Roche cobas t 411 User manual

Type
User manual
cobas t 411 coagulation analyzer
Open Channel Manual
Version 2.0
Software version v1.54_6 and higher
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
2
Publication information
Edition notice This publication is intended for supervisors of the
cobas t 411 coagulation analyzer. In the cobas t 411
software, the supervisor user group is implemented as
labhead login.
Every effort has been made to ensure that all the
information is correct at the time of publishing. However,
Roche Diagnostics reserves the right to change this
publication as necessary and without notice as part of
ongoing product development.
Where to find information The Safety Manual contains important safety
information. You must read the Safety Manual before
operating the instrument.
The Operator’s Manual focuses on routine operation
and maintenance. The chapters are organized according
to the normal operation workflow.
!
General attention
To avoid incorrect results, serious or fatal injury, ensure
that you are familiar with the instructions and safety
information before you use the instrument.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument in a way that is not
described in this publication.
r Store all publications in a safe and easily retrievable
place.
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, or path names visible
therein must not be used for laboratory purposes.
Publication
version
Software version Revision date Change description
1.0 v1.51_6 November 2014 First version, not published.
2.0 v1.54_6 and higher August 2017 First published version
y Revision history
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
3
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 © 2014-2017, F. Hoffmann-La Roche Ltd. All rights
reserved.
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 use. 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 marks demonstrate compliance:
Contact addresses
Complies with the IVD directive 98/79/EC.
Kommanditgesellschaft Behnk Elektronik GmbH & Co
Hans-Böckler-Ring 27
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 and higher · Open Channel Manual · Version 2.0
4
T
able of contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Symbols and abbreviations . . . . . . . . . . . . . . . . . . . 6
About the measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
About cuvette bars . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Measuring principle . . . . . . . . . . . . . . . . . . . . . . . . . 9
Detection principle . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Workflow: Setting up an open channel test . . . . . . . . 12
Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Printing barcode labels . . . . . . . . . . . . . . . . . . . . . . 17
Printing barcode labels . . . . . . . . . . . . . . . . . . . 17
List of test settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Test settings panel . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Test information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
(a1) Test name. . . . . . . . . . . . . . . . . . . . . . . . . . . 19
(a2) Test abbreviation. . . . . . . . . . . . . . . . . . . . . 19
(a3) Test manufacturer. . . . . . . . . . . . . . . . . . . . 19
(a4) Test version . . . . . . . . . . . . . . . . . . . . . . . . . 19
(a5) Test protected . . . . . . . . . . . . . . . . . . . . . . . 20
Times list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
(b1) Incubation sec. . . . . . . . . . . . . . . . . . . . . . . 20
(b2) Start sec. . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
(b3) Measuring 1 sec . . . . . . . . . . . . . . . . . . . . . 21
(b4) Measuring 2 sec . . . . . . . . . . . . . . . . . . . . . 22
(b5) Single minimum . . . . . . . . . . . . . . . . . . . . . 23
(b6) Single maximum . . . . . . . . . . . . . . . . . . . . . 24
(b7) Pipetting time . . . . . . . . . . . . . . . . . . . . . . . 24
(b8) Pipetting sequence. . . . . . . . . . . . . . . . . . . 25
Testparameters list . . . . . . . . . . . . . . . . . . . . . . . . . . 27
(d1) Double . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
(d2) Tolerance %. . . . . . . . . . . . . . . . . . . . . . . . . 27
(e3) Tolerance delta abs. . . . . . . . . . . . . . . . . . . 27
(e4) Range delta abs. . . . . . . . . . . . . . . . . . . . . . 28
(e5) Measuring range low . . . . . . . . . . . . . . . . . 28
(e6) Measuring range high . . . . . . . . . . . . . . . . 28
(d3) Normal minimum . . . . . . . . . . . . . . . . . . . . 29
(d4) Normal maximum . . . . . . . . . . . . . . . . . . . . 29
(d5) Following test (FT) . . . . . . . . . . . . . . . . . . . 29
