Roche cobas t 411 User manual

Brand: Roche

Model: cobas t 411

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

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

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.

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

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

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

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

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

• 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

B B

Roche Diagnostics

cobas t 411 coagulation analyzer · Software version v1.54_6 and higher · Open Channel Manual · Version 2.0

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

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

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)

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

Workflow

Step Details Related information

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.

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)

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)

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

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)

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)

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

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)

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.

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

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.

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

Printing barcode labels

• 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

Choose the configuration panel and press Enter:

• QC configuration

• Or: Reagent configuration

• Or: Calibration config.

Choose the row for which you want to print barcode

labels.

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

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

Roche cobas t 411 User manual

Roche cobas t 411 User manual

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