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cobas t 411 coagulation analyzer
Quick Reference Guide
3.0
Software version v1.54_6
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
2
Publication information
Edition notice This publication is intended for operators of the
cobas t 411 coagulation analyzer.
Every effort has been made to ensure that all the
information is correct at the time of publishing. However,
Roche Diagnostics International Ltd. reserves the right to
change this publication as necessary and without notice
as part of ongoing product development.
Keep this publication in a safe place to ensure that it is
not damaged. This document should always be easily
accessible.
Related publications Use this publication together with the cobas t 411
coagulation analyzer Safety Manual.
To avoid serious or fatal injury, read the Safety Manual
thoroughly before you use the analyzer.
For detailed instructions, read the cobas t 411
coagulation analyzer Operator’s Manual.
Copyright © 2014-2016, F. Hoffmann-La Roche Ltd. All rights
reserved.
Contact addresses
Publication version Software version Revision date Change description
1.0 v1.51_6 July 2014 First version
2.0 v1.53_6 September 2015 Changed calibration and QC information
3.0 v1.54_6 July 2016 Completely revised information structure: overview tables
instead of text. Changed document title from "Quick Start
Guide" to "Quick Reference Guide".
y Revision history
Behnk Elektronik GmbH & Co. KG
Hans-Böckler-Ring 27
D-22851 Norderstedt
Made in Germany
Distributed by Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
3
T
able of contents
Keyboard commands . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Quick reference: Before operation. . . . . . . . . . . . . . . . 7
Reagent loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Overview of reagent loading . . . . . . . . . . . . . . . . . . 9
Quick reference: Loading reagents . . . . . . . . . . . . 10
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Calibration loading overview . . . . . . . . . . . . . . . . . . 12
Quick reference: Calibrating PTS%INR, PTS %,
PTS INR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Quick reference: Validating PTSINR2, PTS sec,
aPTT, TT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Quick reference: Manually activating a
calibration curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Quick reference: Starting a QC. . . . . . . . . . . . . . . . 18
Quick reference: Viewing a Levey-Jennings chart 19
Sample processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Quick reference: Processing samples . . . . . . . . . . 20
Quick reference: Handling sample results . . . . . . 21
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Quick reference: Daily maintenance . . . . . . . . . . . 23
Quick reference: Weekly maintenance . . . . . . . . . 24
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
4 Keyboard commands
Keyboard commands
You use the keyboard to work with the software.
The table below describes all available keyboard
commands in alphabetical order.
q To look up the descriptions of the keyboard
commands at any time during operation, press F1. F1
opens the Help window.
Key Keyboard command Function Context
Arrow keys Chooses the next or previous (editable) table cell,
row, or field.
Tables
Lists
Shift+Arrow key Selects several orders. Results Samples
panel (Results > Send
to host)
Esc Returns to the previous screen.
Enter Confirms a user entry (and chooses the next
editable table cell or field).
Opens a view with more details. Results panels
F1 Opens the Help window, which displays the
descriptions of UI symbols, keyboard commands,
and data alarms.
F2 Starts order processing for samples after manual
order editing or pipetting stop.
Shift+F2 Starts sample processing:
o Transports one sample rack after the other past
the barcode reader and to the sample pipetting
area.
o Reads the barcode data and requests missing
data from the LIS, if connected.
o For all samples with complete order data: Starts
pipetting and measuring.
This keyboard command does the same as the Start
button on the button bar.
F3 Completes pipetting of the current cuvette bar, and
then stops pipetting.
y Keyboard commands in alphabetical order
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
5
Shift+F3 Stops processing the samples in the sample
pipetting area and starts processing the sample
rack that is on the right of the output buffer, next to
the STAT button .
When the sample rack with STAT orders is
processed, the analyzer continues processing the
open orders for the samples in the sample pipetting
area.
This keyboard command does the same as the STAT
button on the button bar.
F4 Confirms that the operator has recognized the
information in a status message or has dealt with an
error message. Must be pressed to continue.
Pressing the key has the following effects:
o The message is not displayed anymore.
o If any processes on the analyzer were
interrupted by the message, they resume.
o If any functions in the software were blocked by
the message, they are available again.
o The system stores the message in the Results
Errors panel (Results > Errors).
o If the problem described in an error message is
not solved, the error message is displayed again.
This keyboard command does the same as the
Inhibit alarm button on the button bar.
Shift+F4 Moves the output buffer to the left so you can
unload the processed sample racks. When the
output buffer is extended, pressing Shift+F4 again
retracts the buffer back to the right.