(e7) FT trigger point < . . . . . . . . . . . . . . . . . . . . 30
(e8) FT trigger point > . . . . . . . . . . . . . . . . . . . . 30
(d6) Derived test . . . . . . . . . . . . . . . . . . . . . . . . . 30
(d7) Dilution when repeat . . . . . . . . . . . . . . . . . 31
(d8) Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
(d9) Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
(e1) Sensitivity. . . . . . . . . . . . . . . . . . . . . . . . . . . 33
(e2) Max. tests in cuv. rack . . . . . . . . . . . . . . . . 33
Calculation list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
5
About first value and second value . . . . . . . . . 34
(g1) First value: type . . . . . . . . . . . . . . . . . . . . . . 34
(g2) First value: unit . . . . . . . . . . . . . . . . . . . . . . 35
(g3) First value: format . . . . . . . . . . . . . . . . . . . . 35
(g4) Second value: type . . . . . . . . . . . . . . . . . . . 35
(g5) Second value: unit . . . . . . . . . . . . . . . . . . . 36
(g6) Second value: format . . . . . . . . . . . . . . . . . 36
(g7) Raw data QC . . . . . . . . . . . . . . . . . . . . . . . . 36
Calibration list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
(k1) Interpolation . . . . . . . . . . . . . . . . . . . . . . . . 37
(k4) Graphic scale . . . . . . . . . . . . . . . . . . . . . . . 37
(k5) Interpolation c2. . . . . . . . . . . . . . . . . . . . . . 38
(k6) Graphic scale c2 . . . . . . . . . . . . . . . . . . . . . 38
(k3) Depending test . . . . . . . . . . . . . . . . . . . . . . 38
Volumes tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
About the volumes tables . . . . . . . . . . . . . . . . . 40
List of minimum and maximum volumes. . . . . 40
Settings for reagent mixing in the cuvette . . . 41
(m1) (n1) Liquid . . . . . . . . . . . . . . . . . . . . . . . . . 41
(m2) (n2) Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
(m3) (n3) C. Pos . . . . . . . . . . . . . . . . . . . . . . . . . 42
(m4) (n4) Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
(m5) (n5) Down. . . . . . . . . . . . . . . . . . . . . . . . . . 42
(m6) (n6) Wash . . . . . . . . . . . . . . . . . . . . . . . . . . 43
(m7) (n7) Dil.speed. . . . . . . . . . . . . . . . . . . . . . . 43
(m8) (n8) Incub. . . . . . . . . . . . . . . . . . . . . . . . . . 44
User interface: Description of configuration panels . 45
QC configuration panel . . . . . . . . . . . . . . . . . . . . . . 45
Reagent configuration panel. . . . . . . . . . . . . . . . . . 48
Calibration config. panel . . . . . . . . . . . . . . . . . . . . . 50
Hardware components and accessories . . . . . . . . . . . 52
Analyzer overview. . . . . . . . . . . . . . . . . . . . . . . . . . . 52
List of supported containers . . . . . . . . . . . . . . . . . . 53
List of supported racks . . . . . . . . . . . . . . . . . . . . . . 54
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
6 Preface
Preface
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
Product names Except where the context clearly indicated otherwise, the
following product names and abbreviations are used.
Symbols used in the publication
Product name Abbreviation
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
cobas t 411 coagulation
analyzer Operator’s Manual
Operator’s Manual
y Product names
Symbol Explanation
o List item
u Related topics containing further information
q Tip. Extra information on correct use or useful
hints.
r Start of a task
I Extra information within a task
f Result of a user action within 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 used in the publication
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
7
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 used in the publication
Abbreviation Definition
n/a not applicable
MNPT Mean normal prothrombin time
ISI International Sensitivity Index
y Abbreviations
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
8 About the measuring
About the measuring
u
About cuvette bars (8)
Measuring principle (9)
Detection principle (10)
About cuvette bars
Cuvettes always stay in cuvette bars.
One cuvette bar holds four cuvettes.
One side of the cuvette bar is serrated for optimal grip on
the cuvette conveyor.
A Cuvette
B Pipetting chambers
C Reaction chamber
D Cuvette chambers
E Mixing ball
F Serration for transport on cuvette conveyor
A Cuvette
B Pipetting chambers
C Reaction chamber
D Cuvette chamber 1 (L)
E Cuvette chamber 2 (H)
F Mixing ball
G Serration for transport on cuvette conveyor
C
B B
B
B
C
D
D
F
A
E
C
B B
B
B
C
D
E
G
A
F
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
9
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 and immuno-turbidimetric tests,
it measures the kinetic reaction.
