cobas c 111 analyzer
Quick Reference Guide Version 1.0
Software version 4.2
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
2
Publication information
Edition notice This publication is intended for operators of the
cobas c 111 analyzer with the installed software.
Every effort has been made to ensure that all the
information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities. These updates
may lead to a new version of this publication.
Where to find information The User Assistance contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• A software reference
• Configuration information
• Background information
The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
system.
The User Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow.
Copyright © 2006–2017, F. Hoffmann-La Roche Ltd. All rights
reserved.
Contact address
Publication
version
Software version Revision date Change description
1.0 4.2 September 2017 First version
y Revision history
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
3
T
able of contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Symbols and abbreviations . . . . . . . . . . . . . . . . . . . 4
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Quick Guide: Daily operations . . . . . . . . . . . . . . . . . . . 6
Quick Guide: Prepare wizard . . . . . . . . . . . . . . . . . . . . 12
Quick Guide: Performing calibrations . . . . . . . . . . . . . 15
Quick Guide: Performing QCs. . . . . . . . . . . . . . . . . . . . 16
Quick Guide: Ordering and analyzing samples . . . . . 17
Quick Guide: End Shift wizard . . . . . . . . . . . . . . . . . . . 19
Quick Guide: Utilities > Configuration . . . . . . . . . . . . 22
Quick Guide: Configuration > Workflow . . . . . . . . 23
Quick Guide: Configuration > Host Settings . . . . 26
Quick Guide: Configuration > Result Handling . . 30
Quick Guide: Configuration > Calibration. . . . . . . 32
Quick Guide: Configuration > QC . . . . . . . . . . . . . 33
Quick Guide: Configuration > System. . . . . . . . . . 34
Quick Guide: Configuration > Date and Time . . . 37
Quick Guide: Configuration > Maintenance. . . . . 38
Quick Guide: Configuration > Abs Adjustment . . 40
Quick Guide: Utilities > Applications. . . . . . . . . . . . . . 41
Quick Guide: Applications > Reagent Mixing
Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Quick Guide: Applications > Laboratory
Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Quick Guide: Application > General . . . . . . . . 45
Quick Guide: Application > Calibration. . . . . . 47
Quick Guide: Application > Control. . . . . . . . . 49
Quick Guide: Application > Calculation . . . . . 51
Quick Guide: Application > Result
Conversion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Quick Guide: Ratio application > Calculation. 56
Quick Guide: Ratio application> Laboratory
Correlation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Quick Guide: Ratio application > Reference
Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
4 Preface
Preface
Use this publication together with the
cobas c 111 analyzer User Guide or User Assistance.
Operation and maintenance actions are described in the
User Guide and User Assistance.
Intended use
The cobas c 111 analyzer is a continuous random-
access analyzer intended for the in vitro determination of
clinical chemistry and electrolyte parameters in serum,
plasma, urine, or whole blood (HbA1c).
It is important that the operators read this manual
thoroughly before using the system.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Symbols used on product
Product name Descriptor
cobas c 111 analyzer cobas c 111
cobas c 111 with operating software System
Cuvette Segment Cuvette segment
Ion selective electrode ISE
Activator for cobas c 111 Activator
Calibrator for automated systems Cfas
PreciControl ClinChem Multi 1 PCCC1
PreciControl ClinChem Multi 2 PCCC2
ISE Reference Solution REF
y Product names
Symbol Explanation
Global Trade Item Number.
y Symbols used on product
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
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Acronyms The following acronyms are used:
Introduction
!
General attention
To avoid serious or fatal injury, read this publication
thoroughly before you use the analyzer.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the system in a way that is not described in
this publication.
r Keep this publication in a safe place to ensure that it
is not damaged and remains available for use. This
publication must always be easily accessible.
Acronym Definition
ANSI American National Standards
Institute
CFR Code of Federal Regulations
CISPR Comité International Spécial des
Perturbations Radioélectriques
FCC Federal Communications
Commission
IEC International Electrical
Commission
ISO International Organization for
Standardization
SOP Standard Operating Procedure
y Acronyms
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
6 Quick Guide: Daily operations
Quick Guide: Daily operations
The following table gives an overview of the tasks you
might need to perform during daily operation. Roche
recommend using the sequence of steps in the way given
below; but you may perform the tasks differently. For
details on the individual steps, see the relevant sections in
this chapter.
