent disk container.
5 Close the main cover.
6 Store the reagent disk container in a refrigerated place.

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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.

a To log off the system

1 Choose Overview > button with your user name.

Automatic logoff
You can configure the system to automatically log off the user after a configurable period of
inactivity (Utilities > Configuration > System > Screen Saver Wait ≠ 0; Utilities >
Configuration > System > Auto Log-off = On).

Viewing alarms while you are logged off

You can view alarms any time, even when you are logged off.

e For configuring automatic logoff, see System on page B-168.

If there is no other shift, you can now switch off the main instrument.

Switching off the system

When you switch off the system, reagent cooling stops. Therefore, you need to remove the
reagent disk and store it in a cool place before switching off the system.

Preconditions The system must be in Standby status.

a To switch off the main instrument

1 Press O on the toggle switch.

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Using the barcode scanner

Using the barcode scanner

e For information on the barcodes, see Barcode scanner on page A-61.

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.

Injury through reagents and other working solutions

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

Malfunction due to spilled liquid

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

Reading reagent bottle barcodes

a To use the barcode scanner for reading reagent bottle barcodes

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

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Using the barcode scanner

Reading barcodes from sheets

a To use the barcode scanner for reading barcodes from sheets

1 When a screen is displayed, asking you to scan, use the barcode scanner and scan
the barcode.
2 Place the barcode transfer sheet on a flat surface and smooth it out.
3 Hold the scanner at a distance of approximately 20 cm (8 in) from the barcode,
pull the trigger on the scanner and point the red light just outside the barcode.
4 Move the light slowly across the barcode.
5 Wait until you hear a beep and release the trigger.
If the reading was successful, a screen is displayed, asking you to place the item.

Reading sample tube barcodes

For safety reasons, the barcode scanner is set to only read barcodes that contain a check-
sum.

a To use the barcode scanner for reading sample tube barcodes

1 When a screen is displayed, asking you to scan, use the barcode scanner and scan
the barcode.
2 Make sure not to tilt the sample tube while scanning its barcode.
3 Hold the scanner at a distance of approximately 20 cm (8 in) from the barcode,
pull the trigger on the scanner and point the red light at the barcode.
4 Wait until you hear a noise and release the trigger.
If the reading was successful, a screen for selecting tests is displayed.

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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.

In this chapter Chapter 6

Deleting sample orders ............................................................................................. B-93
Deleting sample results ............................................................................................. B-94
Calibration ................................................................................................................. B-95
Deleting calibration results ................................................................................. B-95
Setting up your calibration schedule .................................................................. B-96
Deleting QC results .................................................................................................. B-96
Lot handling .............................................................................................................. B-98
Viewing the current lot definitions .................................................................... B-98
Calibrator and QC lots .................................................................................. B-98
Reagent lots .................................................................................................... B-99
Viewing the lot details of fluids that were used ............................................... B-101
Adding a new lot ................................................................................................ B-101
Exporting data ......................................................................................................... B-104
Exporting the database ...................................................................................... B-104
Exporting results ............................................................................................... B-105
Interpreting result data ..................................................................................... B-106
Exporting log files ............................................................................................. B-110
Importing data ........................................................................................................ B-111
Importing applications ..................................................................................... B-111
Importing software ............................................................................................ B-113
Importing a database ......................................................................................... B-114
Importing certificates ........................................................................................ B-115
Importing automatic mixing and extra wash cycle definitions ...................... B-116
Preparing a new disk ............................................................................................... B-116
Assigning tests to test tabs ....................................................................................... B-119
Deleting bottle sets from the Inventory list ........................................................... B-120
Refilling printer paper ............................................................................................. B-122
Removing condensation water from the reagent cooler ....................................... B-124
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Table of contents

Replacing the probe ................................................................................................. B-125

Connecting and disconnecting the external fluid containers ............................... B-127
Adjusting the touchscreen ...................................................................................... B-130
Cleaning the touchscreen ........................................................................................ B-131

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Deleting sample orders

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.

o By deleting a sample order, you delete the associated results as well.

o You can delete a running order. After deleting the order, cuvettes and reagents that
were not used are released again for future use

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Deleting sample results

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.

a To delete sample results

1 Choose Workplace > Result Review.
A screen is displayed that lists all results.
2 Do one of the following:

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

Deleting calibration results

Obsolete calibration results are automatically deleted as part of the daily end of shift
activities if there are more than five obsolete calibration results for the test.
(Calibration results become obsolete when the empty set is removed or if it was
removed more than 30 days ago.)
This section describes how to proceed if you need to delete results outside the normal
daily routine.
e For deleting calibration results at the end of a shift, see Cleaning up the database on
page B-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

Setting up your calibration schedule

The cobas c111 instrument provides convenient software-supported procedures for

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

Definition item Configuration path Effect

Forecast Hours Utilities > Period of time, starting with the current
Configuration > date, within which calibration falls due.
Calibration Defining a forecast period (value other than
zero) allows to concentrate calibration per-
formance to specific days.
Cal Auto Accept Utilities > If on, results that are not flagged are auto-
Configuration > Result matically accepted.
Handling Results with flags that are marked in a pre-
defined list of acceptable flags would also be
automatically accepted.
Cal Acceptable Flags Utilities > List of calibration relevant flags. Flags that
Configuration > Result are marked are automatically accepted if Cal
Handling Auto Accept is on.
Table B-10 Calibration definitions and their effect

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

a To delete QC results from the QC Status list

1 Choose Workplace > QC Status.
2 Press .
A screen for selecting results is displayed.
3 Do one of the following:

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.

a To delete QC results from the QC History

1 Choose Workplace > QC History.
2 Press .
A screen for selecting results is displayed.
3 Do one of the following:

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:

You want to delete the results of the selected 1. Choose Selected.

control:

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)

Viewing the current lot definitions

Calibrator and QC lots

a To view calibrator or lot data

1 Choose Workplace > Lot Data.
2 Press either Controls or Calibrators.
A screen is displayed that lists all installed lots.

The following description shows an example of viewing a calibrator lot.

A B C

A Calibrator name. B Lot ID

Asterisk: The lot data were changed by the C Expiration date
operator.
[not installed]: The associated applica-
tion is not installed.

Figure B-30

3 Select the calibrator and expand the entry.

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4 Select a test and expand the entry.

B
C

A Calibrator name B Associated test

Asterisk: The lot data were changed by the C Lot values
operator.
[not installed]: The associated applica-
tion is not installed.

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.

a To check the status of an individual reagent set

1 Choose Overview > .
2 Press a reagent set icon.
A screen is displayed that contains information on the selected reagent set,
including its lot number.

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Lot handling

a To gain a general overview of the currently defined reagent sets

1 Choose Utilities > Inventory.
The Bottle sets list is displayed. It contains 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 has not
passed yet.

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

2 Select a set and press .

A dialog box is displayed that contains detailed set information.
3 Press .
A dialog box is displayed that contains set, calibration, and QC information.
4 Press to close the dialog boxes until the Utilities tab is displayed.

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Lot handling

Viewing the lot details of fluids that were used

For sample, calibration, and QC results, you can check to which lot the used fluids
belong (reagents, calibrators, controls).

a To check context information of a result

1 Do one of the following:

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.)

2 Scroll to display the information, if required.

3 Press to close the screen.

Adding a new lot

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

Defining lots manually requires utmost diligence

During lot definition you need to type data that are directly relevant to result generation.

You would for example define the lot data manually if you cannot read the barcode
for some reason, or in the case where you work with lab-specific controls or third-
party controls that do not include barcode transfer sheets for lot data.

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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.

a To define a control lot

1 Choose Workplace > Lot Data.
2 Press Controls.
A screen is displayed that lists all installed control lots.
3 Press .
A screen is displayed, asking you to scan the barcode transfer sheet or to type the
data manually.
4 Define the lot values.
Do one of the following:

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

1 Choose Workplace > Lot Data.
2 Press Calibrators.
A screen is displayed that lists all installed calibrator lots.
3 Press .
A screen is displayed, asking you to scan the barcode or to type the data manually.
4 Define the lot values. Do one of the following:

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 c 111 instrument.

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Exporting data

Exporting data

f Utilities > Export

Exporting the database

The database is normally exported as part of the daily backup during the end of shift
activities.
e See Performing the daily backup on page B-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.

a To export the database

1 Choose Utilities > Export > Database.
A screen is displayed, asking you to insert the USB stick.
2 Insert the USB stick.
3 Press .
4 Select the directory.
5 Press to confirm the selection.
The data are copied to the USB stick.
Database files names have the following name format:
dba_yyyymmddhhmmss.tgz.

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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:

Data set File name

Sample results res_yyyymmddhhmmss.csv
QC results qcs_yyyymmddhhmmss.csv
QC history results qch_yyyymmddhhmmss.csv
Calibration results cal_yyyymmddhhmmss.csv
Process event log pev_yyyymmddhhmmss.csv

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

a To export the support data

1 Choose Utilities > Export > Full Results.
A screen is displayed, asking you to insert the USB stick.
2 Insert the USB stick.
3 Press .
4 Select the directory.
A screen is displayed for selecting a directory.
Press <*.csv> to archive files only.
Press <*.*> to display all files and directories.
5 Press to confirm the selection.
The data are copied to the USB stick. The screen for exporting data is displayed
again.

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Exporting data

Interpreting result 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.

res_yyyymmddhhmmss.csv Column Title Description

Instr Instrument ID (always 30 for cobas c111)
Msg Message Type:
7 Result for sample, control, or calibration
Index 166 ID of the data set used
App Application code
Date Date when the result was calculated
Time Time when the result was calculated
SW-Version Software version installed on the instrument
Serial Serial number of the instrument
Test Short name of the application
User User name ($SYS$ if Auto Accept is on)
Sample Sample ID
Order-Time Time when the order was started
Result Results of the measurement
Unit Defined display unit
Flags Flag name
Rates Rate value calculated in Abs. (Last Calculation Point - First
Calculation Point)
Raw1 - Raw40 Absorbance value of cycle 1 through 40 in Abs. (one cycle = 18 s)
isSTAT Generated as part of a STAT order
Table 33 Explanations on test results

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Exporting data

cal_yyyymmddhhmmss.csv Column Title Description

Instr Instrument ID (always 30 for cobas c111)
Msg Message Type:
7 Result for sample, control, or calibration
Index 151 Calibration data
152 Std-1 value
153 Std-2 value
154 Std-3 value
155 Std-4 value
156 Std-5 value
157 Std-6 value
App Application code
Date Date when the result was generated
Time Time when the result was calculated
SW-Version Software version installed on the instrument
Serial Serial number of the instrument
Cal/Std Calibrator ID (C.f.a.s. = 401) and standard number
User User name ($SYS$ if Auto Accept is on)
Lot Lot number
LS/Value Calibration type/Target value of corresponding calibrator
L Lot calibration
S Set calibration
Unit Defined display unit
Flags Flag name
R0/Rate Offset and factor of the calibration curve
Kc/Raw01 Kc parameter value or absorbance value of cycle 1 in Abs.
A/Raw02 A parameter value or absorbance value of cycle 2 in Abs.
B/Raw03 B parameter value or absorbance value of cycle 3 in Abs.
C/Raw04 C parameter value or absorbance value of cycle 4 in Abs.
Raw05 - Raw40 Absorbance value of cycle 5 through 40 in Abs. (one cycle = 18 s)
Test Short name of the application
Table 34 Explanations on calibration results

If the calibration results were accepted using Use Old, "???" is displayed as the Date and
Time values, and the corresponding values for Raw1 - Raw40 are missing.

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Exporting data

qcs_yyyymmddhhmmss.csv Column Title Description

Instr Instrument ID (always 30 for cobas c111)
Msg Message Type:
7 Result for sample, control, or calibration
Index 161 Data values
App Application code
Date Date when the result was generated
Time Time when the result was calculated
SW-Version Software version installed on the instrument
Serial Serial number of the instrument
Ctrl Control ID
User User name ($SYS$ if Auto Accept is on)
Lot Lot ID
Mean Mean value
Result Result value
Unit Defined display unit
Flags Flag name
Rate Rate value calculated in Abs. (First Calculation Point - Last
Calculation Point)
Raw1 - Raw40 Absorbance value of cycle 1 through 40 in Abs. (one cycle = 18 s)
Test Short name of the application
Ignored "I" if the QC result was ignored
Table 35 Explanations on QC results

qch_yyyymmddhhmmss.csv Column Title Description

Instr Instrument ID (always 30 for cobas c111)
Msg Message Type:
8 QC history result
Index 151 Data values
App Application code
Date Date when the result was calculated
Time Time when the result was calculated
SW-Version Software version installed on the instrument
Serial Serial number of the instrument
Ctrl Control ID
User User name ($SYS$ if Auto Accept is on)
Lot Lot ID
Mean Mean value
Result Result value
Unit Defined display unit
Flags Flag name
SD Standard deviation
Test Short name of the application
Ignored "I" if the QC result was ignored
Table 36 Explanations on QC history results

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Exporting data

pev_yyyymmddhhmmss.csv Column Title Description

Instr Instrument ID (always 30 for cobas c111)
Msg Message Type:
9 Process event
Index 191 Reagent usage changed
192 Calibrator assigned valued changed
193 QC assigned valued changed
199 Other process event
App Application code
Date Date when the event took place
Time Time when the event took place
SW-Version Software version installed on the instrument
Serial Serial number of the instrument
Event Description of the event
User User name ($SYS$ "system user" = ??? if nobody is logged in)
Test Short name of the application
Table 37 Explanations on process events

The following figure is an example of a test result file that was opened in a spreadsheet
tool. Rows 11 and 12 represent the raw data of a development channel application
with the short name DCBLG.

Figure 3 Example of spreadsheet representation of a test result raw data file

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Exporting data

Exporting log files

During troubleshooting, you may be asked to export the log files and to send them to
by the service representative for examination.
The log-files contain the alarm messages and system logs.

a To export the log files

1 Choose Utilities > Export > Log Files.
A screen is displayed, asking you to insert the USB stick.
2 Insert the USB stick.
3 Press to confirm the insertion.
A screen is displayed for selecting a directory.
Press *.tgz to display cobas c111system files only.
Press *.* to display all files and directories.
4 Select the directory.
5 Press to confirm the definitions.
The data are copied to the USB stick. The screen for exporting data is displayed
again.

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Importing data

Importing data

f Utilities > Import

You can import the following kinds of data:
o Application data (application definitions)
o Software (software updates)
o Database (as exported using Utilities > Export > Database)
o Certificates (digital records that ensure the authenticity of reagent barcodes)
o Extra wash cycle and mixing rule definitions

Importing applications

Importing an application consists of two steps:

1. Importing the data to the instrument by reading a barcode or a data file. This step
stores the data on the instrument.
2. Installing the application. This step activates the application on the instrument
and so makes it available for use.

a To import application data

1 Do one of the following:
o Choose Utilities > Applications > Laboratory Parameters, then continue with
step 2.
o Choose Utilities > Import > Application, then continue with step 4.
2 Press .
3 Press Import Application.
A screen is displayed, asking you to scan the barcode or to import the data from
the USB stick.
4 Do one of the following:

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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Importing data

The following table lists the basic situations.

