Roche cobas p 480 v2 User manual

cobas p 480 v2 instrument

Operator's Manual

Version 1.1

Software version 2.1.1

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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Publication information

Edition notice This publication is intended for operators of the

cobas p 480 v2 instrument.

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 serious or fatal injury, ensure that you are

familiar with the system 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 and graphics The screenshots and graphics 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 2.1.1 March 2017 First version

1.1 2.1.1 September 2017 o Cap term explanation

o Workflow loading information

o User right depending workflow settings

o Minimum sample fill volume

o Sample barcode handling

y Revision history

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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Warranty Any customer modification to the instrument 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.

License information cobas p 480 software is protected by contract law,

copyright law, and international treaties. cobas p 480

software contains a user license between F. Hoffmann-La

Roche Ltd. and a license holder, and only authorized

operators may access the software and use it.

Unauthorized use and distribution may result in civil and

criminal penalties.

Open Source and Commercial Software cobas p 480 software may include components or

modules of commercial or open-source software. For

further information on the intellectual property and other

warnings, as well as licenses pertaining to the software

programs included in cobas p 480 software, refer to the

electronic distribution included with this product.

The respective authorization is no longer valid according

to the corresponding legislation should any unauthorized

changes be made to cobas p 480 software or

cobas p 480 instrument.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS P, 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.

Approvals The cobas p 480 instrument meets the requirements of

the Directive 98/79/EC.

Directive 2011/65/EU of the European Parliament and of

the Council of 8 June 2011 on the restriction of the use of

certain hazardous substances in electrical and electronic

equipment.

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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The following marks demonstrate compliance:

Contact addresses

Complies with the IVD directive 98/79/EC.

For in vitro diagnostic use.

Issued by CSA Group for Canada and the US.

Global Trade Item Number.

cobas p 480 v2 instrument

Made in Switzerland by Hamilton Bonaduz AG for

Roche Molecular Systems, Inc.

1080 US Highway 202 South

Branchburg, NJ 08876

USA

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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Table of contents 7

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

Table of contents

Publication information 3

Contact addresses 5

Table of contents 7

Intended use 9

Symbols and abbreviations 9

What is new in the Operator’s Manual

version 1.1 11

What is new in software version 2.1 12

System description

1 Overview of the system

Instrument overview 17

Consumables overview 39

Operation

2 Overview of the instrument

Hardware overview 53

Supplies overview 54

3 Overview of operation

Overview of the workflow 59

Introduction to the user interface 64

4 Before operation

Before operation 73

5 Operation

Basic operational tasks 79

Workflows 93

Error handling 123

6 After operation

Shutting down the system 131

7 Maintenance

About periodic, specific, and preventive

maintenance 135

Maintenance schedule 136

Maintenance information in the user

interface 137

Daily maintenance 138

Weekly maintenance 150

8 Configuration

Changing laboratory name and the folder

location for reports 159

Changing the workflow settings 160

About managing users 161

Troubleshooting

9 Troubleshooting

Troubleshooting information in the user

interface 171

Stopping the instrument in exceptional

situations 173

Placing carriers when a stop hook is

broken 175

Restoring the instrument from a stop 176

Creating a problem report 193

Remote support 194

Appendix

10 Technical specifications

Instrument capacities 199

Specifications of instrument and software 200

Specifications of barcode readers and

barcode labels 203

Index 207

8 Table of contents

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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Intended use

The cobas p 480 instrument is a stand-alone general

purpose laboratory instrument to minimize repetitive

manual tasks associated with specimen handling. This

instrument is intended to perform pre-analytics

processing such as decapping and recapping, pipette-

and spin-mixing specimens, and aliquoting specimens to

secondary vials. Additional hardware components and

programing flexibility allow automation of more complex

pre-analytic processes including reagent addition and

heating.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the

following product names and abbreviations are used.