# Task Step Navigation
With wizard As individual steps
1 Starting the system 1. Switch on the system
2 Logging on the system Overview > Log On
3 Preparing the system Start the Prepare wizard. Overview > Prepare
1. Check the external fluid containers
Overview > >
3. Perform the maintenance actions
that are due
Overview >
4. Load the reagent disk
Overview > >
5. Check the reagents
Overview >
6. Check the cuvettes
Overview >
7. Perform mixing
Overview > > Test >
8. Perform calibrations that are due Workplace > Calibrations >
>
y Overview of the daily operation tasks
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
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4 Performing calibrations
Performing individual
calibrations
1. Start the wizard
Workplace > Calibrations >
2. Choose the test Select the test check box and
choose the button
3. Prepare and place the calibrators
Confirm with the button
4. Start the calibration measurement
5. Validate the calibration results Workplace > Calibrations >
choose calibration result
> >
o Accept Set
o Accept Lot
o Repeat
o Use Old
o Retransmit
6. Remove the calibrators
Performing all due
calibrations
1. Start the wizard
Workplace > Calibrations >
2. o Select all tests with due
calibrations
o Select all tests with calibration
due within the forecast
period
Select the test check box and
choose the button
3. Prepare and place the calibrators.
Confirm with the button
4. Start the calibration
5. Validate the calibration results Workplace > Calibrations >
choose calibration result
> >
o Accept Set
o Accept Lot
o Repeat
o Use Old
o Retransmit
6. Remove the calibrators
# Task Step Navigation
With wizard As individual steps
y Overview of the daily operation tasks
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
8 Quick Guide: Daily operations
5 Performing QCs
Performing Default QC 1. Start the wizard
Overview > Order >
Overview > STAT >
2. Choose a QC and place the tube
o Repeat until there are no QC
left on the panel
Choose a QC
Place the corresponding tube
within 10 seconds on the sample
area
3. Start the QC measurement
4. Validate the QC results Workplace > QC Status >
choose QC result >
o Accept
o Ignore
o Retransmit
5. Remove the QCs n.a.
Performing an individual QC
measurement
1. Start the wizard
Workplace > QC Status > choose test >
2. Choose a test n.a.
3. Choose a QC and place the tube
o Repeat until there are no QC
left on the panel
Choose a QC and confirm with
the button
Place the corresponding tube
within 10 seconds on the sample
area
4. Start the QC measurement
5. Validate the QC results Workplace > QC Status >
choose QC result >
o Accept
o Ignore
o Retransmit
6. Remove the QCs n.a.
Performing all due QC
measurements
1. Start the wizard
Overview > Order >
2. Choose a QC and place the tube
o Repeat until there are no QC
left on the panel
Choose a QC and confirm with
the button
Place the corresponding tube
within 10 seconds on the sample
area
3. Start the QC measurement
4. Validate the QC results Workplace > QC Status
>
choose QC result >
o Accept
o Ignore
o Retransmit
5. Remove the QCs n.a.
# Task Step Navigation
With wizard As individual steps
y Overview of the daily operation tasks
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
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6 Defining sample orders Start the Orders wizard. Overview > Orders
Overview > STAT
1 Identify the sample n.a.
2. Choose the tests n.a.
3. Place sample tube n.a.
4. Start the run
7 Monitoring the progress n.a.
6 Validating test results 1. View test results n.a. Workplace > Result Review
2. Handle test results with flags n.a. Workplace > Result
Review > choose test
result >
o Accept
o Repeat
o Rerun
3. Accept test results Workplace > Result
Review > choose test
result >
o Accept
# Task Step Navigation
With wizard As individual steps
y Overview of the daily operation tasks
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
10 Quick Guide: Daily operations
9 Finishing the shift 1. Check for unfinished orders
Workplace > Orders >
> Not Finished >
2. Check for non-validated results Workplace > Result Review
> > Not Accepted >
3. Check for non-transmitted results
o If working with a host system
only
Workplace > Result Review
> > Not Sent to Host
>
4. Start the End Shift wizard Overview > End Shift
5. Perform the daily backup Utilities > Export > Database >
insert USB flash drive > choose
folder > choose button
6. Export the full results Utilities > Export > Full
Results> insert USB flash drive >
choose folder > choose format >
choose button
7. Clean up the database
Deleted results are:
o Accepted patient results (sent
to host and/or printed)
o Accepted QC results
o QC history older than previous
month
o Obsolete calibration results
Workplace > Orders >
> choose the List button or the
Selected [xy] button
Workplace > Result Review
> choose result > > choose
the List button or the Selected
[xy] button
Workplace > QC Status >
> choose the All button, the All
Accepted button, or the
Selected [xy] button
Workplace > QC History
>
> choose the List button, the
Older Than Previous Month
button, or the Selected [xy]
button
Workplace > Calibrations
> >
8. Perform the maintenance actions
that are due
Utilities > Maintenance
> choose a maintenance action
> choose the button
9. Replace cuvettes
Overview >
10. If last shift, remove the reagent
disk
Overview > >
11. Check the external fluid containers
Overview > >
12. Log off the system Overview > button with your
login name
13. If last shift, shut down the system
and switch off the analyzer
> Shutdown
# Task Step Navigation
With wizard As individual steps
y Overview of the daily operation tasks
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
11
u Related topics
• Quick Guide: Prepare wizard (12)
• Quick Guide: Performing calibrations (15)
• Quick Guide: Performing QCs (16)
• Quick Guide: Ordering and analyzing samples (17)
• Quick Guide: End Shift wizard (19)
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
12 Quick Guide: Prepare wizard
Quick Guide: Prepare wizard
Step User action
1
Start the Prepare wizard. 1. On the Overview tab, choose the Prepare button.