If… This happens…

Both, the application code and The laboratory parameters, for example the short
the short name exist: name, are retained from the existing application.
The application definitions are replaced on the system
by the new ones.
The application code exists, and The laboratory parameters of the new application are
the short name does not exist for used, for example the short name.
any application on the system: The application definitions are replaced on the system
by the new ones.
The short name exists, but the A screen is displayed for changing the short name to a
application code does not: unique short name.
If you do not change the short name, the application
is not imported.

e For detailed information on possible conflicts when importing applications, see the
section on installing and configuring development channel applications in the
cobas c111 Development Channel Operator’s Manual.

If you want to replace both the laboratory parameters and the application definitions,
you first need to uninstall and delete the existing application and then to import the
new application.

If the application you are importing is a development channel application, note

the following possible exceptional situations:

Situation Explanation and possible actions

No crypto module is installed. A message is displayed, informing the operator of this
fact.
The system does not import the application.
The maximum number of devel- A message is displayed, informing the operator of this
opment channel applications is fact.
already installed. 1. Uninstall and then delete a development channel
application.
2. Start the import process again.

The applications list (Utilities > Applications > Laboratory Parameters) is

displayed. The application name is displayed in square brackets, for example
[GLU2], to indicate that the application is not installed yet.
To make the application available for performing tests, you now need to install it.

a To install an application
1 Choose Utilities > Applications > Laboratory Parameters.
2 Select an application whose name is in square brackets.
3 Press .

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Importing data

4 Choose Install Application.

The system checks whether there is already an application installed on the system
with identical application code or short name.
In the applications list, the application name is displayed without brackets and in
the profile details the short name is displayed.
The profiles that use this application are included in the test selection screen,
provided that all applications of the profiles are installed.
5 Prepare the application.
e See Preparing applications on page B-140.

Importing software

This function is usually used for installing software updates.

a To import system software

1 Choose Utilities > Import > Software.
A screen is displayed, asking you whether you want forced download of controller
software, that is whether you want to overwrite the current controller firmware
irrespective of its current status.
2 Do one of the following:
o Press to overwrite the controller firmware .
o Press to perform standard import.
A screen is displayed, asking you to insert the USB stick.
3 Insert the USB stick.
4 Press .
5 Select the software package.
You recognize the software packages by their file extension .tar.
6 Press to confirm the selection.
The software is installed on the system. A message will inform you when the
installation is complete.
The system will automatically reboot.
When the import is complete, the Overview tab is displayed, and the system is in
Standby status.

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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.

Typical situations Importing a database is mainly done in the following situations:

o You want to restore your existing system to a previous status, for example from a
backup version of the database that was generated on the same system.
o You want to install a known system setup on another system (cloning).
The following table illustrates the different effects in the two situations.

Data item Identical source and Different source and

target system target systems
Installed applications Overwrite Write, overwrite if present
System configuration Overwrite Write, overwrite if present
Bottle set inventory Overwrite Write, overwrite if present
Bottle sets Mark as removed Mark as removed
Lot information for calibra- Overwrite Write, overwrite if present
tors and controls
Sample orders and results Overwrite Delete if present
QC orders and results Overwrite Delete if present
QC history results Overwrite Delete if present
Calibration orders and Overwrite Delete if present
results
Abs. Air/Water Calibration Delete Delete if present
Administrator password Reset to default value Reset to default value
Electrode definitions Delete Delete if present
ISE fluid bottle definitions Delete Delete if present
Table B-11 Effects on existing data when importing a database

a To import the database

1 Remove all bottles of all bottle sets of all disks defined on the target system, using
the appropriate software features.
e See Preparing the reagents on page B-22.

2 Choose Utilities > Import > Database.

A confirmation screen is displayed, informing you about the major effects of the
import.
e For details see Table B-11 on page B-114.

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

6 Select the database file.

Typically, the file format looks like this: dba_yyyymmddhhmmss.tgz.
Press *.tgz to display cobas c111system files only.
Press *.* to display all files and directories.
7 Press to confirm the selection.
When the data are imported, a message is displayed, asking you to restart the
system.
8 Choose > Restart to restart the system.

After the database installation

o Load all bottle sets that are defined, using the appropriate software features.
o Perform Abs. Air/Water Calibration maintenance action.

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

Importing automatic mixing and extra wash cycle definitions

Mixing and extra wash cycle information is contained in a separate barcode on a

barcode transfer sheet.

a To import mixing and extra wash cycle information

1 Choose Utilities > Import > EWC/Mixing.
A screen is displayed, asking you to scan the barcode.
2 Scan the barcode.
The data are installed on the system. A message will inform you when the
installation is complete. The screen for importing data is displayed again.
e For information on defining extra wash cycles see Defining extra wash cycles on
page B-170.

Preparing a new disk

Injury through reagents and other working solutions

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

Infection by biohazardous materials

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

Personal injury or damage to the analyzer due to contact with instrument

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

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Preparing a new disk

NOTICE Damage to the reagent disk

The reagent disk is designed to handle reagents while it is loaded on the instrument. The
cover is equipped with a locking mechanism.
Remove or insert bottles only when the reagent disk is loaded on the instrument and
always use the software functions to perform these tasks.

You can use up to eight different reagent disks on one cobas c111 instrument. Each
reagent disk is equipped with numbered tabs. For automatic disk identification by the
instrument, one—and only one—of these tabs is removed. The number of this
removed tab is the disk ID. When you label the disk, make sure that the number on
the label corresponds to that of the removed tab.

A
A

B
C
D

A Reagent disk IDs. There are eight possible C Identification tabs

IDs. D The tab has been removed for automatic
B Disk label. The number must correspond to disk recognition
the reagent disk ID.

Figure B-38 Reagent disk ID

a To prepare a new reagent disk

Defining the disk ID 1 Be sure to select an ID that is not used by any other reagent disk you intend to use
on this cobas 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.

Loading the disk 4 On the system, choose Overview > .

A disk overview screen is displayed.
5 Press .
A screen is displayed, asking you to insert the disk.
6 Open the main cover.
7 Place the reagent disk in the reagent cooler.
Make sure the reagent port faces the front and align the cut-outs with their
counterparts on the reagent cooler.
The system automatically detects that a disk was inserted.
A screen is displayed, asking you to close the main cover.
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Preparing a new disk

8 Close the main cover.

At this stage, the system identifies the disk.
A screen is displayed that shows the status of the reagent sets.

Loading reagent sets 9 Press .

A screen is displayed, asking you to scan the bottle barcode.
10 Scan the barcode on the bottle.
11 Remove the cap from the bottle and place it in the reagent bay.
12 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 of a set is loaded, the reagent set is defined. From this
moment on, the reagents are handled as part of the set. You no longer handle
them as individual reagents.
13 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.

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

Assigning tests to test tabs

The system provides two order modes: Easy and Full. When working in Easy mode,
the test selection screen consists of one panel, if working in Full mode, the screen
contains up to six panels, each is identified by a tab.
To make a test available for selection from the test selection screen, you need to assign
it to a test tab. This is done in two steps:
1. Naming the tabs (if required).
2. Assigning the tests to the tabs.

You need Lab Manager or Administrator rights for assigning tests to tabs.

Assignment when importing When you import applications, the tests are assigned to the tabs as follows:
applications
o If you work in Easy mode, the tests are added to the Easy panel. (If the panel is full,
they will not be displayed.)
o If you work in Full mode, the tests are added to the Easy panel (if there is space)
and to the first Full mode tab. If there is not enough space on the first Full mode
tab, the test is added to the next tab that has space available.

a To name a test tab

1 Choose Utilities > Configuration > Workflow.
2 Expand the Workflow entry, scroll down, and select Test Tab 1...6 Name.
3 Press .
A screen for typing text is displayed.
e For details on typing text see Typing text on page A-76.

4 Type up to four characters.

This is the name of the tab on the screen for assigning tests.
5 Press .
The tab name is now available on the screen for assigning tests. See below.

a To assign a test to a tab

1 Choose Utilities > Applications > Laboratory Parameters.
2 Select the test you want to assign to a tab.
3 Press .
4 Select General and expand the entry.
5 Select Test Tabs.
6 Press .
A screen is displayed that provides a button for each of the possible tabs.
The Easy button is always available. It is the standard panel for working in Easy
order mode. (You cannot rename it.)

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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.

a To remove a test from a tab

1 Choose Utilities > Applications > Laboratory Parameters.
2 Select the test you want to remove.
3 Press .
4 Select General and expand the entry.
5 Select Test Tabs.
6 Press .
7 Cancel the selection of the button of the tab to which the test is assigned to.
8 Press .
The test is no longer available from the corresponding tab on the test selection
screen.

To move a test from one tab to another, delete it from the original tab and assign it to the
new tab.

Deleting bottle sets from the Inventory list

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.

a To delete a bottle set from the Inventory list

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

Deleting the bottle set 2 Choose Utilities > Inventory.

The Bottle sets list is displayed. It contains 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 has not
passed yet.

Figure B-39

In the D column, removed bottle sets are marked with R (A).

3 Select the bottle set you want to delete.
4 Press
A confirmation dialog box is displayed. If the set cannot be deleted a message will
inform you.
5 Press to confirm the deletion.

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

Refilling printer paper

You can refill the printer paper any time, provided printing is not in progress.

a To check the printer status

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

a To replace the printer paper

1 Make sure the printer is not currently printing.
2 Open the printer panel.

Be sure to press down the release button (A) firmly before you pull the panel. The
panel should open without resistance.

3 Lift the empty printer paper roll from its holder.

4 Remove the pin from the roll.
5 Insert the pin in the new roll.
6 Place the new roll on the holder.
Make sure the paper unrolls at the top and towards you.

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Refilling printer paper

7 Insert the paper in the slot in the printer panel and pull some through.

8 Close the printer panel.

The system feeds some paper.
If the system ran out of paper during printing, it will resume printing.
9 On the Overview tab, press the System status button.
The printer button should now be green, and the status description should
be OK.

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Removing condensation water from the reagent cooler

Removing condensation water from the reagent cooler

a To remove water from the reagent cooler

1 Make sure the system is in Standby status.
2 Choose Overview > > .
3 Open the main cover.
4 Remove the reagent disk.
Be sure not to tilt it and place it on an even surface.
5 Wipe the inside of the reagent cooler with a cloth or paper to remove the water.

6 Insert the reagent disk.

7 Close the cover.

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Replacing the probe

Replacing the probe

If the probe is bent, broken, or corroded, you need to replace it.

Tools and materials required o Probe and tubing set

o Tube with ISE Deproteinizer
o Tube with Activator
o Glass beaker

Injury through working solutions

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

Infection by biohazardous materials

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

a To remove the probe

1 Make sure the system is in Standby status.
2 Switch off the system.
3 Remove the transfer head cover.
Press the release buttons on both sides and lift.
4 Release the tube leading to the probe from all tubing clips.

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Replacing the probe

5 Remove the sensor tubing adapter (A).

A Sensor tubing adapter D Probe holder

B Example of tubing clip E Tube fixation screw on distribution block
C Tube fixation screw on holder

Figure B-40

6 Remove the probe holder (D) from the carriage.

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

a To install the new probe

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

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Connecting and disconnecting the external fluid containers

6 Install the transfer head cover.

Push down until the release buttons latch on.
7 Switch on the system.
The system performs internal checks and routines.
The startup phase may take a few minutes.
When the instrument is ready for use, the Overview tab is displayed, and its status
is Standby.
8 Log on the system.
9 Perform the Deproteinize Probe maintenance action.
e See Deproteinize the probe on page C-10.

Connecting and disconnecting the external fluid containers

Before switching on the system, make sure that all external fluid containers are placed
on the rack and properly connected.

a To connect the water container

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

A B C

A Water container C Water connector

B Tubing adapter

Figure B-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 To connect the waste container

1 Place the empty yellow waste container on the tray.
2 Connect the waste tubing by pushing the plug firmly in the socket.

A B C

A Waste container C Waste connector

B Tubing adapter

Figure B-42

3 Insert the tubing adapter in the container and push it down firmly.

a To connect the cleaner bottle

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

A B C

A Cleaner bottle C Cleaner connector

B Tubing adapter

Figure B-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

a To disconnect a tube from the instrument

1 Remove the right side panel.
2 Do one of the following:

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

A Release clamp on water connecting socket C Waste connector release clamp.

B Diluent connector screw

Figure B-44

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6 Special operations cobas c 111
Adjusting the touchscreen

Adjusting the touchscreen

With a touchscreen, it is important that the point where you press the screen
corresponds exactly with its hardware equivalent. If this were not the case, pressing a
screen item such as a button might not lead to the expected result.

a To adjust the touchscreen

1 Press the global button.
A screen is displayed that offers several kinds of stopping.
2 Press the global button again.
A screen for adjusting the screen is displayed.

3 Press exactly in the center of the black cross.

The cross turns green and the next cross turns black.
4 Press exactly in the center of the black cross.
The cross turns green and the next cross turns black.
5 Press exactly in the center of the black cross.
All crosses are green.
6 Press anywhere in the screen and observe where exactly a small red square (pixel)
is displayed.
The red square should be exactly where you pressed.
7 Do one of the following:

If Do this
The red square is exactly where you pressed: 1. Press .
The red square is some distance from where 1. Press .
you pressed: 2. Repeat the whole procedure, make sure
that you press exactly in the center of
the crosses.

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Cleaning the touchscreen

Cleaning the touchscreen

Because the touchscreen gets easily soiled you should clean it regularly.

Tools and materials required m 70% ethyl alcohol

m Tissues
m Protective gloves

a To clean the touchscreen

1 Pour or spray some alcoholic solution on a tissue.
2 Wipe the screen.
Exert as little pressure as possible.
3 Wipe the screen with a clean tissue.

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B-132 Operator’s Manual · Version 3.0
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.