This keyboard command does the same as the
Unload button on the button bar.
F5 Initiates communication with the LIS.
Retrieves order information for the selected order
from the LIS, such as tests to be performed.
Orders panel
Sends the results of the selected order to the LIS. Results Samples
panel (Results > Send
to host)
Shift+F5 Initiates communication with the LIS.
Retrieves order information for all displayed orders
from the LIS, such as tests to be performed.
Orders panel
Sends the results of all displayed orders to the LIS. Results Samples
panel (Results > Send
to host)
Ctrl+F5 Reactivates the LIS when it is offline. A message
informs you about communication errors due to the
offline status when you want to perform a task
involving the LIS.
F6 Reactivates the selected order.
Use this key to avoid unloading and reloading of the
sample rack when you want to repeat tests.
Orders panel.
Only during the time
when the sample rack
for the order is in the
sample pipetting area.
Key Keyboard command Function Context
y Keyboard commands in alphabetical order
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
6 Keyboard commands
Shift+F6 Reactivates the orders of the selected sample rack.
Use this key to avoid unloading and reloading of the
sample rack when you want to repeat tests.
Orders panel.
Only during the time
when the sample rack
is in the sample
pipetting area.
F8 Activates or deactivates cap piercing for the
selected order.
Orders panel
Shift+F8 Activates or deactivates cap piercing for the
selected sample rack.
Orders panel
F9 Activates manual order editing. Orders panel
Activates comment editing. Results Samples
panel
Results QC material
panel
F10 Displays the calibration curve or the Levey-Jennings
chart (QC) of the selected run.
Results panels
Letter key Chooses a command that starts with this letter. Menus
Page Up
Page Down
Chooses the previous or next row in a table within
the same column.
QC configuration
panel
Reagent
configuration panel
Chooses the previous or next sample rack within the
same column and the same rack position.
Orders panel
Print Screen Prints specific data or barcode labels, determined
by the context:
Prints calibration data, parameters, and chart. Calibration panel
Prints barcode labels of the selected QC material. QC configuration
panel
Prints barcode labels of the selected reagent. Reagent
configuration panel
Prints barcode labels of the selected calibrator. Calibration config.
panel
Prints the results of the selected sample as data or
as chart.
Results Samples
panel
Shift+Print Screen Prints the screen that is displayed.
Ctrl+Print Screen Reactivates the printer when it is offline. A message
informs you about the offline status when you want
to print.
Spacebar Displays predefined values in the selected table cell
or field.
Fields
Tables
Lists
Marks a result as invalid or valid. Results QC material
panel
Key Keyboard command Function Context
y Keyboard commands in alphabetical order
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
7
Quick reference: Before operation
Perform before operation tasks to ensure correct
operation.
Steps User action
1
Fill the water container. 1. Remove the liquid level sensor.
2. Unscrew the cap.
3. Fill the water container with
deionized water.
4. Screw on the cap.
5. Insert the liquid level sensor.
2
Empty the liquid waste
container.
1. Remove the cap with the liquid waste
tubing.
2. Empty the liquid waste container.
3. Screw on the cap with the liquid
waste tubing.
3
Start up the system. 1. Switch on the monitor.
2. Switch on the control unit.
3. Switch on the analyzer.
q The analyzer takes
approximately 15 minutes to warm
up.
4
Log on. 1. While the analyzer warms up, log on
with operator access rights.
2. Wait until the message [st04] is
displayed.
5
Load cuvette bars. 1. Remove the cuvette bar compartment
from the analyzer, and the cuvette
bar counter weight from the cuvette
bar compartment.
2. Insert the cuvette bar stack in the
cuvette bar compartment.
3. Remove the stack bracket.
4. Place the cuvette bar counter weight
on top of the cuvette bars.
5. Place the cuvette bar compartment
on the analyzer.
y Quick reference: Before operation
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
8 Quick reference: Before operation
6
Load Day Clean wash solution. 1. Place the wash solution on position 8
of a reagent rack with 5 + 1
positions.
2. Load the reagent rack on the left
reagent area, on the left rack slot.
7
Prime the fluid system.
(Prime system)
1. Choose Maintenance > Transfer
> Syringe > Prime system and
press Enter.
8
Check the reference position of
the probe.
(Check reference position)
1. Choose Maintenance > Transfer
> Probe: > Check reference
position and press Enter.
2. Ensure that the probe tip is situated
exactly over the red dot, level with the
analyzer surface.
