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cobas t 411 coagulation analyzer
Operator’s Manual
Version 3.0
Software version v1.54_6
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 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.
Training Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
Screenshots The screenshots in this publication have been added
exclusively for illustration purposes. Configurable and
variable data, such as tests, results, path names etc.,
visible therein must not be used for laboratory purposes.
Warranty Any customer modification to the system renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative or perform such updates with their
assistance.
Copyright © 2014-2016, F. Hoffmann-La Roche Ltd. All rights
reserved.
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 May 2016 New DD calibration information.
Added reagent cup 30 mm.
New cover page.
y Revision history
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
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Trademarks The following trademarks are acknowledged:
COBAS, COBAS T, and LIFE NEEDS ANSWERS are
trademarks of Roche.
All other trademarks are the property of their respective
owners.
Feedback Every effort has been made to ensure that this publication
fulfills the intended purpose as mentioned above. All
feedback on any aspect of this publication is welcome
and is considered during updates. Contact your Roche
representative, should you have any such feedback.
Instrument approvals The cobas t 411 coagulation analyzer meets the
requirements of the Directive 98/79/EC.
The following mark demonstrates compliance:
Contact addresses
Complies with the IVD directive 98/79/EC.
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 · Operator’s Manual · Version 3.0
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Table of contents 5
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
Table of contents
Publication information 2
Contact addresses 3
Table of contents 5
Intended use 7
Symbols and abbreviations 7
What is new in publication version 3.0 9
Operation
1 Overview of the analyzer
Measuring principle 15
Analyzer overview 16
Operator areas and elements 18
List of accessories 22
2 Introduction to the user interface
Screen layout 33
Keyboard commands 35
Working with the user interface 38
Access rights 41
3 Overview of operation
Operating modes 45
Overview of the workflow 46
Overview of reagent loading 48
About code, lot number, and PSN 49
4 Before operation
Preparing the water container and the
liquid waste container 53
Starting up the system 56
Loading cuvette bars 58
Loading wash solution for startup 60
Performing maintenance actions for startup 62
5 Calibration
About calibration 69
Calibrating PTS%INR, PTS %, or PTS INR
(calibrator set method) 74
Calibrating FIB, AT, or DD (universal
calibrator method) 83
Validating PTSINR2, PTS sec, or aPTT
(validation without calibration) 91
Result handling for calibrations 92
Manually activating a calibration curve 97
6QC
About QC 103
Overview of QC methods and loading
positions 104
Performing a QC using the reagent area 105
Performing a QC using the sample area 112
New QC lot: Configuring QC material 115
Result handling for QC 117
7 Sample processing
About orders 135
About manual order editing 136
Processing routine samples 138
Processing STAT samples 150
Processing samples in a setup without LIS 152
Result handling for samples 155
8 Refilling consumables
Replacing wash solution 171
Replacing a dilution rack 173
Loading cuvette bars 175
9 After operation
Unloading all samples 179
Unloading all reagents 181
Disposing of liquid and solid waste 182
Backing up data 183
Shutting down the system 185
10 Maintenance
Maintenance overview 189
Periodic maintenance actions 191
Specific maintenance actions 202
11 User administration
Switching users 247
Changing a password 249
Troubleshooting
12 Troubleshooting
Troubleshooting overview 255
About data alarms 256
Status messages and error messages 257
Interrupting the pipetting procedure 280
Erroneous sample tubes 281
Barcode reading errors 284
Pipetting errors 289
Cuvette bar transport errors 292
LIS errors 303
Connection errors 305
6 Table of contents
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
Software reference
13 Software reference
Panels for sample processing 311
Panels for calibration and QC 319
Panels for maintenance and
troubleshooting 337
Panels for results, statistics, and backup 345
Test Parameters panel 363
Panels for user administration 364
Reagent scan window 366
Help window 370
Appendix
14 System specifications
General specifications 375
Environmental conditions 376
Dimensions and weights 377
Power supply 378
Control unit interface 379
Barcode types and placement 380
15 Glossary
Index 383
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
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Intended use
The cobas t 411 coagulation analyzer is a fully
automated blood plasma analysis system intended for in
vitro determination of coagulation. It performs optical
clotting time detection, using chronometric, chromogenic,
and immuno-turbidimetric measurement methods. It is
designed for 24h/day operation.
