cobas® 6800/8800 Systems

User Guide
Publication version 3.1

Software version 1.2

2

Publication information

Publication version Software version Revision date Change description

1.0 1.0 August 2014 First version
1.1 1.0 August 2014 Added videos and utility films to the User
Assistance.
1.2 1.0 October 2014 Added information on how to create
reports, implemented information related to
findings from usability tests, changed
procedure on how to empty solid waste.
2.0 1.1 July 2015 Section About the interval of the automatic
delete archived data maintenance action
removed.
Section Defining the interval to delete
archived data added.
Section About the automatic IG server
cleanup removed.
Section Defining automatic IG server
cleanup added.
2.1 1.1.10 January 2016 Publication title Operator’s Manual changed
to User Guide.
Section Cleaning up the instrument during
startup updated.
Section Canceling a run updated.
3.0 1.2 September 2016 Added new section about the minimum
volumes for primary gel tubes.
Updated the list of supported sample tubes
and the procedure to replace the liquid
waste container.
u What is new in publication version
3.0 (12)
3.1 1.2 August 2017 Intended use updated. New instrument
approval. New radio equipment
specifications.
Update about repeat test.
Updated maintenance tasks to clean
processing module from front and to clean
covers. New maintenance task to
decontaminate rack trays.
u What is new in publication version
3.1 (11)
y Revision history

Edition notice This publication is intended for operators of the

cobas® 6800/8800 Systems.

Every effort has been made to ensure that all the

information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.

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Where to find information The User Assistance contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• Configuration information
• Background information

The Safety Manual contains important safety

information. You must read the Safety Manual before
operating the instrument.

The User Guide 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 instructions and safety information
before you use the system.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the system 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.

Images The screenshots and hardware images in this publication

have been added exclusively for illustration purposes.
Configurable and variable data in screenshots, such as
tests, results, or path names visible therein must not be
used for laboratory purposes.

Warranty Any customer modification to the system will render the

warranty or service agreement null and void.

For conditions of warranty, please contact your local sales

representative or refer to your warranty contract partner.

Software updates must be performed by or with the

assistance of a Roche Service representative.

Copyright © 2014-2017, F. Hoffmann-La Roche Ltd. All rights

reserved.

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Trademarks The following trademarks are acknowledged:

COBAS, COBAS OMNI, 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.

Instrument approvals The cobas® 6800/8800 Systems meets the requirements

laid down in:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical
devices.

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.

Directive 2014/53/EU of the European Parliament and of

the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making
available on the market of radio equipment and repealing
Directive 1999/5/EC.
To view the full text of the 2014/53/EU declaration of
conformity, go to the Roche DiaLog Global Web Site
(https://dialog1.roche.com/) and choose the eLabDoc
link.
If you are unable to access Roche DiaLog, contact a
Roche Service representative.

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

The following marks demonstrate compliance:

Complies with the provisions of the applicable EU

directives.

For in vitro diagnostic use.

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Issued by Underwriters Laboratories, Inc. (UL) for

Canada and the US.

Issued by CSA Group for Canada and the US.

C US

'Laboratory Equipment' is the product identifier as

shown on the type plate.

Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland

Distributed in the United States by Roche Diagnostics

9115 Hague Road
Indianapolis
Indiana, USA

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Table of contents

Publication information 2 5 Sample processing

Contact addresses 5 Setting the system to Ready status 125
Table of contents 7 Handling test orders 126
Intended use 9 Overview of loading/unloading procedures 130
Symbols and abbreviations 9 Handling racks for clotted tips 135
What is new in publication version 3.1 11 Loading samples 140
What is new in publication version 3.0 12 Unloading sample racks 149
What is new in publication version 2.1 13 Starting a run 154
What is new in publication version 2.0 14 Canceling a run 157
What is new in publication version 1.2 15 Masking/unmasking a module or magazine 158
Reviewing test results 160
Test result reports 172
Operation Releasing test results 178
Releasing test results via remote
1 Overview of the system connection 179
About the cobas® 6800/8800 Systems 21 Downloading files from the IG server 180
Overview of the sample supply module 23 Viewing audit trail entries 181
Overview of the transfer module 26 Exporting test results 183
Overview of the processing module 28 Priming the instrument 184
Overview of the analytic module 31
Buttons and power switches on the system 32 6 After operation
Pausing and resuming the system 187
2 Overview of operation Setting the system to Hibernate status 188
Overview of the software 39 Shutting down the system 190
Overview of the main workflow 52 Restarting by power switch 193
Quick start guide 55 Shutting down the IG server 195
Starting the IG server 196
3 Before operation Setting the system to powerless status 197
Starting up the system 61 Shut down for more than 10 days 200
System alarm concept 71
7 Maintenance
4 Reagents and consumables List of maintenance intervals 203
Overview of the reagents and consumables 85 Periodic maintenance 204
Unloading the amplification plates 86 Moving the movable platform 235
Handling the wash/waste drawer 88 Regular maintenance 239
Loading the bulk reagent drawer 102 Automatic maintenance actions 242
Loading the consumables drawer 107 Decontamination 247
Loading and unloading the reagent cassette
drawer 114
Appendix

8 Specifications
List of system specifications 261
Supported material 264

9 Glossary
Index 271

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Intended use

The cobas® 6800/8800 Systems support an automated

and integrated workflow to run Polymerase Chain
Reaction (PCR) based Nucleic Acid Testing (NAT).
The cobas® 6800/8800 Systems combine the
functionalities of instrumentation, consumables, reagents,
and data management to provide an efficient workflow
from sample processing to result interpretation.

Symbols and abbreviations

Product names Except where the context clearly indicates otherwise, the
following product names and descriptors are used.

Product name Descriptor

cobas® 6800 System system

cobas® 6800/8800 Systems system

cobas® 6800/8800 Systems software

software
cobas® 8800 System system
cobas omni Amplification Plate amplification plate
cobas omni Liquid Waste liquid waste container
Container
cobas omni Lysis Reagent lysis reagent
cobas omni MGP Reagent MGP reagent
cobas omni Pipette Tips tip rack
cobas omni Processing Plate processing plate
cobas omni Solid Waste solid waste container
Container
cobas omni Specimen Diluent diluent
cobas omni Wash Reagent wash reagent
y Product names and abbreviation

Symbols used in the publication The following symbols are used:

Symbol Explanation
o List item
u Related topics containing further information
Tip. Extra information on correct use or useful
q
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.
y Symbols used in the publication

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Symbol Explanation
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.
Figure. Used in figure titles and cross-
w
references to figures.
Table. Used in table titles and cross-references
y
to tables.
Equation. Used in cross-references to
z
equations.
Code example. Used in code titles and cross-
k
references to codes.
y Symbols used in the publication

Symbols used on the product

Symbol Explanation

Global Trade Item Number

Quantity contained in the package.

Hardware coding of the cobas omni

Amplification Plate

Hardware coding of the cobas omni Pipette

Tips

Hardware coding of the cobas omni

Processing Plate

y Symbols used on the product

Abbreviations The following abbreviations are used:

Abbreviation Definition
ANSI American National Standards Institute
EC European Community
EN European standard
IEC International Electrical Commission
LIS Laboratory information system
MGP Magnetic glass particles
NAT Nucleic acid testing
n/a not applicable
PCR Polymerase chain reaction
y Abbreviations

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What is new in publication version 3.1

Intended use The intended use statement was updated.

u Intended use (9)

Additional directive New directive added to instrument approvals.

u Instrument approvals (4)

Radio equipment specifications Specifications for radio equipment were added.

u Radio equipment specifications (263)

Repeat test Tip added how to retest invalid individual sample. Further
reason added why no repeat test is possible. Information
added about repeat test with history calculation.
u Reviewing test results (160)
u No repeat test possible (168)
u Repeat test with history calculation (168)

Cleaning of processing module The maintenance procedure for cleaning the processing
module from the front was updated.
u To clean the processing module from the front p (231)

Cleaning of blue acrylic windows The maintenance procedure for cleaning covers and
doors was updated. Information to not clean the blue
acrylic windows with ethanol was added.
u To clean the covers and doors p (239)

General decontamination procedure The general decontamination procedure was updated to

include lint-free cotton swabs.
u General decontamination procedures (247)

Decontaminating rack trays Decontamination of rack trays was separated from

decontamination of sample racks. A maintenance task to
decontaminate rack trays was added.
u Decontaminating sample racks (253)
u Decontaminating rack trays (254)

Cleaning up of processing module for The troubleshooting procedure to clean up the

troubleshooting processing module from the front was updated.
u Refer to the section To clean up the processing
module from the front in the User Assistance.

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What is new in publication version 3.0

Strong magnetic field label Information added about this new safety label.
u Refer to the section List of safety labels on the system
in the User Assistance

List of supported sample tubes Update of the sample tube types and dimensions
supported by the system.
u List of supported sample tubes (264)

Minimum volumes for primary gel tubes New section listing the minimum volumes required for
primary gel tubes.
u Minimum volumes for primary gel tubes (264)

Replacing the liquid waste container Previous task (Emptying the liquid waste container)
updated.
u Replacing the liquid waste container (94)

Barcode settings The minimum number of characters supported in

barcodes was updated.
u Refer to the section Barcode settings in the User
Assistance

Automatic hibernation and startup Section for the new feature to set up a time to hibernate
or start up the system automatically.
u Refer to the section Automatic system hibernation and
startup processes in the User Assistance

New options to configure the LIS connection Steps added to include the new settings available for the
LIS connection.
u Refer to the section Defining the connection to the LIS
in the User Assistance

Defining regional settings Section for the new feature that allows configuring
default language and regional settings.
u Refer to the section Defining regional settings in the
User Assistance

Defining print and report settings Section for the new feature that allows configuring print
and report options.
u Refer to the section Defining print and report settings
in the User Assistance

Troubleshooting of open reagent cassette What to do if you fin the reagent cassette drawer open
drawer after restarting the system.
u Refer to the section Reagent cassette drawer open in
the User Assistance

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What is new in publication version 2.1

User Assistance The section describing installation and use of the User
Assistance has been updated. The topic has also been
moved to a more prominent position within the
publication.
u Refer to the section User Assistance in the User
Assistance.

Starting up the system from off status A step explaining how to manually start up the IG server if
power switch 2 was set to "0" was added.
u Starting up the system from Off status (61)

Loading/Unloading procedures Information was added to the step explaining how to

close the drawer. The user who has opened the drawer is
listed in the audit trail for all loading and unloading
activities carried out while the drawer was open.

Information was added that the system must not be in

Initializing status when opening drawers (except
wash/waste drawer).
u Unloading the amplification plates (86)
u Loading diluent and lysis reagent bottles (103)
u Unloading/loading the consumables drawer (107)
u Unloading control and reagent cassettes (117)
u Loading tip racks, reagent, and control cassettes (114)

Loading samples Added hazard statement not to use damaged or

compromised sample tubes.
u Loading samples (140)

Handling barcode reading errors If a barcode on a sample tube cannot be read repeatedly,
remove the sample tube from the sample rack. Only then
can the sample rack be loaded.
u Handling barcode reading errors (144)

Canceling a run The procedure has been corrected. After canceling the
run, the sample orders are not shown in the load list (as
described previously) but in the list of sample orders.
u Canceling a run (157)

Resetting test orders after error The information was added to the precondition of the
procedure, stating that the system must not be in one of
the following statuses: Running, Stopping, Pausing,
Ready, Preparing.
u Resetting test orders after error (128)

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Test result formatting Information was added that Ct values are displayed also
for invalid results.
u About test result formatting (160)

Priming the instrument Corrected precondition from Ready status to Standby

status.
u Priming the instrument (184)

Periodic maintenance The subprocedure Starting the periodic maintenance

wizard to open the covers has been updated. The movable
platform must be in home position before starting the
maintenance wizard.
u Periodic maintenance (204)

Cleaning up the instrument The troubleshooting procedure describing how to clean

up the instrument during startup has changed. The
emergency stop button is no longer used. A maintenance
wizard is used to open the front cover. A subprocedure
has been added instructing to unload the amplification
plate drawer as part of the cleanup procedure.
u Refer to the section Cleaning up the instrument during
startup in the User Assistance

Barcode settings The sections Defining the barcode settings and About
barcodes were updated to reflect the current behavior of
the software.
u Refer to the section Barcode settings in the User
Assistance.

Disassembling the gripper finger The number of gripper fingers that are visible on the
system has been corrected.
u Refer to the section Disassembling the gripper finger
in the User Assistance.

What is new in publication version 2.0

Hardware explorers A new tab in the User Assistance allowing graphical

navigation through the system.
u Video - Using the User Assistance (24)

Emptying solid waste A new procedure describing how to empty the solid
waste was added. It is also possible to empty solid waste
by replacing the solid waste container.
u Replacing the solid waste container (91)

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Canceling a run A new procedure describing how you can cancel all runs
that are not yet being processed by stopping the analytic
system.
u Canceling a run (157)

Test result formatting Reactive test results are now highlighted in red in test
result views and reports.
u About test result formatting (160)

Control batch report This section was added to describe how to create a
control batch report.
u To create a control batch report p (174)

Automatic delete archived data maintenance Section About the interval of the automatic delete
action archived data maintenance action was replaced by
Defining the interval to delete archived data.
u Refer to the section Defining archiving settings and
interval in the User Assistance.

Automatic IG server cleanup Section About the automatic IG server cleanup was
replaced by Defining automatic IG server cleanup.
u Refer to the section Defining automatic IG server
cleanup in the User Assistance.

What is new in publication version 1.2

This update is related to documentation updates only. No

changes were done in the software of the system.

Moved component descriptions to User The descriptions of the components (such as sample
Assistance pipetter, heating station) were removed from the User
Guide and moved to the User Assistance.

Archive and IG server cleanup Added information that the Archive and IG server cleanup
maintenance actions must not be performed.

Creating test result reports A procedure describing how to create test result reports
was added.
u Test result reports (172)

Emptying solid waste The procedure describing how to empty the solid waste
was updated. As sharp objects may pierce the solid waste
bags, additional caution is required. It is necessary to
perform a visual check of the solid waste bags and the
solid waste container. Also, it is necessary to
decontaminate the solid waste container if a leakage was
detected.
u Emptying the solid waste container (88)
u Cleaning the solid waste container (1 of 3) (211)
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Cleaning up the instrument The troubleshooting procedures describing how to clean

up the instrument during startup was updated. All
references to the cleanup wizard were removed. The
procedures describe how the instrument can be cleaned
up without using the cleanup wizard.
u Refer to the section Cleaning up the instrument
during startup in the User Assistance

Weight specification The specification of the weight of the instrument was

updated.
u Dimensions and weight (262)

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cobas® 6800/8800 Systems · Software version 1.2 · User Guide · Publication version 3.1
 Operation

1 Overview of the system ........................................................................................ 19

2 Overview of operation........................................................................................... 37
3 Before operation ..................................................................................................... 59
4 Reagents and consumables ............................................................................... 83
5 Sample processing .............................................................................................. 123
6 After operation ...................................................................................................... 185
7 Maintenance .......................................................................................................... 201

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Table of contents

Overview of the system 1

In this chapter 1
About the cobas® 6800/8800 Systems . . . . . . . . . . . . 21
Overview of the sample supply module. . . . . . . . . . . . 23
About the sample supply module. . . . . . . . . . . . . . 23
About the IG server . . . . . . . . . . . . . . . . . . . . . . . . . 25
Overview of the transfer module . . . . . . . . . . . . . . . . . 26
About the transfer module . . . . . . . . . . . . . . . . . . . 26
Components of the transfer module . . . . . . . . . . . 27
Overview of the processing module. . . . . . . . . . . . . . . 28
About the processing module. . . . . . . . . . . . . . . . . 28
Components of the processing module . . . . . . . . 29
Overview of the analytic module . . . . . . . . . . . . . . . . . 31
About the analytic module . . . . . . . . . . . . . . . . . . . 31
Buttons and power switches on the system . . . . . . . . 32
About the emergency stop button . . . . . . . . . . . . . 32
About power switch 1 . . . . . . . . . . . . . . . . . . . . . . . 32
About power switch 2 . . . . . . . . . . . . . . . . . . . . . . . 34
About power switch 3 . . . . . . . . . . . . . . . . . . . . . . . 34
About the sample supply module switch . . . . . . . 34

1 Overview of the system

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Table of contents
1 Overview of the system

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 Overview of the system 21

About the cobas® 6800/8800 Systems

The cobas® 6800/8800 Systems integrate fully
automated total nucleic acid isolation directly from
primary and secondary tubes, automated PCR setup, and
real time PCR.

The main features are:

• Fully automated system with maximum walk-away
time and minimum hands-on time required.
• Universal sample preparation.
• Amplification and detection using universal real time
PCR.
• Per sample, up to three tests can be performed in one
run.
• Reagents and controls are stored on board.
A cobas® 6800 System

The product name cobas® 6800/8800 Systems stands for

two systems:
• cobas® 6800 System
• cobas® 8800 System

The cobas® 8800 System has the same functionalities as

the cobas® 6800 System, but higher throughput. The
cobas® 8800 System has one extra processing module
and provides extra magazines to load tip racks. It also has
three extra analytic units, located in the additional
analytic module.

1 Overview of the system

A cobas® 8800 System

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 22 About the cobas® 6800/8800 Systems

Overview of the cobas® 6800/8800 Systems

6DPSOHVXSSO\WUDQVIHUSUHSDUDWLRQDPSOLÀFDWLRQDQGGHWHFWLRQ

• 1 Sample supply module •

6DPSOHLQSXWDQGRXWSXW

• 2 Transfer module •
• 6DPSOHLGHQWLÀFDWLRQ
• 7UDQVIHURIVDPSOHVDQGFRQWUROVWR
SURFHVVLQJSODWHV

• 3 Processing module •
6DPSOHSUHSDUDWLRQDQG3&5VHWXS
• Lysis
• :DVKLQJ
• Elution

• 4 Analytic module •
• $PSOLÀFDWLRQDQGGHWHFWLRQ

Product names and images used in this In this publication, the descriptions, images, and
publication procedures are based on the cobas® 6800 System. If you
are working with a cobas® 8800 System, you must carry
out the described steps also for the additional modules.
1 Overview of the system

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 Overview of the system 23

Overview of the sample supply module

In this section
About the sample supply module (23)
About the IG server (25)

About the sample supply module

The sample supply module is used to load and unload
sample tubes.

Loading capacity You can load the contents of up to three rack trays on the
input buffer, loading one rack tray at a time. Each rack
tray holds 15 racks, each holding 5 sample tubes. This
makes up a total of 225 sample tubes.

A Front cover C Front door

Access to input buffer, output buffer Access to IG server
B Side cover (Restricted to users with supervisor user rights)
Access to error output line, output line, input line

w Sample supply module, front view

1 Overview of the system

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 24 Overview of the sample supply module

D
J

E
F I

G H

A Side cover F Start button

B Status indicator of the error output line G Output buffer
C Status indicator of the input line H Input buffer
D Rear part of the output buffer I Status indicators
E Control panel J Rear part of the input buffer
1 Overview of the system

w Top view of the sample supply module

u Related topics
• About the IG server (25)

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 Overview of the system 25

About the IG server

The sample supply module also houses the Instrument
Gateway (IG) server.

If multiple instruments are used in a cluster, there is only

one IG server used for all the instruments. Only one of the
instruments houses the IG server.

The IG server provides the following functions:

• Storage of test orders and test results
• Storage of reports, problem reports, export files, and
screenshots.
• Management of test orders and test results and their
statuses
• Sending test orders to the instruments
• Sending test results to the LIS
• Calculation of test results

u Related topics
• About the sample supply module (23)

1 Overview of the system

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 26 Overview of the transfer module

Overview of the transfer module

About the transfer module

The transfer module transfers samples and controls to the
processing plate.

The main functions of the transfer module are:

• Handling and transferring sample racks. Racks are
first identified and then placed in a rack slot on the
rack platform.
• Sample identification.
• Transferring and pipetting samples and controls.
Controls and samples are transferred to the
processing plate.
• Loading and unloading the reagent and control
cassettes and the tip racks.
• Storing the reagent and control cassettes in the
refrigerated reagent storage.

u Related topics
• Components of the transfer module (27)
1 Overview of the system

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 Overview of the system 27

Components of the transfer module

K
B

C
J

D
I

F
G

A Transfer module handler G Tip rack magazines

B Rack platform (rack handler beneath the cover, not visible H Transfer position
1 Overview of the system
in this image)
C Teaching post I Park position of the control cassette
D Park positions for processing plates J Park positions of the tip racks
E Reagent drawer K Teach tool
F Reagent magazine L Sample pipetter
(Access to reagent storage) (Using processing tips to pipette sample and controls into
processing plates)

w Top view of the transfer module

u Related topics
• Refer to the section Installing temperature sensors in
the User Assistance.
• About the transfer module (26)

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 28 Overview of the processing module

Overview of the processing module

About the processing module

The processing module prepares the samples for
subsequent amplification and detection.

Before preparation starts, the required reagent cassettes

are transferred from the reagent storage to the interim
reagent storage. The magnetic glass particles (MGP)
cassette is transferred to its shaking position on the
module.

Sample preparation is done in several steps:

1. Lysis, stabilization, and deproteinization using lysis
reagent and proteinase. Nucleic acid is released and
stabilized against enzymatic degradation. Inhibitory
proteins and RNases are degraded. An internal
control is added to each sample.
2. Capturing and washing using magnetic glass particles
and wash reagent. Nucleic acid binds to the magnetic
glass particle. The magnetic glass particles are
captured by magnets. Wash reagent removes
unbound substances and impurities.
3. Elution of purified nucleic acid at elevated
temperature using elution buffer.

The eluate is then transferred to the amplification plate

where the master mix reagent is added. The amplification
plate is sealed and transferred to the analytic module for
amplification and detection.
1 Overview of the system

If the next run uses the same test, the reagent cassettes
remain on the processing module. If the reagent
cassettes are not used for the next run, they are
transferred to the reagent storage. The MGP cassette
remains on the processing module. Empty MGP cassettes,
reagent cassettes, used tip racks, waste inserts, and
processing plates are transferred to the solid waste
container.

u Related topics
• Components of the processing module (29)

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 Overview of the system 29

Components of the processing module

U
S
A
B Q

B S
A R
Q
C P

O
D

E N

F
M

G
L
H

I
K
J

A Heating station L Transport lock (red) 1 Overview of the system

B Separation station M Sealing station
C Wash station N Drawer of sealing station
Below this drawer is the access to the solid waste station.
D Reagent transfer head O Access to the interim reagent storage
E Cooling station P Transport locks (red)
F MGP cassette shaker Q Liquid waste station
G Transfer position R Processing module handler
H Consumables drawer S Park position for tip rack
I Magazines for processing plates T Teach post
J Magazine for MGP cassettes U Transport lock (red)
K Magazine for amplification plate cassettes

w Top view of the processing module (without processing transfer head)

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 30 Overview of the processing module

u Related topics
• About the processing module (28)
1 Overview of the system

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 Overview of the system 31

Overview of the analytic module

About the analytic module

The analytic module is used for amplification and
detection of nucleic acid in the prepared samples using
real time PCR.

The real time PCR reaction is carried out by employing

fluorescence spectroscopy.

Function of the analytic module:

• Handling sealed amplification plates.
• Amplifying and detecting nucleic acid in the prepared
samples.
• Unloading the amplification plates in the amplification
plate drawer after the run is finished.

1 Overview of the system

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 32 Buttons and power switches on the system

Buttons and power switches on the system

About the emergency stop button

Pressing the emergency stop button stops all movable
parts, deactivates all heat sources, unlocks the covers
and doors, and aborts the current runs.

Only use the emergency stop button if you need to

instantly stop instrument operation.

Risk of sample loss If you press the emergency stop button during a run, all
samples that are currently being processed are lost.

Risk of breaking reagent needles If you press the emergency stop button, the reagent
needles of the reagent transfer head might be in the wash
station, or in a reagent or MGP cassette. If so, moving the
reagent transfer head can damage the reagent needles.
Make sure to lift the reagent needles to top position
before moving the reagent transfer head.

About power switch 1

1 Overview of the system

The power switch 1 is located behind the service door of

the transfer module. It is used to set the system to
powerless status.

Only use the power switch 1 in the following, exceptional

cases:
• To set the system to the Off status. In this status, also
the reagent storage is shut down.
• To restart the system after failure if the software does
not respond to user input.

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 Overview of the system 33

The power switch 1 can be used to restart the system

after a software error when the software is not
responding. In this case, you must turn the power
switch 1 to resolve the situation. Make sure to wait 30
seconds before turning the switch on again.

Risk of corrupting the software Never shut down the system using power switch 1 while
the software is still reacting to user input. By doing this,
you risk corrupting the software installation.

Reagent storage stops cooling Shutting down the system by turning off power switch 1
disconnects the system from power. The reagent storage
stops cooling.

Reagents become invalid To prevent reagent invalidation after a power failure, the
temperature in the reagent storage is logged for the first
36 hours in powerless status.

After the system is powered on again, all reagents that

are still on board are invalidated by the software in the
following cases:
• If the temperature in the reagent storage is > 37 °C or
< 2 °C.
• If the system was in powerless status for more than
36 hours.
• If the reagent storage is > 8 °C and < 37 °C, the time
is deducted from the onboard stability. Once the
onboard stability is exceeded, reagents are
invalidated. The onboard stability may vary from
reagent to reagent and is specified in the Instructions

1 Overview of the system

for Use.

u Related topics
• Starting up the system from Off status (61)
• About power switch 2 (34)
• About power switch 3 (34)

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 34 Buttons and power switches on the system

About power switch 2

Power switch 2 is connected to the input power source of
the sample supply module and the IG server (if available
in this instrument). It is located at the back of the sample
supply module.

Never turn off power switch 2.

Turning off power switches 2 and 3 results in a shut down

of both the IG server and the sample supply module.

u Related topics
• About power switch 1 (32)
• About power switch 3 (34)

About power switch 3

Power switch 3 is used as a redundant power supply for
the IG server. If a UPS is connected, it is also used for the
UPS.

Never turn off power switch 3.

Turning off power switches 2 and 3 results in a shut down

of both the IG server (if available in this instrument) and
the sample supply module.
1 Overview of the system

About the sample supply module switch

The sample supply module switch is used to turn on/off
the power of the sample supply module.

This switch affects the sample supply module only. It is

not connected to the IG server.

In an error situation, if the sample supply module is no

longer reacting to user input, you can restart the sample
supply module by switching the sample supply module
switch off and on.

After restarting, you must perform the initialization

procedure.
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 Overview of the system 35

u Related topics
• Starting up the sample supply module (64)
• Starting up the system from Hibernate status (62)

1 Overview of the system

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1 Overview of the system Buttons and power switches on the system

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Table of contents

Overview of operation 2

In this chapter 2
Overview of the software. . . . . . . . . . . . . . . . . . . . . . . . 39
About the software. . . . . . . . . . . . . . . . . . . . . . . . . . 39
The global information area . . . . . . . . . . . . . . . . . . 40
About the global information area . . . . . . . . . . 40
About the task overview . . . . . . . . . . . . . . . . . . 41
About the work area . . . . . . . . . . . . . . . . . . . . . . . . 42
Tabs and panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
About panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
About the home panel . . . . . . . . . . . . . . . . . . . . 44
About navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
About the instrument overview. . . . . . . . . . . . . . . . 46
Generic software elements . . . . . . . . . . . . . . . . . . . 47
About callouts . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Using virtual keyboards . . . . . . . . . . . . . . . . . . . 48
About system information . . . . . . . . . . . . . . . . . 48
Creating a screenshot . . . . . . . . . . . . . . . . . . . . . . . 49
Filtering and sorting information . . . . . . . . . . . . . . 49
About filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Using filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Creating and deleting filters . . . . . . . . . . . . . . . 50
Overview of the main workflow . . . . . . . . . . . . . . . . . . 52
Quick start guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

2 Overview of operation

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Table of contents
2 Overview of operation

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 Overview of operation 39

Overview of the software

About the software

The software has the following main structure:
• Software
- Global information panel
- Work area

A Global information panel B Panel ID C Work area

w Main structure of the software 2 Overview of operation

Global information panel Provides permanently available information such as the
task indicator, connection information, and system status.

