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cobas p 480 v2

Roche cobas p 480 v2 User manual

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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
3
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.
Copyright © 2014–2017, F. Hoffmann-La Roche Ltd. All rights
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
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 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
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
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
18 Instrument overview
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
/