Terms

Product name Abbreviation

cobas p 480 instrument instrument

cobas p 480 software software

cobas

®

PCR Media

CPM

PreservCyt

®

PC

Roche Cell Collection

Medium

PC

cobas

®

PCR Cell Collection

Media

PC

SurePath

™

SP

y Product names

Term Explanation

system Used when the emphasis is on

software and hardware as a

whole.

CPM cap Cap T01, 19 mm

PC cap Cap N01, 42 mm

SP cap Cap B01, 34 mm

MPA Workflows operating with 5-

position racks without stabilizers

for tubes with a diameter of

15.8 ± 0.2 mm.

y Terms

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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Symbols

Abbreviations The following abbreviations are used.

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 an 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 Table. Used in table titles and cross-references

to tables.

y Symbols used in the publication

Abbreviation Definition

ANSI American National Standards Institute

CSA Canadian Standards Association

EC European Community

EN European standard

ID Identification number

IEC International Electrical Commission

IVD In vitro diagnostic

LED Light-emitting diode

UI User interface

USB Universal serial bus

y Abbreviations

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cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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What is new in the Operator’s Manual version 1.1

An overview of the changes compared to the previous

version of the manual is provided below.

Caps The term explanation is adjusted

u Terms (9)

Workflow tables For workflows, the information about the maximum

loading of racks and samples is improved.

u Decapping run (all media) (94)

u Decapping run (PC only) (97)

u Decapping run - MPA rack (99)

u Recapping run (all media) (102)

u Recapping run (PC only) (105)

u Recapping run - MPA rack (107)

u Aliquoting run (all media) (110)

u Aliquoting run - MPA rack (113)

u Heating and reagent addition run (117)

u Heating and reagent addition run - MPA rack (120)

Workflow settings Description for changing the workflow settings according

to the user rights.

u Changing the workflow settings (160)

Minimum fill volume For the Aliquot run and the Heating and reagent addition

run a recommended sample fill volume is provided.

u About the recommended minimum sample fill

volume (206)

Sample barcode dimensions To avoid sample barcode reading errors, the sample

barcode dimensions have been adapted.

u See:

Dimensions of barcode labels on primary containers

and tubes (44)

Dimensions of barcode labels on containers (204)

Sample barcode handling To avoid instrument errors because of a wrong sample

bercode handling, a quick guide is provided.

u See:

Quick sample container barcode labeling guide (46)

Quick sample container barcode labeling guide (205)

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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What is new in software version 2.1

An overview of the changes compared to the previous

version of the manual is provided below.

MPA rack carriers The cobas p 480 system provides workflows for sample

handling in which the samples are placed on MPA rack

carriers as a final step.

u MPA racks (33)

u MPA rack carrier for CPM tubes (34)

u MPA rack carrier for secondary tubes (35)

u Decapping run - MPA rack (99)

u Recapping run - MPA rack (107)

u Aliquoting run - MPA rack (113)

u Heating and reagent addition run - MPA rack (120)

Sample limitations for decapping runs Decapping runs are not limited to 96 samples. You can

use the entire sample area for loading.

u Decapping run (93)

Loading error handling The software offers more precise error handling. So if

there is a loading error only the involved carriers can be

unloaded for investigation.

u Handling loading errors (123)