Panel ID Each panel has a unique identification. The panel ID can

be used as a reference for troubleshooting.

Work area The work area displays the tabs, the navigation bars, and
the panels.

u Related topics
• The global information area (40)
• About the work area (42)

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 40 Overview of the software

The global information area

About the global information area

The global information area is always accessible. It
contains the following elements:
• The Overview panel - this area provides a summary
of pending tasks.
• The task indicator - identify the number of pending
tasks.
• The logon status - identifies who is logged on.
• The Log on / Log off button.
• System name and status.
• IG server connection information.
• LIS connection information. Choose the button to
reconnect to the LIS if the LIS has been offline.
• The button - for screenshot functionality.
• The button - for screen sharing functionality.
• The button - provides information about the
system version, modules, and session.

A B C D E F G H I J K

A Task indicator G Printing functionality

B Log on status H LIS and IG server connection information
C Log on / Log off button I Screenshot functionality
D System name J Screen sharing functionality
E System status K Information about the system version
2 Overview of operation

F User Assistance (currently not implemented)

w Parts of the global information area

u Related topics
• About system information (48)
• Creating a screenshot (49)
• Refer to the section Enabling/Disabling screen
sharing in the User Assistance.

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 Overview of operation 41

About the task overview

The task overview shows the list of open tasks.

The tasks are grouped according to their status. The

priority of each task is indicated by its color and by its
position. In the task list, the tasks are grouped from top to
bottom. The most urgent tasks (red) are listed on top.

Number of open tasks The number in the task indicator indicates the total of
open tasks.

Navigation If you select a task from the list, the corresponding panel
opens in the software. For example: If you choose a
maintenance action from the task overview, the
Maintenance actions panel opens.

u Related topics
• About the global information area (40)
• About the work area (42)

2 Overview of operation

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 42 Overview of the software

About the work area

The work area contains the Routine, Monitoring, and
Administration tabs. It is the center of your activities
when working with the software. Each tab has a
navigation bar on top and displays the panels.

B E

C D

A Navigation bar with (Back), (Forward) buttons C Panel splitter E Refresh button
and navigation path
B Main panel D Detail panel

w Split screen mode with main panel on the left and detail panel on the right

u Related topics
2 Overview of operation

• About the global information area (40)

• About navigation (44)

Tabs and panels

Tabs are used to group information and software
functions into units that can be displayed on one screen.
The information on a tab is contained on panels. Two
view modes are available:
• Split-screen mode
• Full-screen mode

Use the panel splitter to change between split-screen and

full-screen mode.

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Split-screen mode Two panels are displayed side by side in split-screen

mode. The left panel is the main panel and the right panel
is the detail panel that displays details of the selected
element from the main panel.

Full-screen mode In full-screen mode only one panel is displayed.

About panels
A panel is an organizational unit within a tab.
Panels include the following elements:

A
B
F
E

C D

2 Overview of operation
A Panel title C Panels E Table
B Task button D Button F Filter

w Panels and elements

u Related topics
• About the work area (42)
• About navigation (44)
• Filtering and sorting information (49)

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 44 Overview of the software

About the home panel

The home panel is the first panel of a tab and contains
the task buttons for frequently used tasks on that tab.
Choose a task button to go to the selected location.

A Task button

w Home panel of the Routine tab

u Related topics
• About panels (43)
• About the work area (42)
• About navigation (44)
• About the instrument overview (46)
2 Overview of operation

About navigation
The navigation bar is at the top of the work area above
the panels. It contains these navigation aids:
• Backward and forward buttons to navigate your
browse history.
• Navigation path that shows the path back to the home
panel of the current tab.

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 Overview of operation 45

A B

A (Back) and (Forward) buttons B Navigation path

w Navigation bar

Back and Forward buttons While you navigate through the work area performing
tasks and managing your work, each location is
automatically stored in a browse history. To browse the
history, use the and buttons on the navigation bar.

Navigation path The path from the home panel of the tab to the current
location is shown as a navigation path in the navigation
bar. Choose a path element to go back to that location.

u Related topics
•
•
About panels (43)
About the work area (42)
2 Overview of operation
• About the global information area (40)
• About the task overview (41)
• About the instrument overview (46)

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 46 Overview of the software

About the instrument overview

w Instrument overview panel

The instrument overview panel is on the Monitoring tab.

Select a module or a drawer on the overview to view its
status, and to open or close drawers for loading or
unloading reagents, controls, and consumables.
2 Overview of operation

A B

A Module status B Drawer information

w Instrument overview information

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 Overview of operation 47

Generic software elements

Generic software elements are:
• Callouts
• Keyboards

About callouts
A callout is a context-specific interaction element. It
shows detailed information, offers context-specific tasks,
or confirms operator actions.

A callout always points to the software element it belongs

to, and has a close button. A callout may contain extra
elements, such as task buttons that provide access to
other panels in which the next tasks required are
performed.

2 Overview of operation

w Callout

u Related topics
• About system information (48)
• Using virtual keyboards (48)
• About the instrument overview (46)
• About navigation (44)

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 48 Overview of the software

Using virtual keyboards

Virtual keyboards are used to enter information. The
keyboard is displayed automatically whenever an input is
required.

w Virtual keyboard

About system information

To view information about the system version, choose
the button.
2 Overview of operation

u Related topics
• Using virtual keyboards (48)
• Creating a screenshot (49)
• Refer to the section Enabling/Disabling screen
sharing in the User Assistance.

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Creating a screenshot
The software includes a functionality for creating
screenshots.

r To create a screenshot

1 Navigate to the required panel.

2
2 On the global information area, select the button.
f The resulting screenshot can be accessed via
remote connection under Administration > File
management > Screenshots.

u Related topics
• About the global information area (40)
• Refer to the section Enabling/Disabling screen
sharing in the User Assistance.
• Creating a screenshot (49)

Filtering and sorting information

About filters
The software includes filtering and sorting tools for
managing information displayed in tables.

Filters can be predefined with preferred options.

Depending on the panel you are in, the filtering criteria

2 Overview of operation
can display different selections.

You can group and sort the data that you filtered to
facilitate information searching.

q Sort data in ascending or descending order by

clicking the column headers.

q When no date is defined in the filtering criteria, a

range of 10 days is used by default. Therefore, tests older
than10 days are not displayed in the filtered list.

u Related topics
• Using filters (50)
• Creating and deleting filters (50)

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 50 Overview of the software

Using filters

r To use a filter

1 Navigate to the required panel.

2 On the panel displaying the table, choose the

2
button.
f The filtering panel is displayed.

3 From the filtering drop-down lists, choose the criteria

3
you want to filter by, and then choose the Apply
button.
f The matching data is displayed.

u Related topics
• About filters (49)
• Creating and deleting filters (50)

Creating and deleting filters

Custom and default filter You can create multiple custom filters but you can only
have one default filter. The default filter applies every time
2 Overview of operation

you open a panel with a filter.

r To create a custom filter

1 Navigate to the required panel.

2 Choose the button.

2
f The filtering panel is displayed.

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 Overview of operation 51

3 From the filtering drop-down lists, choose the criteria

3
you want to add to your custom filter, and then choose
the Save button.

4 Enter a title for your custom filter, and then choose the
4
Save button.
f The title for the created filter is displayed in the
filtering drop-down list.

r To create a default filter

1 Follow steps 1 to 3 of the procedure to create a

custom filter.

2 Enter “Default” as title for your custom filter, and then

2
choose the Save button.
f The default filter is displayed in the filtering drop-
down list.

r To delete a custom filter

2 Overview of operation
1 Follow steps 1 and 2 of the procedure to create a
custom filter.

2 From the filtering drop-down list, choose the custom

filter you want to delete, and then choose the Delete
button.
f A callout is displayed, asking you to confirm.

3 Choose the Confirm button.

f The custom filter is deleted.

u Related topics
• About filters (49)
• Using filters (50)

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Overview of the main workflow

The main workflow includes procedures for system
startup, loading supplies and samples, and reviewing and
releasing results.

q The order of steps of the main workflow can be

adapted based on specific workflow needs.
Be sure to follow laboratory best practice and change
your lab gloves following any handling of liquid or solid
waste materials.
2 Overview of operation

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cobas®6\VWHPVPDLQZRUNÁRZ

Sample supply module Software Transfer module Processing module Analytic module

1 Starting up the system from hibernate status

2
Removing the used
DPSOLÀFDWLRQSODWHV

10
Choosing the
software start button

3
Emptying solid and
liquid waste

11 9 Loading tip racks

Loading racks for
clotted tips
4
Loading wash
reagent

8
Loading reagents
12 Loading sample
and control cassettes
racks
5
Loading lysis reagent
and diluent

2 Overview of operation
7
Unloading empty
control cassettes

6
Loading processing
plates, MGP
13 cassettes and
Starting the run DPSOLÀFDWLRQSODWH
cassettes

14
Reviewing and
releasing test results

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 54 Overview of the main workflow

u Related topics
• Quick start guide (55)
2 Overview of operation

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 Overview of operation 55

Quick start guide

In the following table, the main workflow is summarized.

For detailed information, refer to the corresponding tasks

described in this publication.

Steps User action

1 Start up the system. 1. If the system is in the Standby status,
continue with step 2 to start up the sample
supply module.
2. If the system is in the Hibernate status,
press the button below the monitor.

2 Start up the sample supply 1. If the rack tray on the output buffer is full,
module. remove it.
2. Start up the sample supply module.
3. Wait for the output buffer to change
to status and load an empty rack tray.
4. If the system was not already in the
Standby status, wait for the system to
change to the Standby status.
5. If sample racks were unloaded during
initialization, remove them from the
module.
6. Once the status indicator is green, log on
to the system.
3 Remove the amplification 1. Open the amplification plate drawer.
plates. 2. Remove and dispose of all the sealed
amplification plates.
3. Close the drawer.

4 Empty solid and liquid waste 1. Open the wash/waste drawer.

2 Overview of operation
containers. 2. Empty the solid waste. Confirm in the
software.
3. Open the liquid waste drawer.
4. Remove the full liquid waste containers
and replace them with empty ones.
5. Solid waste is potentially biohazardous and
liquid waste may be harmful to eyes and
skin and to the environment. Dispose of it
according to local regulations.
6. Close the liquid waste drawer.
5 Load wash reagent. 1. Open the wash reagent drawer.
2. Load the wash reagent container.
3. Close all the drawers.

y Quick start guide

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 56 Quick start guide

Steps User action

6 Load lysis reagent and 1. Open the bulk reagent drawer.
diluent. 2. Load the diluent bottles (white).
3. Load the lysis reagent bottles (black).
4. Close the drawer.

7 Load processing plates, MGP 1. Open the consumables drawer.

cassettes, and amplification 2. Load the processing plates.
plates. 3. Load the MGP cassettes.
4. Unload empty amplification plate
cassettes.
5. Load new amplification plate cassettes.
6. Close the drawer.

8 Unload empty control 1. Open the reagent storage drawer.

cassettes. 2. Unload the empty control cassettes.

9 Load tip racks, reagent 1. Load the tip racks.

cassettes, and control 2. Load the reagent cassettes.
cassettes. 3. Load the control cassettes.
4. Close the drawer.

10 Setting system to Ready 1. On the Monitoring tab, choose the Start

status. button.
The system changes to the Preparing
status.
2. Wait for the system to change to Ready
status. This procedure can take up to 15
2 Overview of operation

minutes.

11 Load racks for clotted tips. 1. Make sure that the system is in Ready
status.
2. Make sure that the input buffer is
in status.
3. Load 2 racks for clotted tips, loaded with
empty tubes.

12 Load samples 1. Make sure that the system is in Ready

status.
2. Make sure that the input buffer is
in status.
3. Place the rack tray with the sample racks
on the input buffer.

y Quick start guide

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Steps User action

13 Start the run manually. 1. Make sure that the system is in Ready
status.
2. Choose Batches.
3. Check if all samples and supplies are
loaded.
4. If the batch is full, or the timeout has been
reached, the system starts processing
automatically.
5. If the run is not full and you do not want to
wait for the timeout to end, choose Start
manually. The system starts processing
the samples.
6. Remove the rack tray with the processed
sample racks from the output buffer.
14 Review and release test 1. Choose Routine > Test results to view
results. the results.
2. Review and release the test results.

y Quick start guide

u Related topics
• List of system statuses (79)
• About the global information area (40)
• Starting up the system (61)
• List of statuses on the sample supply module (65)
• Unloading the amplification plates (86)
• Handling the wash/waste drawer (88)
• Loading the bulk reagent drawer (102)
• Loading the consumables drawer (107)
• Loading and unloading the reagent cassette
drawer (114)

2 Overview of operation
• Handling test orders (126)
• Handling racks for clotted tips (135)
• Loading samples (140)
• Starting a run (154)
• Reviewing test results (160)

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2 Overview of operation Quick start guide

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 59
Table of contents

Before operation 3

In this chapter 3
Starting up the system . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Starting up the system from Off status . . . . . . . . . 61
Starting up the system from Hibernate status . . . 62
Starting the system from Paused status . . . . . . . . 63
Starting up the sample supply module . . . . . . . . . 64
List of statuses on the sample supply module . . . 65
Restarting after a long shutdown . . . . . . . . . . . . . . 69
Logging on to the system . . . . . . . . . . . . . . . . . . . . 70
System alarm concept . . . . . . . . . . . . . . . . . . . . . . . . . . 71
About system alarms . . . . . . . . . . . . . . . . . . . . . . . . 71
Monitoring statuses and messages . . . . . . . . . . . . 73
List of status colors . . . . . . . . . . . . . . . . . . . . . . . . . 75
List of sample supply module message codes . . . 76
List of system statuses. . . . . . . . . . . . . . . . . . . . . . . 79

3 Before operation

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Table of contents
3 Before operation

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 Before operation 61

Starting up the system

The sample supply module must be started up separately
from the instrument. Make sure to start the instrument
first.

Startup includes the following procedures:

In this section
Starting up the system from Off status (61)
Starting up the system from Hibernate status (62)
Starting the system from Paused status (63)
Starting up the sample supply module (64)
List of statuses on the sample supply module (65)
Restarting after a long shutdown (69)
Logging on to the system (70)

Starting up the system from Off status

The instrument is typically not turned off but set to the
Hibernate status. In the exceptional case that the system
is turned off, adhere to the following procedure.

r To start up the instrument from Off

status

1 Before starting, ensure that the reagent storage

1
service door is closed.

3 Before operation

2
2 Check whether the power switches 2 and 3 are set to
"1".
• If they are, proceed with step 5.
• If they are not, turn the power switches 2 and 3
from "0" to "1" and proceed with step 3.

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 62 Starting up the system

3
3 If the power switch 2 was set to "0" and you turned it
to "1", restart the IG server (u 196).

4 If you had to start up the IG server, wait for 15

4
minutes.
• Then, turn the power switch 1 from "0" to "1".
I To avoid communication problems with the IG
server, you must wait for the IG server to start up
completely before turning power switch 1.

5 Wait for the software to start up and log on to the

5
system.

u Related topics
• Starting the IG server (196)
• Starting up the system from Hibernate status (62)

Starting up the system from Hibernate status

Hibernate status is the recommended status when the
shift has ended and the system is idle. You can restart
from Hibernate status anytime.
3 Before operation

Checking the system status

To see whether the system is in Hibernate status, check

whether power switches 1, 2, and 3 on the rear of the
system are set to "1". If the power switches are set to "1"
and the monitor is blank, the system is in Hibernate
status.

If the monitor is on, the system status is shown in the

global information area of the software.

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 Before operation 63

Maximum 10 days Do not leave the system in Hibernate status for more
than 10 days.

If it is necessary to shut down the system for more than

10 days, contact your Roche Service representative.

r To start up the system from Hibernate

status

1
1 Below the monitor, press the button.
f The software is starting up and the system
changes to the Initializing status. The initialization
procedure takes about 15 minutes.

2 If the sample supply module was shut down, start up

the sample supply module.

u Related topics
• About the global information area (40)
• Starting up the system from Off status (61)
• Starting up the sample supply module (64)
• Logging on to the system (70)

Starting the system from Paused status

You can restart the system from Paused status anytime.

j m The system must be in Paused status.

r To start the system from Paused

status
3 Before operation

1
1 On the Monitoring tab, next to the system overview,
choose the Start button.
f The system changes to Standby status.

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 64 Starting up the system

Starting up the sample supply module

The sample supply module must be started up separately
from the instrument. Make sure to start the instrument
before starting the sample supply module.

Separate status indicator The status of the sample supply module is not displayed
on the monitor of the instrument. Check the statuses on
its own set of status indicators.

r To start up the sample supply module

1 Remove all sample racks from the input and output

1
lines.

2
2 Remove the rack trays from the input and the output
buffer.

3 On the control panel, press the button.

3
3 Before operation

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 Before operation 65

4 After the output buffer has changed to status, load

4
an empty rack tray on the output buffer.

5 Wait for the sample supply module to initialize.

5

6
6 If sample racks were unloaded during initialization,
remove the rack trays from the module.

u Related topics
• Starting up the system from Hibernate status (62)
• Starting up the system from Off status (61)
• List of statuses on the sample supply module (65)
• Logging on to the system (70)

List of statuses on the sample supply module

The status of the sample supply module is independent
from the rest of the system. It is not displayed on the
software.
3 Before operation

The sample supply module provides five status indicators.

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 66 Starting up the system

C
B

D
E

A Main status indicator: Overall status of the sample supply D Status of the output buffer
module and error codes
B Status of the input and output lines E Status of the input buffer
C Status of the error output line

w Status indicators on the sample supply module

Color coding Different colors are used to indicate different severities of

statuses.

Status Meaning Measures

indicator
Green No measures required.
The sample supply module is in operating
mode.
Orange To avoid a system stop, you have to react to an alarm or
Warning message.
Red To resolve the error, you have to react to an alarm or message.
The sample supply module is in error mode
3 Before operation

and has stopped running.

y Color coding of the status indicators on the sample supply module

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 Before operation 67

Overall status of the sample supply module

Status Meaning Measures

indicator
Green No measures required.
The sample supply module is in operating
mode.
Orange blinking Contact your Roche Service representative.
The sample supply module is in
maintenance mode.
Red Shut down the sample supply module, unload all sample racks
The sample supply module is in error mode. and rack trays.
Refer to the list of error messages in the troubleshooting
section and resolve the error, if possible.
Otherwise, contact your Roche Service representative.
Red with number displaying the error code. Shut down the sample supply module, unload all sample racks
and rack trays.
Refer to the list of error messages in the troubleshooting
section and resolve the error, if possible.
Otherwise, contact your Roche Service representative.
Hour glass No measures required.
The sample supply module is shutting down.

y Main status indicator of the sample supply module

Status of the error output line

Status Meaning Measures

indicator
The error output line is in operating No measures required.
mode.
The area is locked. No operator action allowed. Do not reach inside the module.

A rack has arrived in the error output Unload the rack.

line.
A rack has arrived in the error output Unload the racks. If the rack is not unloaded, the system changes
line. The error output line is almost full. to the Error status as soon as the error output line is full.
The error output line is full. Unload the racks.

A rack has not arrived in the error output Shut down the sample supply module and resolve the error.
line.
3 Before operation

y Status of the error output line

Status of the input and output lines

Status Meaning Measures

indicator
Sample rack elevator and input line are No measures required.
in operating mode.
The area is locked. No operator action allowed. Do not reach inside module.

The input line is empty. Load a rack if necessary.

y Status of the input and output lines

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 68 Starting up the system

Status Meaning Measures

indicator
The input line is full. Unload the racks.

An error occurred in the sample rack Shut down the sample supply module and resolve the error.
elevator.
The maximum rack height was exceeded. Remove the rack and resolve the error.

A rack has been inserted the wrong way Turn the rack so that the barcodes of the sample tube face to the
round. right.

y Status of the input and output lines

Status of the output buffer

Status Meaning Measures

indicator
The output buffer is in operating mode. No measures required.

The area is locked. No operator action allowed. Do not reach inside module.

There is no empty rack tray available. You can now load an empty rack tray if necessary.

The output rack tray is full. You can now unload the output rack tray.

There is no empty rack tray available. You need to load an empty rack tray soon.

The output rack tray is full. The output You need to unload a full rack tray soon.
buffer is almost full.
There is no empty rack tray available. The Load an empty rack tray.
output buffer is full.
Both the rack tray and the output buffer Unload the rack trays and load empty rack trays.
are full.

y Status of the output buffer

Status of the input buffer

Status Meaning Measures

3 Before operation

indicator
The input buffer is in operating mode. No measures required.

The area is locked. No operator action allowed.

There is no rack tray available. Load a rack tray if necessary.

The rack tray is available. Unload the empty rack tray on the input buffer.

The maximum rack height was exceeded. Remove the rack and resolve the error.

y Status of the input buffer

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 Before operation 69

Restarting after a long shutdown

If the system was shut down for longer than 10 days, you
must perform the following procedure in order to start up
the system.

If the system was shut down for more than 10 days, the
fluid system was drained. It is therefore essential that the
system is primed twice. This is necessary to ensure that
all air is flushed out of the tubings.

r To restart after a long shutdown

1 Before restarting, ensure that the reagent storage

1
service door is closed.

2 Open the service door of the transfer module and turn

2
the power switch 1 from "0" to "1".
f The software is starting up and the system
changes to Initializing status. The initialization
procedure takes a few minutes.

3
3 While waiting for the system to initialize, start up the
sample supply module. 3 Before operation
4 Log on to the system.

5 Wait for the system to change to Standby status.

Load reagents and consumables on the instrument.

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 70 Starting up the system

6
6 On the Monitoring tab, choose the Start button.
f The instrument is being primed. This can take up
to 10 minutes.

7
7 Wait for the system to change to Ready status.
• Then, choose the Stop button.

8 On the Monitoring tab, choose the Start button.

f The instrument is being primed again. This can
take up to 10 minutes.
f Wait for the system to change to Ready status.

u Related topics
• Starting up the system from Off status (61)
• Starting up the system from Hibernate status (62)
• Starting the system from Paused status (63)
• Starting up the sample supply module (64)
• Logging on to the system (70)

Logging on to the system

To log on to the system, either use the logon dialog or
swipe your badge over the panel below the monitor.
3 Before operation

r To log on to the system

1 In the software, choose the Log on button and

1
perform one of the following two steps:
• Below the monitor, swipe your badge over the left
side of the panel.
• In the Log on callout, enter your user name and
password and choose the Log on button.

u Related topics
• Starting up the system (61)

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 Before operation 71

System alarm concept

To inform the operator about the status, status indicators
show the presence and status of open tasks and
messages.

In this section
About system alarms (71)
Monitoring statuses and messages (73)
List of status colors (75)
List of sample supply module message codes (76)
List of system statuses (79)

About system alarms

Different colors are used to indicate the level of urgency
of an open task or message. The system provides status
information on the following levels:

B
D

C
3 Before operation

A Status light on top of the B Software C Status indicators in the D Sample supply module
system bulk reagent and
wash/waste drawers

Status light The status light on top of the system displays the color of
the task or message with the highest priority. If there is a
message with Error severity, the status light on top of the
system is red.

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 72 System alarm concept

Software The status name shown in the global information area

informs about the overall status of the system,
independent of the open tasks or messages. The system
can be in Running while a red task indicates that an
operator action is required to prevent imminent run abort.

The task indicator shows the number of pending tasks.

To view the full list of tasks, choose the task indicator. On

the right of the task you find the name of the instrument.

The Messages panel provides a list of messages.

The fill level of reagents, controls, and consumables is

indicated in the callouts on the Monitoring tab.
3 Before operation

At supply The containers in the bulk reagent and the wash/waste

drawers each have a status indicator.

Status of the sample supply module The system status indicated in the software does not
include any information about the status of the sample
supply module. Always check the status of the sample
supply module separately. Refer to the status indicators of
the sample supply module.

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 Before operation 73

u Related topics
• List of statuses on the sample supply module (65)
• About the global information area (40)
• About the task overview (41)

Monitoring statuses and messages

To monitor the status of the system, view the status
information on four levels:
• Status light on top of the system
• Task overview and the messages on the software
• Status indicators of the containers in the bulk reagent
and the wash/waste drawer
• Sample supply module status indicators

r To monitor statuses and messages

1
1 Check the color of the status light on top of the
system.
• If the status light is green, no maintenance actions
or troubleshooting tasks must be performed
immediately.

2
2 If the status light on top of the system is orange or red,
check the task overview.
• If there are medium priority tasks, perform the
tasks soon.
• If there are high priority tasks, perform the tasks
immediately. If you do not carry out a high priority
3 Before operation
task, you risk losing samples.

3
3 If the status light on top of the system is orange or red,
under the Monitoring tab, select the corresponding
instrument.

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 74 System alarm concept

4
4 If the status light on top of the system is orange or red,
choose Monitoring > Messages and check the
messages.
• If there are messages with Error severity, resolve
the error before resuming operation.
• If there are messages with Warning severity,
resolve the warning soon.
• If there are only messages with Information
severity, you do not need to react immediately.

5 If you have read the message and resolved the

problem, choose the Confirm button.
I You can select several messages and then confirm
them.
f If you do not confirm the message, the status light
on top of the system remains orange or red.

6
6 To view the overall status of all connected
instruments, choose Monitoring. The Monitoring
panel lists all connected instruments and their status.

7
7 To check the maintenance actions and their status,
choose Monitoring > Maintenance actions.

8
8 If you are handling containers in the bulk reagent or
the wash/waste drawer, check the status indicators
inside the drawer.
3 Before operation

9
9 To view the overall status of the sample supply
module, view the main status indicator of the sample
supply module.
I For an explanation of the numeric message codes,
refer to the list of sample supply module message
codes.

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 Before operation 75

u Related topics
• List of statuses on the sample supply module (65)
• List of sample supply module message codes (76)
• List of status colors (75)

List of status colors

Impaired color vision If your color vision is impaired, refer to the task overview,
the messages, and the overall system status provided on
the software.

In the task list, the tasks are sorted according to their

priority: Red tasks are on top, gray tasks on the bottom of
the list.

Color coding of the status light The status light on top of the system uses the following
color coding.

Color Meaning Measures

None Status light is switched off. The system is in Off or Hibernate status.
System is in operating mode. No measures required.

Green
Warning o The system is operating correctly but an operator
o At least one status is in warning status. interaction is required soon.
Orange o If the operator does not act, the system could change to
Error status or samples might be lost.
o Check the tasks on the task overview and the messages
under Monitoring > Messages.
o At least one status on one of the levels is in o To avoid sample loss, you have to react to an alarm or
alarm status. message immediately.
Red o Imminent risk of sample loss. o Check the tasks on the task overview and the messages
under Monitoring > Messages
y Color coding of the status light

Color coding of the task overview The color coding concept of the status light and the task
overview are similar. The task overview uses gray to
3 Before operation
indicate a low priority.

Color Meaning
Alarm condition. High-priority task:
Immediate action is required.
Red
Warning condition. Medium-priority
task: OK, but action required in a
Orange certain time frame.
Information message. Low-priority
task. No immediate action required.
Gray
y Color coding of the task overview

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 76 System alarm concept

Orange service light In addition to the status light on top of the system, an
orange service light is installed inside the system.

Service light Meaning Measures

Warning - moving parts o Do not operate the system if the service light is
o Risk of injury due to moving parts. blinking.
Orange blinking o Contact your Roche Service representative.

y Service light

u Related topics
• List of statuses on the sample supply module (65)
• List of sample supply module message codes (76)
• List of system statuses (79)

List of sample supply module message codes

The status indicator of the sample supply module displays
a range of message codes to inform you about pending
user actions or errors.

This list provides information on how to react to such a

message.