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
10 About the measuring
Detection principle
To determine the clotting time, the analyzer uses an
algorithm with defined threshold values.
w Detection for clotting tests (as visible when logged on with service access rights)
To determine delta absorbance, the analyzer detects the
turbidity for period of time. The period of time is defined
in the test settings.
A Start of adjusting D Thresholds
(defined by (d9) Detection)
B Start of detection (defined by (b2) Start sec)
C Detected end point
C
D
D
B
A
1. Start of adjusting (A) 2. Start of detection (B) 3. Detected end point (C)
After the cuvette bar is tilted and sample
and reagents are mixed, the analyzer
dynamically adjusts the light intensity of
the LED.
Detection of the clotting time starts. The
analyzer continuously detects and
records the optical density (turbidity).
Clotting causes changes in turbidity.
When turbidity reaches a threshold
value, the curve crosses the threshold.
Measuring ends and the analyzer
records the end time.
About the thresholds (C):
o In the (d9) Detection setting, you define which thresholds are used.
o There is a positive threshold for tests where turbidity decreases (pos).
o There is a negative threshold for tests where turbidity increases (neg).
y About the clotting test curve
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
11
w Detection for chromogenic and immuno-turbidimetric tests (as visible when logged on with service access rights)
A Start of detection (defined by (b3) Measuring 1 sec) B End of detection (defined by (b4) Measuring 2 sec)
B
A
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
12 Workflow: Setting up an open channel test
Workflow: Setting up an open channel test
After your Roche Service representative has activated an
open channel test, you complete the test settings,
configure the reagents, and calibrate the test.
Prerequisites:
m A Roche service representative has activated an open
channel test.
- The initial name (a1) of the open channel test is
OpenCh.
- Open channel tests can only be in the X1-X17
positions in the Test menu.
- A maximum of 20 tests can be activated (Roche
tests and open channel tests).
Required materials and reagents:
m Instructions for use
m Calibrator (if required)
m QC material
m Reagents
m Stop watch
m Barcode label sheets for printing
Label format:
- Avery Zweckform 3666
- Size: 38 x 21.2 mm
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
13
Workflow
Step Details Related information
1
Access your test to be set
up.
1. Log on with supervisor access rights.
2. Choose the Test settings command, then an OpenCh
test, and press Enter.
2
Define the test settings. Adapt the given default settings.
Start with these settings in this order:
1. Set the (d9) Detection setting.
2. In the (b7) Pipetting time setting, set 400 as value.
3. Set the calculation settings and the calibration settings
((g) and (k) settings).
4. Set up both volumes tables.
o To prevent carryover, initially define an extra rinsing
step at the end of your test: In the last row of each of
your volumes tables, set 4C or 5C as value for the
(m6), (n6) Wash setting.
5. Set all remaining test settings.
Tip: Since the content of the Volumes single and the
Volumes double table is often similar, it is helpful to copy
and edit the content. To copy the content from the Volumes
single table, press Shift+F7.
u (d9) Detection (32)
u (b7) Pipetting time (24)
u Calculation list (34)
u Calibration list (37)
u Volumes tables (39)
u (m6) (n6) Wash (43)
3
Configure the test reagents. 1. In the Reagent configuration panel, change the given
default settings.
o The rows for your reagents must not contain -1
values.
o Liq.: Set the reagent abbreviations for (m1) and
(m2) as you have defined them in the Volume
single table for this test.
o Reagent: Enter the name of the reagent.
o PSN: Set a value between 1 and 63.
o Expiry date: Enter the expiry date of the reagent. The
expiry date must be in the future.
o Stir: If the reagent requires stirring, set to Yes by
pressing the spacebar.
o Cool: If the reagent requires cooling, set to Yes by
pressing the spacebar.
o Sz: Must always be set to 0.
o OS: Enter the defined onboard stability of the reagent
in hours.
o M: Set 2 or 3 as value.
o T: Set 0 as value.
o R: Set a unique value greater than 50.
o Code: Is automatically filled after you perform the
first calibration or validation.
o Lot No.: Type the lot number.
u Calibration config.
panel (50)
4
Print the reagent barcodes. 1. Put the barcode label sheets in the printer.