2
Check the status of the external
containers.
1. Refill the water container, if necessary, and confirm
by pressing the Water button. (If you refill the
water, empty the waste as well.)
2. Empty the waste container, if necessary, and
confirm by pressing the Waste button.
3. Replace the cleaner bottle, if necessary, and
confirm by pressing the cleaner button.
4. To proceed to the next step in the Prepare wizard,
choose the button.
3
Perform the maintenance
actions that are due.
1. Check which maintenance actions are due.
2. Perform the Daily Prepare Actions maintenance
actions.
Perform at least all red maintenance actions.
3. To proceed to the next step in the Prepare wizard,
choose the button.
4
Prepare the reagent disk. 1. If the reagent disk was stored outside of the
instrument in a refrigerator, choose
the button.
2. Open the main cover.
3. Place the disc on the instrument. Make sure that
the arrow indicators on the disc cover are in the
front.
4. Close the main cover.
After the instrument has read the disc ID a screen
is displayed, showing the reagent status.
y Prepare wizard
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
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5
Prepare the reagents. Deal with at least all red and orange buttons.
1. Choose a reagent button to check the details.
Replace the empty reagents.
1. Choose the button.
2. Open the main cover
3. Remove the bottle.
4. For confirmation, choose the button.
5. Remove the remaining bottles of the set.
6. For confirmation, choose the button.
7. Choose the button.
8. Scan the bottle barcode and place the new bottle.
9. For confirmation, choose the button.
10. Load the remaining bottles of the set.
11. To proceed to the next step in the Prepare wizard,
choose the button.
6
Prepare the cuvettes.
q To avoid timing errors, ensure that all
available cuvette segment positions are filled.
Always replace any used cuvette segments. A partially
used cuvette segment does not have to be replaced.
Replace all red cuvette segments.
1. Choose the cuvette segment button.
2. Open the main cover.
3. Replace the cuvette segment.
4. For confirmation, choose the button.
5. Replace the remaining segments that need
replacing.
6. To proceed to the next step in the Prepare wizard,
choose the button.
7
Perform reagent mixing. 1. Choose one or more tests.
2. Choose the button.
3. To proceed to the next step in the Prepare wizard,
choose the button.
Step User action
y Prepare wizard
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
14 Quick Guide: Prepare wizard
8
Perform calibrations. Perform the calibrations.
1. Check the test selection.
2. Choose the button.
3. Place the calibrators on their assigned positions.
4. On the placement screen, choose the button.
5. Choose the button.
6. Validate the results.
o Choose Workplace > Result Review
Handle test results with flags
o Choose Workplace > Result Review
o Choose test result
o Choose the Edit button
o Choose one of the following options:
Repeat
Rerun
Accept test results
o Choose Workplace > Result Review
o Choose test result
o Choose the Edit button
o Choose the Accept button
Step User action
y Prepare wizard
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
15
Quick Guide: Performing calibrations
Step User action
1. Create calibrations order 1. Choose Workplace > Calibrations
2. Choose the button.
2. Choose the calibration type 1. Choose from the following options:
To perform all calibrations with the status due,
choose the button.
To perform all calibrations that are due within the
forecast period, choose the button.
To perform individual test calibrations, select the
check boxes on the test buttons.
2. Choose the button.
3. Place calibrator tubes on the
sample area
1. If necessary, check and print the placement list.
2. Prepare and place calibrator tubes according to the
placement list.
3. Choose the button.
4. Start processing
Choose the button.
5. Validate the calibration results 1. Choose Workplace > Calibrations
2. Choose the calibration result you want to validate.
3. For detailed information, choose the button.
For validating, choose the button.