Message code Message Measure

0003 The maximum height of the sample rack has Remove the sample rack and press the button above
been exceeded. the input buffer.
0102 The output buffer contains more than 19 sample Load an empty rack tray on the output buffer soon.
racks.
3 Before operation

0103 The output buffer is full. The transfer module can Load an empty rack tray on the output buffer.
no longer move sample racks to the sample
supply module.
0105 The output buffer contains more than 19 sample Unload a full rack tray from the output buffer soon.
racks.
0106 The output buffer is full. The transfer module can Unload a full rack tray from the output buffer.
no longer move sample racks to the sample
supply module.
0202 There is room for only one more rack on the Unload a sample rack from the error output line soon.
error output line.
0203 The error output line is full. The transfer module Unload a sample rack from the error output line now.
can no longer move sample racks to the sample
supply module.
y List of sample supply message codes

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 Before operation 77

Message code Message Measure

0302 Unload the sample rack from the input line.
0303 Unload the sample rack from the output line.
0304 One of the sample racks in the input line Remove the sample rack from the input line and push
exceeds the maximum height. the sample tube fully into the sample rack. Check if the
sample tubes and sample rack comply with the
specifications.
0305 The sample rack is invalid. Unload the sample rack and check the orientation of the
rack. The barcodes must face to the right.
0306 The sample rack in the sample rack elevator Unload all sample racks from the sample rack elevator.
cannot be moved.
1054 The sample rack cannot be moved. Shut down the sample supply module and restart. If the
problem persists, contact your Roche Service
representative.
1061 The output line is waiting for a sample rack to be No measures required. After 30 seconds, operation
moved from the transfer module to the sample continues.
supply module. If the problem persists, contact your Roche Service
representative.
1062 There is a sample rack in the output line that was Press the button of the output buffer to remove the
not announced by the transfer module. sample rack from the output line.
1065 Sample rack is stuck behind the rack guiding Shut down the sample supply module. Unload all
pin. sample racks from the output buffer. Restart and reload.
1067-1071 Contact your Roche Service representative.
1072 The error output line is waiting for a rack to be No measures required. After 30 seconds, operation
moved from the transfer module to the sample continues.
supply module.
1073 The motor of the sample rack elevator is Contact your Roche Service representative.
defective or the conveyor connection plate is not
correctly mounted.
1074 The sensor at the output line is permanently Clean the sensor at the output line. If the problem
reacting. persists, contact your Roche Service representative.
1075 The sensor at the output line is not reacting. Clean the sensor at the output line. If the problem
persists, contact your Roche Service representative.
1076-1088 Contact your Roche Service representative.
1089 Sample rack in the tray area of the input buffer Shut down the sample supply module and make sure
cannot be moved. that the sample racks and the rack trays of the input
buffer are all in place. Restart the sample supply
module.
1090 Sample rack in the back area of the input buffer Shut down the sample supply module and make sure
cannot be moved. that the all the sample racks are in place. Restart the
3 Before operation
sample supply module.
1091-1092 A sample rack in the output buffer cannot be Shut down the sample supply module and unload the
moved. sample racks from the output buffer. Restart the sample
supply module.
1093 A sample rack on the input line cannot be Shut down the sample supply module and unload the
moved. sample racks from the input line. Restart the sample
supply module.
1094 A sample rack in the output line cannot be Shut down the sample supply module and unload the
moved. sample racks from the output line. Restart the sample
supply module.
1095 A sample rack in the error output line cannot be Shut down the sample supply module and unload the
moved. sample racks from the error output line. Restart the
sample supply module.
y List of sample supply message codes

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 78 System alarm concept

Message code Message Measure

1096-1098 Motion error in the sample rack elevator. Shut down the sample supply module. Check the
sample rack elevator. Restart the sample supply module.
1094 A sample rack in the output line cannot be Shut down the sample supply module and unload the
moved. sample racks from the output line. Restart the sample
supply module.
1095 A sample rack in the error output line cannot be Shut down the sample supply module and unload the
moved. sample racks from the error output line. Restart the
sample supply module.
1096-1098 Motion error in the sample rack elevator. Shut down the sample supply module. Check the
sample rack elevator. Restart the sample supply module.
1099 Temperature inside of the sample supply module Check the environmental conditions and check if the
is too high. fans are working. Contact your Roche Service
representative.
1100 Contact your Roche Service representative.
1337 One of the covers is open. The sample supply Make sure that all covers are closed.
module performed an emergency stop.
1338-1348 Contact your Roche Service representative.
6001-6010 Contact your Roche Service representative.
y List of sample supply message codes

u Related topics
• List of statuses on the sample supply module (65)
• List of system statuses (79)
• About system alarms (71)
• Monitoring statuses and messages (73)
• List of status colors (75)
3 Before operation

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 Before operation 79

List of system statuses

The status of the system determines what actions you can
perform. Some of the status changes are initiated
automatically by the system. Other status changes you
can initiate manually.

Status 1 Status 2 Comment Steps required to change to status 2

Off Starting up Off: System is shut down and the power Turn the power switches from "0" to "1".
switches are set to "0".
In Off status the reagent storage is turned off. The system must not be kept in Off status for
Therefore, all reagents must be unloaded from more than 10 days without contacting your
the reagent storage beforehand. Roche Service representative.
Hibernate Starting up In Hibernate status, the system is shut down Press the button below the monitor.
and the power switch is turned to "I".
The reagent storage is still running.
Hibernate status is the recommended status
when the shift has ended and the system is
idle.
The system must not be kept in Hibernate
status for more than 10 days.
If you need to power off your system for more
than ten days, contact your Roche Service
representative.
Undefined Starting up The status is considered "undefined" if the Turn the power switch 1 from "0" to "1".
power supply has been interrupted
unexpectedly or the power switch 1 has been
turned to "0" after an otherwise unresolved
failure.
E.g., if the main switch was turned during
operation.
Starting up Initializing This transition is automatic if the button
below the monitor has been pressed and all
covers are closed.
Initializing Standby In Standby status, you can load and unload This transition is automatic if the initialization
consumables and reagents. Samples cannot process has been completed successfully.
be loaded yet.
Standby Preparing Prerequisite: No open maintenance actions. Log on to the system.
In Preparing status, the system is being Choose the Start button on the software.
primed. During priming, the fluid system is
rinsed with diluent, lysis and wash reagent to
eliminate air bubbles and traces of reagents
3 Before operation
used previously.
Preparing Ready Ready status is the prerequisite to load This transition is automatic if the needle bent
samples and to start a run. detection and the priming maintenance
After six hours in Ready status, the system actions have been completed successfully.
status automatically changes to Standby
status.
Ready Running Running status means that a run is being A run is started automatically (enough
processed. samples loaded or timeout reached) or
You can load samples, reagents, controls, and manually (Start manually button).
consumables while the system is in Running
status.
y System status changes

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 80 System alarm concept

Status 1 Status 2 Comment Steps required to change to status 2

Running Pausing/ In Pausing status, the system completes runs If an external control failed, or the Pause
Paused which are currently processed. No new runs button was pressed, the system changes to
are started. the Pausing status.
The system continues processing and enters
Paused status, as soon as all runs are
completed.
Stopping Running Prerequisite: The system is still finishing a When the system is no longer in Stopping
current run. The Stop button has been status, choose the Start button.
pressed but the system is still processing a The system changes to Running status.
run.
Pausing Paused This transition is automatic after all current
runs have been completed.
Paused Ready Press the button below the monitor, or
choose the Resume button.
Ready Standby If the system status is being changed from Choose the Stop button.
Ready to Standby status, all racks that are on After six hours in Ready status, the system
the transfer module are moved to the output status automatically changes to Standby
buffer. status.
Running Stopping/ If you choose the Stop button while the Choose the Stop button.
Standby system is running, the system changes to The system changes to Stopping status.
Stopping status. This process can take up to After all runs have been completed, and all
2.5 hours. racks from the input have been moved to the
All current runs are completed. transfer module, the system changes to
All racks that are not on the input buffer are Standby status.
moved to the output buffer.
Do not shut down the system while it is in
Stopping status. You could lose the samples
on board.
To avoid damage to the instrument, do not
leave the system in Standby status for an
extended period. Always hibernate the system
if you are not operating it.
In all statuses other than Off and Hibernate
status, including Standby status, the
instrument produces 30 mL/h of condensation
water. The water is collected in the liquid
waste container. If the liquid waste container is
full, the instrument may be damaged by the
condensation water.
Running Ready If the system has finished processing, the The transition from Running to Ready status
status changes from Running to Ready is automatic.
status.
3 Before operation

Standby Maintenance Maintenance status is used to access the Choose a maintenance action from the
wizards and to perform system maintenance maintenance overview or from the task list.
actions. The system status changes from Standby
status to Maintenance status.
If the maintenance action is an automatic one,
the status changes automatically.
y System status changes

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 Before operation 81

Status 1 Status 2 Comment Steps required to change to status 2

Standby Hibernate Always hibernate the system if you are not Choose the Hibernate button.
operating it. Do not leave the system in Changing to Hibernate status may take up to
Standby status for more than 12 hours. 5 minutes.
In all statuses other than Off and Hibernate
status, including Standby status, the
instrument produces 30 mL/h of condensation
water. The water is collected in the liquid
waste container. If the liquid waste container is
full, the instrument may be damaged by the
condensation water.
The system must not be kept in Hibernate
status for more than 10 days.
Standby Shutting Shutting down status is a prerequisite to the Unload all consumables, control and reagent
down Off status. cassettes, and waste. To prevent the
aspiration filters from drying out, leave the
bulk reagent containers on board. On the
software, choose the Shut down button.
Shutting Off After the software has shut down, open the
down lower service door of the transfer module and
turn power switch 1 to from "1" to "0".
Any Error To resolve the Error status, choose the Shut Unresolved error occurred.
down button to restart the system. Only if this
does not resolve the Error status, use the
power switch 1 to restart the system.
y System status changes

u Related topics
• List of statuses on the sample supply module (65)
• About system alarms (71)
• Monitoring statuses and messages (73)
• List of status colors (75)

3 Before operation

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3 Before operation System alarm concept

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Table of contents

Reagents and consumables 4

In this chapter 4
Overview of the reagents and consumables. . . . . . . . 85
Unloading the amplification plates . . . . . . . . . . . . . . . 86
Handling the wash/waste drawer . . . . . . . . . . . . . . . . 88
Emptying the solid waste container . . . . . . . . . . . . 88
Replacing the solid waste container . . . . . . . . . . . 91
Overview of liquid waste and wash reagent
containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Replacing the liquid waste container . . . . . . . . . . 94
List of statuses of the liquid waste container . . . . 98
Loading the wash reagent containers . . . . . . . . . . 98
Loading the bulk reagent drawer. . . . . . . . . . . . . . . . . 102
Overview of lysis reagent and diluent bottles . . . . 102
List of statuses of reagent containers . . . . . . . . . . 103
Loading diluent and lysis reagent bottles . . . . . . . 103
Loading the consumables drawer . . . . . . . . . . . . . . . . 107
Unloading/loading the consumables drawer . . . . 107
About processing plates . . . . . . . . . . . . . . . . . . . . . 111
About amplification plate cassettes . . . . . . . . . . . . 112
About MGP cassettes . . . . . . . . . . . . . . . . . . . . . . . 113

4 Reagents and consumables

Loading and unloading the reagent cassette drawer 114
Loading tip racks, reagent, and control cassettes 114
Unloading control and reagent cassettes . . . . . . . 117
About tip racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
About reagent cassettes . . . . . . . . . . . . . . . . . . . . . 120
About control cassettes . . . . . . . . . . . . . . . . . . . . . . 121

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Table of contents
4 Reagents and consumables

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Overview of the reagents and consumables

Before you can start a run, consumables and reagents
need to be loaded and/or unloaded. The graphic provides
an overview of their location on the system.

‡ Tip racks ‡ Processing plates

‡Reagent cassettes ‡ MGP cassettes
‡Control cassettes ‡ $PSOLÀFDWLRQSODWHFDVVHWWHV

‡ Lysis reagent bottles ‡ Solid waste container ‡$PSOLÀFDWLRQSODWHV

‡ Diluent bottles ‡ Wash reagent container
‡ Liquid waste container

w Overview of the reagents and consumables on board

4 Reagents and consumables

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 86 Unloading the amplification plates

Unloading the amplification plates

Before setting the instrument to Ready status, remove
the used amplification plates from the amplification plate
drawer.

c At the latest after 12 runs. The amplification plate drawer

can hold up to 12 amplification plates.

If the amplification plate drawer is full, the system does

not start the next run. In the task overview, a high priority
task will prompt you to remove the amplification plates.

j m Wear personal protective equipment

m The system must not be in status Initializing.

r To unload the amplification plates

1
1 On the Monitoring tab, choose the amplification
plate drawer.

2 Choose the Open drawer button.

4 Reagents and consumables

3
3 CAUTION! Risk of personal injury due to moving parts
inside the analytic module. Do not reach inside the
module.
3 From the amplification plate drawer, remove the
sealed amplification plates.
I Always remove all the amplification plates. If there
is an amplification plate left, the software prompts
you to empty the amplification plate drawer.
f You may notice residues of magnetic glass
particles in some of the wells. The particles have
no influence on the PCR. No action is required.

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4 Manually close the amplification cassette drawer and

4
ensure that it clicks into place.
• Ensure that the drawer is closed properly.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

5 Dispose of the amplification plates according to local

regulations.

u Related topics
• Overview of the reagents and consumables (85)
• Handling the wash/waste drawer (88)
• Loading the bulk reagent drawer (102)
• Loading the consumables drawer (107)
• Loading and unloading the reagent cassette
drawer (114)

4 Reagents and consumables

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 88 Handling the wash/waste drawer

Handling the wash/waste drawer

To obtain information on how to empty the solid and
liquid waste containers or to load the wash reagent
containers, refer to the following topics.

In this section
Emptying the solid waste container (88)
Replacing the solid waste container (91)
Overview of liquid waste and wash reagent
containers (94)
Replacing the liquid waste container (94)
List of statuses of the liquid waste container (98)
Loading the wash reagent containers (98)

Emptying the solid waste container

During a run, the system collects the used processing
plates, tip racks, waste inserts, and the empty reagent
and MGP cassettes in the solid waste container.

q Be sure to follow laboratory best practices and

change your lab gloves following any handling of liquid or
solid waste materials.

c At the latest after three full runs (3x 96 tests). If only small
4 Reagents and consumables

runs are performed (< 49 tests), the solid waste container

must be emptied after five runs.

If the solid waste container is full, the system starts the

next run and creates a high priority task prompting the
operator to empty the solid waste container. The solid
waste of the current run stays on the processing module
until the full solid waste container is emptied.

j m Wear personal protective equipment.

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 Reagents and consumables 89

r To empty the solid waste container

1
1 On the Monitoring tab, choose the wash/waste
drawer.

2
2 Check the fill level of the solid waste container.

3 If you need to empty the solid waste container, choose

the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

4 Wait for the wash/waste drawer to automatically open

4
slightly and then manually open it fully. Then turn the
solid waste container to the right side until it clicks
into place.

4 Reagents and consumables

5 Remove the solid waste bag fastener.
5

6
6 CAUTION! Risk of personal injury, infection, and
contamination. Do not empty and reuse solid waste
bags.
6 Close the full solid waste bags and carry the solid
waste container to the disposal site.

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 90 Handling the wash/waste drawer

7
7 CAUTION! Risk of personal injury, infection, and
contamination. The solid waste bags may be pierced
by sharp objects inside.
7 Check the solid waste bags for perforation while
removing them from the solid waste container.

8 Dispose of solid waste bags according to local

regulations.

9
9 If you notice any perforation of the solid waste bag
and find liquid inside the solid waste container,
decontaminate the solid waste container.
• Follow the decontamination procedure.

10 Change lab gloves.

11
11 WARNING! Risk of personal injury or contamination of
the system if using solid waste bags that were not
supplied by Roche.
11 Taking two solid waste bags, place one inside the
other and reach inside with both hands.
• Fold over the bottom corners and place the bags in
the solid waste container.

12 Make sure that the bags reach the bottom and line the
4 Reagents and consumables

12
solid waste container.

13 Place the waste bag fastener back on the solid waste

13
container.

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 Reagents and consumables 91

14 Ensure that the bags reach the bottom of the solid

14
waste container.
• Choose the Confirm that solid waste container
is empty. button.
f The fill level of the solid waste changes to 0%.

15 If you have to empty the liquid waste or reload a wash

reagent container, leave the wash/waste drawer open.
Otherwise, close the wash/waste drawer.

u Related topics
• Replacing the solid waste container (91)
• Replacing the liquid waste container (94)
• Loading the wash reagent containers (98)
• Decontaminating solid and liquid waste
containers (255)

Replacing the solid waste container

Follow this procedure to replace a defective solid waste
container, or as an alternative to replace the solid waste
bag.

q Be sure to follow laboratory best practices and

change your lab gloves following any handling of liquid or
solid waste materials.

4 Reagents and consumables

At the latest after three full runs (3 x 96 tests). If only
small runs are performed (< 49 tests), the solid waste
container must be emptied after five runs.

If the solid waste container is full, the system starts the

next run and creates a high priority task prompting the
operator to empty the solid waste container. The solid
waste of the current run stays on the processing module
until the full solid waste container is emptied or replaced.
The run can become invalid if you do not replace the solid
waste container on time.

j m Wear personal protective equipment.

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 92 Handling the wash/waste drawer

r To replace the solid waste container

1
1 On the Monitoring tab, choose the wash/waste
drawer.

2
2 Choose the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

3
3 Wait for the wash/waste drawer to automatically open
slightly and then manually open it fully. Then turn the
solid waste container to the right side until it clicks
into place.
4 Reagents and consumables

4
4 Remove the solid waste container from the solid waste
drawer. Seal the solid waste container and dispose of
it according to local regulations.

5 If necessary, clean the surface of the solid waste

5
drawer with a lint-free cloth moistened with deionized
water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

6 Change lab gloves.

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 Reagents and consumables 93

7
7 Insert a replacement solid waste container into the
solid waste drawer.

8 Choose the Confirm that solid waste container is

8
empty. button.

9
9 Close the wash/waste drawer.

u Related topics
• Emptying the solid waste container (88)

4 Reagents and consumables

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 94 Handling the wash/waste drawer

Overview of liquid waste and wash reagent containers

Waste and wash reagent containers are located in the
wash/waste drawer in the processing module.

A Wash reagent drawer C Liquid waste drawer

B Wash reagent container: 3 containers per module, 4.2 L D Liquid waste container, 3 containers per module, 5 L per
per container container

w Overview of liquid waste and wash reagent containers on the instrument

u Related topics
• Emptying the solid waste container (88)
4 Reagents and consumables

• Replacing the liquid waste container (94)

• Loading the wash reagent containers (98)

Replacing the liquid waste container

The liquid waste containers collect diluent, lysis reagent,
wash reagent, and condensation water from the interim
reagent storage. Check the fill level of the liquid waste
containers before starting a run.

q Be sure to follow laboratory best practices and

change your lab gloves following any handling of liquid or
solid waste materials.

d m A dry, empty, and free of damage liquid waste

container for each container that needs replacing.

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 Reagents and consumables 95

j m Wear personal protective equipment.

r To replace the liquid waste container

1
1 On the Monitoring tab, choose the wash/waste
drawer.

2
2 Choose the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

3 Wait for the wash/waste drawer to automatically open

3
slightly. Then, manually open it fully. Then turn the
solid waste container to the right side until it clicks
into place.

4
4 Pull out the liquid waste drawer. 4 Reagents and consumables

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 96 Handling the wash/waste drawer

5
5 Check the fill levels to find the container that needs to
be exchanged. Choose the Unlock button to unlock
the waste dispense caps.
I Once you have pressed the Unlock button, you
must insert a completely empty liquid waste
container. Do not insert a partially filled liquid
waste container.

6 Wait for the click sound. Check whether the status

6
indicator next to the waste dispense cap is turned off.

7 If the status indicator is turned off, lift the waste

7
dispense cap.
f If the status indicator is still on, look at the monitor
to check whether the waste dispense cap is
unlocked. Choose the Unlock button again if
necessary.

8 Close the full liquid waste containers with the screw

8
4 Reagents and consumables

cap.

9 Remove the liquid waste container from the liquid

9
waste drawer.
I Never remove all the liquid waste containers.
Always leave at least one liquid waste container
installed.

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 Reagents and consumables 97

10 Inspect the surface of the liquid waste drawer for salt

10
residues.
• If necessary, clean the surface with a lint-free cloth
moistened with deionized water.
• Take a second lint-free cloth moistened with 70%
ethanol and clean again.

11 Load empty liquid waste containers.

11
• If you are reusing them, make sure that they are
free of damage and completely dry (drying time is
approximately 8 hours).

12 Remove the screw cap, and then close the waste

12
dispense cap.
• Push the waste dispense cap down completely
until the status indicator lights up green.

13 Push the liquid waste drawer back in.

4 Reagents and consumables

13

14 If you have to load a new wash reagent container,

14
leave the wash/waste drawer open. Otherwise close
the drawer fully.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

u Related topics
• Emptying the solid waste container (88)
• Loading the wash reagent containers (98)
• List of statuses of the liquid waste container (98)

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 98 Handling the wash/waste drawer

List of statuses of the liquid waste container

Status of a liquid waste container A status indicator next to the liquid waste container
indicates the status.

Color Meaning Measures

None The status indicator is switched off. Possible Load a container if necessary and close the waste dispense
reasons are: cap.
o The waste dispense cap is pulled up.
o No container is loaded.
Normal condition No measures required.
o The container is empty or partially full.
Green
Warning condition Replace the liquid waste container with an empty liquid waste
o The container is full and has to be replaced. container.
Yellow
Alarm condition Contact a Roche Service representative.
o The waste dispense cap is defective.
Red
y Meaning of status colors used for the liquid waste container.
4 Reagents and consumables

Loading the wash reagent containers

The wash reagent is used in the processing plates to
wash the samples after lysis and to wash the reagent
needles between usage of different reagents. Load
sufficient wash reagent before starting a run.

j m Wear personal protective equipment.

m Before unpacking, make sure that the primary and
secondary packaging is not damaged and there has
been no leakage.

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r To load the wash reagent containers

1
1 On the Monitoring tab, choose the wash/waste
drawer.
• Check, which wash reagent container must be
replaced.

2
2 Choose the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.
f The wash/waste drawer unlocks and automatically
opens slightly.

3 Pull out the wash reagent drawer. Make sure that the
3
wash reagent drawer is pulled out fully and clicks into
place.

4 WARNING! Risk of sample loss and compromising the

integrity of test results. Never force open the reagent
aspiration arm. Always use the Unlock button.
4 In the software, check the fill levels. For the container
that must be replaced, choose the Unlock button.

4 Reagents and consumables

5 Wait for the click sound and the status indicator to
5
turn off.
• Pull out the reagent aspiration arm and turn it to
the reagent aspiration arm park position.

6 Close the empty container with the screw cap and

6
remove the container.

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100 Handling the wash/waste drawer

7 WARNING! Risk of damaging the sensor, of carryover,

7
and, of compromising the integrity of test results. Do
not touch or clean the part of the reagent aspiration
arm that is in contact with reagent.
7 For each container, inspect the wash reagent drawer
surface for salt residues.
• If necessary, clean the surface with a lint-free cloth
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

8 Install a new wash reagent container.

8
• Never remove an empty wash reagent container
without replacing it with a full wash reagent
container.

9 Remove the screw cap and place it into the reagent

9
aspiration arm park position.
4 Reagents and consumables

10 Close the reagent aspiration arm. Push it down until

10
the status indicator lights up again.
I If the status indicator is red, the container is either
empty or expired.

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 Reagents and consumables 101

11 In the software, verify whether the fill level shows

11
100%.

12 Push the wash reagent drawer back in and close the

12
wash/waste drawer fully.

13 Dispose of the wash reagent containers according to

local regulations.

u Related topics
• List of statuses of reagent containers (103)
• Replacing the liquid waste container (94)
• Emptying the solid waste container (88)

4 Reagents and consumables

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102 Loading the bulk reagent drawer

Loading the bulk reagent drawer

In this section
Overview of lysis reagent and diluent bottles (102)
List of statuses of reagent containers (103)
Loading diluent and lysis reagent bottles (103)

Overview of lysis reagent and diluent bottles

Diluent and lysis reagent are located in the processing
module.

A
B

A Bulk reagent drawer C Lysis reagent bottle: 2 bottles per module, 875 mL per
4 Reagents and consumables

B Diluent reagent bottle: 2 bottles per module, 875 mL per bottle

bottle

w Overview of lysis reagent and diluent bottles on the instrument

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List of statuses of reagent containers

An LED next to the container indicates its status.

Status of a reagent container

Color Meaning Measures
None Status indicator is switched off. Possible reasons Close the reagent aspiration arm.
are:
o The reagent aspiration arm is open.
Green No measures required.
o The container is full or partially full.
Yellow Replace the container.
Warning
o The container is empty and has to be
replaced.
Red To resolve the error, perform one of the following procedures:
o The reagent is expired. o Replace the container.
o No container is loaded. o Load a container. The container position should not be
o The reagent aspiration arm is defective. empty longer than necessary.
o If the reagent aspiration arm is defective, contact your
Roche Service representative.
y Meaning of status colors used for reagent containers

u Related topics
• Loading diluent and lysis reagent bottles (103)
• Loading the wash reagent containers (98)
• Overview of lysis reagent and diluent bottles (102)
• Overview of liquid waste and wash reagent
containers (94)

4 Reagents and consumables

Loading diluent and lysis reagent bottles

! WARNING
Risk of incorrect results
Loading diluent and lysis reagent at refrigeration
temperature may cause too low temperature on the
heating station.
r Always bring diluent and lysis reagent to room
temperature before loading.

j m Wear personal protective equipment.

m Before unpacking, make sure that the primary and
secondary packaging of the diluent and the lysis
reagent bottles are not damaged and there were no
leakages.
m Always bring diluent and lysis reagent to room
temperature before loading.
m The system must not be in Initializing status.
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104 Loading the bulk reagent drawer

r To load diluent and lysis reagent

1 On the Monitoring tab, choose the bulk reagent

1
3
drawer, and then choose the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.
f The bulk reagent drawer unlocks and
automatically opens slightly.

2 Manually pull out the bulk reagent drawer.

2

3 Check the fill level of lysis reagent and diluent in their

3
respective bottles.

4 WARNING! Risk of sample loss and compromising the

integrity of test results. Never force open the reagent
aspiration arm. Always use the Unlock button.
4 To unlock a reagent aspiration arm, choose the
Unlock button of the respective bottles, and then wait
until the status indicator light is off.
• Lysis reagent bottles are black.
4 Reagents and consumables

• Diluent bottles are white.

5 WARNING! Risk of compromising the integrity of test

5
results. Do not touch or clean the part of the reagent
aspiration arm that comes into contact with liquid.
5 If the status indicator of the respective bottle is turned
off, pull up the reagent aspiration arm. Turn it to the
reagent aspiration arm park position.

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 Reagents and consumables 105

6 Close the empty bottle with its screw cap.

6

7 Remove the bottle and dispose of it according to local

regulations.

8 For each bottle, inspect the bulk reagent drawer

8
surface for salt residues. If necessary, clean the
surface with a lint-free cloth moistened with deionized
water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

9 Load a new bottle. Never remove a bottle without

9
replacing it with a new one.
I While loading, take care that the beveled corner of
the bottle fits the bulk reagent drawer.

10 Remove the screw cap of the bottle and place it into

4 Reagents and consumables

10
the reagent aspiration arm park position.

11 Close the reagent aspiration arm. Push it down until

11
the status indicator lights up again. It should now be
green.

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106 Loading the bulk reagent drawer

12 Verify whether all the status indicators are green and

12
whether the fill level of all the bottles shows 100%.
• If a status indicator is not green, make sure that
the reagent aspiration arm is closed and that the
bottle is not empty.
I If the status indicator is red, the bottle is either
empty or expired.

13 Choose the Close drawer button.

14 Wait for the click sound, and then push the bulk
14
reagent drawer back in until it is fully closed.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

u Related topics
• List of statuses of reagent containers (103)
• Overview of lysis reagent and diluent bottles (102)
• Unloading/loading the consumables drawer (107)
• Loading the wash reagent containers (98)
4 Reagents and consumables

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 Reagents and consumables 107

Loading the consumables drawer

In this section
Unloading/loading the consumables drawer (107)
About processing plates (111)
About amplification plate cassettes (112)
About MGP cassettes (113)

Unloading/loading the consumables drawer

Before starting a run, unload expired and empty supplies
and load new ones. You can load supplies at any time
during a run.