3. Choose Maintenance > Transfer
> Probe: > Go to wash position
and press Enter.
9
Check the fluid system.
(Check volume)
1. Choose Maintenance > Transfer
> Probe: > Check volume and
press Enter.
2. Place an empty, labeled calibration
cup on position 10 of a reagent rack
with 10 positions.
3. Load the reagent rack on the left
reagent area, and press Enter.
4. While the probe is dispensing water
into the empty calibration cup,
observe the water jet for any
irregularities.
5. Wait until the message [st04] is
displayed (standby mode).
6. Choose Maintenance > Transfer
> Probe: > Go to wash position
and press Enter.
7. Unload the calibration cup.
Steps User action
y Quick reference: Before operation
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
9
Reagent loading
Overview of reagent loading
You use different containers and reagent racks for
different reagents. Depending on whether cooling is
required, they are loaded either on the left or right
reagent area.
q Make sure that the containers have the caps
removed and that they have standard barcode labels
attached.
q Allow all listed reagents to equilibrate to operating
temperature before using them.
Reagent Container Rack Positioning on the analyzer
Test reagent As indicated in the Instructions for
Use:
o Original reagent bottle
o Or: Reagent cup
Reagent rack Right reagent area (cooled)
QC material As indicated in the Instructions for
Use:
o Original QC material bottle
o Or: Reagent cup
Reagent rack Left reagent area (not
cooled)
QC using the sample area:
o Pediatric sample insert and
conical bottom micro tube
o Or: Sample Cup
Sample rack Sample area
Calibrator Calibrator set:
o Original calibrator bottles
Reagent rack Left reagent area (not
cooled)
Universal calibrator:
o Original calibrator bottle
and
o Empty calibration cups
Diluent As indicated in the Instructions for
Use:
o Original diluent bottle
o Or: Reagent cup
Reagent rack Right reagent area
Day Clean (wash solution) Original Day Clean bottle Reagent rack with 5 + 1
positions, on rack position 6
Left or right reagent area
CleanSol Calibrator cup Reagent rack with 10
positions, on position 10
Left reagent area
Reagent to be stirred Container with magnetic stirring bar Reagent rack, on rack
position 1
Right reagent area (cooled)
y Overview of reagents, containers, and their placement
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
10 Reagent loading
Quick reference: Loading reagents
The basic procedure for reagent loading applies to test
reagents, diluents, calibrators, QC material, wash solution,
and CleanSol.
q For refill: Load the refilled reagent on the same
position on the rack, and on the same rack slot from
where you took it before.
Steps User action
1
Prepare the reagent. 1. Remove the cap of the original
container.
2. Check the Instructions for Use
whether reagent preparation is
required. For example:
o Transfer the reagent into a
reagent cup and affix a barcode
label to the container.
o Put a magnetic stirring bar in the
container.
2
For refill only: Unload the
reagent rack to be refilled.
1. If orders are in progress, press F3.
2. Wait until the [st07] message is
displayed.
3. Make a note of the rack slot. You
must later reload the reagent rack on
the same rack slot.
4. Unload the reagent rack.
5. Make a note of the position of the
reagent to be refilled.
3
Scan the reagent rack. 1. Place the containers on a suitable
reagent rack, with the barcode labels
facing to the right.
2. Insert the reagent rack in the barcode
reading slot.
y Quick reference: Loading reagents
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
11
4
Check the Reagent scan
window and handle any
displayed messages.
o If there is a Yes value in the Stir
column: The container must contain a
magnetic stirring bar and be placed
on rack position 1.
o If there is status information in the
rightmost column: Before
proceeding, perform all required
actions and scan the reagent rack
again.
o If the [er376] message is displayed,
you have loaded a reagent of a new
lot.
1) Remove the reagent rack from
the barcode reading slot.
2) In the preselected Lot No.
column, type the new lot number.
3) Press Enter twice, until the
Reagent scan window is not
displayed any more.
4) Scan the reagent rack again.
5
Load the reagent rack. 1. Insert the reagent rack in a rack slot
in the right reagent area.
6
For refill only: Continue
processing.
1. If you have interrupted order
processing before, press F4.
Steps User action
y Quick reference: Loading reagents
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
12 Calibration
Calibration
Calibration loading overview
For calibration, it is crucial that you use the correct
containers, reagent racks, and loading positions. They are
different for each test. Use this table as a quick reference.
For all tests: Only load the calibrators and test reagents
required for the test you want to calibrate. No other
reagents must be on board.