In this chapter Chapter 7

Introduction ............................................................................................................ B-135
Viewing values ................................................................................................... B-135
Changing values ................................................................................................ B-135
Applications ............................................................................................................. B-137
Installing applications ....................................................................................... B-137
Activating and deactivating applications ......................................................... B-139
Preparing applications ...................................................................................... B-140
Uninstalling applications .................................................................................. B-143
Deleting applications ......................................................................................... B-144
Defining the processing order ........................................................................... B-145
Defining ratio applications ............................................................................... B-146
Profiles ............................................................................................................... B-148
Defining profiles .......................................................................................... B-148
Adding tests to a profile .............................................................................. B-148
Removing tests from a profile ..................................................................... B-149
Deleting profiles .......................................................................................... B-149
Defining control definitions and lots .............................................................. B-149
Defining calibrator definitions and lots ........................................................... B-150
Short guide to application definitions .............................................................. B-152
Version ......................................................................................................... B-152
Code ............................................................................................................. B-152
General application definitions .................................................................. B-152
Calibration definitions ................................................................................ B-153
Control definitions ...................................................................................... B-154
Calculation definitions ................................................................................ B-155
Calculation definitions (ratio applications) ............................................... B-155

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Table of contents

Laboratory correlations (ratio applications) ............................................. B-156

Reference range definitions (ratio applications) ........................................ B-156
Result conversion definitions ...................................................................... B-156
Configuration .......................................................................................................... B-157
Changing your password .................................................................................. B-157
Scheduling maintenance actions ...................................................................... B-158
Handling user interface language ..................................................................... B-158
Uninstalling a language ............................................................................... B-160
User management .............................................................................................. B-161
Defining a user ............................................................................................. B-161
Deleting a user ............................................................................................. B-161
Editing the acceptable flags list ......................................................................... B-162
Mapping the host codes .................................................................................... B-162
Short guide to configuration definitions .......................................................... B-164
Workflow definitions ................................................................................... B-164
Host definitions ........................................................................................... B-165
Result handling ............................................................................................ B-167
Calibration ................................................................................................... B-167
QC ................................................................................................................ B-167
System .......................................................................................................... B-168
Date and time .............................................................................................. B-169
Maintenance ................................................................................................ B-169
Abs adjustment ............................................................................................ B-169
Defining extra wash cycles ................................................................................ B-170
Activating, deactivating and deleting extra wash cycles .................................. B-171
Short guide to extra wash cycle definitions ...................................................... B-172
Extra wash cycle definitions ........................................................................ B-172
Short guide to reagent mixing rules ................................................................. B-173
Reagent mixing rule definitions .................................................................. B-173
Printing mixing rules ........................................................................................ B-173
Deleting mixing rules ........................................................................................ B-174

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cobas c111 7 Configuration
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.

5 Type the new value or press a value button.

6 Do one of the following:

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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cobas c111 7 Configuration
Applications

Applications

Installing applications

To make available a new application on a cobas c111 instrument, you need to perform
the following steps:
1. Import the data to the instrument by reading its barcode or by reading them from
a USB stick. This step saves the data on the instrument.
It is possible to import a new version of an application with identical application
code, but you cannot install it.
e To import application data on page B-137.
2. Install the application. This step activates the application on the instrument and
so makes it available for use.
e Installing applications on page B-137.
3. Prepare the application. This step associates the application with lot data and
auxiliary fluids such as calibrators and controls.
e To prepare an application on page B-140.

a To import application data

1 Do one of the following:
o Choose Utilities > Applications > Laboratory Parameters, then continue with
step 2.
o Choose Utilities > Import > Application, then continue with step 4.
2 Press .
3 Press Import Application.
A screen is displayed, asking you to scan the barcode or to import the data from
the USB stick.
4 Do one of the following:

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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The following table lists the basic situations.

If… This happens…

Both, the application code and The laboratory parameters, for example the short
the short name exist: name, are retained from the existing application.
The application definitions are replaced on the system
by the new ones.
The application code exists, and The laboratory parameters of the new application are
the short name does not exist for used, for example the short name.
any application on the system: The application definitions are replaced on the system
by the new ones.
The short name exists, but the A screen is displayed for changing the short name to a
application code does not: unique short name.
If you do not change the short name, the application
is not imported.

e For detailed information on possible conflicts when importing applications, see the
section on installing and configuring development channel applications in the
cobas c111 Development Channel Operator’s Manual.

If you want to replace both the laboratory parameters and the application definitions,
you first need to uninstall and delete the existing application and then to import the
new application.

If the application you are importing is a development channel application, note

the following possible exceptional situations:

Situation Explanation and possible actions

No crypto module is installed. A message is displayed, informing the operator of this
fact.
The system does not import the application.
The maximum number of devel- A message is displayed, informing the operator of this
opment channel applications is fact.
already installed. 1. Uninstall and then delete a development channel
application.
2. Start the import process again.

The applications list (Utilities > Applications > Laboratory Parameters) is

displayed. The application name is displayed in square brackets, for example
[GLU2], to indicate that the application is not installed yet.
To make the application available for performing tests, you now need to install it.

a To install an application
1 Choose Utilities > Applications > Laboratory Parameters.
2 Select an application whose name is in square brackets.
3 Press .

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4 Choose Install Application.

The system checks whether there is already an application installed on the system
with identical application code or short name.
In the applications list, the application name is displayed without brackets and in
the profile details the short name is displayed.
The profiles that use this application are included in the test selection screen,
provided that all applications of the profiles are installed.
5 Prepare the applications.
e See Preparing applications on page B-140.

Activating and deactivating applications

When an application is installed on the system, it is automatically activated.

e Installing applications on page B-137.

You can deactivate an application to temporarily make unavailable the test on the test
panel. All associated fluids and data remain unchanged. You can activate the
application later again and continue using the test.

a To activate or deactivate an application

1 Choose Utilities > Applications > Laboratory Parameters.
2 Expand the application entry.
3 Expand the General entry.
4 Select Active.
5 Press .
6 Choose On if you want to use the application.
Choose Off if you do not want to use the application.
7 Press .

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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.)

Version The version uniquely identifies a particular set of application definitions.

The version number increases whenever there is a change to the application
definitions, for example from version 1.0 to 1.1.

General definitions 3 Expand the General entry, select Short Name, and press .
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.

8 Press to confirm the definitions.

Calibration definitions For Roche calibrators, recommended definitions are automatically defined for each
application. You can change the sequence, interval, and the replicate value, if
required.

Roche recommend not to change the calibration definitions of Roche reagents.

9 Expand the Calibration entry, select Sequence, and press .

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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.

Calibration definition changes require subsequent calibration of the tests.

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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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.

Incorrect results due to inappropriate formula

The formula defines how the values of the applications and coefficients are mathemat-
WARNING ically combined to generate a result.
It is the responsibility of the user to ensure that the formula is appropriate for the appli-
cation that is being defined.

20 Press to confirm the definitions.

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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Uninstalling applications

Uninstalling an application means making the application unavailable for use in

testing.
You can reinstall an uninstalled application.
e See Installing applications on page B-137.

Before you can uninstall an application, you need to perform some preparation tasks:

a To prepare uninstalling an application

1 Delete all associated sample results.
e See Deleting sample results on page B-94.

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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Deleting applications

Deleting an application means removing the data from the system.

The process of removing an application from the system consists of the following steps:
1. Delete all associated sample results.
e See Deleting sample results on page B-94.
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.
3. Uninstall the application. This process makes the application unavailable for use
in testing.
e See Uninstalling applications on page B-143.
4. Remove all associated reagent sets from any of the reagent disks. (The disk may be
off board, and you might need to load it in order to remove the reagents.)
e See To load the reagent disk on page B-21
See Removing a reagent set on page B-25.
5. Delete the application. This process removes the application data from the system.

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.

Situation Proceed as follows

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

A confirmation screen is displayed.

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4 Press .
The application data are deleted.

Defining the processing order

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.

a To define the processing sequence

1 Choose Utilities > Applications > Process Sequence.

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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Defining ratio 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.

a To define a ratio application

1 Choose Utilities > Applications > Laboratory Parameters.
2 Press .
3 Press Add Ratio.
4 Type the code and press .

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 .

You can define between one and four applications.

8 Define the other applications, if required.
9 Type the first coefficient and press .

You can define between one and four coefficients.

10 Define the other coefficients, if required .
11 Type the formula and press .
The formula relates the applications with the coefficients. You can use the
following operands: +, -, *, /, (, ), space, and application subindex 1 and 2.

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Incorrect results due to inappropriate formula

The formula defines how the values of the applications and coefficients are mathemat-
WARNING ically combined to generate a result.
It is the responsibility of the user to ensure that the formula is appropriate for the appli-
cation that is being defined.

12 Type the factor to compensate for differences in measuring methods of different

instruments, then press .

13 Type the offset and press .

14 Select whether the offset/correlation factor is going to be used or not, then press
.

15 Select the valuation type, then press .

No valuation means that no valuation will be performed.

Reference range means that the result will be compared with the defined reference
ranges.
16 Select whether the low range will be used or not, then press .

17 Select whether the high range will be used or not, then press .

18 Type the low limit, then press .

19 Type the high limit, then press .

20 Type the standard unit, then press .

21 Type the laboratory unit, then press .

22 Type the conversion factor, 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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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.

Adding tests to a profile

a To add tests to a profile

1 Choose Utilities > Applications > Laboratory Parameters.
2 Select the profile.
3 Expand the entry.
4 Expand the General entry.
5 Select Applications.
6 Press .
A test selection screen is displayed.
7 Select the tests.
8 Press to confirm the selection.
e For information on assigning a profile to tabs on the test selection screen, see Assigning
tests to test tabs on page B-119.

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Removing tests from a profile

a To remove tests from a profile

1 Choose Utilities > Applications > Laboratory Parameters.
2 Select the profile.
3 Expand the entry.
4 Expand the General entry.
5 Select Applications.
6 Press .
A test selection screen is displayed.
7 Clear the selection of the tests you want to remove.
8 Press to confirm the selection.

Deleting profiles
e See Deleting applications on page B-144.

Defining control definitions and lots

f Workplace > Lot Data

a To define control definitions and lots

Perform the following steps for all controls.
1 Choose Workplace > Lot Data.
2 Press Controls.
A screen is displayed that lists all installed control lots.
3 Press .
A screen is displayed, asking you to scan the barcode transfer sheet or to type the
data manually.

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4 Define the lot values.

Do one of the following:

If… Do this…
The lot data are 1. Scan the barcode.
available from a The screen is displayed again that lists all installed control lots.
barcode The new lot is selected.
You want to type 1. Press .
the data manually 2. Type the name and press .
3. Type the material code and press .
You find this code in Utilities > Applications > select a test >
> Control.
4. Type the Lot ID and press .
5. Type the expiration date. Use the date format as indicated on
the screen.
6. Press to confirm the definitions.
If a lot with the same ID already exists on the system, a screen is
displayed, asking you whether you want to replace the existing
lot.
Press to confirm the definitions.
7. Press *Add new test*.
8. Press .
A screen is displayed that contains all tests that use this control
and that have not yet been assigned to this lot.
9. Select a test and press .
10. Type the value for the mean concentration and press .
11. Type the value for the standard deviation.
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.

Defining calibrator definitions and lots

You need to perform the definitions for all calibrators.

a To define a calibrator lot

1 Choose Workplace > Lot Data.
2 Press Calibrators.
A screen is displayed that lists all installed calibrator lots.
3 Press .
A screen is displayed, asking you to scan the barcode or to type the data manually.

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4 Define the lot values. Do one of the following:

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 c 111 instrument.

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Short guide to application definitions

The following tables provide reference information on the meaning and use of application
definitions the user might want to change.

Version
The version uniquely identifies a particular set of application definitions.

Code
The Roche application code identifies the application. 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.)

General application definitions

Item Values Comment

Short Name Up to 5 alphanumeric The short name is used on the screens, for exam-
characters ple on the test selection screen or the results list.
Long Name Up to 30 alphanu- The long name is a telling description of the test.
meric characters It is particularly useful if the short name is not
generally familiar in the laboratory environ-
ment.
Active On, Off Tests that not active are not available for use. You
cannot see them on the screens. Their applica-
tion definitions remain on the system.
Test Tabs See Workflow Choose one or several of the buttons. The test
definitions on will be included in the corresponding test tabs.
page B-164. Choose Easy if you work with order mode Easy.
Clear all selections to prevent the test from being
selected in the test selection screens.
Table B-12 General application definitions

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Calibration definitions

ISE applications do not have calibration definitions.

Item Values Comment

Sequence The sequence values define when calibration becomes due, and the sys-
tem automatically informs you about due calibrations.
No Interval The system does not inform you about the due
status. Use this value if the reagent is stable
enough over the whole period until it is empty
and you replace it.
Calibration is due whenever a new reagent set is
loaded on the instrument.
Interval Only Due whenever the reagent interval has expired.
Each Set and Interval Due whenever a new reagent is loaded and when
the interval has expired.
The interval starts again whenever you place a
new reagent set.
You can turn off the interval check by defining
its duration as 0 (zero).
Each Lot and Interval Due whenever the fist reagent of a new lot is
loaded and then each time the interval has
expired.
The interval (re)starts whenever you calibrate a
reagent set.
You can turn off the interval check by defining
its duration as 0 (zero).
If you install a reagent set of the same lot, no cal-
ibration is required. (The system uses the Lot
calibration result as the Set calibration result of
the new reagent set.)
Interval Number of days. Use 0 (zero) if the Sequence is set to No Interval.
(For ISE, 1 day fixed.)
Replicates 1, 2 Number of times each measurement should be
repeated.
Table B-13 Calibration definitions

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Control definitions

Item Values Comment

Sequence No Interval The system does not inform you about the due
status.
Use this value if you intend to perform QC as
part of standard sample testing and not as a sep-
arate task, and if QC should be handled by a host
computer.
Note that an accepted QC result is required for a
test before it can be used.
Interval Only Due whenever the reagent interval has expired.
The system automatically informs you about due
QCs.
Interval Number of days Use 0 (zero) if the Sequence is set to No Interval.
(hours for ISE
applications)
For each of the controls:
Mat. Code 0 ... 999 Unique identification of the control material.
Numbers 801 through 999 are reserved for non
Roche controls.
You need to define this initially for every applica-
tion.
QC After Cal On, Off QC needs to be performed after each calibration
of the test.
Default QC On, Off Mark the test to have QC performed as part of
the Default QC function.
Default QC is an automated process for per-
forming all QC measurements that are currently
due. This is the ideal method if you want to per-
form QC periodically during routine operation.
Table B-14 Control definitions

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Calculation definitions

Item Values Comment

Factor Used for sample and control results.
Final result = (result * Factor) + Offset
The correlation factor is used to compensate for
differences in measuring methods of different
instruments. By applying a factor, the final
results of the different instruments can be
directly compared.
Offset The offset is used to compensate for differences
in measuring methods of different instruments.
By adding the offset, the final results of the dif-
ferent instruments can be directly compared.
Valuation No Valuation
Reference Range Use the limits defined as Low Limit and High
Limit.
Low Used On, Off Refers to Low Limit.
High Used On, Off Refers to High Limit.
Low Limit Results that are outside the limit are flagged.
High Limit Results that are outside the limit are flagged.
1...3:Flag QC Fail On, Off Choose On to ensure that all sample results are
flagged that were generated using a test whose
QC results were marked with a flag.
The initial number refers to the control that was
used for performing the QC. (See also Control
definitions.)
Table B-15 Calculation definitions