Processing plates, MGP cassettes, and amplification plate

cassettes are loaded in the consumables drawer.

Supplies discarded by the system The system discards the following supplies to the solid
waste container during the run:
• Empty MGP cassettes

4 Reagents and consumables

• Used processing plates

Finalized amplification plates are moved to the

amplification plate drawer.

Supplies to be unloaded manually Before starting a run, you have to unload the following
supplies:
• Expired MGP cassettes
• Empty amplification plate cassettes
• Expired processing or amplification plates

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108 Loading the consumables drawer

j m To prevent particles from contaminating the

consumables, make sure to open the primary
packaging of consumables immediately before
loading.
m Make sure that the consumables are not damaged
and do not show signs of abrasion or contamination.
Otherwise, discard the consumables.
m If a consumable fell to the ground, discard the
consumable.
m Always bring diluent, lysis reagent, processing plates
and MGP cassettes to room temperature before
loading.
m Wear personal protective equipment.
m The system must not be in Initializing status

r To unload empty amplification plate

cassettes, and expired MGP
cassettes

1 Move the monitor out of the way.

1
4 Reagents and consumables

2
2 On the Monitoring tab, choose the consumables
drawer, and then choose the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.
f The consumables drawer unlocks and
automatically opens slightly.

3 Pull out the consumables drawer completely.

3

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 Reagents and consumables 109

4 Unload the empty amplification plate cassettes.

4
• If there is an expired MGP cassette, the magazine
also brings up the MGP cassette. Unload the MGP
cassette.

5 Dispose of the supplies.

6 To load new MGP and amplification plate cassettes,

leave the consumables drawer open.

r To load processing plates, MGP

cassettes, and amplification plate
cassettes

1 Move the monitor out of the way.

1

2
2 On the Monitoring tab, choose the consumables
drawer, then choose the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

4 Reagents and consumables

f The consumables drawer unlocks and
automatically opens slightly.

3 Check which supplies must be loaded.

4 Open the consumables drawer fully until it clicks into

4
place.
f The magazines adjust in height so that new
processing plates, amplification plate cassettes,
and MGP cassettes can be loaded into the
magazines.

5 Before unpacking the consumables and the MGP

cassettes, make sure the primary and secondary
packaging are not damaged and there has been no
leakage.

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110 Loading the consumables drawer

6 The processing plates, MGP and amplification plate

6
cassettes all have one beveled corner. Ensure that the
beveled corner is on the front left side when loading
consumables.

7
7 CAUTION! Risk of sample loss. Deformed material
could cause a handling error on the instrument. If
processing plates show signs of damage, abrasion or
contamination, discard them.
7 If necessary, load new processing plates into the
corresponding magazine.
• Do not stack consumables when loading. Before
loading a new plate, wait for the barcode to be
read and for the information in the software to be
updated.
I All cassettes are hardcoded. The marked corner
must face towards the front left side.

8 CAUTION! Risk of sample loss. Deformed material

8
could cause a handling error on the instrument. If
MGP cassettes show signs of damage, abrasion or
contamination, discard them.
8 Only load a new MGP cassette if the magazine is
empty. Otherwise, the MGP cassettes which are
already loaded might expire.
• Never load partially used MGP cassettes while the
4 Reagents and consumables

system is in Running status. If you must load

partially used MGP cassettes, load them while the
system is in Standby status.
• If necessary, load new MGP cassettes into the
corresponding magazine.
• Do not stack cassettes when loading. Wait for the
RFID tag to be read and the status in the software
to be updated before loading another cassette.

9 CAUTION! Risk of compromising the integrity of test

9
results. If amplification plate cassettes show signs of
damage, abrasion or contamination, discard them.
9 If necessary, load new amplification plate cassettes
into the corresponding magazine.

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10 In the callout, check the loading status. If all the

10
supplies are loaded, choose the Close drawer button.

11 Wait for the click sound, and then push the

11
consumables drawer back in until it clicks into place.

u Related topics
• About processing plates (111)
• About amplification plate cassettes (112)
• About MGP cassettes (113)

About processing plates

The processing plate is a deepwell plate used for
preparing up to 48 samples and controls.

The plate is transferred from the transfer module to the

4 Reagents and consumables

processing module after pipetting of samples and
controls has been completed.

After sample preparation, the eluate is transferred from

the processing plate to the amplification plate.

The processing plates, MGP and amplification plate

cassettes all have one beveled corner. Ensure that the
beveled corner is on the front left side when loading
consumables.

You can load eight processing plates per consumables

drawer.

After processing, the plate is disposed of in the solid

waste container.

q To avoid contamination, never touch the wells of a

processing plate.

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u Related topics
• Loading the consumables drawer (107)
• About amplification plate cassettes (112)
• About MGP cassettes (113)

About amplification plate cassettes

The amplification plate cassette holds four amplification
plates.

The system does not discard empty amplification plate

cassettes. You have to unload them manually.

You can load two amplification plate cassettes (eight

amplification plates) per consumables drawer.

The amplification plate is a microwell plate of 96 wells. It

has room for up to 96 samples and controls.

The amplification plate holds the eluate of the sample

preparation of up to two processing plates.

The amplification plate is transferred from the processing

module to the analytic module where the eluate is
amplified and detected.

The amplification plate is sealed with a sealing film before

being moved into the analytic module to prevent
4 Reagents and consumables

evaporation.

The processing plates, MGP and amplification plate

cassettes all have one beveled corner. Ensure that the
beveled corner is on the front left side when loading.

u Related topics
• Unloading the amplification plates (86)
• Loading the consumables drawer (107)
• About processing plates (111)
• About amplification plate cassettes (112)
• About MGP cassettes (113)

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About MGP cassettes

The MGP cassette contains magnetic glass particles
(MGP) in a suspension for 480 tests.

The magnetic glass particles are used to separate nucleic

acid from proteins, cellular debris, or potential PCR
inhibitors. The magnetic glass particles capture nucleic
acids during the wash steps.

The MGP cassette is shaken in the MGP cassette shaker.

This ensures a homogeneous distribution of the magnetic
glass particles before pipetting into the processing plate.

The processing plates, MGP and amplification plate

cassettes all have one beveled corner. Ensure that the
beveled corner is on the front left side when loading.

You can load two MGP cassettes per consumables

drawer. Make sure never to load partially used MGP
cassettes while the system is in Running status. If you
must load partially used MGP cassettes, load them while
the system is still in Standby status.

q Possible carryover of magnetic glass particles into

the amplification plates has no influence on PCR reaction
and detection.

u Related topics
• Unloading the amplification plates (86)

4 Reagents and consumables

• Loading the consumables drawer (107)
• About processing plates (111)
• About amplification plate cassettes (112)
• About MGP cassettes (113)

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Loading and unloading the reagent

cassette drawer
In this section
Loading tip racks, reagent, and control cassettes (114)
Unloading control and reagent cassettes (117)
About tip racks (119)
About reagent cassettes (120)
About control cassettes (121)

Loading tip racks, reagent, and control cassettes

The system automatically discards used tip racks and
empty reagent cassettes into the solid waste container. If
reagents are expired, however, you have to unload them
manually before loading new supplies.

Tip racks, reagent, and control cassettes are loaded in the

reagent cassette drawer.

q After transporting control cassettes and before

loading, ensure that control cassettes are correctly
assembled. Control mini racks must be straight and
clicked into the control cassette on both sides.
4 Reagents and consumables

j m Always bring tip racks to room temperature before

loading.
m To prevent particles from contaminating the
consumables, open the primary packaging of
consumables immediately before loading.
m Make sure that the consumables or reagents are not
damaged and do not show signs of abrasion or
contamination. Otherwise, discard the consumables or
reagents.
m Wear personal protective equipment.
m The system must not be in Initializing status.

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r To load tip racks, reagent, and control

cassettes

1 Move the monitor out of the way.

1

2
2 On the Monitoring tab, choose the reagent cassette
drawer, and then choose the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.
f The reagent cassette drawer unlocks and
automatically opens slightly.

3 Manually open the reagent cassette drawer.

3

4 Before unpacking the consumables and the reagent

and control cassettes, make sure the primary and
secondary packaging are not damaged and there has
been no leakage.

4 Reagents and consumables

5 The tip racks, reagents, and control cassettes all have
5
one beveled corner.
• Make sure that the beveled corner is on the front
left side when loading.
• Make sure all control mini racks are aligned with
the control cassette, and all mini racks have
clicked into place.
• If the reagent or control cassette is still valid but
the system does not load it, wait a few minutes and
try reloading it. The onboard reagent storage could
have been regulating its temperature.

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6 WARNING! Risk of carryover due to droplets caused

6
by temperature difference between pipette tip and
reagent. Make sure all tip racks are at room
temperature.
6 Refill the tip racks one after the other.
• Wait until the barcode of each tip rack is read and
the callout is updated.
• Do not stack consumables when loading.

7 In the callout, check if any reagent cassettes must be

7
unloaded. Unload them if necessary.

8 WARNING! Empty reagent and control cassettes can

contaminate the environment.
8 Dispose of the reagent and control cassettes
according to local regulations.

9 CAUTION!
9
Risk of hand injury from moving parts. Do not reach
inside the magazine when loading reagents.
9 Make sure that the reagent cassettes are not
damaged and do not show signs of abrasion or
contamination. Otherwise, discard the cassettes.
• Wait until the system is ready to load a new
reagent cassette.
4 Reagents and consumables

• Load the reagent cassette.

I All cassettes are hardcoded. The marked corner
must face towards the front left side.

10 CAUTION!
10
Risk of hand injury from moving parts. Do not reach
inside the magazine when loading control cassettes.
10 Make sure that the control cassettes and the control
mini racks are not damaged and do not show signs of
abrasion or contamination. Otherwise, discard the
cassettes or the control mini rack.
• Wait until the control cassettes have been moved
into the reagent storage.
• Load the control cassette.
• Make sure that the mini racks are placed correctly.
I All cassettes are hardcoded. The marked corner
must face towards the front left side.

11 If all consumables and reagents are loaded, in the

callout, choose the Close drawer button.

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12 Wait for the click sound, then push the reagent

12
cassette drawer back in manually until it is fully
closed.

u Related topics
• About tip racks (119)
• About reagent cassettes (120)
• About control cassettes (121)
• Unloading control and reagent cassettes (117)

Unloading control and reagent cassettes

The system does not discard empty or expired control
cassettes in the solid waste container but stores them in
the reagent storage. To ensure that there is enough space
in the reagent storage, it is necessary to unload empty or
expired control cassettes manually before loading the
reagent storage for a run.

It is also necessary to unload expired or unused reagent

cassettes.

It is possible to unload control and reagent cassettes

during a run.

j m Wear personal protective equipment.

m The system must not be in Initializing status

4 Reagents and consumables

r To unload control cassettes

1 Move the monitor out of the way.

1

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118 Loading and unloading the reagent cassette drawer

2
2 On the Monitoring tab, choose the reagent cassette
drawer and choose the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.
f The reagent cassette drawer unlocks and
automatically opens slightly.

3 Manually open the reagent cassette drawer fully until

3
it clicks into place.

4
4 Choose the Unload empty cassette button.
4 Reagents and consumables

5 WARNING! Handle control cassettes as potentially

5
infectious. Direct contact with control reagent may
cause skin irritation or burns. Wear protective
equipment.
5 Wait until the control cassette is in the unloading
position, then remove it from the magazine.

6 WARNING! Empty control cassettes can contaminate

the environment.
6 Dispose of the control cassette according to local
regulations.

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7 If you have to load tip racks or control or reagent

7
cassettes, leave the reagent cassette drawer open.
Otherwise, in the callout, choose the Close drawer
button and close the reagent cassette drawer
manually.

u Related topics
• About control cassettes (121)
• Loading tip racks, reagent, and control cassettes (114)

About tip racks

Two types of pipette tips are used. The tip rack holds 48
of each type.
• Processing tips (1 mL) are used for pipetting samples
and controls in the transfer module and during sample
preparation in the processing module.
• Eluate tips (0.3 mL) are used for transferring the
eluate from the processing plate to the amplification
plate.

Pipette tips are used for pipetting samples and eluate and
for mixing. They are stored in a tip rack until needed.
Each pipette tip in the tip rack is kept in a closed
compartment of the tip rack to prevent tip to tip
contamination. Each tip is used for a dedicated well on
the processing or amplification plate. The processing tip
is reused during the whole sample preparation process.

4 Reagents and consumables

The eluate tip is used only once to transfer the eluate and
for mixing.

A waste insert underneath the tip rack is placed on the

liquid waste station. It ensures that pipette tips do not
splash during liquid waste disposal and that there is no
carryover.

The tip rack is finally disposed of in the solid waste.

The tip racks, reagents and control cassettes all have one
beveled corner. Ensure that the beveled corner is on the
front left side when loading.

You can load four tip racks per magazine. If you work
with the cobas® 6800 System, you can load eight tip
racks. If you work with the cobas® 8800 System, you can
load 16 tip racks.

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u Related topics
• Loading tip racks, reagent, and control cassettes (114)
• Unloading control and reagent cassettes (117)

About reagent cassettes

The reagent cassette provides the test-specific reagents,
such as protease, internal control, elution buffer, and
master mix reagents. Those reagents are stored in
separate vessels with different volumes.

The reagent cassette has a storage capacity of 96 or 480

tests. It is stored in the refrigerated reagent storage,
located in the transfer module.

When needed, the reagent cassettes are transferred from

the reagent storage to the interim reagent storage on the
processing module.

You can load up to 12 reagent cassettes. However, if you

load 12 reagent cassettes, there is only room for four
control cassettes on the system.

The reagents cassettes all have one beveled corner.

4 Reagents and consumables

Ensure that the beveled corner is on the front left side

when loading.

Invalidated reagents If the system is set to the Off status, all reagents that are
still on board become invalid if the temperature in the
reagent storage is >37 °C or <2 °C.

The reagents also become invalid when the system is off

for longer than 36 hours.

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If the reagent storage is >8 °C and <37 °C, the time is

deducted from the onboard stability. Once the onboard
stability is exceeded, reagents are invalidated. The
onboard stability may vary from reagent to reagent and is
specified in the Instructions for Use.

Unload reagents and controls before shutting down the

system.

u Related topics
• Loading tip racks, reagent, and control cassettes (114)

About control cassettes

The control cassette contains four control mini racks with
reagents, which are used as controls to monitor the
functionality of reagent cassettes.

There are positive and negative control cassettes. The

positive control cassettes are test specific while the
negative control cassette is generic for all tests. For every
run started, at least one set of negative and one set of
positive controls must be processed.

You can combine different control mini racks for different

control types in one cassette if necessary.

You can load up to eight control cassettes.

Control cassettes all have one beveled corner. Ensure that

4 Reagents and consumables

the beveled corner is on the front left side when loading.

u Related topics
• Unloading control and reagent cassettes (117)
• Loading tip racks, reagent, and control cassettes (114)

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4 Reagents and consumables Loading and unloading the reagent cassette drawer

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Table of contents

Sample processing 5

In this chapter 5
Setting the system to Ready status . . . . . . . . . . . . . . . 125
Handling test orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
About test orders . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Creating a test order manually . . . . . . . . . . . . . . . . 126
Resetting test orders after error . . . . . . . . . . . . . . . 128
Overview of loading/unloading procedures . . . . . . . . 130
About the operating modes of the sample supply
module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
About the standalone mode . . . . . . . . . . . . . . . . . . 131
About the unidirectional mode . . . . . . . . . . . . . . . . 132
About the bidirectional mode . . . . . . . . . . . . . . . . . 133
Handling racks for clotted tips . . . . . . . . . . . . . . . . . . . 135
Loading racks for clotted tips . . . . . . . . . . . . . . . . . 135
Prioritized loading of racks for clotted tips . . . . . . 138
Loading samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Placing barcode labels on sample tubes. . . . . . . . 140
Loading samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Handling barcode reading errors . . . . . . . . . . . . . . 144
Loading priority samples . . . . . . . . . . . . . . . . . . . . . 146
Unloading sample racks . . . . . . . . . . . . . . . . . . . . . . . . 149
Unloading sample racks from the output buffer . 149
Unloading a rack tray that is not full . . . . . . . . 149
Unloading a full rack tray . . . . . . . . . . . . . . . . . 151
Unloading sample racks from the error output 5 Sample processing
line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
Starting a run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Starting a run manually . . . . . . . . . . . . . . . . . . . . . . 154
Starting a run automatically . . . . . . . . . . . . . . . . . . 155
Canceling a run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Masking/unmasking a module or magazine . . . . . . . 158
Reviewing test results . . . . . . . . . . . . . . . . . . . . . . . . . . 160
About test result formatting . . . . . . . . . . . . . . . . . . 160
Reviewing test results . . . . . . . . . . . . . . . . . . . . . . . 161
Reviewing test results by control batch. . . . . . . . . 163
Adding a review comment to a test result . . . . . . 164
List of flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Viewing the tracking information . . . . . . . . . . . . . . 166
Ordering a repeat test . . . . . . . . . . . . . . . . . . . . . . . 168

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Table of contents

Loading samples for a repeat test . . . . . . . . . . . . . 170

Test result reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
About test result reports . . . . . . . . . . . . . . . . . . . . . 172
Creating reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Releasing test results . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Releasing test results via remote connection . . . . . . . 179
Downloading files from the IG server . . . . . . . . . . . . . 180
Viewing audit trail entries . . . . . . . . . . . . . . . . . . . . . . . 181
Exporting test results . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Priming the instrument . . . . . . . . . . . . . . . . . . . . . . . . . 184
5 Sample processing

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Setting the system to Ready status

After starting up and loading supplies, the system is
typically in Standby status. In order to load sample racks
and racks for clotted tips, you must set the system to
Ready status.

j m System is started up.

m The waste containers are not full.
m Supplies are loaded.

r To set the system to Ready status

1 In the task overview, ensure that there is no

1
maintenance action in a red status. If a maintenance
action is overdue, perform the maintenance action
first.

2 On the Monitoring tab, choose the Start button.

2
f The system changes to Preparing status.

3 Wait for the system to change to Ready status before

you start loading. This process can take up to 15
minutes.
f The system is then ready to load racks for clotted
tips and sample racks.

u Related topics
• Starting up the system from Hibernate status (62)
• Emptying the solid waste container (88)
• Replacing the liquid waste container (94)
• Unloading/loading the consumables drawer (107)
• Loading diluent and lysis reagent bottles (103) 5 Sample processing
• Loading tip racks, reagent, and control cassettes (114)

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Handling test orders

Handling test orders includes the following topics:

In this section
About test orders (126)
Creating a test order manually (126)
Resetting test orders after error (128)

About test orders

The system supports three options to enter a test order.
Typically, test orders are received from the LIS. If you are
not using an LIS, the system can create rack-based
orders. Additionally, you can enter a test order manually
using the user interface.

No test orders received If the system does not receive a test order for a loaded
sample ID within 15 minutes after reading the sample
tube barcode, the rack is moved to the output line.

u Related topics
• Creating a test order manually (126)
• Resetting test orders after error (128)

Creating a test order manually

You can create a test order manually on the user
interface. This can be useful if a sample is not yet
registered in the LIS but needs to be processed with
higher priority.
5 Sample processing

Editing a test order Once a test order has been created, you cannot edit it. To
change an existing order, delete it and create a new one.

Invalid test order If you add an invalid test order, all existing test orders for
that sample ID are deleted.

What causes test orders to be invalidated? A test order is invalidated if the test orders added to a
sample do not match. For example, if you choose different
sample types for the same sample ID.

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r To manually create a test order

1 Choose Routine > Sample orders.

1

2 Below the Samples: table, choose the Assign button.

3 Under Sample:, enter the sample ID as shown on the

3
barcode, sample type, and, optionally, secondary
sample ID.
I You can use the secondary ID to enter any meta
data about the sample. This ID is also displayed in
the test results view.

4 Enter the test, volume, pool size, and, optionally, a

comment. If you do not pool, choose n/a or 0.
I Do not disclose patient information in the
comment field.

5 To assign another test order to the sample, choose the

Assign test button.
• Enter the details of the additional test.

6 If the test order is complete, choose the Save and

create new button.

7 Repeat the procedure for all samples for which you

want to create a test order manually.

8 To finalize, choose the Save button. 5 Sample processing

9 Place the sample rack on the rack tray on the input
buffer or on the input line.
• Make sure that the rack ID is not part of a range
used for rack-based orders.

u Related topics
• About test orders (126)
• Resetting test orders after error (128)

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128 Handling test orders

Resetting test orders after error

If a malfunction caused a run abort, the system changes
to the Error status. You must then reset the test orders
and/or order a repeat test.

Resetting test order, ordering a repeat test You must reset the test orders with Processing or
Scheduled status. These statuses apply to samples that
are already loaded onto the system but are not or only
partly processed. Test orders in Processing status are
invalidated by the system. For these, you must order a
repeat test.

Why is this necessary? If the test orders are not reset, they are registered on the
system with Scheduled or Processing status. In this
case, if you load the samples again, the system does not
process them.

j m The system must be in Error status.

m The system must not be in any of the following
statuses: Running, Stopping, Pausing, Ready,
Preparing

r To reset test orders after error

1 To be sure that all results are available for review, wait

for the IG server to finish processing and to show the
test results.

2 Review the test orders. Check which test orders have

not been processed.

3
3 If not all test orders were processed, choose
5 Sample processing

Administration > Settings > System settings

> Manage instruments.

4 From the list of instruments, choose your instrument.

5 Choose the Reset test orders button.

f All test orders that were in Scheduled or
Processing status, are reset.
f The test orders that were in status Scheduled
change to status Received.
f The test orders that were in status Processing
change to status Unreleased. The test result is
invalidated.

6 For the test orders in Processing status, order repeat

tests.

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7 Resolve the error that caused the system to change to

Error status.

8 Reload the sample racks.

I If you load a sample that has already been
processed previously, the sample rack is moved to
the output buffer as soon as the barcode has been
read.

u Related topics
• Refer to the section Cleaning up the instrument
during startup in the User Assistance
• Reviewing test results (161)
• About test orders (126)
• Creating a test order manually (126)

5 Sample processing

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Overview of loading/unloading procedures

About the operating modes of the sample supply module

Typically, you load the samples on rack trays on the input
buffer and unload them on the output buffer. However, it
is also possible to load and unload samples via conveyor
belts.

Three different modes The sample supply module supports three different
modes:
• Standalone mode: The samples are loaded and
unloaded on rack trays via input and output buffer.
• Unidirectional mode: The samples are loaded via
conveyor belt through the input line. Unloading is
done via output buffer.
• Bidirectional mode: The samples are loaded and
unloaded via conveyor belt through the input and
output line.

u Related topics
• About the unidirectional mode (132)
• About the bidirectional mode (133)
• About the standalone mode (131)
5 Sample processing

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About the standalone mode

A
B
C
Unidirectional
Standalone

Bidirectional

D E

A Error output line D Output buffer

B Output line: Deactivated E Input buffer
C Input line: Priority input

w Standalone operating mode of the sample supply module

No conveyor belt If no conveyor belt is connected, you are working in

standalone mode.

The operating mode switch on the rear of the sample

supply module is set to standalone.

5 Sample processing

Loading/unloading via buffer You load the racks on a rack tray on the input buffer, and
unload them with a rack tray from the output buffer.

Error output line You can unload error racks from the error output line.

Output line deactivated In standalone mode, the output line is deactivated.

However, there is one situation, where the output line is

used: If you shut down the sample supply module, the
sample racks that are still on the output rail are moved to
the output line.

Priority input line To load priority samples, load the rack on the priority
input line.

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132 Overview of loading/unloading procedures

u Related topics
• About the unidirectional mode (132)
• About the bidirectional mode (133)
• About the operating modes of the sample supply
module (130)

About the unidirectional mode

A
B
C
Unidirectional
Bidirectional
Standalone

D E

A Error output line D Output buffer

B Output line: Deactivated E Priority input
C Input line

w Unidirectional operating mode of the sample supply module

One conveyor belt If you are loading via conveyor belt on the input line and
unloading via output buffer, you are working in
unidirectional mode.
5 Sample processing

The operating mode switch on the rear of the sample

supply module is set to unidirectional.

Loading via input line The sample racks are loaded via conveyor belt on the
input line.

Unloading via output buffer You unload the sample racks with a rack tray from the
output buffer.

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Error output line You can unload error racks from the error output line.

Output line deactivated In unidirectional mode, the output line is deactivated.

However, there is one situation, where the output line is

used: If you shut down the sample supply module, the
sample racks that are still on the output rail are moved to
the output line.

Priority input via input buffer To load priority samples, load the rack on a rack tray and
on the input buffer.

u Related topics
• About the standalone mode (131)
• About the bidirectional mode (133)
• About the operating modes of the sample supply
module (130)

About the bidirectional mode

A
B
C
Bidirectional
Unidirectional
Standalone

5 Sample processing
D E

A Error output line D Output buffer: Deactivated

B Output line E Priority input
C Input line

w Bidirectional operating mode of the sample supply module

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134 Overview of loading/unloading procedures

Two conveyor belts If you load and unload via conveyor belt, you are working
in bidirectional mode.

The operating mode switch on the rear of the sample

supply module is set to bidirectional.

Loading via input line The sample racks are loaded via conveyor belt on the
input line.

Unloading via output line The sample racks are unloaded via conveyor belt on the
output line.

Error output line You can unload error racks from the error output line.

Priority input via input buffer To load priority samples, load the rack on a rack tray and
on the input buffer.

Output buffer deactivated In bidirectional mode, the output buffer is deactivated.

u Related topics
• About the standalone mode (131)
• About the unidirectional mode (132)
• About the operating modes of the sample supply
module (130)
5 Sample processing

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Handling racks for clotted tips

If a clot is detected in a pipette tip during aspiration, the
tip is not discarded in the solid waste container but in a
special rack type. This rack is referred to as rack for
clotted tips.

The handling of racks for clotted tips includes the

following procedures:

Unloading racks for clotted tips The racks for clotted tips are unloaded via output buffer.

Unloading samples with clots The racks that carry the samples that have clots are
unloaded via error output buffer.

In this section
Loading racks for clotted tips (135)
Prioritized loading of racks for clotted tips (138)

Loading racks for clotted tips

The system has capacity for 2 racks for clotted tips, so it
can handle 10 clots. If not enough sample tubes are
available to discard clotted tips, the system stops
processing and you risk losing samples.

You can load additional racks for clotted tips at any time.
The system replaces the racks containing clotted tips with
empty racks for clotted tips. The frequency of reloading
should be adjusted to the typical clot rate in the
laboratory.

Standalone mode This procedure describes loading if the sample supply

module is in standalone mode. If you are loading the
sample racks via conveyor belt on the input line, you must
5 Sample processing
also load the racks for clotted tips via conveyor belt on
the input line.
u Overview of loading/unloading procedures (130)

d m Racks for clotted tips (pink, rack ID starting with "R")

m Empty sample tubes, ideally without barcode.
If you use sample tubes with a barcode, turn the
barcode away from the opening on the side of the
sample rack, so that the barcode cannot be read by
the system.

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136 Handling racks for clotted tips

j m Sample supply module is initialized.

m Consumables and reagents are loaded, waste
containers are empty.
m System is in Ready status.

r To load racks for clotted tips

1
1 Open the front cover of the sample supply module.

2 Ensure that the output buffer is in status.

3 Load an empty rack tray on the output buffer.

3
f If the rack tray is placed correctly, the status
indicator changes to status.

4 To ensure that the system can identify the rack as a

4
rack for clotted tips, check the rack ID on top of the
rack. The rack ID must start with "R".
5 Sample processing

5 Place five empty sample tubes into the rack for clotted
5
tips.
• You can use any of the sample tubes listed in the
specifications. However, it is recommended to use
sample tubes of type 16 x 100 mm.
• Ideally, use sample tubes without barcodes. If you
use a barcode, turn the barcode away from the
opening on the side of the sample rack. In this
way, the barcode cannot be read by the system.