Use this label format:
o Avery Zweckform 3666
o Size: 38 x 21.2 mm
2. Print the barcodes for each reagent:
1) In the Reagent configuration panel, choose a row.
2) Press Print Screen.
3. Place the barcode labels horizontally on the reagent
bottles or the reagent cups.
u Printing barcode
labels (17)
u List of supported
containers (53)
y Workflow: Setting up an open channel test
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
14 Workflow: Setting up an open channel test
5
Configure the calibration. 1. In the Calibration config. panel, change the given
default settings.
o The rows for your calibrators must not contain -1
values.
o PSN: Set a value between 1 and 63.
o Expiry date: Enter the expiry date of the calibrator or
buffer. The expiry date must be in the future.
o Stir: Must always be set to No.
o Cool: Must always be set to No.
o Sz: Must always be set to 0.
o OS: Enter the defined onboard stability of the
calibrators or/and buffer in hours.
o M: Set 2 or 3 as value.
o T: Set 2 as value.
Exception: If a diluent (BU) is also used as a test
reagent in your test, set 0 as value. For such a diluent,
there must be two identical rows, one in the Reagent
configuration panel and one in the Calibration
config. panel.
o R: Set a unique value greater than 50.
o Code: Is automatically filled after you perform the
first calibration or validation.
o Lot No.: Type the lot number.
u Calibration config.
panel (50)
6
Print the calibrator
barcodes.
1. Put the barcode label sheets in the printer.
Use this label format:
o Avery Zweckform 3666
o Size: 38 x 21.2 mm
2. Print the barcodes for each reagent:
1) In the Calibration config. panel, choose a row.
2) Press Print Screen.
3. Place the barcode labels horizontally on the calibrator
bottles or the calibration cups.
u Printing barcode
labels (17)
u List of supported
containers (53)
7
Configure the QC. 1. In the QC configuration panel, change the given default
settings.
o The rows for your QC material must not contain -1
values.
o PSN: Set a value between 1 and 63.
o Expiry date: Enter the expiry date of the QC material.
The expiry date must be in the future.
o Sz: Must always be set to 0.
o OS: Enter the defined onboard stability of the QC
material in hours.
o M: Set 2 or 3 as value.
o T: Set 1 as value.
o R: Set a unique value greater than 50.
o Validity: Enter the time interval between two QC runs
in hours. This defines how long a QC run should be
valid.
o Target: Enter the Mean target value as indicated in
the package insert of the QC material.
o Range: Enter the Lower and Upper limits of the
target range as indicated in the package insert of the
QC material.
2. In the QC panel, change the given default settings:
o Lot No.: Type the lot number.
o Code: Is automatically filled after you perform the
first QC run.
u QC configuration
panel (45)
Step Details Related information
y Workflow: Setting up an open channel test
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
15
8
Print the QC material
barcodes.
1. Put the barcode label sheets in the printer.
Use this label format:
o Avery Zweckform 3666
o Size: 38 x 21.2 mm
2. Print the barcodes for each QC material:
1) In the QC configuration panel, choose a row.
2) Press Print Screen.
3. Place the barcode labels horizontally on the QC material
bottles.
u Printing barcode
labels (17)
u List of supported
containers (53)
9
Perform a dummy
calibration.
For tests that require calibration:
1. Choose Calibration, the test, and press Enter.
2. Choose Manually and press Enter.
3. Load the test reagents.
o Load all reagents that are listed in the displayed
messages.
o Use the reagent bottles with the barcode labels you
have printed before.
4. Enter dummy calibration values.
5. Press Esc.
6. Choose Show curve.
7. Press Esc.
8. In the Valid: field, choose Yes.
9. Press Esc.
For tests that do not require calibration (validation without
calibration):
1. Choose Calibration, the test, and press Enter twice.
2. Load the test reagents.
o Load all reagents that are listed in the displayed
messages.
o Use the reagent bottles with the barcode labels you
have printed before.