Calculation definitions (ratio applications)

Item Values Comment

Application A Up to 5 alphanumeric Short names of the installed applications.
through D characters
Coefficient w 000 … 999 Numeric variable for use in the formula.
through z
Formula Defined application The formula relates the defined applications
and coefficient letters. with the coefficients.
Operands: For example: (A * w + B) * A / B
+, -, *, /, (, ), and space
Table B-16 Calculation definitions for ratio applications

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Laboratory correlations (ratio applications)

Item Values Comment

Factor Used for sample and control results.
Final result = (result * Factor) + Offset
The correlation factor is used to compensate for
differences in measuring methods of different
instruments. By applying a factor, the final
results of the different instruments can be
directly compared.
Offset The offset is used to compensate for differences
in measuring methods of different instruments.
By adding the offset, the final results of the dif-
ferent instruments can be directly compared.
Used On, Off Choose On to ensure that the defined factor and
offset are applied the final ratio result.
Table B-17 Laboratory correlation definitions for ratio applications

Reference range definitions (ratio applications)

Item Values Comment

Valuation No Valuation No valuation is performed by the system.
Reference Range Use the limits defined as Low Limit and High
Limit.
Low Used On, Off Refers to Low Limit.
High Used On, Off Refers to High Limit.
Low Limit Values in standard Results that are outside the limit are flagged.
units.
High Limit Values in standard Results that are outside the limit are flagged.
units.
Table B-18 Reference range definitions for ratio applications

Result conversion definitions

Item Values Comment

Standard Unit
Laboratory Unit Alphanumeric Type the unit.
characters
Factor Conversion factor for converting results from
one unit to another, for example from mg/dL to
mmol/L.
Displayed Unit Standard Unit
Laboratory Unit
Dec. Position 0 ... 4 Number of digits after decimal point that are
displayed on the screens.
Table B-19 Result conversion definitions

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B-156 Operator’s Manual · Version 3.0
cobas c111 7 Configuration
Configuration

Configuration

Changing your password

NOTICE Damage to data and programs due to unauthorized access to the cobas c 111
instrument
User access to the cobas c 111 instrument is controlled by a login name and password.
Users are administered by a system administrator.
Roche recommend to periodically change the password of the system administrator and to
store the current password in a safe place with adequate access control.

User name and password are case sensitive. This means that for example Admin and
admin are two different names.

a To change you password

1 Do one of the following:

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

2 Type your user name.

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

4 Press Change Password.

5 Type your old password.
6 Press .

7 Type the new password

8 Press .

9 Type the new password a second time.

10 Press .

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Operator’s Manual · Version 3.0 B-157
7 Configuration cobas c 111
Configuration

Scheduling maintenance actions

The cobas c111 instrument facilitates performing the maintenance actions in bundles
at times that suit your laboratory work processes. To that purpose, you can define one
day of the week as your maintenance day.

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

a To define the main maintenance day

1 Choose Utilities > Configuration > Maintenance.
2 Expand the main entry and select Major Maint. Day.
3 Press .
A screen is displayed for selecting a day of the week.
4 Press one of the weekday buttons.
5 Press .

The definition of the minor maintenance day has currently no practical influence on the
maintenance scheduling, because there are no maintenance actions with intervals of
between two and six days.

Handling user interface language

You can choose from up to six languages. (You could install more than six languages,
but only the first six in the alphabetic sequence are available for selection.)
In the software and the user interface, the languages are identified by their two-letter
abbreviation (ISO 639-1). The following languages are available:

Abbreviation Language Abbreviation Language

DE German EL Greek
EN English ES Spanish
FI Finnish FR French
HU Hungarian ID Indonesian
KO Korean PL Polish
PT Portuguese TR Turkish
ZH Chinese
Table B-20 Abbreviations for user interface languages

Roche Diagnostics
B-158 Operator’s Manual · Version 3.0
cobas c111 7 Configuration
Configuration

Prerequisites o Make sure that there are no pending or unfinished orders.

o The system must be in Standby status.
o You need Lab Manager or Administrator user rights.

a To install a new language

1 Copy the language file (c111_xx.tar, where xx is the language code) to the Root
directory of a USB stick.
2 Choose Utilities > Import.
3 Press Software.
A screen is displayed, asking you whether you want forced download of controller
software, that is whether you want to overwrite the current controller firmware
irrespective of its current status.
4 Press to perform standard import.
A screen is displayed, asking you to insert the USB stick.
5 Insert the USB stick.
6 Press .
A screen is displayed that shows the file structure on the stick.
You should see the c111_xx.tar file, where xx stands for the language abbreviation,
for example c111_en.tar represents the English language file.
7 Select the c111_xx.tar file.
8 Press to confirm the selection.
The software is installed on the system. A message will inform you when the
installation is complete.
9 When the installation is complete, remove the USB stick.
For the language to become active you need to restart the system.
10 Press .

11 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.
12 Wait until the system is in Standby status.

a To change the user interface language

1 Choose Utilities > Configuration > System.
2 Expand the list.
3 Select Language.
4 Press .
A screen is displayed that contains a button for each of the currently installed
languages. The buttons are labelled with the two-letter language abbreviation.
e See Table B-20 on page B-158.

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7 Configuration cobas c 111
Configuration

5 Press the button for the required language.

6 Press .

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

7 Press .

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.

Prerequisites o The current user interface language must be English.

e See To change the user interface language on page B-159.
o The system must be in Standby status.
o The uninstall language file c111_uninstall_languages.tar has been copied to a
USB stick.
o You need Lab Manager or Administrator user rights.

a To uninstall user interface languages

1 Choose Utilities > Import.
2 Press Software.
A screen is displayed, asking you to insert the USB stick.
Insert the USB stick.
3 Press .
A screen is displayed that shows the file structure on the stick.
4 Select the c111_uninstall_languages.tar file.
5 Press to confirm the selection.
All languages except English are deleted from the system. A message will inform
you when uninstalling is complete.
6 When the installation is complete, remove the USB stick.

Roche Diagnostics
B-160 Operator’s Manual · Version 3.0
cobas c111 7 Configuration
Configuration

User management

You need Administrator user rights to define or delete a user.

Defining a user

a To define a user
1 Choose Utilities > Users.
A screen is displayed that lists all currently defined users.
2 Press .

3 Type the user name.

Make sure it is unique within your laboratory.
4 Press .

5 Type the password.

6 Press .

7 Press the appropriate user level button.

o Press Operator for users who should perform routine tests.
o Press Supervisor for users who should perform routine tests as well as
calibration and QC.
o Press Lab Manager for users who should perform all test actions and who
should be able to update or add applications and perform diagnostics tasks.
o Press Administrator to define the administrator of the cobas c111 instrument.
The administrator can, in addition to all Lab Manager actions, perform user
administration.
8 Press .

Deleting a user

a To delete a user
1 Choose Utilities > Users.
A screen is displayed that lists all currently defined users.
2 Select the user you want to delete.
3 Press .

A confirmation screen is displayed.

4 Press to confirm the deletion.

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Operator’s Manual · Version 3.0 B-161
7 Configuration cobas c 111
Configuration

Editing the acceptable flags list

When working with automatic accepting of results, results that are not flagged are
automatically accepted. Results with flags that are marked in an acceptable flags list
are accepted as well. There is such a list for sample, QC, and calibration results.

a To add or remove a flag from an acceptable flags list

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

A list of relevant flags is displayed.

5 Press the square to the left of a flag name to select it or to cancel its selection.
A selected flag shows a check mark (l).
6 Press .

Mapping the host codes

Applications are delivered with a unique ID called code. Laboratories often use their
own codes for applications. By mapping the codes used by the laboratory (host codes)
to those defined by the application manufacturer, the laboratory can work with their
own accustomed codes. The cobas c111 instrument provides a mapping table that can
easily be edited.
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.

a To export the mapping table

1 Choose Utilities > Applications > Host Codes.
2 Press .
A screen is displayed, asking you to insert the USB stick.
3 Insert the USB stick.
4 Press .
5 Select the directory where you want to save the mapping file.

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B-162 Operator’s Manual · Version 3.0
cobas c111 7 Configuration
Configuration

6 Press to confirm the selection.

The file is exported as a text file of the name format hct_yyyymmddhhmmss.txt.

a To re-import the mapping table

1 Choose Utilities > Host Codes.
2 Press .
A screen is displayed, asking you to insert the USB stick.
3 Insert the USB stick.
4 Press .
5 Select the mapping file.
Typically, mapping files have the name format hct_yyyymmddhhmmss.txt.
Press *.txt to display text files only.
Press *.* to display all files and directories.
6 Press to confirm the selection.
The file is installed on the system. The screen with the mapping table is displayed
again.

a To use the manufacturer’s application codes

1 Choose Utilities > Host Codes.
2 Press .
The host codes are set to values that are identical to the application codes.
By pressing again, you can revert to the original values.

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Operator’s Manual · Version 3.0 B-163
7 Configuration cobas c 111
Configuration

Short guide to configuration definitions

Workflow definitions

Item Values Comment

Working Mode Defines the way in which you select tests during order
definition.
Manual Use this definition if the cobas c111 instrument is
used as a stand-alone system.
During order definition, the test selection screen is
displayed, allowing you to select the tests or to make
changes to the selection.
Host Use this definition if the cobas c111 instrument is
connected to a host computer or to a computer run-
ning the cobas c111 Printer Tool.
The orders are automatically defined, the test selec-
tion screen is not displayed. After identifying the sam-
ple, you are asked to place the sample.
Sample Barcode On, Off You can work with or without barcodes on sample
tubes. Use Off only if you exclusively work without
barcodes.
If you use On, during order definition the option to
type the sample ID manually is skipped
Order Mode Easy You work with one test panel on the test selection
screen, containing up to 25 tests.
Typical situation for this mode: You work with one or
two reagent disks, manual order identification, iden-
tical sample and order IDs, possibly but not necessar-
ily with host connection.
Full You can work with up to six test tabs on the test selec-
tion screen, each containing up to 20 tests.
Typical situation for this mode: You distribute the
reagents across several (up to eight) reagent disks and
you predominantly work with specific groups of tests,
for example for emergency situations or for testing
diabetes. You also work with a host connection with
automatic order identification and result upload.
Sample ID Order ID = The order ID is automatically defined when you iden-
Handling Sample ID tify the sample.
Independent IDs You define the sample ID and order ID independently
of each other.
Grouped Sample Order and sample ID are identical.
ID For a given sample, the same sample ID is used all the
time. A three digit number is appended and automat-
ically increased with each new order.
Examples: 789-001 for the first order, 789-002 for the
second order, and so on.
Table B-21 Workflow definitions

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B-164 Operator’s Manual · Version 3.0
cobas c111 7 Configuration
Configuration

Item Values Comment

Sample ID One This definition is used in combination with Grouped
Separator alphanumeric Sample ID. It defines the character that separates the
character sample ID from the automatically appended number.
Examples: 789-001, 789.001, 789_001.
Auto Order-ID On, Off If you use On, the system automatically increments
the order ID number by one whenever you define a
new order.
If you use On, choose Off for Order ID = Sample ID.
Auto Print On, Off If you use On, sample results are printed as soon as all
Results results of the order are available and accepted.
Test Tab 1... 6 Up to four Display name for the test tab 1... 6
Name alphanumeric Test tabs are used to group tests that are usually used
characters together.
You can assign a test to more than one tab.
Test Tab 1... 6 On, Off Use On to make available the tab on the test selection
Visible screen.
Table B-21 Workflow definitions

Host definitions

Item Values Comment

Baud Rate Data transmission rate for host interface communica-
tion.
Select one of the predefined values.
Handshake Off An exchange of signals between two devices when
Hardware communication begins in order to ensure synchroni-
zation.
XON/XOFF
Line Mode Number of bits and stop bits used during data trans-
mission.
Select one of the predefined values.
Parity Check On, Off An error detection technique that tests the integrity of
digital data in memory or on disk.
Communication Off Download to the cobas c111instrument is possible,
Mode but upload to host is not.
Batch Only manual upload to the host is possible.
Realtime Results and queries are sent during processing.
Checksum On, Off A value used to ensure that data are stored or trans-
mitted without error. It is stored with the data. When
the data are retrieved from memory or received at the
other end of a network, a new checksum is computed
and matched against the existing checksum. A non-
match indicates an error.
Table B-22 Host definitions

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Operator’s Manual · Version 3.0 B-165
7 Configuration cobas c 111
Configuration

Item Values Comment

Order Query Query mode allows real-time communication during
Mode order definition of regular, rerun, and repeated tests.
Off No queries are sent.
Test orders have to be defined either manually or by
downloading them from the host.
Once A query is sent only when the sample is identified the
first time.
Always A query is sent every time the sample is identified.
Timeout 10 ... 300 s Period of time the system will wait for a response
from the host when working in Order Query Mode.
This definition applies to routine, STAT and rerun
sample tests.
Send Result Off The results are sent to the host manually.
Mode Complete The results are automatically sent to the host when all
results of the order are available and accepted.
Immediate Each result is automatically sent to the host as soon as
it has been accepted.
Send Raw Data On, Off Raw data include all measurement results made dur-
ing the measuring cycles, not just the calculated test
results.
Trace On, Off The Trace function records the content of the com-
munication with the host in a trace file.
This is a troubleshooting function. Do not work with
it during normal daily operation.
The trace file can be exported as a log file (Utilities >
Export > Log Files; file format: htryyyymmddh-
hmmss.log.)
System Device ID Up to 10 The ID is used on reports and for communication
alphanumeric between the cobas c111 instrument and the host.
characters.
Host Device ID Up to 10 The ID is used on reports and for communication
alphanumeric between the cobas c111 instrument and the host.
characters.
Table B-22 Host definitions

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B-166 Operator’s Manual · Version 3.0
cobas c111 7 Configuration
Configuration

Result handling

Item Values Comment

Sample Auto On, Off Results that do not contain a flag are automatically
Accept accepted. Results with flags that are marked in a list of
acceptable flags are accepted as well.
Sample Accept. List of possible flags. Results with marked flags are
Flags automatically accepted if Sample Auto Accept is on.
QC Auto Accept On, Off Results that do not contain a flag are automatically
accepted. Results with flags that are marked in a list of
acceptable flags are accepted as well.
QC Acceptable List of possible flags. Results with marked flags are
Flags automatically accepted if QC Auto Accept is on.
Cal Auto Accept On, Off Results that do not contain a flag are automatically
accepted. Results with flags that are marked in a list of
acceptable flags are accepted as well.
Cal Acceptable List of possible flags. Results with marked flags are
Flags automatically accepted if Cal Auto Accept is on.
Table B-23 Result handling definitions

Calibration

Item Values Comment

Forecast Hours 0 ... 999 h Calibrations that fall due within this period will be
performed collectively.
0 means working without this feature.
The default value is 8.
Table B-24 Calibration definitions