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6 Place two racks on an empty rack tray.

6

7 Alternatively, if you do not want to load the racks for

7
clotted tips separately, load them together with your
regular sample racks.
• Place the racks for clotted tips in the front position
of the rack tray.
• Reload racks for clotted tips as often as required,
depending on the number of clotted tips that are
typically generated.

8 Ensure that the input buffer is in status.

8

9 CAUTION! Risk of hand injury due to moving parts.

9
Keep your hands away from the rack transport pins.
9 Load the rack tray on the input buffer.
f The racks for clotted tips are loaded.

10 After loading the tray, keep your hands out of the 5 Sample processing
loading area.
f Do not remove the rack tray until loading has been
completed and the status indicator is green again.

u Related topics
• List of statuses on the sample supply module (65)
• Prioritized loading of racks for clotted tips (138)
• Loading samples (141)

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138 Handling racks for clotted tips

Prioritized loading of racks for clotted tips

If you need to prioritize the loading of racks for clotted
tips, you can load via input line. This can be useful if you
have already started loading sample racks on the input
buffer.

Standalone mode This section describes how prioritized loading works if the
sample supply module is in standalone mode. In
standalone mode, the input line operates as the priority
input.

If you are loading via the conveyor belt on the input line,
you must use the input buffer for prioritized loading.
u Overview of loading/unloading procedures (130)

r To load racks for clotted tips via input

line

1 Open the front cover of the sample supply module.

1

2 Ensure that the output buffer is in status.

3 Load an empty rack tray on the output buffer.

3
f If the rack tray is placed correctly, the status
indicator changes to status.
5 Sample processing

4 To ensure that the system can identify the rack as a

4
rack for clotted tips, check the rack ID on top of the
rack. The rack ID must start with "R".

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 Sample processing 139

5 Place five empty sample tubes into the rack for clotted
5
tips.
• You can use any of the sample tubes listed in the
specifications. However, it is recommended to use
sample tubes of type 16 x 100 mm.
• Ideally, use sample tubes without barcodes. If you
use a barcode, turn the barcode away from the
opening on the side of the sample rack. In this
way, the barcode cannot be read by the system.

6 Wait until the status on the input line changes to

6
the status.

7 Lift the side cover of the sample supply module.

7
f For security reasons, the motors of the sample rack
elevator are stopped as soon as the cover is
opened.

8 Place the rack for clotted tips on the input line. Ensure
8
that the barcode of the sample rack faces to your
right.

5 Sample processing

9 Close the side cover.

9
f The rack for clotted tips is moved to the transfer
module.

u Related topics
• List of statuses on the sample supply module (65)
• Loading racks for clotted tips (135)
• Loading samples (141)
• Overview of loading/unloading procedures (130)

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140 Loading samples

Loading samples
In this section
Placing barcode labels on sample tubes (140)
Loading samples (141)
Handling barcode reading errors (144)
Loading priority samples (146)

Placing barcode labels on sample tubes

The system identifies each sample with a unique barcode
label attached to the tube.

j m Ensure that your barcode labels comply with the

specifications provided in this manual.

r To place a barcode label on a tube

1
1 If there is already a barcode label on the tube, remove
the old barcode label.

10 mm
2 Remove all residues of glue or label on the tube.

14 mm
3 When placing the label on the tube, adhere to the
following specifications:
• The barcode must be perpendicular to the tube.
Quiet zone • 3.5 mm

• The barcode must be centered in the symbol

placement zone.
Symbol placement zone

Label placement zone

• The size of the label placement zone depends on

Barcode symbol

the tube size.

5 Sample processing

• For example: For a tube height of 100 mm, the

label placement zone is 81 mm, and the symbol
placement zone is 66 mm.

u Related topics
• Loading samples (141)

20 mm
9 mm

• 10 mm
Symbol height

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Loading samples
After loading the consumables and reagents, you can
start loading the samples. To see whether you have to
remove or load a rack tray, check the status indicators of
the input and output buffers.

Supported sample types For a list of supported sample types, refer to the
Instructions for Use of the test you want to perform.

Standalone mode This procedure describes how loading works if the

sample supply module is in standalone mode.

If you are loading via the conveyor belt, loading is done

automatically via the input line.
u Overview of loading/unloading procedures (130)

d m Do not use damaged or otherwise compromised

sample tubes.

j m Wear personal protective equipment.

m The system is in Ready status.

r To load samples

1 Ensure that the output buffer is in status and no

status indicators are red.

2 Load an empty rack tray on the output buffer.

2
f If the rack tray is placed correctly, the status
indicator changes to status and then
to status.

5 Sample processing

3 On the sample supply module, ensure that the input

3
buffer is in status.

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142 Loading samples

4 CAUTION! Risk of instrument contamination. Do not

4
load damaged or otherwise compromised sample
tubes.
4 Place the sample tubes into the sample racks.
• Ensure that the tube contains enough sample
material, especially when using primary gel tubes.
To check the fill volume for primary gel tubes, see
the specifications about minimum volumes for
primary gel tubes.
• Ensure that the barcode labels on the sample
tubes are not damaged or wet and are visible
through the openings on the side of the sample
rack.
• Let samples reach room temperature.
• Ensure that the labels are attached as defined in
the section on placing barcode labels on sample
tubes.

q Do not place secondary tubes from the pooling

instrument into a sample rack whose ID belongs to an
ID range reserved for rack-based orders.
u List of supported sample tubes (264)

5 Make sure to use only those rack types that are listed
in the specifications.
• Do not use racks where additional rubber disks
have been inserted into the bottom of the rack. The
total height must not exceed 79 mm.
• Do not use red sample racks.

6 Push the sample tubes down into the rack. Make sure
that the sample tubes are inserted fully into the rack.

7 Load the rack onto a rack tray. When the handle of the
7
rack tray is on your right-hand side, the barcodes of
the racks must face towards you.
5 Sample processing

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8 Open the front cover of the sample supply module.

8

9 CAUTION! Risk of hand injury due to moving parts.

9
Keep your hands away from the rack transport pins.
9 Ensure that the handle of the rack tray is facing to
your right. Place the rack tray with the sample racks
on the input buffer.

10 Keep your hands out of the loading area. Do not move

the rack tray before loading has been completed.

11 Check the status of the input buffer.

11
f If the rack tray was placed properly, the input
buffer changes to status.
f If a rack is accepted, it is moved to the next empty
slot of the rack platform.

12 If a barcode cannot be read, the rack is moved to the

12
error output line.
• Perform the steps described under Handling
barcode reading errors (144)

5 Sample processing

13 Load the next rack tray.

13

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144 Loading samples

14 When you are finished, close the front cover.

14

u Related topics
• Placing barcode labels on sample tubes (140)
• List of statuses on the sample supply module (65)
• Handling barcode reading errors (144)
• List of supported sample racks (266)
• List of supported sample tubes (264)
• Minimum volumes for primary gel tubes (264)
• Loading priority samples (146)
• Overview of loading/unloading procedures (130)

Handling barcode reading errors

If the system cannot read a barcode, it moves the rack to
the error output line. You must then enter the barcode
manually.

r To handle barcode reading errors

1 If a barcode could not be read, the rack is moved to

1
the error output line and a warning is displayed in the
task overview.

2
2 Choose the task.
f The Manual barcode entry tab is displayed.

3
3 Remove the rack from the error output line.
5 Sample processing

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 Sample processing 145

4 Place the cursor into the Sample rack ID: field. Use
4
the hand-held barcode reader to enter the barcode of
the sample rack.

5 Place the cursor into the Barcode field.

5

6 Use the hand-held barcode reader to enter the

6
barcode of the sample tube that is indicated on the
monitor.
• To confirm, enter the barcode again.

7 If the hand-held barcode reader cannot read the

barcode, use the virtual keyboard to enter the barcode
manually.

8 Verify if the barcode is entered correctly.

8

9 Place the tube back on the rack. Make sure to place it

in the position that is indicated on the monitor.
• If there are 2 sample tubes with unreadable
barcodes, make sure not to mix up the positions.

10 CAUTION! Risk of hand injury due to moving parts. 5 Sample processing

10
Keep your hands away from the rack transport pins.
10 Load the rack tray with the sample racks.

11 Keep your hands out of the loading area. Do not move

the tray before loading has been completed.

12 If the rack still cannot be loaded, replace the barcodes

on the affected rack or tube.
• If the barcode of a tube cannot be read, the entire
rack cannot be processed.
• To process the other sample tubes in this sample
rack, remove the sample tube with the faulty
barcode.

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146 Loading samples

u Related topics
• Loading samples (141)
• Refer to the Barcode settings section in the User
Assistance.

Loading priority samples

If you need to process a sample quickly, but the input
buffer is already full, you can use the input line. If sample
racks are on the input line, they are loaded before the
ones on the input buffer.

Standalone mode This procedure describes how prioritized loading works if

the sample supply module is in standalone mode. In
standalone mode, the input line operates as the priority
input.

If you are loading via the conveyor belt, you must use the
input buffer for prioritized loading.
u Overview of loading/unloading procedures (130)

d m Do not use damaged or otherwise compromised

sample tubes.

j m Wear personal protective equipment.

m The system is in Ready status.
m If the test order for the priority sample is not in the LIS,
ensure that rack-based ordering is enabled or enter
the test order manually.

r To load a priority sample

5 Sample processing

1 CAUTION! Risk of instrument contamination. Do not

1
load damaged or otherwise compromised sample
tubes.
1 Place the sample which has to be processed with
higher priority into a sample rack.

2 Push the sample tubes down into the rack. Ensure that
the sample tubes are inserted fully into the rack.

3 Ensure that the barcodes on the sample tubes are

visible through the open slots of the sample rack.

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4 Wait until the status on the input line changes to

4
the status.

5 Lift the side cover of the sample supply module.

5
f For safety reasons, the motors of the sample rack
elevator are stopped as soon as the cover is
opened.

6 Place the sample rack on the input line. Make sure the
6
barcode face to your right.

7 Close the side cover.

7
f The sample rack is moved to the transfer module.

8 If the barcode could not be read, enter the barcode

manually.
• On the Monitoring tab, choose the Manual 5 Sample processing
barcode entry button.
• Use the hand-held barcode reader to enter the
barcodes of the sample rack and the sample tube.

9 To load more racks on the input line, wait until the

9
sample rack elevator changes to status.

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148 Loading samples

10 Then, lift the side cover and place the sample rack on
10
the input line.

11 Close the side cover.

11

u Related topics
• Creating a test order manually (126)
• Loading samples (141)
• List of statuses on the sample supply module (65)
• Placing barcode labels on sample tubes (140)
• Handling barcode reading errors (144)
• List of supported sample racks (266)
• List of supported sample tubes (264)
5 Sample processing

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Unloading sample racks

Unload sample racks regularly. If no room is available for
racks in the output buffer, the sample supply module
stops processing.

If the system is left idle for an extended time after

completing runs, racks remaining in the transfer module
can cause the system to enter Error status. The idle time
is approximately 9 h.

In this section
Unloading sample racks from the output buffer (149)
Unloading sample racks from the error output line (152)

Unloading sample racks from the output buffer

To unload a sample rack from the output buffer, perform
one of the following procedures, depending on whether
the rack tray is full.

In this section
Unloading a rack tray that is not full (149)
Unloading a full rack tray (151)

Unloading a rack tray that is not full

After pipetting, the system moves the sample racks to the
output buffer.

Always unload the rack tray, even if you only have to

unload a single sample rack.
5 Sample processing
If the rack tray is not full yet, make sure to follow the
unloading procedure.

j m Wear personal protective equipment.

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150 Unloading sample racks

r To unload a rack tray that is not full

1 Open the front cover of the sample supply module.

1

2 On the control panel, press the output buffer button.

2

3 Keep your hands out of the output buffer. Do not

3
move the rack tray before the status indicator has
changed to status.

4 CAUTION! Risk of hand injury due to moving parts.

4
Keep your hands away from the rack transport pins.
4 Unload the rack tray from the output buffer.
5 Sample processing

• When unloading the sample racks, store them in

the same order as they were on the output buffer.
This makes it easier to find a specific rack ID in
case you need to perform a repeat test.
f The status indicator changes to status.

5 Load an empty rack tray on the output buffer. Ensure

5
that the handle of the rack tray is facing to your right.
f If the rack tray is placed correctly, the status
indicator changes to status.

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6 Keep your hands out of the output buffer.

6

7 Close the front cover.

7
f The sample supply module is now ready to
process.

u Related topics
• Refer to the Troubleshooting section.
• Unloading a full rack tray (151)

Unloading a full rack tray

As soon as a rack tray is full, you can unload it. You can
unload full rack trays during processing.

j m The output buffer must be in status.

m If the status indicator is not set to status, the rack
tray is not full yet.
m Wear personal protective equipment.

r To unload a full rack tray

1 Open the front cover of the sample supply module. 5 Sample processing
1

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152 Unloading sample racks

2 CAUTION! Risk of hand injury due to moving parts.

2
Keep your hands away from the rack transport pins.
2 Unload the full rack tray from the output buffer.
• When unloading the sample racks, store them in
the same order as they were on the output buffer.
This makes it easier to find a specific rack ID in
case you need to perform a repeat test.

3 Load an empty rack tray on the output buffer. Ensure

3
that the handle of the rack tray is facing to your right.
f If the rack tray is placed correctly, the status
indicator changes to status.

4 Keep your hands out of the unloading area. Do not

4
move the rack tray before the status indicator has
changed to status.

5 Close the front cover.

5
f The sample supply module is now ready to
process.

u Related topics
• Refer to the Troubleshooting section in the User
5 Sample processing

Assistance.
• Unloading a rack tray that is not full (149)

Unloading sample racks from the error output line

The error output line receives the sample racks with
sample tubes that could not be processed by the system.

j m Wear personal protective equipment.

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r To unload a rack from the error

output line

1
1 Check the status indicator of the error output line. If
the status is either , , or the rack is ready to
be unloaded.

2 Hold the rack between thumb and index finger, lift it

2
slightly and slowly pull it out of the error output line.
f Any additional racks are now moved to the error
output line.

u Related topics
• Unloading a full rack tray (151)
• Unloading a rack tray that is not full (149)

5 Sample processing

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154 Starting a run

Starting a run
Starting a run means to start the sample preparation and
amplification and detection process. You can manually
start a run at any time or have it start automatically after
120 minutes or if the batch is full.

In this section
Starting a run manually (154)
Starting a run automatically (155)

Starting a run manually

j m The system must be in Ready status.

m Especially when you start multiple runs, ensure that
the waste containers are empty.
m Ensure that enough supplies and the sample racks are
loaded.
m Wear personal protective equipment.

r To start a run manually

1 On the Monitoring tab, next to the system overview,

1
choose the Start button.
f The system changes to Preparing status and
primes all needles. This takes up to 10 minutes.
5 Sample processing

2 To view the current batch details, choose the Batches

2
button.
f After a rack has passed the barcode reading
station of the transfer module, the run status and
the requested test are displayed in the Batches
panel.

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 Sample processing 155

3 Check if all required supplies are loaded. Load them if

3
necessary.

4 As soon as you have loaded the samples and missing

4
supplies, choose the Start manually button.
f The system changes to Running status and starts
the run.

q A run takes up to 3.5 hours. The duration of the

run depends on how many samples are in the run and
how many tests per sample must be pipetted.

u Related topics
• Unloading/loading the consumables drawer (107)
• Starting a run automatically (155)
• Masking/unmasking a module or magazine (158)
• Reviewing test results (161)

Starting a run automatically

A run starts automatically after 120 minutes or if the
batch is full.

j If one of the following conditions is true, a run starts

automatically:
m The number of samples added to the run equals 5 Sample processing
maximum run size.
Maximum run size is lower than 96 samples per
amplification plate - depending on the test and the
number of controls required.
m At least one of the samples of the run has been
onboard for more than 120 minutes.

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156 Starting a run

r To start a run automatically

1 On the Monitoring tab, next to the system overview,

1
choose the Start button.
f The system changes from Standby status to
Preparing status. At this stage, all needles are
being primed. This can take up to 10 minutes.

2 To view the current run details, choose Monitoring

2
> Batches.
f When a rack passes the barcode reading station,
the run status and the requested tests are
displayed in the Batches panel.

3 Check if all required samples and supplies are loaded.

3
Load them if necessary.

4 As soon as your samples and missing supplies are

4
loaded, the Start manually button becomes active.

5 You can now walk away from the system without

starting the run.
• If the maximum number of samples per run has
5 Sample processing

been reached:
The system changes to Running status and starts
the run automatically.
• If the run is not full:
The system changes to Running status and starts
the run if at least one of the samples of the run has
been on board the transfer module for more than
120 minutes.
f A run takes up to 3.5 hours, depending on how
many tests you requested.

u Related topics
• Starting a run manually (154)
• Reviewing test results (161)
• Masking/unmasking a module or magazine (158)

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Canceling a run
You can cancel all runs that are not yet being processed
by stopping the analytic system.

q Be sure to update the load list when the button is

highlighted. Not updating the view can result in delayed
results.

j m The system is in Running status.

r To cancel runs

1 On the Monitoring tab, choose the Stop button.

1
I Test orders that are stopped are automatically
reset.
f Runs that are being processed will be completed.
f All runs that have not yet begun will be canceled,
the sample racks will be unloaded to the output
buffer.

2 Remove the racks from the output buffer.

3 To view the sample IDs of the canceled tests, choose

Routine > Sample orders

4 From the Sample orders panel, identify the samples

for the repeat test.

5 Sample processing

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158 Masking/unmasking a module or magazine

Masking/unmasking a module or magazine

If a processing or analytic module is in Error or Standby
status, you can mask this module. You can also mask the
magazines for processing plates, tip racks and
amplification plate cassettes. The system then does not
use this module and continues processing with the
remaining modules.

Masking Masking allows you to continue processing until you can

resolve the error in one module.

q Bear in mind that scheduled maintenance activities

fail if the module is masked.

Unmasking After the problem has been resolved, you can unmask the
module. It is then used again normally.

q Do not unmask a module or magazine until the

problem is resolved and you perform a full instrument
restart. You should not use this feature to recover the
system from an error.

j m You can only mask the additional processing module

or the additional analytic units on the cobas® 8800
System. On the cobas® 6800 System, only the
magazines for processing plate cassettes, tip racks
and amplification plates can be masked.
m The module must be in Error or Standby status.

r To mask a module or magazine

5 Sample processing

1 On the Monitoring tab, choose the module or

1
magazine that you want to mask.

2 In the callout, choose the Mask module or Mask

magazine button.
f The system ignores that module and continues
processing with the remaining module.

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r To unmask a module or magazine

1 On the Monitoring tab, choose the module or

1
magazine that is masked.

2 In the callout, choose the Unmask module button.

f The system starts using this module again.

u Related topics
• Starting a run manually (154)
• Starting a run automatically (155)

5 Sample processing

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160 Reviewing test results

Reviewing test results

If you have reviewed a test result but want to repeat a
test, you can order a repeat test if it has not been released
yet. After you have released a test result, the test result
itself and its review comments are sent to the LIS for
medical validation.

q A repeat test must be actively ordered to retest an

invalid individual sample if all conditions are met.

Reviewing and releasing test results, and ordering a

repeat test includes the following tasks:

In this section
About test result formatting (160)
Reviewing test results (161)
Reviewing test results by control batch (163)
Adding a review comment to a test result (164)
List of flags (165)
Viewing the tracking information (166)
Ordering a repeat test (168)
Loading samples for a repeat test (170)

About test result formatting

Reactive test results are highlighted in red in test result
views and reports.

Depending on the configuration of the test definition

parameters, reactive test results in qualitative single
channel, multi channel, and mixed tests are automatically
5 Sample processing

highlighted in red.

For non quantitative tests only.

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w Highlighting of reactive tests

q For each test result, an overall result and the results

for each individual target is displayed.
Independently of result validation (validated by controls)
each target can be displayed as reactive / positive, non-
reactive / negative, or the titer (quantitative test) is
displayed.

Reviewing test results

As soon as a test result has been generated, you can
review it by accessing the result list. The result list shows
the test results of the samples and pools as well as the
test results of the controls.
5 Sample processing

r To review test results

1
1 In the software, choose Routine > Test results.

2 To review the test details, select a test from the table.

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3
3 In the details view, review the measurement
information.

4 To review the flag details, check the Flag details

4
table.

5
5 To review the history, choose the Tracking button.

u Related topics
• Adding a review comment to a test result (164)
• List of flags (165)
• Viewing the tracking information (166)
• Ordering a repeat test (168)
• Releasing test results (178)
5 Sample processing

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Reviewing test results by control batch

You can review test results by control batch. If you
choose a control batch, all test results that were validated
by this control are shown in the list.

r To review test results by control

batch

1 In the software, choose Routine > Control batch.

1

2 Select the relevant control batch from the list.

2
I Only negative controls are listed.

3 In the details view, review the measurement

3
information.

4 To review the flag details, check the Flag details

table.

5 Sample processing

5
5 To review the history, choose the Tracking button.

u Related topics
• Reviewing test results (161)
• Adding a review comment to a test result (164)
• List of flags (165)
• Viewing the tracking information (166)
• Ordering a repeat test (168)
• Releasing test results (178)

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Adding a review comment to a test result

If you have review findings, you can add a comment to a
test result. The comment is sent along with the result to
the LIS.

r To add a comment to a test result

1
1 Choose Routine > Test results.

2 From the list, choose the test result to which you wish
to add a review comment.

3
3 To add a comment, in the result details, choose the
Comments button.
I For privacy and security reasons, do not disclose
patient information in the comment field.

5
4 Add your comment and save it.
I The comment is sent to the LIS together with the
5 Sample processing

result.

u Related topics
• Reviewing test results (161)
• List of flags (165)
• Viewing the tracking information (166)
• Ordering a repeat test (168)
• Releasing test results (178)

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List of flags

Flag Description
C01 Calculation error
C01H1 Calculation error for target 1
C01H2 Calculation error for target 2
C01H3 Calculation error for target 3
C01H4 Calculation error for target 4
C01H5 Calculation error for target 5
C01T Clot was detected while dispensing in neighbouring well of the deepwell plate. Risk of
carryover.
C02 Data cannot be analyzed
C02H1 Data for target 1 cannot be analyzed.
C02H2 Data for target 2 cannot be analyzed.
C02H3 Data for target 3 cannot be analyzed.
C02H4 Data for target 4 cannot be analyzed.
C02H5 Data for target 5 cannot be analyzed.
P01T A process execution error occurred in transfer module.
P02T Clot has been detected while aspirating sample.
P03T Clot has been detected while dispensing sample.
P04T Insufficient volume was detected in sample tube, sample was not pipetted into deepwell plate.
P05P A process execution error occurred in processing module.
P06P An error occurred while dispensing reagent. Volume is insufficient.
P07P Not enough supernatant was removed.
P08P Processing temperature in heating station was not reached.
P09P Processing temperature in heating station is out of range.
P10P Timeout was reached.
P11A A process execution error occurred in analytic unit.
P12H0 Fluorescence signal for IC/QS was saturated.
P13H1 Fluorescence signal for target 1 was saturated.
P13H2 Fluorescence signal for target 2 was saturated.
P14H3 Fluorescence signal for target 3 was saturated. 5 Sample processing
P14H4 Fluorescence signal for target 4 was saturated.
P14H5 Fluorescence signal for target 5 was saturated.
P15 Test order has expired.
Q01 Control error
Q02 Control batch was invalidated.
R01 Supply could not be validated.
R02 Supply could not be validated.
U01T Sample pipettor was blocked while pipetting sample.
Possible cause: a cap on the tube or an unexcpected tube bottom was detected.
U02T Insufficient volume was detected in sample tube, sample was not pipetted into deepwell plate.
Consider ordering a low volume test or take preanalytical measures
U03 RFID parameter error
U03P Check of initial volume of reagent cassette or MGP cassette has failed.
y Flags

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Flag Description
U04 Test order was canceled by user.
U05 Safety interlock was activated by the user.
U06T Insufficient volume aspirated. Sample not transferred.
Y01T Transfer module is not available.
Y02T A hardware error occurred in transfer module.
Y03P Processing module is not available.
Y04P A hardware error occurred in processing module.
Y05A Analytic module is not available.
Y06A A hardware error occurred in analytic module.
Y07B A hardware error occurred in consumable drawer.
Y08F A hardware error occurred in infrastructure.
Y10 An error occurred while handling a consumable, reagent cassette, or sample rack.
Y20M An instrument software error occurred.
Y21W IG server software error
Y22V Pooling management software error
Y23K Pooling instrument software error
Y24X Analysis package error
Y40T Liquid level detection error occurred while pipetting sample.
Y41T Pipette tip could not be picked up. Control could not be pipetted.
Y43 Onboard temperature is out of range.
y Flags

u Related topics
• Reviewing test results (161)
• Viewing the tracking information (166)
• Ordering a repeat test (168)
• Releasing test results (178)

Viewing the tracking information

5 Sample processing

For each result you can track all processing steps,

controls, consumables, and reagents that were involved
in generating that result.

For example: Sample tracking provides information on

which rack the sample was located. The control ID shows
in which mini rack the control was located.

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r To view the tracking information

1 Choose Routine > Test results and choose the test

1
result you want to track.

2 In the details view, choose the Tracking button.

2

3
3 To view how much time was spent on each module,
see the Process step data table.

4 To view the lot number of the consumables that were

used for this test, see the Consumables table.

5 To view on which position and on which rack the

sample was processed, see the Samples table.

6 To view the lot number of the reagents that were used

for that test, see the Reagents table.

7 To view which control was used to validate that test,

see the Control batches table.

5 Sample processing

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168 Reviewing test results

8
8 To view the lot number of the control that was used to
validate the test, look up the type and control ID in the
Control batches table.
• Note the type and control ID.
• Choose the button to the right of the control
batch row.
• In the Control batches table, choose the
button to the right of the corresponding control ID.
• In the details view, choose the Tracking button.
• See the lot number in the Controls table.
I The control ID consists of the following elements:
“C + Serial No. of control mini rack + position of
mini rack in control cassette”.
For example: C19047801, C19047802, C19047803

u Related topics
• Reviewing test results (161)
• Releasing test results (178)

Ordering a repeat test

If you order a repeat test, the system creates another test
order for an already completed test. After you have
reloaded the sample, the test is repeated for that sample.

No repeat test possible It is not possible to order a repeat test in the following
cases:
• If the result has already been released.
• If a repeat test has been ordered already.
5 Sample processing

• If the configuration setting allowing a repeat test for

valid reactive results is disabled.

Repeat test with history calculation History calculation is only applied given the following
conditions:
• Sample overall result is invalid.
• Test is using multi-result interpretation.
• Repeat test is ordered.

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If history calculation is applied to a repeat test, an initial

result and a test result are displayed in this test result’s
details. The initial result represents the actual result
measured. The test result considers the test history as
follows:
• Valid target results overrule invalid target results.
• Reactive results overrule non-reactive results.

q Samples with valid results can be retested, but

without history calculation.

! WARNING
History lost due to not actively ordering a retest
If a retest is not ordered, previous reactive samples are
not displayed in the final results when the retest is non-
reactive.
r To ensure history calculation of the sample that you
want to retest, choose the Retest button before
loading the sample to the analytic system.

Repeat test for valid reactive results Whether repeat tests for valid reactive results can be
ordered or not is defined in the configuration settings.

If you want to change this configuration, contact your

Roche Service representative.

Repeat test versus duplicate test order A repeat test is a test that is ordered by the technical
validator for a test that has already been completed. The
repeat test is ordered if the validity of the result is
questioned. A duplicate test order is a test that has been
ordered twice (identical sample ID, sample type, test
type). The system can be configured not to accept
duplicate test orders within a predefined time.
5 Sample processing
j m You need technical validator user rights to order a
repeat test.

r To order a repeat test

1 Choose Routine > Test results.

1

2 From the list, choose the test result or the test results
for which you wish to order a repeat test.

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3
3 Choose the Retest button.
f The system creates a test order for each of the
tests you selected. The status of the test result
changes to Repeated.