3. If required for your test, enter the ISI: value and the
Normal: value.
4. In the Valid: field, choose Yes.
5. Press Esc.
Result: The software updates your entries in the
configuration panels. they are now complete and correct.
For details about how to
perform a calibration or a
validation without calibration,
see the Operator’s Manual.
10
To verify the pipetting time,
process NaCl as sample.
1. Start order processing for 4 samples.
2. Time the pipetting duration of one cuvette bar.
o Pipetting duration: Duration between the moment
when the probe moves out of the rinse station and
the moment when the cuvette bar moves out of the
pipetting station.
3. In the Test settings panel, change the value for the (b7)
Pipetting time setting.
u (b7) Pipetting time (24)
u Analyzer overview (52)
For details about sample
processing, see the
Operator’s Manual
Step Details Related information
y Workflow: Setting up an open channel test
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
16 Workflow: Setting up an open channel test
11
Perform calibration or
validation
1. Enter the target or reference values.
o Tests with calibrator set method:
Enter the target values of all calibrators defined in the
Calibration config. panel. Each calibrator needs a
value. 0.00 is not allowed.
o Tests with universal calibrator method:
Enter the given Reference value.
Select the dilution stages (using the spacebar) as
indicated in the package insert.
If required for your test, enter the ISI value and the
Normal value.
2. Validate the volumes tables during calibration:
o Observe which pipetting sequence the analyzer
performs.
o In the Test settings panel, change the volumes
tables settings if required.
3. If changes are made, perform a new calibration.
4. For tests without calibration, perform the validation.
12
Validate the results. 1. Load reagents and QC materials.
2. Perform a QC.
3. Check the results.
u List of supported
containers (53)
u Volumes tables (39)
u See also Operator’s
Manual
Step Details Related information
y Workflow: Setting up an open channel test
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
17
Printing barcode labels
u
Printing barcode labels (17)
Printing barcode labels
You can print barcode labels for reagents, QC materials,
and calibrators from the configuration panels.
d Label format:
Avery Zweckform 3666
Size: 38 x 21.2 mm
j m Empty barcode label sheets are placed in the printer.
r To print barcode labels
1
Choose the configuration panel and press Enter:
QC configuration
Or: Reagent configuration
Or: Calibration config.
2
Choose the row for which you want to print barcode
labels.
3
Press Print Screen.
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
18 List of test settings
List of test settings
u Related topics
Measuring principle (9)
Test settings panel
w Test settings panel
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
19
Test information
(a1) Test name
(a2) Test abbreviation
(a3) Test manufacturer
(a4) Test version
Description Full name of the test
Is printed on the first line of printouts. Is not printed on result printouts.
Unit n/a
Value range Max. 23 characters
Description Abbreviation of the test name.
o Is displayed in the Menu panel, in configuration and results panels.
o Is printed on the first line of result printouts.
Unit n/a
Value range Max. 7 characters
Description Name of the reagent manufacturer.
You need this information when contacting your Roche Service representative for troubleshooting.
Unit n/a
Value range Max. 23 characters
Description Version number of the test settings.
Allows you to change and back up different settings for the same test.
Unit n/a
Value range 0-99
Note If you want to back up different settings versions for the same test, use a different USB flash drive
for each settings version. The software does not save histories. Every time you back up test settings,
the software overwrites previous settings on the USB flash drive.
Roche Diagnostics
cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0
20 List of test settings
(a5) Test protected
Times list
(b1) Incubation sec
This setting means basically the same for all test types,
but some details only apply to one test type.
Description Not used.
Indicates whether the test is a Roche-defined or an open channel test. If the value is Yes, the test
is a Roche-defined test and you cannot adapt it.
Clotting tests
Description Incubation time of sample and reagent.
Unit Seconds
Value range 40-999
Tip o See the instructions for use of the manufacturer.
o The analyzer processes different tests in the same cuvette bar if they have the same (b1)
Incubation sec value and the same (d9) Detection value.
Chromogenic and
immuno-turbidimetric
tests
Description Incubation time of sample and reagent.
Unit Seconds
Value range 40-999
Tip See the instructions for use of the manufacturer.
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Roche cobas t 411 User manual

Type
User manual

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