QC

Item Values Comment

Rule 1 Rule: A flag is generated if one result is outside a limit.
s : Standard deviation. The value for the standard
deviation is defined in the QC lot.
Off
2.5s
3s
Rule 2 Rule: A flag is generated if two consecutive results are
outside the same limit.
s : Standard deviation. The value for the standard
deviation is defined in the QC lot.
Off
2s
Table B-25 QC definitions

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Operator’s Manual · Version 3.0 B-167
7 Configuration cobas c 111
Configuration

System

Item Values Comment

Language Language ID The language English is always included.
according to Choose one of the available languages. (The first five
ISO 639-1. languages in the alphabetical sequence of the installed
See Table B-20 on languages and English are displayed.)
page B-158.
Date Format dd.mm.yyyy Examples for June 14, 2006:
dd-mm-yyyy o dd.mm.yyyy: 14.06.2006
yyyy.mm.dd o mm/dd/yyyy: 06/14/2006
yyyy-mm-dd
mm/dd/yyyy
Time Format 24 Hours
12 Hours
Screen Saver Wait 0 ... 120 min Time after which the screen saver feature becomes
active.
0 (zero) means that the screen saver function is off.
The screen saver time is linked to the Auto Log-off
feature. For example, if you define a Screen Saver Wait
time of 5 minutes, then after 5 minutes of inactivity,
the screen saver feature becomes active and the user is
automatically logged off, provided Auto Log-off is on.
Auto Log-off On, Off If you work with On the user is automatically logged
off after a certain number minutes of inactivity on the
instrument. This number is defined in the Screen
Saver Wait definition.
Sound Effects On, Off Acoustic signals when handling instrument items, e.g.
clicking sound when typing. (Does not affect the
acoustic signals for alarms and warnings.)
Volume 0 ... 100 Volume of any acoustic signal generated by the
instrument, including alarm and warning signals.
0 (zero) means silent.
Host Server On The host interface of the instrument is enabled,
allowing it to communicate with a host.
Off The host interface of the instrument is disabled.
Communication with a host computer is not possible.
Host definitions have no effect.
Table B-26 System definitions

Date and time

Item Values Comment

Date Format: Date that is used for time records, for example with
dd.mm.yyyy results. Example: 17.02.2006 for February 2, 2006.
This format is for entry purposes only. It does not
influence the format of displayed dates.
Time Format: hh:mm Time that is used for time records, for example with
results. Example: 08:32. This format is for entry pur-
poses only. It does not influence the format of dis-
played times.
Table B-27 Date and time definitions

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B-168 Operator’s Manual · Version 3.0
cobas c111 7 Configuration
Configuration

Maintenance

Item Values Comment

Major Maint. Day in the week when you usually perform mainte-
Day nance actions.
Minor Maint. This definition has currently no effect.
Day
Table B-28 Maintenance definitions

Abs adjustment
The absorbance adjustment values cannot be changed.

Item Values Comment

Adjustment Valid On, Off
H2O Signal For each wave length, the adjustment value for the
cuvette filled with water is given.
H2O Cuv Signal For each wave length, the adjustment value for the
empty cuvette is given.
Table B-29 Absorbance adjustment definitions

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Operator’s Manual · Version 3.0 B-169
7 Configuration cobas c 111
Configuration

Defining extra wash cycles

Extra wash cycles are used to minimize carry-over.

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

a To define an extra wash cycle

1 Choose Utilities > Applications > Extra Wash Cycles.
A screen is displayed that lists the currently defined extra wash cycles.
2 Select Add new rule.
3 Press .
4 Do one of the following.

If… Do this…
The definitions are available 1. Read the barcode.
on a barcode: The definitions will be installed on the system.
You want to define the 1. Press .
values manually: 2. Choose when—in relation to the pipetting action from
the bottle defined in Trigger Bottle Code and Pipetting
Type—the extra wash cycle should be performed
(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 3.0
cobas c111 7 Configuration
Configuration

Activating, deactivating and deleting extra wash cycles

You can deactivate an extra wash cycle if you do not want to use it. (The definitions
remain on the system. You can activate the extra wash cycle later again.)

To ensure the highest effectiveness of probe cleaning, extra wash cycles are performed
automatically by the cobas c 111 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 c 111 Development Channel Operator’s
Manual.

a To activate or deactivate an extra wash cycle

1 Choose Utilities > Applications > Extra Wash Cycles.
A screen is displayed that lists the currently defined extra wash cycles.
2 Select and expand the extra wash cycle entry.
3 Press .
4 Choose On to activate the extra wash cycle.
Choose Off to deactivate the extra wash cycle.
5 Press .

A screen is displayed for entering your password.

6 Type your password and confirm by pressing .

a To delete an extra wash cycle

1 Choose Utilities > Applications > Extra Wash Cycles.
A screen is displayed that lists the currently defined extra wash cycles.
2 Select the extra wash cycle entry.
3 Press .

A screen is displayed for entering your password.

4 Type your password and confirm by pressing .

The extra wash cycle definitions are deleted.

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Short guide to extra wash cycle definitions

f Utilities > Applications > Extra Wash Cycles >

Extra wash cycle definitions

Item Values Comment

Active On, Off Defines whether the extra wash cycle can be applied
or not.
Action None Defines when, in relation to the pipetting action from
Before the bottle defined in Trigger Bottle Code and Pipet-
After ting Type, the extra wash cycle should be performed.
Trigger-Bottle 0 ... 999 Bottle set code of the fluid that triggers performance
Code of the extra wash cycle.
If you use the pipetting type Sample, it defines the
bottle whose fluid will be prevented from being car-
ried over to the sample by using the extra wash cycle.
Pipetting Type Reagent 1 Defines the individual bottle (bottle of the set or a
Reagent 2 sample tube) whose pipetting triggers performance of
Start Reagent the extra wash cycle.
Sample
Cleaner-Bottle 0 ... 999 Material code of the cleaner.
Code
Volume µL Amount of cleaner that will be pipetted during the
extra wash cycle.
Table B-30 Extra wash cycle definitions

Roche Diagnostics
B-172 Operator’s Manual · Version 3.0
cobas c111 7 Configuration
Configuration

Short guide to reagent mixing rules

f Utilities > Applications > Reagent Mixing >

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.

Reagent mixing rule definitions

You cannot change these definitions.

Item Values Comment

Active Defines whether this rule can be applied to an appli-
cation or not.
Initial Mixing Defines the duration of the mixing for the first mix-
Time ing.
Mixing Interval Defines the time after which mixing must be per-
formed again.
Periodic Mixing Defines the duration of the mixing for the second or
Time subsequent mixing.
Relaxing Time Defines the time after mixing before the reagent can
be used.
Table B-31 Reagent mixing rule definitions

Printing mixing rules

You can print mixing rules.

a To print mixing rules

1 Choose Utilities > Applications > Reagent Mixing.
2 Select the mixing rule you want to print.
3 Press .
A printing screen is displayed.
4 Select whether you want to print the selected rule set or all defined rule sets.
The rules are printed on the built-in printer.

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Operator’s Manual · Version 3.0 B-173
7 Configuration cobas c 111
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Deleting mixing rules

Prerequisites You need Lab Manager or Administrator user rights to perform this task.

a To delete a mixing rule

1 Choose Utilities > Applications > Reagent Mixing.
A screen is displayed that lists the currently defined mixing rules.
2 Select the mixing rule.
3 Press .

A screen is displayed for entering your password.

4 Type your password and confirm by pressing .

The mixing rule definitions are deleted.

Roche Diagnostics
B-174 Operator’s Manual · Version 3.0
Maintenance C

8 General maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

cobas c111 8 General maintenance
Table of contents

General maintenance
Keeping the instrument going

In this chapter, you will find step-by-step instructions of the maintenance actions that
you must perform to keep the instrument running smoothly and efficiently.

In this chapter Chapter 8

Overview ......................................................................................................................C-5
Performing maintenance actions ..........................................................................C-6
Maintenance actions and their intervals ..............................................................C-7
Maintenance actions ...................................................................................................C-8
Safety information .................................................................................................C-8
Deproteinize the probe .......................................................................................C-10
Prime the fluid system .........................................................................................C-11
Clean the probe manually ...................................................................................C-12
Clean reagent disk and sample area ....................................................................C-14
Clean the water and waste containers ................................................................C-16
Replace water inlet filter ......................................................................................C-19
Clean and disinfect housing ................................................................................C-21
Clean up the database .........................................................................................C-23
Replace photometer lamp ...................................................................................C-24
Contact service representative ............................................................................C-27
Perform an air/water calibration ........................................................................C-28
Initialize degasser fluid sensor ............................................................................C-30
Clean rotor and heating channel ........................................................................C-32

Roche Diagnostics
Operator’s Manual · Version 3.0 C-3
8 General maintenance cobas c 111
Table of contents

Roche Diagnostics
C-4 Operator’s Manual · Version 3.0
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.

All maintenance actions can be performed any time.

Interval For most maintenance actions a fixed maintenance interval is defined. (You cannot
change this interval.) This is the basis upon which the system calculates the date when
the actions need to be performed.
The interval timers and counters are reset whenever you confirm that the
maintenance action has been performed.
Maintenance actions without predefined intervals are performed whenever necessary,
or they are triggered by another maintenance action.

Due date The due date is the last possible maintenance day. This is the date you see when you
check the status of maintenance actions.

Ensuring smooth operation Performing all due maintenance actions during the daily Prepare or End Shift phase
ensures that routine operation does not have to be interrupted for performing
maintenance actions.

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Operator’s Manual · Version 3.0 C-5
8 General maintenance cobas c 111
Overview

Performing maintenance actions

a To perform maintenance actions

Checking when maintenance 1 Choose Utilities > Maintenance

actions are due
A B

A Maintenance action name. D Use the scroll bar to display the

B Due dates, in ascending order. maintenance actions that are currently
C This maintenance action is selected. hidden.

Figure C-1

Interpreting the colors The defined maintenance interval has expired. Perform this maintenance
action now.

This maintenance action should be performed on the next major

maintenance day.

No action is currently required.

This maintenance action is selected.

Preparing the maintenance The maintenance actions are sorted according to the date by when they should be
actions performed. Use these dates for planning the maintenance actions, for example for
ordering the required materials.

Performing the maintenance 2 Select the maintenance action you want to perform.
action
The selected line turns blue.
3 Press .
The first screen of the wizard for performing the selected maintenance action is
displayed. Usually, this is the maintenance description screen.
Press if you want to print the instructions before you start.

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C-6 Operator’s Manual · Version 3.0
cobas c111 8 General maintenance
Overview

4 Follow the instructions on the screen.

A message will inform you when the maintenance action is complete. In addition,
with maintenance actions that take some time, an acoustic signal is sounded. This
allows you to do work away from the instrument while the maintenance action is
in progress.
e For information on how to perform individual maintenance actions, see Maintenance
actions on page C-8.

Incorrect results or processing stop due to incomplete maintenance actions

You can cancel a maintenance action any time by pressing .
WARNING 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.
If at all possible, complete a maintenance action without interrupting it.

Maintenance actions and their intervals

The following table lists the maintenance actions and shows how frequently they need
to be performed.

Every effort has been made to ensure that all the information contained in this table is 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.

Maintenance actions with no defined interval need to be performed in particular situations,

for example during troubleshooting.

Interval Maintenance action

None Prime Fluid System
None Abs. Air/Water Calibration
None Clean Rotor And Heating Channel
None Cleanup Database
Daily Deproteinize Probe
Weekly Clean Probe Manually
Monthly Clean Reagent Disk
Three-monthly Clean Water and Waste
Three-monthly Replace Water Inlet Filter
Six-monthly Clean Housing
Six-monthly Replace Photometer Lamp
Yearly Call Service Rep.
Yearly Initialize Degasser Fluid Sensor
Table C-1 Periodicity of maintenance actions

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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

Injury through working solutions

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

Personal injury or damage to the analyzer due to contact with instrument

mechanism
Do not touch moving parts during instrument operation.

Infection by biohazardous materials

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

Incorrect results due to build-up of contaminants

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

Incorrect results or damage to the analyzer due to dust and soiling

The user can leave the main cover open while the system is in Standby status or while the
instrument is shut down. This can cause dust and dirt being collected in the heating chan-
nel, which in turn might decrease the quality of the cuvettes.
Keep all covers closed. Open them only to perform operation actions.

Incorrect results or processing stop due to skipping maintenance actions

Not performing maintenance actions that are due may lead to situations where the system
cannot continue processing orders, or it may lead to incorrect results. If at all possible, per-
form the maintenance actions when they are due.

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Maintenance actions

Incorrect results or damage to the analyzer due to wrong operation

Operators are required to have a profound knowledge of relevant guidelines and norms as
WARNING well as the information and procedures contained in the Operator’s Manual.
o Do not carry out operation and maintenance unless you have been trained by Roche
Diagnostics.
o Start all maintenance actions on the screen. Do not perform maintenance actions with-
out the assistance of the user interface.
o Carefully follow the procedures specified in the Operator’s Manual for the operation
and maintenance of the system.
o Leave maintenance that is not described in the Operator’s Manual to a trained service
representative.
o Follow standard laboratory practices, especially when working with biohazard material.

Incorrect results or processing stop due to incomplete maintenance actions

You can cancel a maintenance action any time by pressing .
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.
If at all possible, complete a maintenance action without interrupting it.

Danger of poor measurement quality due to inadequate water quality

Inadequate water quality may lead to incorrect results. Always use purified water of the
quality specified in section Technical specifications.

Infection by waste solution

Contact with waste solution may result in infection. All materials and mechanical compo-
nents associated with the waste systems are potentially biohazardous.
o Be sure to wear protective equipment. Take extra care when working with protective
gloves; these can easily be pierced or cut, which can lead to infection.
o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o If waste solution contacts your skin, wash it off immediately with water and apply a dis-
infectant. Consult a physician.

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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Maintenance actions

Deproteinize the probe

f Utilities > Maintenance > Deproteinize Probe

To maintain the efficiency of the instrument, you must clean and deproteinize the
probe regularly to prevent the build-up of contaminants.

Operator time Approximately 5 minutes.

Prerequisites The system must be in Standby status.

Tools and materials required m ISE Deproteinizer

m Activator

Make sure that you have read and understood section Safety information on page C-8.
The 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.

a To deproteinize the probe

1 Prepare one tube with ISE Deproteinizer and one with Activator.
2 Select the maintenance action Deproteinize Probe.
3 Press .
The maintenance definition screen is displayed.
4 Press .
A placement list is displayed.
5 Place the ISE Deproteinizer and Activator on the positions indicated on the
screen.
6 Press to confirm the placing.
The system first deproteinizes and then activates the probe.
A message will inform you when the maintenance action is complete.
7 Remove the tubes.
8 Press .