Symbols and abbreviations
Visual cues are used to help locate and interpret
information quickly. This section explains the conventions
used for this purpose.
Product names Except where the context clearly indicated otherwise, the
following product names and abbreviations are used:
Symbols The following symbols are used:
Official product name Common name in this
publication
cobas t 411 coagulation
analyzer
analyzer
system (if the emphasis is on the
software, or on software and
hardware as a whole)
cobas t 411 software software
Day Clean wash solution
CleanSol n/a
Cal Plasma calibrator
Global Cal calibrator
y Product names
Symbol Explanation
o List item
U Related topics containing further information
Q Tip. Extra information on correct use or useful
hints.
P Start of a task
S End of a task
c Frequency of a task
n Duration of a task
d Materials that are required for a task
j Prerequisites of a task
u Topic. Used in cross-references to topics.
p Task. Used in cross-references to tasks.
w Figure. Used in figure titles and cross-
references to figures.
y Symbols
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
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Abbreviations The following abbreviations are used:
y Table. Used in table titles and cross-references
to tables.
z Equation. Used in cross-references to
equations.
k Code example. Used in code titles and cross-
references to codes.
Symbol Explanation
y Symbols
Abbreviation Definition
CFU Colony-forming unit
EAN International article number
EN European standard
ID Identification number
IEC International Electrical Commission
ISI International Sensitivity Index
INR International Normalized Ratio
IVD In vitro diagnostic
LED Light emitting diode
LIS Laboratory information system
MNPT Mean Normal Prothrombin Time
n/a not applicable
PSN Production Sequence Number
PT Prothrombin time
QC Quality control
RFID Radio frequency identification
SD Standard deviation
STAT Short turnaround time
UL Underwriters Laboratories Inc.
UPCA Universal product code A
UPCE Universal product code E
USB Universal serial bus
y Abbreviations
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
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What is new in publication version 3.0
New DD tests Instructions for the DD calibration were added. A
description of the new [er441] message was added.
u Quick reference: Calibrating DD (87)
u List of messages (258)
Added reagent cup 30 mm You can choose whether to use a reagent cup with a
diameter of 16 mm or 30 mm. Choose the diameter that is
suitable for your reagent rack.
u List of supported containers (22)
New cover page On the cover page, illustrations were added.
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
10
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
Operation
1 Overview of the analyzer ..................................................................................... 13
2 Introduction to the user interface .................................................................... 31
3 Overview of operation........................................................................................... 43
4 Before operation ..................................................................................................... 51
5 Calibration................................................................................................................. 67
6 QC ..............................................................................................................................101
7 Sample processing ..............................................................................................133
8 Refilling consumables ........................................................................................169
9 After operation ......................................................................................................177
10 Maintenance ..........................................................................................................187
11 User administration .............................................................................................245
1 Overview of the analyzer
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
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Table of contents
Overview of the analyzer 1
In this chapter
1
Measuring principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Analyzer overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Operator areas and elements . . . . . . . . . . . . . . . . . . . . 18
About working areas for the operator . . . . . . . . . . 18
List of buttons and status indicators . . . . . . . . . . . 19
List of accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
List of supported containers . . . . . . . . . . . . . . . . . . 22
List of supported racks . . . . . . . . . . . . . . . . . . . . . . 24
List of available accessories and consumables . . 26
About cuvette bars . . . . . . . . . . . . . . . . . . . . . . . . . . 28
About supported reagents . . . . . . . . . . . . . . . . . . . 29
1 Overview of the analyzer
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
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Table of contents
1 Overview of the analyzer
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
Overview of the analyzer 15
Measuring principle
The analyzer performs optical clotting time detection,
using chronometric, chromogenic, and immuno-
turbidimetric measurement methods.
w Measuring principle
1. The analyzer pipets sample and reagents.
2. Incubation ensures that all reaction components in
the cuvettes are at the correct temperature.
3. When the cuvette bar enters the photometer unit, it is
tilted by 90°. Sample and reagents are combined and
actively mixed.
4. The photometer measures light absorbance and time:
- For clotting tests, it measures the change in
turbidity.