6. Remove calibrator tubes from
the sample area
y Calibration workflow
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
16 Quick Guide: Performing QCs
Quick Guide: Performing QCs
Step User action
1. The QC definition is test-
specific:
Utilities > Applications
> Laboratory Parameters
> choose the corresponding
test > Control
To perform a QC measurement,
choose one of the following
options:
Default QC
1. Choose Overview > Order
2. Choose the button.
3. Choose the QC button
You must place the QC material within 10 seconds
on the sample area.
4. Repeat until there are no active QC buttons left on
the panel.
5. Choose the button.
Interval QCs that are due. 1. Choose Overview > Order
2. Choose the button.
3. Choose the button.
4. Choose the button.
5. Choose the QC button
You must place the QC material within 10 seconds
on the sample area.
6. Repeat until there are no active QC button left on
the panel.
7. Choose the button.
Individual QC 1. Choose Overview > Order
2. Choose the button.
3. Select the test check box for which you want to
perform a QC measurement.
4. Choose the button.
5. Choose the QC button
You must place the QC material within 10 seconds
on the sample area.
6. Repeat until there are no active QC button left on
the panel.
7. Choose the button.
2. Validate the QC results 1. Choose Workplace > QC Status
2. Choose the QC result you want to validate.
3. For detailed information, choose the button.
For validating, choose the button.
3. Remove QC tubes from the
sample area
y QC workflow
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
17
Quick Guide: Ordering and analyzing
samples
Step User action
1. Identify the sample If working with sample barcodes:
1. Choose Overview > Order
2. Scan the barcode using the barcode reader.
If working without sample barcodes, type the sample
ID by using the screen keyboards.
1. Choose Overview > Order
2. Choose the button.
3. Type the sample ID.
4. Choose the button.
2. Select the check box of the
tests, ratios, or profiles.
This step is not required if the
workflow setting working mode
is host. Utilities
> Configuration > Workflow.
1. To select a test panel, choose a tab (if necessary).
2. To choose an active test, ratio, or profile, select the
item check box.
To cancel a selection, clear the item check box
3. Choose the button.
3. Place sample tubes on the
sample area
Place the sample on any free position on the sample
area.
q You must place the sample within 10
seconds of choosing the button.
Failing to place the sample tube within 10 seconds
cancels the current identification process. You are
asked again to identify the sample tube.
4. Start processing
Choose the button.
y Analyzing samples workflow
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
18 Quick Guide: Ordering and analyzing samples
5. Validate the test results 1. Choose Workplace > Result Review
2. Choose the test result you want to validate.
For detailed information, choose the button.
3. To validate the test result, choose the button.
On the validation panel, choose one of the
following options:
o Repeat (1:1)
o Rerun (1:x)
o Accept
6. Remove sample tubes from the
sample area
1. Choose the Overview tab.
2. Check the status of the sample tube button that
corresponds to the sample you want to remove.
3. If the sample tube button is green, remove the
tube.
Step User action
y Analyzing samples workflow
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
19
Quick Guide: End Shift wizard
Step User action
1. Check for unfinished tasks 1. To check for unfinished orders, choose
Workplace > Orders > > Not Finished.
1. To check for non-validated test results, choose
Workplace > Result Review > > Not
Accepted.
1. To check for test results that were not
transmitted, choose Workplace > Result
Review > > Not Sent to Host.
2. Start the End Shift wizard 1. On the Overview tab, choose the End Shift
button.
3. Perform data backup 1. Choose the button.
2. Insert the USB flash drive.
3. Choose the folder.
4. Choose the button.
5. Choose the button.
y End Shift wizard
Roche Diagnostics
cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·
20 Quick Guide: End Shift wizard
4. Export full results data 1. Choose the button.
2. If you have removed the USB flash drive, insert
the USB flash drive again.
3. Choose the folder.
4. Choose the button.
5. Remove USB flash drive.
6. Choose the button.
5. Clean up the database 1. Choose the button.
2. Choose the button.
3. Choose the button.
6. Perform maintenance actions 1. Check which maintenance actions are due.
2. Perform at least all red maintenance actions.
3. Choose the button.
7. Check the cuvette status
q To avoid timing errors, ensure that all
available cuvette segment positions are filled.
Always replace any used cuvette segments. A
partially used cuvette segment does not have to
be replaced.
Replace at least all red cuvette segments.
1. Choose the cuvette segment button.
2. Open the main cover.
3. Replace cuvette segments and confirm the
replacement.
4. Close the main cover.
5. Choose the button.
Step User action
y End Shift wizard
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