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Maintenance actions

Prime the fluid system

f Utilities > Maintenance > Prime Fluid System

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

Operator time Approximately 2 minutes.

Prerequisites The system must be in Standby status.

Tools and materials required m Purified water.

a To prime the fluid system

1 Check the external water and waste containers. If required, refill the water and
empty the waste container.
2 Select the maintenance action Prime Fluid System.
3 Press .
The maintenance definition screen is displayed.
4 Press .
The system performs the priming actions automatically.
A message will inform you when the maintenance action is complete.
5 Press .

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Clean the probe manually

f Utilities > Maintenance > Clean Probe Manually

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

Operator time Approximately 1 minute.

Prerequisites The system must be in Standby status.

Tools and materials required m 70% ethyl alcohol

m Tissues

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.

a To clean the probe

1 Select the maintenance action Clean Probe Manually.
2 Press .
The maintenance definition screen is displayed.
3 Press .
The system deactivates the transfer motors.
4 Remove the transfer head cover.
Press the release buttons on both sides and lift.
5 Remove the probe with its holder.
o Remove the tube from at least the first two tubing clips.
o Press the release button on the side of the probe holder carriage and lift the
probe holder with the probe. Be careful not to pull the tubing.

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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.

NOTICE Probe damage and instrument malfunction due to inappropriate probe

handling
Applying unilateral side pressure on the probe can lead to its deformation and conse-
quently to instrument malfunction.
Make sure to apply equal pressure on both sides and to move exactly in the direction
of the probe when wiping it.

7 Wipe the side of the probe holder that faces the level detection contact. Use a
tissue moistened with 70% ethyl alcohol.

8 Reinstall the probe holder with the probe.

Press the release button on the side of the probe holder carriage before you insert
the probe holder. Release the button when the holder is inserted.
Push down firmly until the release button latches on.
9 Fix the tube to the tubing clips.
10 Reinstall the transfer head cover.
Press down until the release buttons latch on.
11 Press .
The system automatically initializes the transfer head and performs the Prime
Fluid System maintenance action.
A message will inform you when the maintenance action is complete.
12 Press .

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Maintenance actions

Clean reagent disk and sample area

f Utilities > Maintenance > Clean Reagent Disk

To remove possible spillages you must clean the reagent disk and sample area
regularly.
This maintenance action involves the following steps:
o Cleaning the reagent disk
o Cleaning the sample area

Operator time Approximately 10 minutes.

Prerequisites The system must be in Standby status.

Tools and materials required m Alcoholic cleansing tissues

m Tissues
m Commercial nonabrasive detergent

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.

a To clean the reagent disk

1 Select the maintenance action Clean Reagent Disk.
2 Press .
The maintenance definition screen is displayed.
3 Press .
4 Open the main cover.
5 Remove the reagent disk.
6 Remove spillages and stains on the disk with alcoholic cleansing tissues.
7 Wipe the inside of the reagent cooler with a cloth dampened with soapy water.
8 Reinsert the reagent disk.
e For information on inserting the reagent disk, see Preparing the reagent disk on
page B-21.

9 Open the right service flap.

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Maintenance actions

10 Lift the sample tray from its fixture.

11 Wash the sample tray using detergent. (You can wash the tray in a dish washer.)

Do not disassemble the sample tray.

12 Leave the sample tray to dry or dry it using tissues.

13 Reinsert the sample tray.
Make sure to align the guides with the pins.

Press down firmly.

14 Close the right service flap and the main cover.
15 Press to confirm that you have performed the maintenance action.
The system initializes automatically.
A message will inform you when the maintenance action is complete.
16 Press .

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Maintenance actions

Clean the water and waste containers

f Utilities > Maintenance > Clean Water and Waste

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

Operator time Approximately 10 minutes.

Prerequisites The system must be in Standby status.

Tools and materials required m Spare waste container

m Purified water
m Hypochlorite solution (0.6%)
m Alcoholic cleansing issues

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.

a To clean the water container

1 Select the maintenance action Clean Water and Waste.
2 Press .
The maintenance definition screen is displayed.
3 Press .
4 Lift the tubing adapter from the white water container.

5 Place the tubing adapter on a clean surface.

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6 Dispose of any remaining water.

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

a To clean the waste container

1 Have the spare waste container ready.
The system periodically performs wash actions. Therefore, an external waste
container must be connected at all times.
2 Remove the tubing adapter from the yellow waste container and insert it in the
spare container.

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.

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13 Wipe the waste inlet with a tissue.

14 Reinsert the tubing adapter into the waste container. Press down firmly.
15 Press .
The maintenance action Prime Fluid System is automatically performed.
A message will inform you when the maintenance action is complete.
16 Press .

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Maintenance actions

Replace water inlet filter

f Utilities > Maintenance > Replace Water Inlet Filter

The water inlet filter in the external water container removes particulate matter from
the water supply. You must replace this filter according to the maintenance action
schedule.
The water container is placed on the rack next to the cobas c111 instrument.

Operator time Approximately 10 minutes.

Prerequisites None

Tools and materials required m Purified water

m Hypochlorite solution (0.6%)
m Tissues
m Water inlet filter

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.

a To replace the water inlet filter

1 Select the maintenance action Replace Water Inlet Filter.
2 Press .
The maintenance definition screen is displayed.
3 Press .
4 Remove the tubing adapter from the water container.
5 Place the tubing adapter on a clean surface.

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6 Replace the water inlet filter.

B C

A
D

A Removing the retaining ring D Retaining ring

B Filter E Tab on retaining ring
C Filter casing

Figure C-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 .

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Maintenance actions

Clean and disinfect housing

f Utilities > Maintenance > Clean Housing

You must clean the housing regularly to ensure that contaminants do not build up
and affect the efficiency of the instrument as a measuring system.

Operator time Approximately 10 minutes.

Prerequisites Instrument is switched off.

Tools and materials required m Ethyl alcohol

m Tissues

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 displayed.)
o Do not press at this stage. You do this only when you have completed the mainte-
nance action. Instead, press to close the screen.

a To clean the housing

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

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18 Switch on the system.

The system performs internal checks and routines.
The startup phase may take a few minutes.
When the instrument is ready for use, the Overview tab is displayed, and its status
is Standby.
19 Log on the system.
20 Choose Utilities > Maintenance > Clean Housing.
21 Press .
The maintenance definition screen is displayed.
22 Press .
A detailed maintenance definition screen is displayed.
23 Press to confirm the completion of the maintenance action.

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Maintenance actions

Clean up the database

f Utilities > Maintenance > Cleanup Database

This maintenance action restores the database to the condition where the instrument
can work at its optimum. You typically use this action when you think that the
instrument suddenly works slow, for example when displaying information on the
screen takes long or when it takes long until an action starts after you have initiated it.

Operator time Approximately 10 minutes.

Prerequisites The system must be in Standby status.

Tools and materials required None

a To clean up the database

1 Select the maintenance action Cleanup Database.
2 Press .
The maintenance definition screen is displayed.
3 Press .
An instructions screen is displayed while the database cleanup is performed.
4 When the maintenance action is complete, press to confirm the completion.

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Maintenance actions

Replace photometer lamp

f Utilities > Maintenance > Replace Photometer Lamp

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

Operator time Approximately 20 minutes.

Prerequisites The system must be in Standby status.

Tools and materials required m Paper tissue

m Photometer lamp assembly (Lamp, socket and cable are pre-assembled.)
m Cuvette segments
m Clean cloth

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.

a To replace the photometer lamp

1 Select the maintenance action Replace Photometer Lamp.
2 Press .
The maintenance definition screen is displayed.
3 Press .
The system switches off the lamp, and the transfer head moves to the home
position.

Preparing the instrument 4 Open the main cover and the right service flap.
5 Remove the sample tray by lifting it.

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Maintenance actions

Injury through hot parts

Direct contact with hot parts may result in injury.
CAUTION Do not touch the lamp assembly with bare hands. Let the lamp cool down for about ten
minutes before touching any part of the lamp housing.

Removing the lamp 6 Unplug the power connector (A).

A Power connector C Cover

B Assembly screw

Figure C-3

7 Lift the photometer lamp housing cover (C).

8 Unscrew (B) the lamp assembly and remove it.

Installing the new lamp 9 Insert the new lamp assembly.

Incorrect results through soiled lamp

Touching the lamp with bare fingers reduces the life of the bulb and may affect the
WARNING consistency of measurements made with the absorbance photometer.
Hold the lamp assembly by its screw.

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.

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Preparing the instrument 13 Reinsert the sample tray.

14 Close the right service flap and the main cover.

15 Press .
The system automatically initializes the instrument.
A message will inform you when the maintenance action is complete.
16 Press .
17 Perform an air/water calibration.
You cannot process orders unless you perform this action.
e See Perform an air/water calibration on page C-28.

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Contact service representative

f Utilities > Maintenance > Call Service Rep.

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

Operator time Approximately 2 minutes.

(A service representative takes about 3 hours to perform preventive maintenance for a
system without an ISE unit, 4 hours including the ISE unit.)

Prerequisites None

a To initiate preventive maintenance

1 A message screen reminds you that you should contact your service representative.
2 Select the maintenance action Call Service Rep.
3 Press .
The maintenance definition screen is displayed.
4 Press .
An instructions screen is displayed.
5 Contact your service representative to arrange for preventive maintenance.
6 Press .

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Maintenance actions

Perform an air/water calibration

f Utilities > Maintenance > Abs. Air/Water Calibration

The absorbance photometer calibration determines the air/water correction values
that are needed for result calculation. In addition, the obtained absorbance values for
an empty cuvette at each wavelength are used as a reference for the cuvette blank
check.

Operator time Approximately 5 minutes.

Prerequisites The system must be in Standby status.

Tools and materials required m 2 cuvette segments with empty cuvettes

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.

a To perform an air/water calibration

1 Choose Utilities > Maintenance > Abs. Air/Water Calibration.
2 Press .
Your are asked to insert a cuvette segment with empty cuvettes.
3 Open the main cover.
4 If there is a segment in the cuvette ring remove it and check whether there are used
cuvettes.
If all cuvettes of this segment are empty, you can reinsert it.
5 Place a cuvette segment with empty cuvettes on the cuvette ring.
6 Press .
Your are asked to insert a second cuvette segment with empty cuvettes.
7 If there is a segment on in the cuvette ring remove it and check whether there are
used cuvettes.
If all cuvettes of this segment are empty, you can reinsert it.
8 Place the cuvette segment with empty cuvettes on the cuvette ring.
9 Close the main cover.
10 Press .
The system performs the calibration measurements. (It first measures all cuvettes
empty, pipettes water in the cuvettes, and measures them again.)
A message will inform you when the measurements are complete.
11 Scroll to display the results, if required.
12 Check the Outlier statistics.

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13 Press to accept the results.

If at this stage, you press , the results are not stored and the maintenance action is
deemed not performed.

14 Remove the used cuvettes or replace them with empty ones.

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Maintenance actions

Initialize degasser fluid sensor

f Utilities > Maintenance > Initialize Degasser Fluid Sensor

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

Operator time Approximately 5 minutes.

Prerequisites The system must be in Standby status.

All covers must be closed.

Tools and materials required m Full external water container

m Clean cloth

a To initialize the degasser fluid sensor

1 Make sure that all covers on the instrument are closed.
2 Choose Utilities > Maintenance > Initialize Degasser Fluid Sensor.
An instructions screen is displayed.
3 Press .
The maintenance definition screen is displayed.
4 Check whether the tube connecting the external water container with the
instrument is full of water or contains air bubbles.

5 Do one of the following:

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 System.
3. Restart the maintenance action Initialize Degasser
Fluid Sensor.

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Maintenance actions

6 Lift the tubing adapter from the white water container.

7 Place the tubing adapter on a clean surface.

Make sure the filter (A) is not obstructed and air can get to it.
8 Press to initialize the fluid sensor.
The system aspirates air through the tubing adapter and initializes the fluid sensor.
When initialization is complete, you will be asked to insert the tubing adapter.
9 Insert the tubing adapter in the water container.
10 Press .
The fluid system is primed.
A message will inform you when the maintenance action is complete.
11 Press .

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Maintenance actions

Clean rotor and heating channel

Perform this maintenance action whenever a message asks you to do so.

Operator time Approximately 15 minutes.

Tools and materials required m 95% ethyl alcohol

m Lint free tissues

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.

a To clean the rotor and heating channel

1 Remove the reagent disk.
o Choose Overview > > .
A screen is displayed, asking you to remove the reagent disk.
o Open the main cover.
o Remove the reagent disk.
o Close the main cover.
2 Remove all cuvettes.
o Choose Overview > .
o Open the main cover.
o Press a segment button.
o Remove the segment.
o Press to confirm the removal.
Remove all segments as described above.
o Close the main cover.
3 Switch off the instrument.
4 Move the transfer head to the sample area.
5 Open and remove the main cover and left service flap.

6 Move the transfer head to its leftmost position.

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7 Open and remove the right service flap.

8 Remove the sample tray.

Removing the rotor 9 Loosen the display fixation screw (A).

10 Tilt forward the display.

11 Move transfer head to its rightmost position.
12 Remove the upper rotor shell.

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13 For each of the two rotor bearings to the right, loosen slightly one of the fixation
screws and completely unscrew the other. (Use a screw driver to loosen the screws,
if required.) Then pull away from the rotor the side of the bearing that you
completely unscrewed.

C D

A E

A Retention pin of motor D Fixed rotor bearings

B Spring-loaded rotor bearing E Photometer lens (not shown)
C Rotor motor

Figure C-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.

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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.

17 Leave the rotor to dry.

Cleaning the heating channel 18 Clean the heating channel (B) with a lint free tissue or a cloth moistened with
ethyl alcohol.
Make sure not to touch the photometer lens (A).

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.

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Operator’s Manual · Version 3.0 C-35
8 General maintenance cobas c 111
Maintenance actions

26 Install the sample tray.

Make sure to align the guides with the pins.

Press down firmly.

27 Install and close the right service flap.
28 Move the transfer head to its rightmost position.
29 Install and close the left service flap and main cover.

Finishing the maintenance 30 Switch on the instrument.

action
31 Wait for initialization to finish.
32 Log on to the system.
33 Insert the reagent disk.
e See Preparing the reagent disk on page B-21

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C-36 Operator’s Manual · Version 3.0
Troubleshooting D

9 Messages and alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

10 Result flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-23
11 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-39
cobas c111 9 Messages and alarms
Table of contents

Messages and alarms

How to make the most of the available information

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

In this chapter Chapter 9

About messages .......................................................................................................... D-5
Message screen ............................................................................................................ D-5
Acoustic signals .......................................................................................................... D-6
Alarm monitor ........................................................................................................... D-6
Reacting to alarm messages ................................................................................. D-7
Printing alarm messages ...................................................................................... D-8
Confirming alarm messages ................................................................................ D-9
Exporting the alarm message log ......................................................................... D-9
List of alarm messages .............................................................................................. D-10

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Operator’s Manual · Version 3.0 D-3
9 Messages and alarms cobas c 111
Table of contents

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D-4 Operator’s Manual · Version 3.0
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

Message screens are displayed automatically as soon as the message is generated.