The table lists mandatory reagent racks and loading
positions. If nothing is specified in the table, use a
suitable rack size and position.
Test Calibration method Reagents Containers Reagent rack/positions (mandatory)
PTS%INR
PTS %
PTS INR
Calibrator set PT Cal Set Original calibrator
bottles (calibrator
set)
o Reagent rack with 8 positions
o Positions 3 to 7, in the correct order
(calibrator 1 on position 3, calibrator 2
on position 4, and so on)
o Left reagent area (not cooled)
Test reagents Original reagent
bottle
o Right reagent area (cooled)
PTSINR2
PTS sec
aPTT M
aPTT H
aPTT L
TT
Validation without
calibration
Test reagents Original reagent
bottle
o Right reagent area (cooled)
FIB Universal calibrator Cal Plasma Original calibrator
bottle
o Reagent rack with 8 positions
o Left reagent area (not cooled)
(empty) One empty, labeled
calibration cup
o Reagent rack with 10 positions
o Position 7
o Left reagent area (not cooled)
NOTE: The analyzer does not check the liquid level in the
labeled calibration cup. If you repeat a failed calibration, make
sure you load a new, empty calibration cup.
Test reagent: Kaolin Labeled, small
reagent bottle
(prepare as
described in the
Instructions for Use)
o Reagent rack with 8 positions
o Position 1 (to be stirred)
o Right reagent area (cooled)
Other test reagents Original reagent
bottles
o Reagent rack with 6 positions
o Right reagent area (cooled)
Diluent Original diluent
bottle
o Reagent rack with 6 positions
o Right reagent area (cooled)
y Calibration loading overview
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
13
AT Universal calibrator Global Cal Original calibrator
bottle
o Reagent rack with 8 positions
o Left reagent area (not cooled)
Test reagents Original reagent
bottles
o Reagent rack with 8 positions
o Right reagent area (cooled)
Diluent Original diluent
bottle
o Reagent rack with 6 positions
o Right reagent area (cooled)
DD Norm
DD High
Universal calibrator Calibrator Labeled calibration
cup
(prepare as
described in the
Instructions for Use)
o Reagent rack with 10 positions
o Position 1
o Left reagent area (not cooled)
(empty) Four empty, labeled
calibration cups
o Reagent rack with 10 positions
o Positions 4, 5, 6, 7
o Left reagent area (not cooled)
NOTE: The analyzer does not check the liquid level in the
labeled calibration cups. If you repeat a failed calibration, make
sure you load new, empty calibration cups.
Test reagent Original reagent
bottle
o Reagent rack with 8 positions
o Right reagent area (cooled)
Diluent Original diluent
bottle
o Reagent rack with 6 positions
o Right reagent area (cooled)
Test Calibration method Reagents Containers Reagent rack/positions (mandatory)
y Calibration loading overview
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
14 Calibration
Quick reference: Calibrating PTS%INR, PTS %, PTS INR
To calibrate the PTS%INR, PTS %, or PTS INR test, you use
the calibrator set method.
You can follow the instructions in the displayed
messages. The messages tell you which calibrators and
reagents you must load in which sequence.
Steps User action
1
Unload all reagent racks. 1. Remove all reagent racks from both
left and right reagent areas.
2
Choose a test and confirm the
calibration method.
1. Choose the Calibration command,
then a test, and press Enter.
2. To confirm the selected calibration
method, press Enter.
3
Load the calibrator. 1. On a reagent rack with 8 positions,
place the calibrators on these
positions:
o Calibrator 1 on position 3
o Calibrator 2 on position 4
o And so on...
2. Load the reagent rack in the left
reagent area.
4
Load Day Clean wash solution. 1. Place the wash solution on position 6
of a reagent rack with 5 + 1
positions.
2. Load the reagent rack on the left
reagent area.
y Quick reference: Calibrating PTS%INR, PTS %, or PTS INR (calibrator set method)
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
15
5
Load the test reagents. 1. Place the containers on a suitable
reagent rack.
2. Load the reagent rack on the right
reagent area.
3. To confirm the messages about
loading, press F4 several times.
6
Enter calibrator properties and
PTS % reagent properties.
(Edit values)
1. Choose Edit values.
2. Look up the required value in the
values sheet and type it in the
selected field.
3. To choose the next field to be filled,
press Enter.
4. When you have entered all required
values, press Esc.
7
Start the calibration run.
(Start calibration)
1. Choose Start calibration and press
Enter.