- For chromogenic tests, including immuno-
turbidimetric measurements, it measures the
kinetic reaction.
u Related topics
• About cuvette bars (28)
1 Overview of the analyzer
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
16 Analyzer overview
Analyzer overview
w Top view
A Cuvette bar compartment H Cuvette conveyor
B Sample pipetting area I Waiting position
C Barcode reader for samples J Pipetting station
D Output buffer K Incubation positions
E Input buffer L Rinse station
F Button bar M Waste chute with cover
G Keyboard N Photometer unit
O Dilution area
P Left reagent area
Q Right reagent area
R Barcode reading slot
I
K
J
A
H
B
D
C
E
F
G
L
O
P
Q
R
M
N
1 Overview of the analyzer
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
Overview of the analyzer 17
w Left and right view
u Related topics
• List of connectors, power switches, and fuses on the
analyzer (305)
• List of connectors and power switches on the control
unit (306)
A Control unit F Solid waste container
B Water container G Waste chute with cover
C Liquid waste container
D Connectors, power switches, and fuses
E Syringe
E
A
B
C
D
F
G
1 Overview of the analyzer
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
18 Operator areas and elements
Operator areas and elements
During normal operation, and to protect the user, access
is only required to few buttons and areas.
u Keyboard commands (35)
u
• About working areas for the operator (18)
• List of buttons and status indicators (19)
About working areas for the operator
For your convenience and protection, areas for regular
operation are situated at the front of the analyzer.
w Covers, button bar, and keyboard
Covers Blue transparent covers designate and protect the areas
where moving parts might cause injury. Keep all covers in
place while the analyzer is operating. Only open the
covers for specific tasks, for example, cleaning or
maintenance, and carefully follow the instructions.
A Cuvette conveyor cover D Keyboard
B Input buffer E Presence detector
C Button bar F Reagent area cover
A
B
F
E
C
D
1 Overview of the analyzer
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
Overview of the analyzer 19
List of buttons and status indicators
You use the button bar to control many aspects of
operation. Some buttons have the same function as keys
on the keyboard.
w Status indicators and buttons
In the following table, the buttons are listed in the order of
their location on the analyzer from left to right.
A Unload button with status indicator F Status indicators for reagent loading
B Start button with status indicator G Status indicator for barcode reading
C STAT button with status indicator H Reset button with status indicator for liquid level detection
D Stop button with status indicator
E Inhibit alarm button
C
A
B
G
D
F
E
H
Button Function Operators tasks
Unload button Moves the output buffer to the left to unload the processed
sample racks. If the output buffer is extended, then pressing
the button again retracts the buffer back to the right.
This button does the same as Shift+F4 on the keyboard.
u Unloading processed
sample racks (146)
Start button 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 order
processing.
This button does the same as Shift+F2 on the keyboard.
u Loading samples (142)
y Buttons on the button bar
1 Overview of the analyzer
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 · Operator’s Manual · Version 3.0
20 Operator areas and elements
Status indicators The status indicators on the button bar show where on
the analyzer samples and reagents are on board and
which status they have.
STAT button Stops processing samples in the sample pipetting area and
starts processing the sample rack that is loaded next to the
button.
When the STAT samples are processed, the analyzer
continues with the open orders for the samples in the sample
pipetting area.
This button does the same as Shift+F3 on the keyboard.
u Loading STAT
samples (150)
Stop button Immediately stops the pipetting operation. Incubation and
measurement of already pipetted tests continues.
Pipetting continues when the button is pressed again.
u Interrupting the pipetting
procedure (280)
Inhibit alarm button Confirms that the operator has noted the information in a
status message or has dealt with an error message. Must be
pressed to continue processing.
Pressing the button has the following effects:
o The message is not displayed anymore.
o Any acoustic alarm for the message is silenced.
o If any processes on the analyzer were interrupted by the
message, they continue.
o If any software functions 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 button does the same as F4 on the keyboard.
u Interrupting the pipetting
procedure (280)
Reset button Resets the electronics for sensoring. When the status
indicator for liquid level detection is red, pressing this button
can in some cases solve the problem.
u Pipetting errors (289)
Button Function Operators tasks
y Buttons on the button bar
Status indicator Color Meaning
Status indicator for the Unload button Off Standby
Green The output buffer is moving.
Orange You can remove sample racks from the output buffer.
Red Error
Status indicator for the Start button Off Standby
Green The analyzer is processing sample racks.
Status indicator for the STAT button Off Standby
Green The analyzer is processing STAT orders.
Orange The analyzer is ready for loading STAT samples. Routine orders
are not in progress or have been successfully interrupted.
Red Error
y Status indicators
/