Figure D-1 Message screen

Read the message and press to close the screen.

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9 Messages and alarms cobas c 111
Acoustic signals

Acoustic signals

The operator is alerted to certain events by an acoustic signal.

The following events trigger an acoustic signal.
o An alarm was generated.
o The Main cover is open while the system is in Operating status.
o A run is finished. (The system status has changed from Operating to Standby.)
o A maintenance action is complete (provided it is a longer maintenance action
where no user intervention is required).
You can adjust the volume of all generated acoustic signals (Utilities > Configuration
> System > Volume).
You can also turn on and off acoustic signals:
o Choose Utilities > Configuration > System > Sound Effects to turn on and off the
acoustic signals other than alarm and warning signals.
o Choose Utilities > Configuration > System > Volume and set the value to zero to
turn off all acoustic signals.
e System on page B-168.

Alarm monitor

Messages concerning an irregularity that occurred during operation can be viewed in

the alarm monitor. The alarm LED alerts you when such messages are generated.

Alarm button and LED

A Alarm LED B Alarm button

Figure D-2 Alarm LED

The alarm button is always active, even if you are not logged on the system.

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D-6 Operator’s Manual · Version 3.0
cobas c111 9 Messages and alarms
Alarm monitor

Reacting to alarm messages

a To react to an alarm message

1 Observe the alarm LED.

No color There are no unconfirmed alarm messages.

Off
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.
An acoustic signal is sounded when an alarm is generated. You can adjust the volume
(Utilities > Configuration > System > Volume).

2 Press the Alarm button .

The most recently generated alarm message in this list is displayed. Which
messages are included in this list depends on the filter criteria that are applied to
it.

A B

F G

A Alarm ID E Display the next alarm message.

B Total number of messages in the list. F Display additional information.
C Display the previous alarm message. G Display the filter options for the alarm list.
D Problem description and short remedy
suggestion

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.

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9 Messages and alarms cobas c 111
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.

Printing alarm messages

When you print alarm messages, their details are included in the printout.

a To print alarm messages

1 Press .
2 Press .
A screen is displayed for defining which alarm messages should be printed.
3 Do one of the following:
o Press All to print all messages that have not been dealt with.
o Press Selected to print the current message.

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D-8 Operator’s Manual · Version 3.0
cobas c111 9 Messages and alarms
Alarm monitor

Confirming alarm messages

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).

Exporting the alarm message log

a To export the message log file

1 Press .
2 Press .
A screen is displayed asking you to insert a USB stick.
3 Insert the USB stick.
4 Press to confirm the insertion.
A screen is displayed for selecting a directory.
Press *.tgz to display log files only.
Press *.* to display all files and directories.
5 Select a directory for the error log.
6 Press to confirm the selection.
All log files are added to a file with the name format log_yyyymmddhhmmss.tgz
and copied to the stick. The error log file has the name format
err_yyyymmddhhmmss.log.

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9 Messages and alarms cobas c 111
List of alarm messages

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 invalid Delete and redefine the order. If the error recurs export
(%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.
5001 Air detected in the fluid system. Water container or
cleaner bottle is empty.
Table D-1 List of alarm messages

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D-10 Operator’s Manual · Version 3.0
cobas c111 9 Messages and alarms
List of alarm messages

ID Message Comment
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 persists
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 service.
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.
5044 [%s] Error main board fan. The fan could not be started Restart the system. If the error persists call service.
or 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 service.
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.
Table D-1 List of alarm messages (Continued)
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9 Messages and alarms cobas c 111
List of alarm messages

ID Message Comment
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] Error sample area fan. Switch off the instrument. Remove the right side panel
and check if the fan is jamming or blocked. If possible
eliminate the problem. Restart the system. If the error per-
sists call service.
5064 [%s] Error fluid sensor degasser. The sensor does not react Restart the system. If the error persists call service.
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 per-
sists 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.
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.
Table D-1 List of alarm messages (Continued)

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cobas c111 9 Messages and alarms
List of alarm messages

ID Message Comment
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.
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. Ensure that there is enough sample present. For mainte-
nance tasks ensure to provide enough Activator, ISE
Deproteinizer and ISE Etcher. If the error persists call ser-
vice.
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.
Table D-1 List of alarm messages (Continued)
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Operator’s Manual · Version 3.0 D-13
9 Messages and alarms cobas c 111
List of alarm messages

ID Message Comment
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] 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.
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 Restart the system. If the error persists call service.
motion 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.
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.
Table D-1 List of alarm messages (Continued)

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D-14 Operator’s Manual · Version 3.0
cobas c111 9 Messages and alarms
List of alarm messages

ID Message Comment
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.
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 probe crashed or the reagent bottle set %s became Check if the probe is obstructed. Check the filling level of
unexpectedly empty. the associated reagent bottle.
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.
Table D-1 List of alarm messages (Continued)

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Operator’s Manual · Version 3.0 D-15
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List of alarm messages

ID Message Comment
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.
7103 [%s] Adjustment of the ISE Ref bottle or ISE Cal bottle Repeat the adjustment: In <Diagnostics> perform
weight sensor failed. <Adjust ISE Ref Bottle Sensor> and <Adjust ISE Cal Bot-
tle Sensor>. 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 sys-
tem. 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.
Table D-1 List of alarm messages (Continued)

Roche Diagnostics
D-16 Operator’s Manual · Version 3.0
cobas c111 9 Messages and alarms
List of alarm messages

ID Message Comment
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.
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 ser-
vice.
7130 [%s] Rotor position error. Switch off the instrument and check if the rotor is blocked
or jamming. If the error recurs call service.
Table D-1 List of alarm messages (Continued)

Roche Diagnostics
Operator’s Manual · Version 3.0 D-17
9 Messages and alarms cobas c 111
List of alarm messages

ID Message Comment
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 ser-
vice.
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 per-
sists 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.
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.
Table D-1 List of alarm messages (Continued)

Roche Diagnostics
D-18 Operator’s Manual · Version 3.0
cobas c111 9 Messages and alarms
List of alarm messages

ID Message Comment
7146 [%d] The initialization of the system 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.
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 Switch off the instrument. Check if the transfer is blocked
to 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 Switch off the instrument. Check if the rotor is blocked or
offset 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 sys-
tem. 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.
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 persists
call service.
12001 The host computer did not answer the order query for Check the communication and existing orders on the host.
sample %s within the time limit.
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 computer Enable the host trace file in the Host Settings in order to
failed. record HIF communication activities.
Table D-1 List of alarm messages (Continued)

Roche Diagnostics
Operator’s Manual · Version 3.0 D-19
9 Messages and alarms cobas c 111
List of alarm messages

ID Message Comment
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 ).
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.
Table D-1 List of alarm messages (Continued)

Roche Diagnostics
D-20 Operator’s Manual · Version 3.0
cobas c111 9 Messages and alarms
List of alarm messages

ID Message Comment
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.
20028 <Daily Prepare Actions> completed.
20029 Database cleanup completed.
20030 <Initialize Degaser Fluid Sensor> completed.
Table D-1 List of alarm messages (Continued)

Roche Diagnostics
Operator’s Manual · Version 3.0 D-21
9 Messages and alarms cobas c 111
List of alarm messages

Roche Diagnostics
D-22 Operator’s Manual · Version 3.0
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.

In this chapter Chapter 10

About flags ................................................................................................................ D-25
Safety ......................................................................................................................... D-27
List of flags ................................................................................................................ D-28
> .......................................................................................................................... D-28
V .......................................................................................................................... D-28
Ag Excess ............................................................................................................. D-28
? Cal ..................................................................................................................... D-29
Cal Error ............................................................................................................. D-29
Calc Error ............................................................................................................ D-29
Curv Dir .............................................................................................................. D-30
Ep Unstab ............................................................................................................ D-30
High Abs ............................................................................................................. D-31
High Act .............................................................................................................. D-31
< Kin Read .......................................................................................................... D-32
Low Act ............................................................................................................... D-32
Non Linear ......................................................................................................... D-33
Non Mono .......................................................................................................... D-33
Out of Rng .......................................................................................................... D-34
? QC ..................................................................................................................... D-34
R 1(2.5s) .............................................................................................................. D-34
R 1(3s) ................................................................................................................. D-35
>R 2(2s) .............................................................................................................. D-35
<R 2(2s) .............................................................................................................. D-35
>Reag Rng ........................................................................................................... D-36
<Reag Rng ........................................................................................................... D-36
> Repl Dev .......................................................................................................... D-36
> RR .................................................................................................................... D-37
< RR .................................................................................................................... D-37
Roche Diagnostics
Operator’s Manual · Version 3.0 D-23
10 Result flags cobas c 111
Table of contents

> Std Dev ............................................................................................................ D-37

> Test Rng ........................................................................................................... D-38
< Test Rng ........................................................................................................... D-38

Roche Diagnostics
D-24 Operator’s Manual · Version 3.0
cobas c111 10 Result flags
About flags

About flags

Flags are automatically generated with results if during processing certain technical
checks were not passed or if the result exceeds or does not reach predefined limits.
Measurements that did not generate flags can be considered technically correct.
Flags are displayed and printed with the results.

a To display flag information

1 Display the result.
Do one of the following:

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.

a To display flag information with the sample still on board

1 Choose Overview > tube button.
A screen is displayed that shows the result, together with the flag of the highest
priority.
e To view all flags that were possibly generated see To display flag information on
page D-25.

Roche Diagnostics
Operator’s Manual · Version 3.0 D-25
10 Result flags cobas c 111
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.

Roche Diagnostics
D-26 Operator’s Manual · Version 3.0
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.

Injury through working solutions

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

Infection by biohazardous materials

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

Personal injury or damage to the analyzer due to contact with instrument

mechanism
Do not touch moving parts during instrument operation.

Incorrect results or damage to the analyzer due to wrong operation

Operators are required to have a profound knowledge of relevant guidelines and norms as
well as the information and procedures contained in the Operator’s Manual.
o Do not carry out operation and maintenance unless you have been trained by Roche
Diagnostics.
o Start all maintenance actions on the screen. Do not perform maintenance actions with-
out the assistance of the user interface.
o Carefully follow the procedures specified in the Operator’s Manual for the operation
and maintenance of the system.
o Leave maintenance that is not described in the Operator’s Manual to trained service
representatives.
o Follow standard laboratory practices, especially when working with biohazard material.

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.

Roche Diagnostics
Operator’s Manual · Version 3.0 D-27
10 Result flags cobas c 111
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

Possible cause The user initiated the repeat.

Recommended actions No action required.

Meaning A rerun result with diluted sample.

Message ID 121

Priority 33

Possible cause The user initiated the rerun.

Recommended actions No action required.

Ag Excess

Meaning Antigen excess.

The sample contains an excess antigen and a valid result cannot be calculated.

Message ID 6

Priority 19

Recommended actions Rerun the test with postdilution.

Roche Diagnostics
D-28 Operator’s Manual · Version 3.0
cobas c111 10 Result flags
List of flags

? Cal

Meaning A result where its calibration is flagged.

Message ID 110

Priority 29

Possible cause The calibration was in question and has been flagged, however the calibration could
be used to calculate the result (compare with Cal Error where the calibration did not
provide a usable result).

Recommended actions Check and redo calibration if needed.

Cal Error

Meaning No valid calibration data available.

Message ID 43

Priority 24

Possible cause Caused by an alarm that occurred during calibration because the calibration could
not provide a usable result.

Recommended actions Check the flags of the calibration and proceed to deal with the calibration first.

Calc Error

Meaning Calculation error.

o General calculation error.
o Slope or nonlinear standard curve cannot be calculated due to a calibration error.

Message ID 16

Priority 13

Possible cause o Calibrator outdated or deteriorated.

o Misplacement of the calibrator tubes.

Recommended actions o Repeat calibration with fresh calibrators.

o If the calibrators were incorrectly positioned, replace the calibrators and repeat the
calibration.

Roche Diagnostics
Operator’s Manual · Version 3.0 D-29
10 Result flags cobas c 111
List of flags

Curv Dir

Meaning Curve direction.

The direction of the calibration curve is incorrect or not as expected.

Message ID 14

Priority 10

Possible cause Misplacement of calibrator tubes

Recommended actions 1. Check the details of the calibration.

2. If the calibrators were incorrectly positioned, replace the calibrators correctly and
rerun the calibration.

Ep Unstab

Meaning End point unstable.

The absorbance values near the endpoint show unacceptable fluctuation.

Message ID 9

Priority 8

Recommended actions CAL

1. Repeat with fresh calibrators if only calibration is flagged.
2. If the flag is on control, sample, or on calibration repeat results, replace the
reagent set.
CNTL
1. If only one control is flagged, repeat with fresh control.
2. If more than one control and sample result is flagged, replace the reagent set.
TEST
1. Rerun diluted.
2. If only one sample result is flagged, repeat with fresh sample.
3. If more than one sample result is flagged or a repeat result, replace the reagent set.
4. If a serum protein test result is flagged, repeat with dilution.

Roche Diagnostics
D-30 Operator’s Manual · Version 3.0
cobas c111 10 Result flags
List of flags

High Abs

Meaning Excessive absorbance.

The absorbance value to be used for calculation and checks is > 2.0 Abs.

Message ID 5

Priority 1

Recommended actions CAL

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

High Act

Meaning High activity.

o The absorbance change during measurement is above the accepted limit, i.e. the
reaction has taken off too fast.

Message ID 56

Priority 9

Recommended actions CAL

1. Check if the correct calibrators are placed on the instrument.
2. Repeat with fresh calibrators.
CNTL
1. Check control. Repeat with fresh control.
TEST
1. Rerun with dilution.

Roche Diagnostics
Operator’s Manual · Version 3.0 D-31
10 Result flags cobas c 111
List of flags

< Kin Read

Meaning Insufficient kinetic reading points.

Message ID 11

Priority 11

Possible cause o Not enough kinetic readings.

o Insufficient absorbance readings were found in the linear part of the reaction to be
able to calculate a rate.
o Not enough readings in kinetic range for calc mode Kinetic.

Recommended actions CAL

1. Check reaction plot.
2. Repeat with fresh calibrator.
CNTL
1. Check reaction plot.
2. Repeat with fresh control.
TEST
1. Check reaction plot.
2. Rerun with dilution or concentration if necessary.

Low Act

Meaning Low activity.

This check is used to identify zero pipetting for samples and reagents.
o The absorbance change during measurement is below the accepted limit, i.e. the
reaction has taken off too slowly. Possibility of substrate exhaustion.
o The absorbance change during the measurement is lower than the defined limit.