4 Load the samples for which you ordered a repeat test

on the input buffer.
I You cannot release a test result for which a repeat
test has been ordered.

u Related topics
• Loading samples for a repeat test (170)

Loading samples for a repeat test

If you have ordered a repeat test, you must reload the
sample for the system to perform the repeat test.

q Be sure to update the load list when the button is

highlighted. Not updating the view can result in delayed
results.

j m You have ordered at least one repeat test.

r To reload a sample for a repeat test

1
1 To find the sample IDs for the repeat tests, choose
Routine > Load list.
5 Sample processing

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2
2 From the Load list: panel, select the sample for repeat
test.
I The Load list: panel shows the sample type, test,
sample ID, rack ID, rack position, and date of
samples for repeat testing.

3 To find the sample tube, check the output buffer and

search for the corresponding sample ID.
I If you are unloading the sample racks, store them
in the same order as they were on the output
buffer. This makes it easier to find a specific rack
ID.

4 Load the sample tube either on the input buffer or the

input lane.
I To perform the repeat test, you do not need to load
the sample on the same rack position or the same
rack. You can use a different rack.

u Related topics
• Ordering a repeat test (168)
• Reviewing test results (161)
• Releasing test results (178)

5 Sample processing

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Test result reports

You can create a PDF report of the current test results or
control batch list. The PDF report is saved on the IG
server.

In this section
About test result reports (172)
Creating reports (174)

About test result reports

There are two panels from which you can generate a PDF
report:
• Test results panel
• Control batch panel

In contrast to the report created from the Test results

panel, the report created from the Control batch panel
also includes the following information:
• Lot information of the reagents used
• Ct-values for targets
• Internal control and QS results
5 Sample processing

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w Test result report created from Control batch panel, first page.

w Test result report created from Control batch panel. Second page, showing test results
5 Sample processing

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w Test result report created from Test results panel

u Related topics
• About test result formatting (160)
• Creating reports (174)

Creating reports
You can create a report to show your current test results.
5 Sample processing

d m You need remote access to download the reports from

the IG server.

r To create a control batch report

1
1 If you need to see the lot information on the report,
choose Routine > Control batch.

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2
2 Choose the control batch for which you want to create
the report.

3
3 From the drop-down list, choose the Preview option.

4
4 In the preview panel, check your report.

5
5 To create a PDF, choose the Export option.

5 Sample processing

6
6 Your report should now be listed under
Administration > File management > Reports.
Reports are stored on the IG server.

7 To download the files from the IG server, use the

remote connection.

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r To create a test result report

1
1 Choose Routine > Test results.

2
2 Select all the tests that need to be listed in the report.
I If your Test results list is filtered or if entries are
deselected, the report does not include them.

3
3 From the drop-down list, choose the Preview option.
5 Sample processing

4
4 In the preview panel, check your report.

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5
5 From the drop-down list, choose the Export option.

6
6 Your report should now be listed under
Administration > File management > Reports.
Reports are stored on the IG server.

7 To download the files from the IG server, use the

remote connection.

u Related topics
• About test result reports (172)
• Downloading files from the IG server (180)

5 Sample processing

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178 Releasing test results

Releasing test results

After reviewing a test result, you have to release it. After
releasing, the test result is sent to the LIS for medical
validation. If you doubt the technical validity of a test
result, you can repeat the test.

j m Review test results before releasing.

m You need technical validator user rights to release
results.

r To release a test result

1
1 In the software, choose Routine > Test results.

2 Review the test results.

3 In the test result table, select the test results you wish
to release.

4
4 In the list view, choose the Release button.
I You cannot release a test result for which a repeat
test has been ordered (Repeated status).
However, it is possible to release invalid test
results.
f The test result is sent to the LIS for medical
validation.

u Related topics
• Reviewing test results (161)
• Viewing the tracking information (166)
5 Sample processing

• Releasing test results (178)

• Adding a review comment to a test result (164)

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Releasing test results via remote

connection
If the remote connection has been set up on your local
computer, you can access the user interface of the
system from your computer via browser. This allows you
to review and release test results from your desk.

r To release test results via remote

connection

1 Open Internet Explorer on your local PC and enter the

link to access the system remotely.
I For example: https://wsig1/UI/RemoteUI.html

2 Log on to the system.

3
3 To review test results, on the Routine tab, choose the
Test results button.

4 Select the test result you want to release from the list.

5 To release the result, choose the Release button.

I You cannot release a test result for which a repeat
test has been ordered.

u Related topics
• Downloading files from the IG server (180)
• Reviewing test results (160)

5 Sample processing

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180 Downloading files from the IG server

Downloading files from the IG server

If the remote connection has been set up on your local
computer, you can access the user interface of the
system from your computer via browser. This allows you
to download files from the IG server.

Reports, problem reports, export files, and screenshots

are saved on the IG server. The files can only be viewed
and downloaded via remote connection.

r To download files from the IG server

1 Open Internet Explorer on your local PC and enter the

link to access the system remotely.
I For example: https://wsig1/UI/RemoteUI.html

2 Log on to the system.

3
3 Choose Administration > File management tab,
and choose the file type you want to download. For
example, the Reports button.

4 Select the files you want to download from the list.

5
5 Choose the Download button and save the file on
your local computer.

u Related topics
• Releasing test results via remote connection (179)
5 Sample processing

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Viewing audit trail entries

All interaction between users and the system that trigger
system changes are logged in an audit trail entry. Audit
trail entries are archived.

The audit trail entry includes information on what was

done when, by which user and on which part of the
system. For example:
• Releasing a test
• Ordering a repeat test
• Editing settings
• Loading consumables and reagents
• Changing system statuses. For example: Starting up,
hibernating the system

r To view audit trail entries

1
1 Choose Administration > Audit trail.

2
2 On the Audit trails: panel, choose an audit trail entry
to view its details.

5 Sample processing

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182 Viewing audit trail entries

3 If necessary, you can filter for a certain type of audit

3
trail entry and print a report.
5 Sample processing

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Exporting test results

You can export test results to an xml file. The files are
saved on the IG server. To view the export files, use the
archive viewer.

j m You must have supervisor user rights to export test

results.

r To export test results

1
1 Choose Routine > Test results.

2 Select the test results you want to export from the list.
2

3 Choose the Export button.

4 Download the export files via remote connection.

5 To view the files, open them in the archive viewer.

u Related topics
• Creating reports (174)

5 Sample processing

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184 Priming the instrument

Priming the instrument

During priming, the fluid system is rinsed with diluent,
lysis and wash reagent to eliminate air bubbles and traces
of reagents used previously. Priming is done during
startup when the system is in Preparing status.

If you choose the Stop button while the instrument is

processing a run, the run will be completed. If the run has
not yet begun, the sample racks will be unloaded to the
output buffer.
u Canceling a run (157)

n Priming takes up to 10 minutes. If the instrument has

already started a run, it will first finalize the run. In this
case, it may take up to 3 hours before priming can be
started.

j m The system is in Running or Standby status.

r To prime the instrument

1 If the system is in Standby status, on the Monitoring

1
tab, choose the Start button.

2 If the system is in Running status, on the Monitoring

tab, choose the Stop button.
f Priming takes up to 10 minutes. If the instrument is
in Running status, it will first finalize the run. In
this case, it may take up to 3 hours before priming
can be started.
f The system moves all sample racks and racks for
clotted tips that are in the transfer module to the
5 Sample processing

output buffer.

3
3 If you want to abort the stopping process, on the
Monitoring tab, choose the Resume button.

4 After the system has changed to Standby status, on

the Monitoring tab, choose the Start button.
f The system changes to Preparing status and
primes the fluid system.

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Table of contents

After operation 6

In this chapter 6
Pausing and resuming the system . . . . . . . . . . . . . . . . 187
Setting the system to Hibernate status . . . . . . . . . . . . 188
Shutting down the system. . . . . . . . . . . . . . . . . . . . . . . 190
Restarting by power switch. . . . . . . . . . . . . . . . . . . . . . 193
Shutting down the IG server . . . . . . . . . . . . . . . . . . . . . 195
Starting the IG server . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Setting the system to powerless status . . . . . . . . . . . . 197
Shut down for more than 10 days . . . . . . . . . . . . . . . . 200

6 After operation

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Table of contents
6 After operation

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 After operation 187

Pausing and resuming the system

In Pausing status, the system completes runs that are
currently processed. No new runs are started.

If a control failed, the system automatically changes to

Pausing status. The system continues processing and
enters Paused status, as soon as all runs are completed.

Pausing versus Stopping In Stopping status, all sample racks are unloaded. In
Paused status, all racks remain on board.

j m The system is in Ready or Running status.

r To set the system to Pausing status

1
1 On the Monitoring tab, choose the Pause button.
f The system changes to Pausing status and
completes runs that are currently processed.
f As soon as the runs are completed, the system
changes to Paused status.
f The Pause button changes to the Resume button.

2 To resume activity, on the Monitoring tab, choose the

Resume button.

u Related topics
• Setting the system to Hibernate status (188)
• Shutting down the system (190)

6 After operation

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Setting the system to Hibernate status

After operation, it is recommended to set the system to
Hibernate status. As the instrument produces
condensation water, it is not recommended to leave the
system in Standby status.

Reagent storage still cooling In Hibernate status, the instrument software and the
system are shut down. The reagent storage is still cooling.

Do not shut down the system by using the power

switches at the back of the system.

NOTICE
Condensation water
Risk of instrument damage due to condensation
water
In all statuses other than Off and Hibernate status,
including Standby status, the instrument produces
30 mL/h of condensation water. The water is collected in
the liquid waste container. If all liquid waste containers
are full, the instrument may be damaged by the
condensation water.
r Hibernate the system when you are not operating it.

Maximum 10 days Do not leave the system in Hibernate status for more
than 10 consecutive days.

j m The system is in Standby status.

r To set the system to Hibernate status

1 Make sure that the system is in Standby status.

1
6 After operation

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 After operation 189

2
2 On the Monitoring tab, choose the Hibernate
button.
f Wait for the system to shut down and for the
monitor to turn off.

3
3 The sample supply module cannot be hibernated.
• To shut down the sample supply module, press
the button for at least 3 seconds.

u Related topics
• Pausing and resuming the system (187)
• Shutting down the system (190)

6 After operation

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Shutting down the system

Shutting down means to set the system in powerless
state. The reagent storage is shut down and no longer
cooling. The IG server is still running.

If you need to shut down the system for longer than

10 days, contact your Roche Service representative.

Risk of corrupting the software Never shut down the system using the power switch
while the software is still reacting to user input. By
shutting down the system directly by power switch, you
risk corrupting the software installation. Always adhere to
the shutdown procedure.

Risk of losing samples If the system is in Stopping status, wait until the process
finishes. Otherwise, you can lose the samples on board.

Reagents become invalid If the system is set to the Off status, all reagents that are
still on board become invalid if the temperature in the
reagent storage is > 37 °C or < 2 °C.

If the reagent storage is > 8 °C and < 37 °C, the time is

deducted from the onboard stability. Once the onboard
stability is exceeded, reagents are invalidated. The
onboard stability may vary from reagent to reagent and is
specified in the Instructions for Use.

The reagents also become invalid when the system is off

for longer than 36 hours. Unload reagents and controls
before shutting down the system.

j m The system must be in Standby status.

r To shut down the system

1
1 On the Monitoring tab, open the reagent cassette
6 After operation

drawer.

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 After operation 191

2
2 Unload all the reagent and control cassettes from the
system.

3
3 Empty the solid waste (u 88).

4
4 Remove the liquid waste container from the drawer
and replace them with empty ones (u 94).
• Dispose of the liquid waste according to local
regulations.

5 To avoid accelerated clogging of filters, leave the

wash reagent containers, the lysis, and diluent bottles
on the system. The containers and bottles should not
be completely empty but contain at least some
residual liquid.

6 Change lab gloves.

7
7 On the Monitoring tab, choose the Shut down
button.
• To ensure that the shutdown was completed
successfully, wait for the monitor to turn off. 6 After operation

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192 Shutting down the system

8
8 On the control panel of the sample supply module,
press the button for at least 3 seconds.

9 Wait for the sample supply module and the system to

shut down.

10
10 Turn the power switch 1 from "1" to "0".

11 If you want to keep your system in the Off status for

more than 10 days, contact your Roche Service
representative.

u Related topics
• Emptying the solid waste container (88)
• Replacing the liquid waste container (94)
• Starting up the system from Off status (61)
• Pausing and resuming the system (187)
• Setting the system to Hibernate status (188)
• Shut down for more than 10 days (200)
6 After operation

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 After operation 193

Restarting by power switch

Only shut down via power switch in exceptional cases.
For example, in failure cases, where the software does not
allow you to hibernate or to shut down.

Risk of corrupting the software Never shut down the system using the power switch
while the software is still reacting to user input. By
shutting down the system, you risk corrupting the
software installation.

Reagent storage stops cooling Shutting down the system by turning off the power switch
disconnects the system from power. The reagent storage
stops cooling.

Reagents become invalid If the system is set to the Off status, all reagents that are
still on board become invalid if the temperature in the
reagent storage is > 37 °C or < 2 °C. They also become
invalid when the system is off for longer than 36 hours.

r To restart by power switch

1
1 Open the lower service door on the rear of the transfer
module.

2
2 Turn the power switch 1 from "1" to "0".
• Wait 20 to 30 seconds for the system to shut down
completely. 6 After operation

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194 Restarting by power switch

3
3 To restart, turn the power switch 1 from "0" to "1".

4
4 Wait for the software to start up and log on to the
system.

u Related topics
• Refer to the Unloading in powerless status procedure
in the troubleshooting chapter of the User Assistance.
6 After operation

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 After operation 195

Shutting down the IG server

If necessary, you can shut down the IG server without
shutting down the system. Shutting down the IG server is
part of the procedure to set the entire system to
powerless status in case of an emergency.

c When setting the system to powerless status or when

necessary.

j m All connected instrument should be in Standby or Off

status.

r To shut down the IG server

1
1 On the Monitoring tab, choose the IG server and
choose the Shut down button.

2
2 Wait for the IG server to shut down completely. Once
the IG server is shut down, the status indicators are
turned off.
I This can take up to 5 minutes.
6 After operation

u Related topics
• Starting the IG server (196)

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196 Starting the IG server

Starting the IG server

If the IG server was shut down on its own, you can restart
the IG server separately.

c When required.

d m Tool to unlock the IG server access door. The tool is

located in the lower rear service door of the transfer
module.

j m Only a specially trained supervisor may open the

access door to the IG server.

r To start the IG server

1
1 Open the front door of the sample supply module and
unlock and open the access door to the IG server.

2 On the IG server, press the button.

u Related topics
• Shutting down the IG server (195)
6 After operation

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 After operation 197

Setting the system to powerless status

The system is in powerless status if all three power
switches are turned of.

Risk of corrupting the software Never shut down the system using the power switch
while the software is still reacting to user input. By
shutting down the system with the power switch, you risk
corrupting the software installation.

Reagent storage stops cooling Shutting down the system by turning off the power switch
disconnects the system from power. The reagent storage
stops cooling.

Reagents become invalid If the system is set to the Off status, all reagents that are
still on board become invalid if the temperature in the
reagent storage is > 37 °C or < 2 °C. The reagents also
become invalid when the system is off for longer than 36
hours.

c When required.

j m The instrument must be in Standby or Error status.

r To set the system to powerless status

1
1 On the Monitoring tab, open the reagent cassette
drawer.

6 After operation

2
2 Unload all the reagent and control cassettes from the
system.

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198 Setting the system to powerless status

3
3 Empty the solid waste container (u 88).

4
4 Remove the liquid waste container from the drawer
and dispose of the liquid waste according to local
regulations.

5 To avoid filters drying out, leave the wash reagent

containers, the lysis, and the diluent bottles on the
system.

6 Change lab gloves.

7
7 To shut down the IG server, on the Monitoring tab,
choose the IG server and choose the Shut down
button.

8
8 On the Monitoring overview, choose the Shut down
button.
6 After operation

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 After operation 199

9
9 On the control panel of the sample supply module,
press the button for at least 3 seconds.

10 Wait for the sample supply module and the system to

shut down.
• Wait for the monitor to turn off.

11
11 Turn the power switch 1 to "0".

12
12 Wait for the IG server to shut down completely. Once
the IG server is shut off, the status indicators are
turned off.
I This can take up to 5 minutes.

13
13 Turn the power switches 2 and 3 to "0".

14 If you want to keep your system in the Off status for

more than 10 days, contact your Roche Service
representative.

u Related topics
• Emptying the solid waste container (88)
6 After operation

• Replacing the liquid waste container (94)

• Shutting down the system (190)

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200 Shut down for more than 10 days

Shut down for more than 10 days

If you need to shut down the system for more than 10
days, contact your Roche Service representative.

u Related topics
• Shutting down the system (190)
• Shutting down the IG server (195)
• Setting the system to powerless status (197)
6 After operation

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 201
Table of contents

Maintenance 7

In this chapter 7
List of maintenance intervals . . . . . . . . . . . . . . . . . . . . 203
Periodic maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 204
About periodic maintenance. . . . . . . . . . . . . . . . . . 204
Unloading and cleaning the reagent cassette
and consumables drawers (1 of 8). . . . . . . . . . . . . 205
Cleaning the bulk reagent drawer (2 of 8) . . . . . . 207
Cleaning the wash/waste drawer (3 of 8) . . . . . . . 211
Cleaning the solid waste container (1 of 3) . . 211
Cleaning the liquid waste drawer (2 of 3) . . . . 214
Cleaning the wash reagent drawer (3 of 3) . . 216
Cleaning the amplification plate drawer (4 of 8) . 218
Cleaning the sample supply module (5 of 8) . . . . 220
Starting the periodic maintenance wizard to
open the covers (6 of 8). . . . . . . . . . . . . . . . . . . . . . 225
Cleaning transfer and processing modules (7 of
8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
Closing the wizard and reloading drawers (8 of
8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
Moving the movable platform. . . . . . . . . . . . . . . . . . . . 235
Moving the platform in powerless status . . . . . . . 235
Moving the platform in Error or Maintenance
status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
Regular maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 239
Cleaning the covers and doors. . . . . . . . . . . . . . . . 239
Checking the status of the hard drives . . . . . . . . . 241
Automatic maintenance actions. . . . . . . . . . . . . . . . . . 242
Data maintenance actions. . . . . . . . . . . . . . . . . . . . 242
IG server restart . . . . . . . . . . . . . . . . . . . . . . . . . 242
7 Maintenance

Starting an archiving maintenance action

manually. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Starting a backup action manually. . . . . . . . . . 243
Starting sample pipetter tightness check
manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
Starting the Teach instrument maintenance
action manually. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
General decontamination procedures . . . . . . . . . . 247
Decontaminating the modules . . . . . . . . . . . . . . . . 250
Decontaminating the sample supply module . . . . 251
Decontaminating sample racks . . . . . . . . . . . . . . . 253

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Table of contents

Decontaminating rack trays . . . . . . . . . . . . . . . . . . 254

Decontaminating solid and liquid waste
containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
7 Maintenance

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List of maintenance intervals

It is recommended that you adhere to the maintenance
intervals stated in this publication.

Periodic maintenance action The tasks that are part of the periodic maintenance action
must be performed in the order provided in this list.

Interval Procedure
Weekly, as part of the periodic maintenance action. u Unloading and cleaning the reagent cassette and
consumables drawers (1 of 8) (205)
u Cleaning the bulk reagent drawer (2 of 8) (207)
u Cleaning the solid waste container (1 of 3) (211)
u Cleaning the liquid waste drawer (2 of 3) (214)
u Cleaning the wash reagent drawer (3 of 3) (216)
u Cleaning the amplification plate drawer (4 of 8) (218)
u Cleaning the sample supply module (5 of 8) (220)
u Cleaning transfer and processing modules (7 of 8) (226)
u Closing the wizard and reloading drawers (8 of 8) (233)
Weekly. Automatic maintenance action. u IG server restart (242)
Manual maintenance action: As required. u Starting an archiving maintenance action manually (243)
u Starting a backup action manually (243)
u Starting sample pipetter tightness check manually (244)
As required. u Moving the movable platform (235)
u Cleaning the covers and doors (239)
u Checking the status of the hard drives (241)
u Starting the Teach instrument maintenance action
manually (244)
u Decontamination (247)
y Maintenance intervals

7 Maintenance

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204 Periodic maintenance

Periodic maintenance
In this section
About periodic maintenance (204)
Unloading and cleaning the reagent cassette and
consumables drawers (1 of 8) (205)
Cleaning the bulk reagent drawer (2 of 8) (207)
Cleaning the wash/waste drawer (3 of 8) (211)
Cleaning the amplification plate drawer (4 of 8) (218)
Cleaning the sample supply module (5 of 8) (220)
Starting the periodic maintenance wizard to open the
covers (6 of 8) (225)
Cleaning transfer and processing modules (7 of 8) (226)
Closing the wizard and reloading drawers (8 of 8) (233)

About periodic maintenance

Periodic maintenance is done to ensure that the system
works properly and to keep the risk of contamination low.

! WARNING
Risk of personal injury or contamination of the
instrument
The material used for cleaning might bring you or the
instrument in contact with hazardous chemicals.
r Dispose of the cloths used for cleaning according to
local regulations.
r Change lab gloves after each cleaning step and
dispose of them according to local regulations.

NOTICE
Risk of instrument damage due to spilled liquid or
unsuitable material
7 Maintenance

Unsuitable liquids, or liquid spilled on the system may

result in malfunction or damage.
o Do not use technical or denatured ethanol for
preparation of the cleaning solution.
o Moisten the lint-free cloths outside the system and
wipe the surfaces and parts as described in these
procedures.
o Take care when applying liquid to the lint-free
cloth. The cloth should be damp, but not saturated
to prevent drops of liquid from falling onto the
system.

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 Maintenance 205

Unloading and cleaning the reagent cassette and

consumables drawers (1 of 8)
Before you can start cleaning, you need to unload the tip
racks from the reagent cassette drawer and the
consumables from the consumables drawer.

cobas® 8800 System When working with the cobas® 8800 System, perform
the procedures for both consumables drawers.

c Recommended interval: Weekly

d m Powder-free lab gloves

m Lint-free cloths
m 70% ethanol p.a.
m Deionized, distilled, or purified water
m Eye protection
m Personal protective equipment

j m The drawers must be empty when you clean the

transfer and the processing module.
m The system must not be in Initializing status.
u List of allowed cleaning solutions (267)

r To empty and clean the reagent

cassette drawer and the
consumables drawer

1 Move the monitor out of the way.

1
7 Maintenance

2 In the software, check if the system is in Standby

2
status.
f If the system is in Ready status, on the
Monitoring tab, choose the Stop button. Wait for
the system to change from Stopping status to
Standby status.

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206 Periodic maintenance

3
3 On the Monitoring tab, choose the reagent cassette
and the consumables drawers and choose the Open
drawer button.
f The drawers unlock and automatically open
slightly.

4 Manually open the drawers fully until they click into

4
place.

5 In the software, open the consumables details view

and choose the Unload buttons.
f The magazines adjust in height so that the
consumables can be unloaded.

6 Unload the tip racks, the processing plates, and the

6
amplification plate cassettes from their magazines.
Place them on a clean surface outside of the
instrument.
• Wait until the end of the periodic maintenance
action before reloading the consumables.

7 Moisten a lint-free cloth with deionized water and

7
clean the magazines and surrounding surfaces.
• Repeat this step using lint-free cloths moistened
with 70% ethanol.
I Do not spray liquid directly on any part of the
system or clean the area around the light barrier.
7 Maintenance

8 In the callout, choose the Close drawer button for

8
both drawers.

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 Maintenance 207

9 Wait for the click sound, then push the drawers back
9
in until they are fully closed.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

10
10 Clean the handle of the drawer with a lint-free cloth
moistened with deionized water.
• Repeat this step using lint-free cloths moistened
with 70% ethanol.

u Related topics
• Cleaning the bulk reagent drawer (2 of 8) (207)

Cleaning the bulk reagent drawer (2 of 8)

The bulk reagent drawer holds lysis reagent and diluent.
Clean the drawer to maintain safe operation of the
system.

cobas® 8800 System When working with the cobas® 8800 System, perform
the procedures for both bulk reagent drawers.

c Recommended interval: Weekly

d m Powder-free lab gloves

m Lint-free cloths
m 70% ethanol p.a.
m Deionized, distilled, or purified water
m Eye protection
7 Maintenance

m Personal protective equipment

j m The system must not be in Initializing status

u List of allowed cleaning solutions (267)

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208 Periodic maintenance

r To clean the bulk reagent drawer

1
1 On the Monitoring tab, choose the bulk reagent
drawer, then choose the Open drawer button.

2
2 Wait for the drawer to automatically open slightly and
then manually open it fully.

3 To unlock the reagent aspiration arms, in the callout,

3
choose the Unlock button for each bottle.
• Wait for the click sound and the status indicator
(red or green) to turn off.

4 WARNING! Risk of compromising the integrity of test

4
results. Do not touch or clean the part of the reagent
aspiration arm that comes into contact with liquid.
4 Pull up the reagent aspiration arm and turn it to the
reagent aspiration arm park position.
7 Maintenance

I Do not pull up more than one aspiration arm at a

time. With multiple reagent aspiration arms pulled
up you increase the risk of touching an aspiration
arm.

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 Maintenance 209

5 Close the bottle with its cap and remove it from the
5
drawer.

6 Inspect the drawer surface for salt residues. If

6
necessary, clean the surface with a lint-free cloth
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

7 Reload the bottle or load a new bottle and remove its

7
cap.
• If you load new bottles, before unpacking, make
sure the primary and secondary packaging are not
damaged and the bottles show no signs of
leakage.

8 Close the reagent aspiration arm.

8
• Push it down until the status indicator lights up
again. If you loaded a full bottle, the status
indicator should now be green.

9 Repeat the cleaning procedure for each bottle. 7 Maintenance

10 Clean the drip tray with a lint-free cloth moistened

10
with deionized water.
• If necessary, remove, rinse, and dry the drip tray.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

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210 Periodic maintenance

11 Clean the area around the reagent aspiration arm park

11
position with a lint-free cloth moistened with
deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

12 Place the drip tray and the screw cap back onto the
12
park position.

13 Verify whether all status indicators are green and

13
push the drawer back in until it is fully closed.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

14 Clean the handle of the drawer with a lint-free cloth

14
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

u Related topics
• Cleaning the wash/waste drawer (3 of 8) (211)
7 Maintenance

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 Maintenance 211

Cleaning the wash/waste drawer (3 of 8)

The wash/waste drawer holds solid waste, liquid waste,
and wash reagent containers.

cobas® 8800 System When working with a cobas® 8800 System, perform the
three procedures for both wash/waste drawers.

In this section
Cleaning the solid waste container (1 of 3) (211)
Cleaning the liquid waste drawer (2 of 3) (214)
Cleaning the wash reagent drawer (3 of 3) (216)

Cleaning the solid waste container (1 of 3)

During a run, the system collects the used processing
plates and tip racks in the solid waste container. If the
solid waste container is full, and the system cannot waste
supplies of the previous run, the system stops processing.

q As an alternative to replacing the solid waste bag

you can also replace the solid waste container.

u Replacing the solid waste container (91)

r To clean the solid waste container

1 On the Monitoring tab, choose the wash/waste

1
drawer. In the callout, choose the Open drawer
button.

7 Maintenance

2 Wait for the drawer to open slightly and open it fully.

2
• Turn the solid waste container to the right side
until it clicks into place.

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212 Periodic maintenance

3 Remove the solid waste bag fastener.

3

4
4 CAUTION! Risk of personal injury, infection, and
contamination. Do not empty and reuse solid waste
bags.
4 Close the full solid waste bags and carry the solid
waste container to the disposal site.

5
5 CAUTION! Risk of personal injury, infection, and
contamination. The solid waste bags may be pierced
by sharp objects inside.
5 Check the solid waste bags for perforation while
removing them from the solid waste container.

6 Dispose of solid waste bags according to local

regulations.