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

System description

1 Overview of the system ........................................................................................ 15

1 Overview of the system

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Table of contents

Overview of the system 1

In this chapter

1

Instrument overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

About the covers on the instrument . . . . . . . . . . . 17

About the LEDs on the instrument. . . . . . . . . . . . . 18

About the instrument deck . . . . . . . . . . . . . . . . . . . 19

About the autoload unit. . . . . . . . . . . . . . . . . . . 21

About the pipetting arm. . . . . . . . . . . . . . . . . . . 23

About the grippers . . . . . . . . . . . . . . . . . . . . . . . 24

About the heating station . . . . . . . . . . . . . . . . . 25

About the decapper/recapper modules . . . . . 26

About the teaching needles . . . . . . . . . . . . . . . 27

About the solid waste station setup. . . . . . . . . 28

About carriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

About collection medium carriers . . . . . . . . . . 32

About secondary tube carriers . . . . . . . . . . . . . 35

About cap carriers . . . . . . . . . . . . . . . . . . . . . . . 36

About the reagent reservoir carrier . . . . . . . . . 37

About the tip rack carrier . . . . . . . . . . . . . . . . . 38

Consumables overview . . . . . . . . . . . . . . . . . . . . . . . . . 39

About the pipette tips . . . . . . . . . . . . . . . . . . . . . . . 39

About the reagent reservoirs . . . . . . . . . . . . . . . . . 40

About caps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

About solid waste consumables. . . . . . . . . . . . . . . 43

About primary containers and tubes . . . . . . . . . . . 43

Quick sample container barcode labeling guide . 46

About secondary tubes . . . . . . . . . . . . . . . . . . . . . . 47

1 Overview of the system

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cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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Table of contents

1 Overview of the system

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

Overview of the system 17

Instrument overview

In this section

About the covers on the instrument (17)

About the LEDs on the instrument (18)

About the instrument deck (19)

About carriers (31)

About the covers on the instrument

w Covers of the instrument

The front cover protects you from moving parts inside the

instrument. The front cover can be opened for user

interaction during maintenance. Always close the front

cover when you have finished maintenance work. During

a run, the front cover must be closed.

Solid waste door The solid waste door gives you access to the small solid

waste bag or the waste chute. During a run, the solid

waste door is locked and must stay closed.

A Left side cover C Right side cover

B Front cover D Solid waste door

A

C

B

D

1 Overview of the system

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

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NOTICE

Loss of materials due to forced opening of front

cover

The front cover is locked during a run. Forcing the front

cover open during a run, causes an emergency stop. The

run is aborted and all on-board reagents and in-process

samples are lost.

r Do not attempt to start the run with the cover open.

About the LEDs on the instrument

The LED bar above the autoload tray indicates the loading

status on the instrument deck. The status LEDs inform

you where to place the carriers on the autoload tray and

which tracks on the instrument deck have a carrier on

them.

A Track

B LED bar above the autoload tray indicating the

loading status

A

B

LED status Meaning User action

No light No carrier loaded. No action necessary.

Green light steady Carrier loaded on this track. No action necessary.

Green light blinking Carrier can be loaded on this track. Place the carrier on the autoload tray on

the indicated tracks. Insert the carrier

until it touches the stop hook.

y Status LEDs on LED bar

1 Overview of the system

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

Overview of the system 19

About the instrument deck

The work area of the instrument is called instrument deck.

The instrument deck holds the following items:

• Removable carriers for samples, secondary tubes,

caps, reagents, and tips.

• Two decapper/recapper modules for decapping and

recapping of collection medium containers and tubes.

• The heating station (optional) for sample incubation.

Instrument deck layout The instrument deck is divided into 43 equal tracks. The

tracks are numbered so that the location where a carrier

must be loaded can be identified. The track positions are

stamped on the surface of the autoload tray. A

corresponding LED on the LED bar above the autoload

tray indicates the loading status of each track.

Track assignment is workflow- and media-specific. The

instrument deck layout below shows an example of the

areas for each carrier type.

1 Overview of the system

Roche Diagnostics

cobas p 480 v2 instrument · Software version 2.1.1 · Operator's Manual · Version 1.1

20 Instrument overview

w Example of the instrument deck layout (for a heating and reagent addition run)

In this section

About the autoload unit (21)

About the pipetting arm (23)

About the grippers (24)

About the heating station (25)

About the decapper/recapper modules (26)

About the teaching needles (27)

About the solid waste station setup (28)

A Tip rack carrier E 24-position sample carriers or MPA rack carriers with

secondary tubes or CPM tubes.

B Heating station for heating and reagent addition runs

(optional)

F Collection medium carriers with collection medium

containers

C Cap carrier G Error carriers

D Reagent reservoir carrier

A

B C D E F G

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Roche cobas p 480 v2 User manual

Roche cobas p 480 v2 User manual

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