Roche cobas t 411 User manual

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.

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

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

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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

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Roche cobas t 411 User manual

Roche cobas t 411 User manual

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