7
7 If you notice any perforation of the solid waste bag
and find liquid inside the solid waste container,
decontaminate the solid waste container.
• Follow the decontamination procedure.
7 Maintenance

8 If you do not find liquid inside but see that it is

8
necessary to clean the solid waste container, use a
lint-free cloth moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

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 Maintenance 213

9 If necessary, clean the surface of the solid waste

9
drawer with a lint-free cloth moistened with deionized
water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

10
10 WARNING! Risk of personal injury or contamination of
the system if using solid waste bags that were not
supplied by Roche.
10 Taking two solid waste bags, place one inside the
other and reach inside with both hands.
• fold over the bottom corners and place the bags in
the solid waste container.

11
11 Make sure that the bags reach the bottom and line the
solid waste container.

12 Place the solid waste bag fastener back on the solid

12
waste container.

7 Maintenance

13 Choose the Confirm that solid waste container is

13
empty. button.
f The fill level of the solid waste changes to 0%.

u Related topics
• Cleaning the liquid waste drawer (2 of 3) (214)

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214 Periodic maintenance

Cleaning the liquid waste drawer (2 of 3)

The liquid waste containers collect diluent, lysis reagent,
and wash reagent that was used during processing.

Clean the liquid waste drawer to maintain safe operation

of the system.

r To clean the liquid waste drawer

1 WARNING! Risk of hand injury due to sharp edges

1
inside the system. Do not reach inside the system
behind the liquid waste containers.
1 Pull out the liquid waste drawer.

2
2 In the callout, choose the Unlock button to unlock the
waste dispense caps.

3 Wait for the click sound. Then, for each liquid waste
3
container, lift the waste dispense cap.
7 Maintenance

4 Close the full liquid waste containers with the screw

4
cap.

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 Maintenance 215

5 Remove the liquid waste containers from the drawer.

5
• Never remove all the liquid waste containers.
Always leave at least one liquid waste container
installed.

6 The liquid waste containers contain lysis reagent.

Dispose of the liquid waste according to local
regulations.

7 CAUTION! Risk of a chemical reaction resulting in

7
cyanide. Make sure not to pour bleach or DNA
AWAY™ Surface Decontaminant into the liquid waste
container.
7 If you reuse the liquid waste container, clean the
bottle neck with a lint-free cloth moistened with
deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

8 For each liquid waste container container, inspect the

8
surface of the liquid waste drawer for salt residues.
• If necessary, clean the surface with a lint-free cloth
moistened with deionized water.
• Take a second lint-free cloth moistened with 70%
ethanol and clean again.

9 Make sure that the liquid waste container is

9
completely empty, free of damage, and does not
contain any foam.
• Load the empty liquid waste container and remove
the screw cap.
• Close the waste dispense cap.
• Push the waste dispense cap down completely
until the status indicator lights up green.
• Repeat these steps for each container.
7 Maintenance

10 Change lab gloves.

11 Verify whether all status indicators are green.

11
• In the software, check if the fill level shows 0%.
• Manually close the liquid waste drawer.
• To be ready for the next step, keep the wash/waste
drawer open.

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216 Periodic maintenance

12 Clean the handle of the drawer with a lint-free cloth

12
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

u Related topics
• Cleaning the wash reagent drawer (3 of 3) (216)

Cleaning the wash reagent drawer (3 of 3)

Clean the wash reagent drawer to maintain safe
operation of the system.

r To clean the wash reagent drawer

1 WARNING! Risk of personal injury due to sharp edges

1
inside the system. Do not reach inside the system
behind the wash reagent containers.
1 Pull out the wash reagent drawer.
• Make sure that the drawer is pulled out fully and
clicks into place.

2
2 To unlock the reagent aspiration arms, in the callout,
choose the Unlock button of the wash reagent
containers.
7 Maintenance

3 Wait for the click sound and the status indicators to

3
turn off.
• For each container, pull out the reagent aspiration
arm and turn it to the reagent aspiration arm park
position.

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 Maintenance 217

4 Close the wash reagent container with its screw cap

4
and remove the container from the drawer.

5 WARNING! Risk of damaging the sensor, of carryover,

5
and, of compromising the integrity of test results. Do
not touch or clean the part of the reagent aspiration
arm that comes in contact with reagent.
5 For each container, inspect the drawer surface for salt
residues.
• If necessary, clean the surface with a lint-free cloth
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

6 Reload each wash reagent container and remove its

6
cap.
• Reinsert the reagent aspiration arm into the
container.
• Push the arm down until the status indicator lights
up green.

7 For each container, moisten a lint-free cloth with

7
deionized water and clean the reagent aspiration arm
park position.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol. 7 Maintenance

8
8 For each container, place the screw cap back into the
park position.

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9 Verify if all status indicators are green.

9
• In the software, check if the fill level is at 100%.
• Manually close the wash reagent drawer.

10 Clean the handle of the drawer with a lint-free cloth

10
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

11 Turn the solid waste container back to its home

11
position and push the wash/waste drawer back in
until it is fully closed.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

12 Clean the handle of the drawer with a lint-free cloth

12
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

u Related topics
• Cleaning the amplification plate drawer (4 of 8) (218)
7 Maintenance

Cleaning the amplification plate drawer (4 of 8)

The amplification plate drawer holds the sealed, used
amplification plates. Clean the drawer to maintain safe
operation of the system.

j m The system must not be in Initializing status

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r To clean the amplification plate

drawer

1
1 On the Monitoring tab, choose the amplification
plate drawer. In the callout, choose the Open drawer
button.

2 Wait for the drawer to automatically open slightly and

2
then manually open it fully.

3 Remove all amplification plates from the drawer.

3
• You may notice residues of magnetic glass
particles in some of the wells. The particles have
no influence on the PCR. No action is required.

4 Dispose of the amplification plates according to local

regulations.

5 Inspect the drawer surfaces for soiling. If necessary,

5
clean the surfaces with a lint-free cloth moistened
with deionized water.
• Make sure not to touch or clean the teaching post
(indicated by the red box).
• Take a second lint-free cloth moistened with 70%
ethanol and clean again.
7 Maintenance

6 Push the amplification plate drawer back in until it is

6
fully closed.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

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7 Clean the handle of the drawer with a lint-free cloth

7
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

u Related topics
• Cleaning the sample supply module (5 of 8) (220)

Cleaning the sample supply module (5 of 8)

The sample supply module is used to load and unload
samples. For periodic maintenance, it is sufficient to clean
the input and output buffers in front of the module.

If you need to clean areas that are not described in this

procedure, contact your Roche Service representative.

3 subprocedures The procedure describing how to clean the sample supply

module is divided into 3 subprocedures:
u To clean the sample supply module from the
front p (220)
u To clean the sample supply module from the
back p (223)
u Starting the sample supply module after
maintenance p (224)

r To clean the sample supply module

from the front

1 Open the front cover of the sample supply module.

1
7 Maintenance

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2 If there are racks on the output buffer, unload the rack

2
tray.

3 To switch off the sample supply module, on the

3
control panel, press the button for at least
3 seconds.

4 Make sure there is an empty rack tray on the input

4
buffer.

5 Push down the locking mechanism. Then, pull the

5
remaining sample racks manually towards the front of
the input buffer.

7 Maintenance

6 To unload the sample racks, move them onto the rack

6
tray.
• Remove all rack trays.

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7
7 Decontaminate the empty sample racks, the rack
trays, and the waste containers as described in the
decontamination section.

8 Do not spray liquid directly on any part of the system.

8
Clean the surfaces of the input and output buffer with
a lint-free cloth moistened with deionized water.
A • Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.
f Do not clean the dampers holding the cover.

A Damper

9 Clean the control panel of the sample supply module

9
with a lint-free cloth moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

10
10 Open the front door.
7 Maintenance

11 Pull out the drip tray and inspect it for soiling.

11

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12 If necessary, clean the drip tray with a lint-free cloth

12
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

13
13 Push the drip tray back in and close the front door.

r To clean the sample supply module

from the back

1
1 Remove the rear cover of the sample supply module.

2
2 Pull out the drip trays and inspect them for soiling. 7 Maintenance

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3
3 If necessary, clean the drip trays with a lint-free cloth
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

4
4 Push the drip trays back in and close the cover.

r Starting the sample supply module

after maintenance

1 On the control panel of the sample supply module,

1
press the button for at least 3 seconds.

2 Wait for the output buffer to change to the status.

2
Then, load an empty rack tray on the output buffer.
7 Maintenance

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3 Close the cover.

3

4 Clean the handle of the cover with a lint-free cloth

4
moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

u Related topics
• Starting the periodic maintenance wizard to open the
covers (6 of 8) (225)
• Decontaminating sample racks (253)
• Decontaminating solid and liquid waste
containers (255)

Starting the periodic maintenance wizard to open the

covers (6 of 8)
To unlock the front and the rear covers of the instrument,
you must use the Periodic maintenance wizard.

j m If you are working with a movable platform: The

movable platform must be in home position.

r To start the Periodic maintenance

wizard

1 On the Monitoring tab, choose the instrument on

7 Maintenance

1
which you need to perform the periodic maintenance
action.

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2
2 Choose the Maintenance actions button.

3
3 From the Maintenance actions: list, choose the
maintenance action to be performed.

4
4 To start the wizard, choose the Perform button.
f The system changes to Maintenance status.

5 Follow the instructions provided in the software.

• To continue with the next step, choose the Next
step button.

u Related topics
• Cleaning transfer and processing modules (7 of
7 Maintenance

8) (226)

Cleaning transfer and processing modules (7 of 8)

Due to the size of the modules, the cleaning task is
divided into three procedures:
• Cleaning the modules from the rear
• Cleaning the transfer module from the front
• Cleaning the processing module from the front

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! CAUTION
Infection by samples and associated materials
The reagent needles on the reagent transfer head can be
contaminated with hazardous chemicals.
r Do not touch the reagent needles or processing
transfer head.
r Be sure to wear appropriate personal protective
equipment, including, but not limited to, eye
protection with side shields, fluid-resistant lab coat,
and approved lab gloves.
r Dispose of the materials according to local
regulations.
r If sample or liquid waste comes into contact with your
skin, immediately apply disinfectant, and then wash it
off with soap and water. Consult a physician.

cobas® 8800 System When working with the cobas® 8800 System, perform
the procedures for both processing modules.

r To clean the modules from the rear

1
1 If your system is on a movable platform, press and
hold the button on the side of the instrument.
f The instrument moves a maximum of 30 cm
towards the front.

q Do not press the button repeatedly. If the button

is pressed more than 20 times within one minute, the
movable platform is inactivated for 10 minutes.

2
2 Manually open the service doors of the transfer and
processing modules.
7 Maintenance

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228 Periodic maintenance

3 Clean the plastic surfaces and covered stations of the

3
processing module. Use a lint-free cloth moistened
with deionized water.
• Do not clean the liquid waste station.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

4 Change lab gloves.

5 Moisten lint-free cloths with deionized water.

A

A Liquid waste stations

6
6 On the transfer module, clean the surfaces of the
plastic covers.
• Work from the rear of the surface towards the
front.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

7 Make sure that no cleaning material or other objects

were left inside the module.

8
8 On the transfer module, make sure that no transport
locks were locked during cleaning.
• Twist each lock to check whether it is locked or
not.
I If locked, the transport locks do not twist. To
unlock, pull out and twist the transport lock.

9
9 On the processing module, make sure that no
transport locks were locked during cleaning.
• Twist each lock to check whether it is locked or
not.
I If locked, the transport locks do not twist. To
unlock, pull out and twist the transport lock.
7 Maintenance

10 Make sure the reagent transfer head and the

processing and the transfer module handlers are in
their park positions. Otherwise, they could collide with
other parts.

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11 Close the service doors of the system.

11

12 Clean the handles of the service doors with a lint-free

12
cloth moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

13
13 If you are using a movable platform, move the
instrument back to home position.

r To clean the transfer module from the

front

1 NOTICE Risk of damaging parts. Do not spray liquid

1
directly on any part of the system.
1 Moisten lint-free cloths with deionized water.
• Clean the gray foot of the main handler.
7 Maintenance

• Clean the lower part of the gripper.

• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

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2 Grab the main handler by its foot and move it in front

2
of the processing module.
I If you observe rests of sample material on the
transfer module deck, decontaminate the affected
parts.

3
3 Moisten lint-free cloths with deionized water.
• Do not clean the teaching posts (gray in image).
• Clean all the plastic-covered surfaces inside the
transfer module. Work from the rear of the surface
towards the front.
• Clean the transfer position.
• Clean the park positions.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

4 Moisten lint-free cloths with deionized water.

4
• Clean the lower part of the transfer module
gripper.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.
• To ensure that the gripper does not collide with the
main handler, push it back into the transfer
module.

5
5 Make sure that no transport locks were locked during
cleaning.
• Twist each lock to check whether it is locked or
not.
I If locked, the transport locks do not twist. To
unlock, pull out and twist the transport lock.
7 Maintenance

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r To clean the processing module from

the front

1 To access the processing module, grab the main

1
handler by its foot and move it in front of the transfer
module.

2 Do not clean the reagent needles or any optical or

electronic parts, such as the light barrier (red light).

3 WARNING! Risk of damaging parts. Do not spray

3
liquid directly on any part of the system.
3 Moisten lint-free cloths with deionized water.
• Clean all plastic-covered surfaces. Work from the
rear towards the front.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

4 Moisten lint-free cloths with deionized water.

4
• Clean the cooling station and the transfer position.
Make sure not to touch or clean the areas around
the light barrier (red light).
• Clean the sealing station.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.

5 Moisten lint-free cloths with deionized water.

5
• Clean the lower part of the processing module
gripper.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.
7 Maintenance

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232 Periodic maintenance

6 Turn the main handler so that it does not collide with

6
the covers or airflow screens.
I The gripper should be on the left of the main
handler, parallel to the airflow screens.

7
7 Move the main handler fully to the left.

8
8 Make sure that the status LED of the sensor in the
base of the main handler is off. If it is on, turn the main
handler slowly until the status LED is off.
I The gripper should be on the left of the main
handler, parallel to the airflow screens.

9 Make sure that no cleaning material or other devices

were left inside the module or magazines.

10
10 Make sure that no transport locks were locked during
cleaning.
• Twist each lock to check whether it is locked or
not.
I If locked, the transport locks do not twist. To
unlock, pull out and twist the transport lock.
7 Maintenance

11
11 To close the front covers, choose the arrow button in
the wizard.
• Within 5 seconds, also press the hardware button
below the monitor.

12 Make sure that all covers, doors and drawers are

closed fully.

13 In the software, choose the Next step button.

f The system changes to Starting up and
Initializing status.

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14 Clean the handle of the front covers with a lint-free

14
cloth moistened with deionized water.
• Repeat the cleaning procedure using a lint-free
cloth moistened with 70% ethanol.

u Related topics
• Closing the wizard and reloading drawers (8 of
8) (233)
• Moving the platform in Error or Maintenance
status (236)
• Decontaminating the modules (250)

Closing the wizard and reloading drawers (8 of 8)

After the modules are cleaned, you have to close the
wizard and load the drawers that were previously
unloaded.

j m Before closing the wizard, make sure you have

cleaned the transfer and the processing modules.
u Cleaning transfer and processing modules (7 of
8) (226)

r To close the wizard and reload

consumables

1 In the software, choose the Finish button.

f The Periodic maintenance wizard is closed.

2 Wait for the system to change to Standby status.

3
3 On the Monitoring tab, open the reagent cassette
and the consumables drawers.
7 Maintenance

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234 Periodic maintenance

4 Load the reagent and control cassettes and the

4
consumables back into the magazines.

5 On the Monitoring tab, close the reagent cassette

and the consumables drawers.

6 Wait for the click sound, then push the drawers back
6
in manually until they are fully closed.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.

7 You have now successfully completed the periodic

maintenance action.

u Related topics
• Unloading/loading the consumables drawer (107)
• Loading tip racks, reagent, and control cassettes (114)
7 Maintenance

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Moving the movable platform

In this section
Moving the platform in powerless status (235)
Moving the platform in Error or Maintenance status (236)

Moving the platform in powerless status

If your system is on a movable platform, you can move the
instrument 30 cm to the front. This allows for better
access to the rear if the instrument is installed very
closely to a wall or another instrument.

d If the system is in powerless state, you need a crank

handle to generate power to drive the motor.

j m All covers and doors must be closed.

r To move the movable platform in

powerless status

1
1 Ensure that there are 30 cm of free space in front of
the instrument.

2
2 Insert the crank handle in the notch on the side panel
of the instrument.
7 Maintenance

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236 Moving the movable platform

3
3 Turn the crank handle clockwise.
f The instrument moves a maximum of 30 cm
towards the front.

4
4 Ensure that the area behind the instrument is clear.
• Ensure that all doors and covers are closed.

5
5 To move the instrument back to its home position, turn
the crank handle counter-clockwise.
• Ensure that the instrument is moved back all the
way to its home position. If it is not in its home
position, you cannot start a run.

6 Check the instrument for signs of damage that may

have occurred during platform movement.

u Related topics
• Moving the platform in Error or Maintenance
status (236)

Moving the platform in Error or Maintenance status

If your system is on a movable platform, you can move the
instrument 30 cm to the front. This provides you better
access to the rear if the instrument is installed very
7 Maintenance

closely to a wall or another instrument.

j m The system must be in Error or Maintenance status

to move the platform.
m All covers and doors must be closed.
m If in Maintenance status: The maintenance wizard
must be started. The wizard page that is used to open
the covers must be open.

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r To move the movable platform in

Error or Maintenance status

1
1 Check if the status indicators above the arrow buttons
on the side of the instrument are green.
• If the status indicator is not green, make sure the
system is in Error or Maintenance status.
• If in Maintenance status: Make sure the
maintenance wizard is started. Navigate to the
wizard page that is used to open the covers.

2
2 Ensure that there are 30 cm of free space in front of
the instrument.

3
3 To move the instrument towards the front, press and
hold the button on the side of the instrument.
f The instrument moves a maximum of 30 cm
towards the front.

q To move the platform, press and hold the button.

Do not press the button repeatedly. If the button is
pressed more than 20 times within one minute, the
movable platform is inactivated for 10 minutes.

4
4 Ensure that the area behind the instrument is clear.
• Ensure that all doors and covers are closed.
7 Maintenance

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238 Moving the movable platform

5
5 To move the instrument back to its home position,
press the button on the side of the instrument.
• Ensure that the instrument is moved back all the
way to its home position. If it is not parked in the
home position, you cannot start a run.

6 Check the instrument for signs of damage that may

have occurred during platform movement.

u Related topics
• Moving the platform in powerless status (235)
7 Maintenance

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Regular maintenance
A few maintenance actions must be carried out in
addition to the procedures described in the periodic
maintenance section.

In this section
Cleaning the covers and doors (239)
Checking the status of the hard drives (241)

Cleaning the covers and doors

The covers and doors must be cleaned regularly.

c When required

d m Powder-free lab gloves

m Lint-free cloths
m Deionized, distilled, or purified water
m 70% ethanol
m Eye protection
m Personal protective equipment
u List of allowed cleaning solutions (267)

r To clean the covers and doors

1 Clean all front covers and doors (including the blue

1
acrylic surfaces) with a lint-free cloth moistened with
deionized water.
7 Maintenance

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240 Regular maintenance

2 Clean all rear covers and service doors (including the

2
blue acrylic surfaces) with a lint-free cloth moistened
with deionized water.

3 Clean the monitor and monitor arm with a lint-free

3
cloth moistened with deionized water.

4
4 Clean all front covers and doors with 70% ethanol,
except the blue acrylic surfaces.

5
5 Clean all rear covers and service doors with 70%
ethanol, except the blue acrylic surfaces.
7 Maintenance

6 Clean the monitor and monitor arm with 70% ethanol.

6

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Checking the status of the hard drives

You must check the status of the hard drives weekly.

If one of the status indicators is red, contact your Roche

Service representative.

c Weekly

n 2 minutes

j m You must have supervisor user rights to open the door

to the IG server.

r To check the status of the hard drives

1
1 To view the status indicators of the IG server, manually
open the front doors of the sample supply module.
I Even if you are working with multiple instruments,
there is only one IG server for all instruments
within a cluster.

2
2 Check if all status indicators of the hard disks of the
IG server are green. If one of them is red, contact your
Roche Service representative.
I If one of the status indicators is red, you can still
finish the current run. Further operation is
possible, but not recommended for reasons of data
security.
7 Maintenance

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242 Automatic maintenance actions

Automatic maintenance actions

In this section
Data maintenance actions (242)
Starting sample pipetter tightness check manually (244)
Starting the Teach instrument maintenance action
manually (244)

Data maintenance actions

IG server cleanup, archiving, and backup are
maintenance actions that are carried out automatically at
a predefined time. Also, sample pipetter tightness check
and teaching can be scheduled to start automatically.
However, if necessary, you can start these maintenance
actions manually.

In this section
IG server restart (242)
Starting an archiving maintenance action manually (243)
Starting a backup action manually (243)

IG server restart
The IG server must be restarted weekly. By default, it
automatically restarts each Monday at 03:00 a.m..

If you need to change the interval of the automatic restart,

contact your Roche Service representative.
7 Maintenance

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 Maintenance 243

Starting an archiving maintenance action manually

The system automatically archives log files, audit trails,
messages, trace files, test results, configuration, and
settings at a predefined time. If necessary, you can
manually start an archiving maintenance action any time.

r To manually start archiving

1 Choose Monitoring > Maintenance > Automated

1
archiving maintenance action.

2 In the Due in (days) and Duration (min): fields,

check when the maintenance action is due and how
long it is going to take.

3 If you want the automatic maintenance action to start

now, choose the Perform button.
f The data is now copied to the external archive
server.

u Related topics
• Refer to the section Defining archiving settings and
interval in the User Assistance.

Starting a backup action manually

Typically, the system performs the backup automatically
at the predefined interval. However, you can manually
start a backup process any time.

r To manually start a backup

1 Choose Monitoring > Maintenance > Backup

1
maintenance action.
7 Maintenance

2 In the Due in (days) and Duration (min): fields,

check when the maintenance action is due and how
long it is going to take.

3 If you want the automatic maintenance action to start

now, choose the Perform button.
f The data is now copied to the external backup
server.

u Related topics
• Refer to the section "Defining the backup settings and
intervals" in the User Assistance.

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244 Automatic maintenance actions

Starting sample pipetter tightness check manually

The system regularly checks the sample pipetter for
tightness. If the check fails (i.e. the pipetters are not
tight), you need to start the check again manually.

r To start the sample pipetter check

manually

1 If the sample pipetter tightness check fails, the system

changes to the Initializing status. A high priority task
(red) is shown in the task overview. Choose the task
from the list.

2 Repeat the tightness check by choosing the Perform

2
button.

3 If the tightness check fails again, contact your Roche

Service representative.

u Related topics
• Data maintenance actions (242)

Starting the Teach instrument maintenance action

manually
7 Maintenance

The positions of the movable units are calibrated after

installation. After a hardware crash, the positions of the
movable units need to be recalibrated. You can initiate
the recalibration by starting the teaching maintenance
action.

Starting manually/automatically You can schedule the Teach instrument maintenance

action to be started automatically after a certain interval.
If the automatic maintenance action is overdue, the
instrument cannot start a run until the maintenance
action has been performed.

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 Maintenance 245

q Do not perform the Teach instrument maintenance

action on the cobas® 8800 System if one of the modules
is masked.

c If required, for example, after a hardware crash or a

mechanical problem with the processing transfer head.

n Approximately 40 minutes.

j m The instrument must be in Standby status to start a

maintenance action.
m All modules must be unmasked.

r To start the Teach instrument

maintenance action

1
1 On the Monitoring tab, choose the instrument on
which you need to perform the Teach instrument
maintenance action.

2 Choose the Maintenance actions button.

2

7 Maintenance

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246 Automatic maintenance actions

3
3 Choose the Teach instrument maintenance action.

4
4 To start the wizard, choose the Perform button.
f The instrument changes to Maintenance status.

5 Follow the instructions provided in the software.

7 Maintenance

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 Maintenance 247

Decontamination
In certain situations, it is necessary to decontaminate the
system.

In this section
General decontamination procedures (247)
Decontaminating the modules (250)
Decontaminating the sample supply module (251)
Decontaminating sample racks (253)
Decontaminating rack trays (254)
Decontaminating solid and liquid waste containers (255)

General decontamination procedures

To get the best result, it is important to follow the outlined
decontamination procedures for DNA AWAY™ Surface
Decontaminant or sodium or potassium hypochlorite
solution (bleach).

q oDo not use technical or denatured ethanol for preparation

of the cleaning solution.
o Do not spray liquid directly on any part of the system.
o Moisten the lint-free cloth outside the system and
wipe the surfaces and parts as described in these
procedures.
o Instead of deionized water you can use distilled or
otherwise purified water.
o Take care when applying liquid to the lint-free cloth.
The cloth should be damp, but not saturated to
prevent drops of liquid from falling onto the system.
o Before using DNA AWAY™ Surface Decontaminant,
read the precautions on the bottle label carefully. For
more information or a Maintenance Safety Data Sheet,
refer to www.mbpinc.com.
7 Maintenance

o Before using sodium or potassium hypochlorite

solution (bleach), read the precautions on the safety
data sheet of the manufacturer.
o Use sodium or potassium hypochlorite solution
(bleach) for decontamination only. Do not use sodium
or potassium hypochlorite solution for routine
cleaning.
o Change lab gloves after each cleaning step.
o Dispose of the material as potentially infective
material.

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248 Decontamination

! CAUTION
Damage to the instrument due to inappropriate use
of decontamination solutions
The recommended decontamination solutions are highly
corrosive. Excessive use may damage the affected
surfaces.
r Exactly follow the outlined decontamination
procedures.
r Use only the recommended decontamination
solutions.
r Make sure to only decontaminate the contaminated
areas.

c When necessary, for example, when sample has

contaminated the system.

n Depends on the area to be decontaminated.

d m Powder-free lab gloves

m Personal protective equipment
m Lint-free cloths or lint-free cotton swabs
m 70% ethanol p.a. or mikrozid®
m Deionized or distilled water
m One of the following decontamination solutions:
m 0.6% (w/v) daily prepared sodium or potassium
hypochlorite solution (bleach)
m DNA AWAY™ Surface Decontaminant (Molecular
BioProducts, Inc.)

r To decontaminate using DNA AWAY™

Surface Decontaminant

1 Clean the surfaces and parts with a lint-free cloth or a

lint-free cotton swab moistened with deionized or
7 Maintenance

distilled water.

2 Clean the surfaces and parts with a lint-free cloth or a

lint-free cotton swab moistened with DNA AWAY™
Surface Decontaminant. Wait for 10 minutes.

3 Clean the surfaces and parts with a lint-free cloth or a

lint-free cotton swab moistened with deionized water.
Wait for 10 minutes.

4 Clean the surfaces and parts with a lint-free cloth or a

lint-free cotton swab moistened with DNA AWAY™
Surface Decontaminant. Wait for 10 minutes.

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 Maintenance 249

5 Clean the surfaces and parts with a lint-free cloth or a

lint-free cotton swab moistened with deionized water.
Wait for 10 minutes.

6 Clean the surfaces and parts with a lint-free cloth or a

lint-free cotton swab moistened with 70% ethanol.
Wait for 10 minutes.

r To decontaminate using sodium- or

potassium hypochlorite solution

1 Clean the surfaces and parts with a lint-free cloth

moistened with deionized or distilled water.

2 Clean the surfaces and parts with a lint-free cloth

moistened with 0.6% sodium or potassium
hypochlorite solution (bleach). Wait for 10 minutes.

3 Clean the surfaces and parts with a lint-free cloth

moistened with deionized water. Wait for 10 minutes.

4 Clean the surfaces and parts with a lint-free cloth

moistened with 0.6% sodium or potassium
hypochlorite solution (bleach). Wait for 10 minutes.

5 Clean the surfaces and parts with a lint-free cloth

moistened with deionized water. Wait for 10 minutes.

6 Clean the surfaces and parts with a lint-free cloth

moistened with 70% ethanol. Wait for 10 minutes.

r To decontaminate after a spillage

1 If a considerable amount of sample, lysis reagent, or

reagent was spilled, contact your Roche Service
representative.