Steps User action
y Quick reference: Calibrating PTS%INR, PTS %, or PTS INR (calibrator set method)
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
16 Calibration
Quick reference: Validating PTSINR2, PTS sec, aPTT, TT
The PTSINR2, PTS sec, aPTT M, aPTT H, aPTT L, and TT
tests do not require calibration. Nevertheless, whenever
you load reagents of a new lot, you must confirm that it is
OK to use this lot. To do so, you perform a validation in
the user interface.
You can follow the instructions in the displayed
messages. The messages tell you which calibrators and
reagents you must load in which sequence.
Steps User action
1
Choose the test. 1. Choose Calibration, the test, and
press Enter twice.
2
Load the test reagents. 1. Load the test reagents on the right
reagent area.
2. For PTSINR2:
1) Choose the Edit values
command and press Enter.
2) Enter the ISI: value and the
Normal: value (MNPT).
3
Confirm the lot. 1. Change the value in the Valid: field
to Yes (press the Spacebar) and
press Enter.
2. Press Esc.
y Quick reference: Validating PTSINR2, PTS sec, aPTT, TT
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
17
Quick reference: Manually activating a calibration curve
If you do not want to use the most recently validated
calibration curve as the basis for your measurements, you
manually activate an older calibration curve.
Steps User action
1
Choose the calibration run. 1. Choose Results > Calibrations and
press Enter.
2. Choose a test and press Enter.
3. Choose a calibration run.
2
Press F10.
3
Choose Activate curve. 1. Choose Activate curve and press
Enter.
The [m55] message confirms successful
completion.
y Quick reference: Manually activating a calibration curve
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
18 QC
QC
Quick reference: Starting a QC
You usually load QC material on the reagent area, the
same way you load test reagents.
Steps User action
1
Load the QC material. 1. Check the Method Sheet whether
preparation of the QC material is
required. For example:
o Transfer the QC material into a
reagent cup and place a barcode
label on the reagent cup.
2. Place the container on a suitable
reagent rack.
3. Load the reagent rack on the left
reagent area.
o When you scan the reagent rack,
the Cool column in the Reagent
scan window must contain a No
value for all occupied rack
positions.
2
Define and start QC runs. 1. Choose QC and press Enter.
2. Choose the Start column of the row
(test and QC material) for which you
want to perform a QC.
3. In the Start column, press the
Spacebar to set the Yes value.
4. Repeat the steps for all rows for
which you want to perform a QC.
5. Press Esc.
6. Press F2.
y Quick reference: Starting a QC using the reagent area
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
19
Quick reference: Viewing a Levey-Jennings chart
For active QC lots, you access the Levey-Jennings chart
from the QC panel.
Steps User action
1
Choose the QC and display the
Levey-Jennings chart.
1. Choose QC and press Enter.
2. Choose a row (QC and unit).
3. Choose the Show table cell and
press Enter.
2
Change the display. o To change the values displayed in the
Levey-Jennings chart, press the
Spacebar (All or Valid).
o To view a specific result, choose the
data point in the graph.
y Quick reference: Viewing a Levey-Jennings chart for an active QC lot
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Quick Reference Guide · 3.0
20 Sample processing
Sample processing
Quick reference: Processing samples
You can process routine samples or STAT samples
(emergency orders), in a setup with or without LIS.
Steps User action
1
Use case 1: Load STAT samples. 1. Place the sample tubes in a sample
rack.
2. Press (STAT).
3. Place one sample rack on the right of
the input buffer, next to the STAT
button .
4. Press (STAT) again.
5. Repeat the steps for each STAT
sample rack.
2
Use case 2: Load routine
samples.
1. Place the sample tubes in a sample
rack.
o For cap piercing, use a dedicated
sample rack.
o For a pediatric sample, use a
conical bottom micro tube and a
pediatric sample insert. Use a
dedicated sample rack.
2. Place the sample racks on the input
buffer.
3. Press (Start).
3
If not connected to an LIS: Edit
the orders and start order
processing.
1. In the Orders panel, press F9.
2. Choose the sample.
3. In the Test column, type the test
abbreviation.
4. To deactivate cap piercing, press F8.
5. When you have entered all
information, press F9.
6. To start order processing, press F2.
4
Unload processed samples. 1. Press (Unload).
2. Check in the Output buffer panel
whether all samples are marked
green.
3. Remove all sample racks from the
output buffer.
4. Press (Unload) again.
y Quick reference: Processing samples
/