Message ID 56

Priority 9

Recommended actions CAL

1. Check if the correct calibrators are placed on the calibrator rack.
2. Repeat with fresh calibrators.
CNTL
1. Check the control. Repeat with fresh control.
TEST
1. Rerun with dilution.

Roche Diagnostics
D-32 Operator’s Manual · Version 3.0
cobas c111 10 Result flags
List of flags

Non Linear

Meaning Abnormal linearity.

Message ID 11

Priority 11

Possible cause o The slope changes between the first and last parts of the reaction curve.

Recommended actions CAL

1. Check reaction plot.
2. Repeat with fresh calibrator.
CNTL
1. Check reaction plot.
2. Repeat with fresh control.
TEST
1. Check reaction plot.
2. Rerun with dilution or concentration if necessary.

Non Mono

Meaning Curve not monotonic.

No calibration curve could be calculated because the rates of the calibrators were non-
monotonic.

Message ID 80

Priority 14

Possible cause Misplacement of a series of calibrators, automatic dilution series failed.

Recommended actions 1. If the calibrators were incorrectly positioned, re-place the calibrators correctly and
rerun the calibration.
2. Check the fluid system
3. Repeat the calibration

Roche Diagnostics
Operator’s Manual · Version 3.0 D-33
10 Result flags cobas c 111
List of flags

Out of Rng

Meaning Curve out of range.

The calibration curve is outside the acceptable/ programmed range.

Message ID 84

Priority 16

Possible cause Deteriorated or outdated calibrator or reagent.

Recommended actions 1. Repeat with fresh calibrators.

2. If the calibrators were incorrectly positioned, re-place the calibrators correctly and
repeat the calibration.
3. If flag reoccurs, repeat with fresh reagent.

? QC

Meaning A result where the quality control measurement is flagged.

Message ID 111

Priority 30

Possible cause The last QC measurement before this measurement was flagged. The dependency is
derived from the time sequence.

Recommended actions Check QC measurement.

R 1(2.5s)

Meaning One control value is above 2.5 standard deviation or below -2.5 standard deviation.

Message ID 36

Priority 28

Possible cause o The reagent has deteriorated (linearity of working curve degraded).
o One control is concentrated or has deteriorated.

Recommended actions 1. Repeat with fresh control.

2. Check that the correct control material has been used.
3. If the flag reappears, check the calibration and reagent status. Repeat with fresh
reagent.

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D-34 Operator’s Manual · Version 3.0
cobas c111 10 Result flags
List of flags

R 1(3s)

Meaning One control value is above 3 standard deviation or below -3 standard deviation.

Message ID 35

Priority 27

Possible cause o Improper control is set.

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

Recommended actions 1. Repeat with fresh control.

2. Check that the correct control material has been used.
3. If the flag reappears, check the calibration and reagent status. Repeat with fresh
reagent.

>R 2(2s)

Meaning Two sequential control measurements are above the 2 standard deviation.

Message ID 29

Priority 26

Possible cause o The controls are not properly prepared.

o The controls are not properly positioned on the instrument.

Recommended actions 1. Repeat with fresh control.

2. Check that the correct control material has been used.
3. If the flag reappears, check the calibration and reagent status. Repeat with fresh
reagent.

<R 2(2s)

Meaning Two sequential control measurements are below the -2 standard deviation.

Message ID 29

Priority 26

Possible cause o The controls are not properly prepared.

o The controls are not properly positioned on the instrument.

Recommended actions 1. Repeat with fresh control.

2. Check that the correct control material has been used.
3. If the flag reappears, check the calibration and reagent status. Repeat with fresh
reagent.

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Operator’s Manual · Version 3.0 D-35
10 Result flags cobas c 111
List of flags

>Reag Rng

Meaning Absorbance above defined reagent range.

o During calibration, the absorbance value of the lowest calibrator is above the
upper defined range.

Message ID 12

Priority 7

Possible cause Deteriorated or outdated calibrator or reagent.

Recommended actions 1. Check the calibration and reagent expiry dates.

2. Repeat with fresh lowest calibrator.
3. If the flag reappears, replace reagent set (a reagent may be contaminated).

<Reag Rng

Meaning Absorbance below defined reagent range.

o During calibration, the absorbance value of the lowest calibrator is below the
lower defined range.

Message ID 12

Priority 7

Possible cause Deteriorated or outdated calibrator or reagent.

Recommended actions 1. Check the calibration and reagent expiry dates.

2. Repeat with fresh lowest calibrator.
3. If the flag reappears, replace reagent set (a reagent may be contaminated).

> Repl Dev

Meaning Greater than replicate deviation.

Deviation between replicates exceed programmed limit. One or more replicates are
erroneous.

Message ID 13

Priority 12

Possible cause Problems in air/water system, air bubbles, clogged probe.

Recommended actions 1. Check the calibrators for air bubbles and repeat the calibration.
2. If the flag reappears, repeat with fresh calibrators.
3. Check the probe.
4. Check the fluid system.

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D-36 Operator’s Manual · Version 3.0
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List of flags

> RR

Meaning Above reference range.

For patient samples, the calculated concentration is greater than the upper limit of the
expected value range.
nnnnn is the actual value that was checked against.

Message ID 40

Priority 22

Recommended actions No action required.

< RR

Meaning Below reference range.

For patient samples, the calculated concentration is less than the lower limit of the
expected value range.
nnnnn is the actual value that was checked against.

Message ID 41

Priority 23

Recommended actions No action required.

> Std Dev

Meaning Greater than standard deviation.

A point in the calibration fell outside the defined limits.

Message ID 17

Priority 17

Recommended actions 1. Check calibration curve.

2. Repeat with fresh calibrators.
3. If the calibrators were incorrectly positioned, replace the calibrators correctly.

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10 Result flags cobas c 111
List of flags

> Test Rng

Meaning PANIC value over (upper) Technical Limit.

The result is higher than the upper limit for the test.

Message ID 26

Priority 20

< Test Rng

Meaning PANIC value below (lower) Technical Limit.

The result is lower than the lowest limit for the test.

Message ID 27

Priority 21

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D-38 Operator’s Manual · Version 3.0
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.

In this chapter Chapter 11

Introduction ............................................................................................................. D-41
Dealing with exceptional situations ........................................................................ D-42
Reacting to messages ................................................................................................ D-44
Detailed procedures ................................................................................................. D-46
Checking the printer status ................................................................................ D-46
Clearing a paper jam .......................................................................................... D-46
Changing the mains fuses .................................................................................. D-47
Changing the low voltage fuses .......................................................................... D-49
Realigning the reagent disk ................................................................................ D-50
Exporting diagnostics screens to USB ............................................................... D-51

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Operator’s Manual · Version 3.0 D-39
11 Troubleshooting cobas c 111
Table of contents

Roche Diagnostics
D-40 Operator’s Manual · Version 3.0
cobas c111 11 Troubleshooting
Introduction

Introduction

Effective troubleshooting requires a good understanding of all basic operating

procedures for the cobas c111 instrument and the system software.

Preventive maintenance You can avoid most unforeseen situations if you observe the recommended
procedures at all times and if the operating environment is effectively controlled by
performing all maintenance actions when they become due in the manner described
in the Operator’s Manual.
e See Maintenance actions on page C-8.

Information about the status of The system performs numerous checks. When a certain event has occurred or when
the system an irregularity is detected, a message is generated. Messages are displayed in two ways:
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 c 111
Dealing with exceptional situations

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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cobas c111 11 Troubleshooting
Dealing with exceptional situations

Situation Affected Possible causes Comments

items
The system does not go System status There are not enough free Load empty cuvette segments.
to Operating status. cuvettes on the instrument. e See Preparing cuvettes on page B-28.
Air/water calibration is Perform Abs. Air/Water Calibration maintenance
required. action.
e See Perform an air/water calibration on page C-28.
In the corresponding calibrator The Last Is Water definition defines what is used as the
lot definitions of at least one of zero calibrator. It is either system water (On) or a stan-
the tests you want to perform, dard, usually water (Off), which would be placed in a
the value for Last Is Water is tube like any other calibrator.
Off. With some tests, calibration does not work with special
zero calibrators, they need the Last Is Water definition
on.
Possible remedies:
1. Delete the current calibration order and redefine it.
2. If the Last Is Water definition is Off, make sure to
place a special zero calibrator on the instrument
when calibrating. (This is usually water.)
If this does not help change the Last Is Water value to
On. (Calibration for this test does not work with a spe-
cial zero calibrator.)
1. Choose Workplace > Lot Data > Calibrators.
2. Select the entry for the test and expand the entry.
3. Select the Last Is Water entry and press .
4. Press On.
5. Press .
6. Delete the current calibration order and redefine it.
A hardware error had occurred. Some hardware conditions prevent the system from per-
forming tests.
1. Press to check the alarm messages.
2. Follow the advise given in the messages.
3. Choose > Restart to restart the system.
Figure D-4 Troubleshooting overview (Continued)

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Operator’s Manual · Version 3.0 D-43
11 Troubleshooting cobas c 111
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 informa-
tion is the number, the texts may be different on the actual instrument.

Message or error code Affected items Possible causes Comments

1.xxx.81 Instrument. Fuse F1, F2, or F4 is defective. Replace the low voltage fuse that is mentioned in
1.xxx.82 the alarm message.

1.xxx.84 e See Changing the low voltage fuses on

page D-49.
[109000572] code raised by Instrument. The probe is bent or the trans- 1. Check that the probe is mounted properly
IC software caused by an fer head is poorly adjusted. and replace it if necessary.
unexpected handling or sys- e See Replacing the probe on page B-125.
tem situation.
2. If the problem persists, contact your service
representative.
No connection to Instrument Instrument. Fuse F3 is defective. Check the LED of fuse F3. Replace the fuse if nec-
Control. essary. (If the fuse has blown, the LED is off.)
e See Changing the low voltage fuses on
page D-49.
The LAN cable is not or not Check that the LAN cable is properly connected:
properly connected. 1. Switch off the instrument.
2. If the cable was not connected, connect it.
If the cable was connected, remove it at both
ends and reconnect it.
3. Start the instrument.
Electronic problem If the above measures are not successful, contact
your service representative.
Figure D-5 Troubleshooting with the help of messages

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D-44 Operator’s Manual · Version 3.0
cobas c111 11 Troubleshooting
Reacting to messages

Message or error code Affected items Possible causes Comments

[1.xxx.73] Level detection Level detection. o Poor water quality. 1. Make sure you use the correct water quality.
error (conductivity). o Contamination with e See Technical specifications on
cleaner (valve is leaking) page A-66.
2. Perform the Prime Fluid System mainte-
nance action.
e See Prime the fluid system on page C-11.
3. If the problem persists, contact your service
representative.
[4.xxx.41] through [4.xxx.44] Photometer. o Lamp defective. Do not attempt to clean the photometer lenses.
Various texts related to o Photometer lens soiled. 1. Replace the photometer lamp.
photometer Gc-0166807. 2. If the problem persists, contact your service
representative.
Figure D-5 Troubleshooting with the help of messages (Continued)

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Operator’s Manual · Version 3.0 D-45
11 Troubleshooting cobas c 111
Detailed procedures

Detailed procedures

Checking the printer status

a To check the printer status

1 On the Overview tab, press the System status button.
The printer button is red.
2 Scroll to display the Printer entry.

Clearing a paper jam

a To clear the paper jam

1 Choose > Stop Printing, if required.
2 Open the printer panel.

Press down the release button (A) firmly before you pull the panel. The panel should
open without resistance.

3 Lift the printer paper roll from its holder.

4 Remove all loose paper. (Cut or tear it off).
5 Place the roll back on the holder.
Make sure the paper unrolls at the top and towards you.

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Detailed procedures

6 Insert the paper in the slot in the printer panel and pull some through.

7 Close the printer panel.

The system feeds some paper and then automatically resumes printing.
8 Choose Overview > .
9 The printer button should now be green, and the status description should be OK.

Changing the mains fuses

a To change the mains fuses

1 Press O on the main toggle switch to switch off the instrument.
2 Disconnect the mains cable from the instrument.

3 Using a screwdriver disengage the clips on both sides of the fuse box cover.

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11 Troubleshooting cobas c 111
Detailed procedures

4 Remove the holder.

5 Remove the two fuses from the holder.

6 Replace both fuses.

Damage to the analyzer due to use of wrong fuses

Always replace fuses with new ones of the same type and specifications.
See Technical specifications on page A-66.

7 Insert the fuse holder in the fuse box.

Press it in firmly until the clips engage.
8 Connect the mains cable to the instrument.
9 The instrument switch should be illuminated.

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D-48 Operator’s Manual · Version 3.0
cobas c111 11 Troubleshooting
Detailed procedures

Changing the low voltage fuses

a To change a low voltage fuse

1 Switch off the instrument.
2 Using a screwdriver size 2 or 3, remove the fuse indicated in the alarm message.

A Low voltage fuses B Slot in low voltage fuse holder

Figure D-6

o Insert the screwdriver in the slot and turn anticlockwise until the holder
disengages.
o Remove the holder with the fuse.

3 Remove the fuse from its holder.

4 Insert the new fuse in the holder.

NOTICE Damage to the analyzer due to use of wrong fuses

Always replace fuses with new ones of the same type and specifications.
See Technical specifications on page A-66.

5 Insert the holder in the socket.

6 Using the screwdriver, lock the holder in position by pressing it in and turning the
screwdriver clockwise until the slot is vertical.
7 Switch on the instrument.

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Operator’s Manual · Version 3.0 D-49
11 Troubleshooting cobas c 111
Detailed procedures

Realigning the reagent disk

a To realign the reagent disk

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

Spillage through tipping reagent disk

When handling the reagent disk, make sure not to tilt it.
CAUTION

2 Insert a pencil in the opening in the center of the underside of the reagent disk.
3 Turn the reagent disk until the arrows of the reagent disk and the cover face each
other.

A B

A Incorrect position: The two arrows do not B Correct position: The two arrows face each
face each other. other.

Figure D-7

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cobas c111 11 Troubleshooting
Detailed procedures

Exporting diagnostics screens to USB

When performing diagnostics actions you can export the content of the screen to the
USB stick.

Prerequisites You need Lab Administrator or Administrator user rights to perform diagnostics
actions, and the system must be in Standby or Stopped status.

a To export the content of the screen

1 Press to start the diagnostics action.
2 Press .
3 Press Send to File.
As screen is displayed, asking you to insert the USB stick.
4 Insert the USB stick.
5 Press .
6 Select the directory.
7 Press to confirm the selection.
The data are copied to the USB stick. (File name format:
prt_yyyymmddhhmmss.txt.)

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Detailed procedures

Roche Diagnostics
D-52 Operator’s Manual · Version 3.0
ISE E

12 ISE description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

13 ISE operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-15
14 ISE maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-39
15 ISE troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-67