2 CAUTION! Risk of a chemical reaction resulting in

cyanide. Make sure not to use bleach or DNA AWAY™
7 Maintenance

Surface Decontaminant if lysis reagent was spilled.

2 If a small amount of sample or reagent was spilled,
decontaminate the area as defined in the
decontamination procedures.

u Related topics
• Decontaminating the modules (250)
• Decontaminating the sample supply module (251)
• Decontaminating sample racks (253)
• Decontaminating rack trays (254)

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250 Decontamination

Decontaminating the modules

The decontamination procedure for the modules is very
similar to the cleaning procedures described in the
periodic maintenance. The difference is that you apply the
general decontamination procedure.

! CAUTION
Infection by samples and associated materials
The reagent needles on the reagent transfer head can be
contaminated with hazardous chemicals.
r Do not touch the reagent needles.
r Be sure to wear appropriate personal protective
equipment, including, but not limited to, eye
protection with side shields, fluid-resistant lab coat,
and approved lab gloves.
r If sample or liquid waste comes into contact with your
skin, immediately apply disinfectant, and then wash it
off with soap and water. Consult a physician.

c When necessary, for example, when sample has

contaminated the system.

n Depends on the area to be decontaminated.

d m Powder-free lab gloves

m Personal protective equipment
m Lint-free cloths
m 70% ethanol p.a. or mikrozid®
m Deionized or distilled water
m One of the following decontamination solutions:
m 0.6% (w/v) daily prepared sodium or potassium
hypochlorite solution (bleach)
m DNA AWAY™ Surface Decontaminant (Molecular
BioProducts, Inc.)
7 Maintenance

r To decontaminate transfer,
processing, or analytic modules

1 To access an area on the transfer, processing, or

analytic module, proceed as described in the periodic
maintenance section.
• Periodic maintenance (204)

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 Maintenance 251

2 To open the doors and covers of the transfer and

processing modules, start the Instrument cleanup
wizard.
• To start the Instrument cleanup wizard, choose
Monitoring > Maintenance > Instrument
cleanup.

3 If necessary, remove the plastic covers in the transfer

3
module.
• Press the mounting bolts to loosen the covers.

4 Decontaminate the contaminated area according to

the general decontamination procedures.
• General decontamination procedures (247)

5 If necessary, remove the plastic covers in the

5
processing module.

6 Decontaminate the contaminated area according to

the general decontamination procedures.
• General decontamination procedures (247)

7 To close the doors and covers, use the Instrument

cleanup wizard.

8 Close the instrument cleanup wizard.

u Related topics
• Periodic maintenance (204)
• General decontamination procedures (247)

Decontaminating the sample supply module

c When necessary, for example, when sample has

contaminated the system.
7 Maintenance

n Depends on the area to be decontaminated.

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252 Decontamination

d m Powder-free lab gloves

m Personal protective equipment
m Lint-free cloths
m 70% ethanol p.a. or mikrozid®
m Deionized or distilled water
m One of the following decontamination solutions:
m 0.6% (w/v) daily prepared sodium or potassium
hypochlorite solution (bleach)
m DNA AWAY™ Surface Decontaminant (Molecular
BioProducts, Inc.)

r To decontaminate the sample supply

module

1 To access the sample supply module, proceed as

1
described in the periodic maintenance.
• Cleaning the sample supply module (5 of 8) (220)

2 If you need to decontaminate an area at the rear of the

2
sample supply module, also remove the cover at the
rear and in the middle of the module.

3 NOTICE Risk of instrument damage. Do not touch

sensors or lights during decontamination.
3 Decontaminate the area as described in the general
decontamination procedures.
• General decontamination procedures (247)

4
4 Close the covers.

u Related topics
7 Maintenance

• General decontamination procedures (247)

• Decontaminating sample racks (253)
• Decontaminating the modules (250)

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 Maintenance 253

Decontaminating sample racks

Sample racks must be decontaminated regularly.

c Recommended: once a week.

d m Powder-free lab gloves

m Personal protective equipment
m Lint-free cloths
m 70% ethanol p.a or mikrozid®
m Deionized or distilled water
m neodisher MediClean®

One of the following decontamination solutions:

m DNA AWAY™ Surface Decontaminant (Molecular
BioProducts, Inc.)
m 0.6% (w/v) daily prepared sodium or potassium
hypochlorite solution (bleach)

r Decontaminating sample racks

1 Soak the sample racks for 10 minutes in 0.6% (w/v)

1
daily prepared sodium or potassium hypochlorite
solution (bleach) or in DNA AWAY™ Surface
Decontaminant in a container or bath with a cover.
During soaking, move the racks gently five times back
and forth to increase cleaning efficiency.

2 Repeat step 1 with deionized water.

3 Leave the sample racks to dry or spray with 70%

ethanol p.a.

u Related topics
• General decontamination procedures (247)
• Decontaminating the sample supply module (251)
7 Maintenance

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254 Decontamination

Decontaminating rack trays

Spills on the rack tray surface can be biohazardous. Clean
up all spills. The cleaning procedure described below is
the same for all types of rack trays.

! WARNING
Personal injury due to the edges on the rack tray’s
center guide rail
The edges on the rack tray’s center guide rail may cause
personal injury.
r Avoid contact with all edges, even when wearing lab
gloves.
r Wear protective equipment such as lab gloves.
r Carefully observe all instructions given in this task.

q If there is sticking and crystallized dirt on the rack

tray, scrape it with a cotton swab.

c Recommended weekly

d m Powder-free lab gloves

m Personal protective equipment
m Lint-free cloths
m Lint-free cotton swab
m 70% ethanol p.a.
m Deionized or distilled water

One of the following decontamination solutions:

m DNA AWAY™ Surface Decontaminant (Molecular
BioProducts, Inc.)
m 0.6% (w/v) daily prepared sodium or potassium
hypochlorite solution (bleach)
7 Maintenance

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 Maintenance 255

r To decontaminate rack trays

1
1 Wipe the rail center in both directions with a lint-free
cotton swab following the general decontamination
procedure.

2 Wipe the rail edge in both directions with a lint-free

cotton swab following the general decontamination
procedure.

3 Wipe the rail groove in both directions with a cotton

swab following the general decontamination
procedure.

4 Wipe the edges on the bottom of the rack tray in both

directions with a cotton swab following the general
A B C D
decontamination procedure.
A Rail edge C Rail center
B Rail groove D Rack tray 5 With an at least 10 mm thick pile of lint-free cloth,
wipe the surface of the rack tray starting from the
center in both directions, and then follow the general
decontamination procedure.
I To do that, hold the rack tray with one hand and
the pile of lint-free cloth with your fingers.

6 Repeat step 5 for the following parts of the rack tray:

• Rear surface
• Bottom surface

7 Visually check the rack trays.

• Make sure that there is no fiber from clothes or
swabs remaining on the rack tray.
• Make sure that there are no wet areas on the rack
tray.

u Related topics
• General decontamination procedures (247)

Decontaminating solid and liquid waste containers

7 Maintenance

The solid and liquid waste container must be

decontaminated weekly.

c Frequency: As defined in the standard operating

procedure of your laboratory.

Recommended option: At least once a week.

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256 Decontamination

d m Powder-free lab gloves

m Personal protective equipment
m Lint-free cloths
m 70% ethanol p.a. or mikrozid®
m Deionized or distilled water
m neodisher MediClean®

One of the following decontamination solutions:

m DNA AWAY™ Surface Decontaminant (Molecular
BioProducts, Inc.)
m 0.6% (w/v) daily prepared sodium or potassium
hypochlorite solution (bleach)

r To decontaminate solid and liquid

waste containers

1
1 Wipe the inside and outside of the solid waste
container as described in the general
decontamination procedures.

2
2 CAUTION! Risk of a chemical reaction resulting in
cyanide. Make sure not to fill bleach or DNA AWAY™
Surface Decontaminant into the liquid waste
container.
2 Wipe all the outside of the liquid waste container and
especially the bottle neck as described in the general
decontamination procedures.

u Related topics
• General decontamination procedures (247)
• Decontaminating the modules (250)
7 Maintenance

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 Appendix

8 Specifications......................................................................................................... 259
9 Glossary.................................................................................................................... 269
Index.......................................................................................................................... 271

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 259
Table of contents

Specifications 8

In this chapter 8
List of system specifications . . . . . . . . . . . . . . . . . . . . . 261
Power rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261
Environmental conditions . . . . . . . . . . . . . . . . . . . . 261
Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . 262
Space required around the system . . . . . . . . . . . . 262
Radio equipment specifications . . . . . . . . . . . . . . . 263
Supported material. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
List of supported sample tubes . . . . . . . . . . . . . . . 264
Minimum volumes for primary gel tubes . . . . . . . 264
List of supported sample racks . . . . . . . . . . . . . . . 266
List of allowed cleaning solutions . . . . . . . . . . . . . 267
List of available accessories and consumables . . 267

8 Specifications

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Table of contents
8 Specifications

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 Specifications 261

List of system specifications

Power rating
The power supply must fulfill the following requirements.
Never operate the system if one of the requirements is
not fulfilled.

International (Europe) US / Canada

Power rating 2 or 3 phase 200-240 V AC, 50/60 Hz 208 V AC, 60 Hz
Power supply No significant fluctuation, max. change ±10%
Uninterruptible power sup- It is highly recommended to connect the IG server and the instrument to a UPS.
ply (UPS)
y Power rating

u Related topics
• Environmental conditions (261)
• Dimensions and weight (262)
• Space required around the system (262)
• Radio equipment specifications (263)

Environmental conditions
The location must comply with the following conditions.
Never operate the system if one of the environmental
conditions is not fulfilled.

International
Ambient temperature During operation 15-32 °C
Ambient humidity (relative humidity) During operation 30-80% (non-condensing)
Pollution Degree 2 (IEC 61010-1)
Altitude above sea level 0-2000 m
y Environmental conditions
8 Specifications

Other environmental conditions • Indoor use only

• Horizontal installation space
• Dust-free environment with adequate ventilation
• No direct sunlight
• No perceptible vibration
• No equipment generating electromagnetic waves in
the vicinity
• No machines discharging ultrahigh frequencies (e.g.,
electric discharger)

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262 List of system specifications

u Related topics
• Power rating (261)
• Dimensions and weight (262)
• Space required around the system (262)
• Radio equipment specifications (263)

Dimensions and weight

The systems have the following dimensions and weight:

System Dimension/weight
Height ®
cobas 8800 System, including status light 216 cm

cobas® 6800 System, including status light 216 cm

cobas® 6800 System, including status light 221 cm for movable platform
Width cobas® 8800 System 429 cm

cobas® 6800 System 292 cm

Depth cobas® 8800 System 129 cm

cobas® 6800 System 129 cm

Weight cobas® 8800 System, excluding IG server / including IG server 2404 kg / 2455 kg

cobas® 6800 System, excluding IG server / including IG server 1517 kg / 1568 kg

cobas® 6800 System, movable platform, excluding IG server / 1675 kg / 1726 kg

including IG server
y Dimensions and weights

u Related topics
• Power rating (261)
• Environmental conditions (261)
• Space required around the system (262)
• Radio equipment specifications (263)

Space required around the system

8 Specifications

Do not operate the system if there is not sufficient free

space around it.

Platform type Minimum space required

Front Movable platform 100 cm
Fixed platform 100 cm
Back Movable platform 50 cm
Fixed platform 80 cm
y Space required around the instrument

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 Specifications 263

u Related topics
• Power rating (261)
• Environmental conditions (261)
• Dimensions and weight (262)
• Radio equipment specifications (263)

Radio equipment specifications

The following modules contain radio equipment:

Monitor Transfer module Processing module

Frequency (MHz) 13.56 13.56 13.56
Maximum radio-frequency power (mW) < 100 < 200 < 200
Number of RFID readers 1 2 4
Number of antennas 1 8 10
y Radio equipment

u Related topics
• Power rating (261)
• Environmental conditions (261)
• Dimensions and weight (262)
• Space required around the system (262)

8 Specifications

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264 Supported material

Supported material

List of supported sample tubes

The system generally accepts primary and secondary
round-bottom sample tubes.

The supported sample tubes should be within the

following dimensions:

Dimension
Height (without cap) 65-103 mm
Outer diameter (with barcode label) 12-16.2 mm
Inner diameter (at the top of the tube) 10.5-15 mm
y Supported sample tube dimensions

For order information, contact your local Roche

representative.

u Related topics
• Minimum volumes for primary gel tubes (264)
• List of supported sample racks (266)
• List of available accessories and consumables (267)

Minimum volumes for primary gel tubes

When using multiple tests with different transfer volumes
for the same sample, always choose the most
conservative option.

Using 1 test per sample

Height of sample phase (mm)
Tube diameter (mm)
Transfer volume (ul)
8 Specifications

Volume (ul)

13 22
850 1700
16 16
13 17
500 1300
16 12
y Minimum serum/plasma volumes and heights for primary
gel tubes (1 test per sample)

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 Specifications 265

Height of sample phase (mm)

Tube diameter (mm)
Transfer volume (ul)

Volume (ul)
13 16
350 1200
16 11
13 13
200 1000
16 9
y Minimum serum/plasma volumes and heights for primary
gel tubes (1 test per sample)

Using 2 tests per sample

Height of sample phase (mm)

Tube diameter (mm)
Transfer volume (ul)

Volume (ul)

13 32
850 2500
16 23
13 24
500 1800
16 17
13 20
350 1500
16 14
13 16
200 1200
16 11
y Minimum serum/plasma volumes and heights for primary
gel tubes (2 tests per sample)

Using 3 tests per sample

Height of sample phase (mm)

8 Specifications
Tube diameter (mm)
Transfer volume (ul)

Volume (ul)

13 43
850 3400
16 31
y Minimum serum/plasma volumes and heights for primary
gel tubes (3 tests per sample)

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266 Supported material

Height of sample phase (mm)

Tube diameter (mm)
Transfer volume (ul)

Volume (ul)
13 30
500 2300
16 21
13 25
350 1900
16 18
13 19
200 1400
16 13
y Minimum serum/plasma volumes and heights for primary
gel tubes (3 tests per sample)

u Related topics
• List of supported sample tubes (264)

List of supported sample racks

The system supports two types of sample racks and one
type of rack for clotted tips. The different types are
labeled with a 4-digit ID on top of the rack. For a detailed
list of available racks, contact your Roche representative.

Supported rack types

The rack ID is shown on top of the rack.

8 Specifications

Rack Rack ID Description Stabilizers Colors

0001-1000 Diameters: 16 mm, 13 mm Yes Gray
1001-4000 Diameter: 13 mm No Dark blue, brown,
light green, yellow
1001-4000 Diameter: 16 mm No Light blue, light green,
yellow
4001 and higher The system does not support rack IDs higher
than 4000.
R001-R025 Rack for clotted tips Yes Pink
y Supported rack types

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 Specifications 267

u Related topics
• List of supported sample tubes (264)

List of allowed cleaning solutions

When cleaning or decontaminating the system, use
substances that are listed below.

• Deionized or distilled water

• 70% ethanol p.a. or mikrozid®
• neodisher MediClean®
• 0.6% (w/v) sodium or potassium hypochlorite
(Bleach, Javel water)
• DNA AWAY™ Surface Decontaminant (Molecular
BioProducts, Inc.)

List of available accessories and consumables

This is a list of globally available accessories and
consumables. For ordering information, contact your
Roche Service representative.

Single use consumables

Image of product Product name
cobas omni Amplification Plate

cobas omni Processing Plate

cobas omni Pipette Tips

y Available accessories and consumables

8 Specifications

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268 Supported material

Generic reagents
Image of product Product name
cobas omni MGP Reagent

cobas omni Specimen Diluent

cobas omni Lysis Reagent

cobas omni Wash Reagent

y Available accessories and consumables

Waste containers and waste bags

Image of product Product name
cobas omni Liquid Waste Container

cobas omni Solid Waste Container

Solid waste bags

y Available accessories and consumables

Other accessories
Image of product Product name
Rack tray

y Available accessories and consumables

u Related topics
• List of supported sample tubes (264)
8 Specifications

• List of supported sample racks (266)

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 Glossary 269
amplification and detection - sample supply module

Glossary 9
amplification and detection Process of generating onboard stability Period of time during which a
multiple copies of nucleic acids and the concurrent or reagent, sample remains viable on board of the system
subsequent detection of these nucleic acids, usually once it has been loaded.
using an automated thermal cycler, fluorescent probes
periodic maintenance Maintenance actions which
and an optical detection system.
need to be performed in regular intervals.
amplification plate Microwell plate with 96 wells
pipette tip Disposable device which aspirates and
used for amplification and detection of nucleic acids.
dispenses liquids.
In order to avoid the evaporation during the thermal
cycling the wells are sealed. processing module Module t which is responsible
for the sample processing and the preparation of the
amplification plate drawer Drawer which provides
PCR reaction.
access to amplification plates after the PCR process.
processing module handler Handler which moves
amplification plate handler Amplification plate
cassettes and consumables in the processing module.
handler of the analytic module.
Processing plate Deepwell plate with 48 wells used
analytic module Module in which the amplification
for sample processing.
and detection process takes place.
processing tip Pipetting tip used for sample
bulk reagent drawer Drawer which provides access
preparation in the processing plate.
to bottles of lysis reagent and diluent.
processing transfer head Transfer head which
consumable Disposable item used during test
holds 48 processing pipetters of the processing
processing which comes into direct contact with
transfer unit. It is used during the preparation of the
reagent or sample. It must be replaced and disposed
PCR reaction.
of according to applicable regulations.
rack for clotted tips Rack which holds tubes into
control cassette Cassette with control materials.
which clotted pipette tips are temporarily disposed
diluent Liquid used to dilute samples or to affect an before they are removed from the system.
analytical reaction.
rack handler Component which moves racks on the
eluate tip Pipette tip used for pipetting the eluate in system.
the amplification plate.
rack tray Standardized transportation device for
elution buffer Reagent used to eluate nucleic acid at carrying and handling racks.
elevated temperatures in the sample preparation
reagent cassette Container for storage and
process.
transportation of reagents.
IG server Server of the system.
reagent cassette drawer Drawer through which the
interim reagent storage handler Handler which new reagent cassettes are supplied to and old ones
moves the reagent cassettes into and out of interim are disposed of the system.
reagent storage.
reagent storage Temperature-controlled section of
liquid waste drawer Drawer which provides access the transfer module that stores reagent and control
to liquid waste containers. cassettes.
lysis reagent Reagent used to lyse (decompose) reagent storage handler Component of the reagent
Glossary

cells in the sample preparation process. storage elevator which handles control and reagent
cassettes.
main handler Handler of the consumable loading
area. It moves consumables and cassettes on the reagent transfer head Transfer head used for
analyzer. pipetting reagent.
MGP cassette Reagent cassette which contains sample supply module Module which supplies
magnetic glass particles. samples to the transfer module and to which samples
are unloaded after pipetting.

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270 Glossary
sample transfer head - wash reagent

sample transfer head Transfer head used for

pipetting the sample.
solid waste bag Bag used for collection of solid
waste.
tip rack Rack containing pipette tips.
transfer module Module in which samples are
transferred from the tubes of sample rack to
processing plate.
transfer module handler Handler which moves
consumables and cassettes on the transfer module.
uninterruptible power supply Temporary, battery
powered, power supply that is used in case of
unexpected interruption of mains power.
wash reagent Reagent used to remove unbound
substances and impurities in the sample preparation
process.
Glossary

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 Index 271

Index

A Color concept
– color coding of status light, 75
Abbreviations, 9 – color coding of task overview, 75
Accessories – impaired color vision, 75
– list of available accessories, 268 – status colors, 75
Addresses, 5 Components
Alarm concept, 71 – of the processing module, 29
– about system alarms, 71 – of the transfer module, 27
– status colors, 75 Consumables
– statuses of the sample supply module, 65 – list of available consumables, 267
– statuses of the system, 79 Contact, 5
Amplification plate cassettes Control cassettes
– loading/unloading, 107 – about, 121
Amplification plates – loading, 114
– about, 112 – unloading emtpy control cassettes, 117
– removing, 86 Conventions used in this publication
Analytic module – abbreviations, 10
– about, 31 – symbols, 9
Archiving, 243 Copyright, 3
Audit trail entries Custom filter
– downloading from IG server, 180 – creating, 50
– viewing, 181 – deleting, 51
Automatic maintenance actions
– archiving, 243
– backup, 243
D
– IG server restart, 242
Decontamination, 247
– starting sample pipetter tightness check, 244
– general decontamination procedures, 247
– starting teach instrument action, 244
– racks, 253
– sample supply module, 251
B – solid and liquid waste containers, 255
– transfer and processing modules, 250
Backup, 243 – trays, 254
Barcodes Default filters
– barcode reading errors, 144 – creating, 51
– placing labels on tubes, 140 Diluent and lysis reagent bottles
Bulk reagent drawer – loading, 103
– overview, 102 Diluent bottles and lysis reagent
– overview, 102
C
E
Callouts, 47
Canceling a run, 157 Edition notice, 2
Carry over Emergency stop button, 32
– amplification plates, 113 Error ouput line
– MGP, 113 – bidirectional mode, 133, 134
Cleaning – standalone mode, 131
– amplification plate drawer, 218 – unidirectional mode, 132
Index

– bulk reagent drawer, 207 Error output line

– covers and doors, 239 – standalone mode, 131
– liquid waste drawer, 214 – unidirectional mode, 133
– reagent cassette and consumable drawers, 205 – unloading sample racks, 152
– sample supply module, 220 Export files
– transfer and processing modules, 226 – downloading from IG server, 180
– wash reagent drawer, 216

Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.2 · User Guide · Publication version 3.1
272 Index

F – tip racks, reagent and control cassettes, 114

– wash reagent containers, 98
Feedback, 4 Logging on to the system, 70
Filter Lysis reagent and diluent bottles
– creating default, 51 – loading, 103
– customizing, 50 – overview, 102
– deleting custom, 51
Filtering
– samples, 50
M
Filters
Maintenance actions
– about, 49
– archiving, 243
– creating/deleting, 50
– backup, 243
– using, 50
– checking status of hard drives, 241
– Cleaning covers and doors, 239
G – decontaminating sample racks and trays, 253
– decontaminating solid and liquid waste containers,
Global information area, 40 255
– about, 40 – decontaminating the modules, 250
– task overview, 41 – decontaminating the sample supply module, 251
– decontamination, 247
– general decontamination procedures, 247
H – IG server restart, 242
– list of maintenance intervals, 203
Hibernating, 188
– moving the movable platform, 236
– periodic maintenance, 204
I – sample pipetter tightness check, 244
– teach instrument, 244
IG server Maintenance intervals, 203
– downloading files, 180 Masking/unmasking a module, 158
– restart, 242 MGP cassettes
Input buffer – about, 113
– priority input, 134 – loading/unloading, 107
– standalone mode, 131 Movable platform
Input line, 134 – moving in error or maintenance status, 236
– loading, 134 – moving in powerless status, 235
– priority loading, 131
– standalone mode, 131
– unidirectional mode, 132
N
Instrument approvals, 4
Navigation, 44
Instrument overview, 46
New in version, 15
Intended use, 9

O
L
Ordering a repeat test, 168
Liquid waste container
Output buffer, 134
– list of statuses, 98
– bidirectional mode, 134
Liquid waste containers
– standalone mode, 131
– emptying/unloading/loading, 94
– unidirectional mode, 132
– overview, 94
– unloading full rack tray, 151
List of flags, 165
– unloading sample racks, 149
Load list, 170
Index

Output line, 134

Loading
– bidirectional mode, 134
– diluent and lysis reagent bottles, 103
– standalone mode, 131
– liquid waste container, 94
– unidirectional mode, 133
– overview of reagents and consumables, 85
Overview
– Processing plates, MGP cassettes, amplification plate
– analytic module, 31
cassettes, 107
– liquid waste and wash reagent containers, 94
– samples, 141

Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.2 · User Guide · Publication version 3.1
 Index 273

– lysis reagent and diluent bottles, 102 Reagents

– main workflow, 52 – list of available reagents, 268
– processing module, 28 Releasing test results, 178, 179
– quick start guide, 55 Repeat test
– reagents and consumables, 85 – loading samples, 170
– sample supply module, 23 – ordering, 168
– software, 39 Reports, 172
– transfer module, 26 – about, 172
– creating, 174
– downloading from IG server, 180
P Reviewing
– test results, 161
Pausing, 187
– test results by control batch, 163
Periodic maintenance, 204
Reviewing test results, 160
– cleaning the amplification plate drawer, 218
Revision history, 2
– cleaning the bulk reagent drawer, 207
Run
– cleaning the liquid waste drawer, 214
– canceling, 157
– cleaning the reagent cassette and consumable
– starting automatically, 155
drawers, 205
– starting manually, 154
– cleaning the sample supply module, 220
– cleaning the wash reagent drawer, 216
– cleaning the wash/waste drawer, 211 S
– cleaning transfer and processing modules, 226
– closing wizard and reloading drawers, 233 Sample pipetter tightness check, 244
– emptying the reagent cassette and consumable Sample racks
drawers, 205 – unloading from output buffer, 149
– emptying the solid waste container, 211 Sample supply module
– starting the periodic maintenance wizard, 225 – bidirectional mode, 133
Power switch 1, 32 – list of messages, 76
Power switch 2, 34 – overview, 23
Power switch 3, 34 – standalone mode, 131
Priming the instrument, 184 – starting up, 64
Priority input – statuses, 65
– input buffer, 134 – unidirectional mode, 132
Problem reports Sample supply module switch, 34
– downloading from IG server, 180 Samples
Processing module – filtering, 50
– about, 28 – loading, 141
– bulk reagent drawer, 102 – prioritized loading, 146
– components, 29 – unloading a rack tray which is not full, 149
– diluent and lysis reagent bottles, 102, 268 – unloading full rack tray, 151
Processing plates – unloading sample racks from error output line, 152
– about processing plates, 111 Screenshot disclaimer, 3
– loading/unloading, 107 Screenshots
– creating, 49
– downloading from IG server, 180
Q Shutdown
– for more than ten days, 200
Quick start guide, 55
– hibernate, 188
– IG server, 195
R – instrument, 190
– pausing, 187
Index

Racks for clotted tips – powerless status, 197

– loading, 135 – restart by power switch, 193
– prioritized loading, 138 – restarting the IG server, 242
Reactive test results, 160 Software
Reagent cassettes – callouts, 47
– about reagent cassettes, 120 – generic software elements, 47
– loading, 114 – instrument overview, 46

Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.2 · User Guide · Publication version 3.1
274 Index

– virtual keyboards, 48 U
Solid waste
– emptying, 88, 91 Unloading sample racks, 149
Solid waste container User interface
– empty, 211 – colors, 75
– replacing, 91
– unloading/emptying, 88
Start up
V
– IG server, 196
Virtual keyboards, 48
Starting a run, 154, 155
Starting up
– from Hibernate status, 62 W
– from off status, 61
– sample supply module, 64, 69 Warranty, 3
– system, 61 Wash reagent containers
Statuses – loading, 98
– colors, 75 – overview, 94
– liquid waste container, 98 Waste
– reagent containers, 103 – containers and waste bags, 268
– sample supply module, 65 – emptying liquid waste container, 94
– system, 79 – emptying solid waste container, 88
Stop button, 184 – replacing solid waste container, 91
System – supplies discarded by the system, 107
– overview, 19 Weekly maintenance, 239
– starting up, 61 – checking status of hard drives, 241
– statuses, 79 – cleaning covers and doors, 239
Work area, 42
Workflow overview, 52
T

Tabs and panels, 42

Task overview, 41
Test order
– about, 126
– creating manually, 126
Test result formatting, 160
Test result reports, 172
– about, 172
– creating, 174
Test results
– adding a review comment, 164
– export, 183
– releasing, 178
– releasing via remote user interface, 179
– reviewing, 160, 161
– reviewing by control batch, 163
– tracking information, 166
Tip racks
– about tip racks, 119
– loading, 114
Tracking information, 166
Trademarks, 4
Index

Transfer module
– about, 26
– components, 27
– overview, 26

Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.2 · User Guide · Publication version 3.1