Roche Cobas 4800 System User guide

cobas®
4800 System
System
Manual
Software Version
2.1

cobas®
4800 System
Document
information
Systeni Manual
Revision history
Instrument approvals
Roche Diagnostics
2
Manual version Software version
Revision date Changes
1.0 2.1
April2013
Table
1
Revsion history
Edition notice
This manual is
for users of the cobas 4800 System.
Every effort has
been made to ensure that all the information contained in this
manual is correct at
the time of printing. However, Roche reserves the right to make
any changes
necessary without notice as part of ongoing product development.
Any customer modification
to the cobas x 480 instrument or cobas z 480 analyzer
will render the warranty or service agreement null and void.
Software updates are done by Roche Service representatives.
The screenshots in this publication have been added exclusively for the
purpose of
ilustration. Configurable and variable data such as parameters, resuits,
path names
etc.
visible therein must not be used for laboratory purposes.
Intended use The
system is intended to be used as a diagnostic or screening system
providing
samplepreparation, amplification and
detection of specific targets from human
samples.
It is important that the operator reads
this manual and the test-specific Operator’s
Manual thoroughly before using the
system.
The system is to be used by laboratory
professionals trained in laboratory techniques
and by instruction on the use of the system.
Copyright
©
2013, Roche
Diagnostics International Ltd. All rights reserved.
Tradernarks The following
trademarks are acknowledged:
COBAS, COBAS Z,
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 manual fulfills the intended purpose as
mentioned above.
All feedback on any aspect of this manual is welcome and will be
considered during updates. Please contact
your Roche representative, should you
have any such feedback.
The instrument and the analyzer meet the
protection requirements laid down in IVD
Directive
98/79/EG.
Furthermore, the analyzer is manufactured and tested according to
the following
international standards:
• lEG 61010-1
• lEG 61010-2-101
• UL61O1O-1
• CAN/CSA
C22.2
No.
61010-1
This manual meets
the European Standard EN ISO 18113-3.
Compliance is
demonstrated by the following marks:
System Manual . Version 1.0

cobas®
4800 System
Systeni
Manual
Contact
addresses
Roche
Diagnostics
System
Manual . Version
1.0
C (
Complies
with the IVD
directive 98/79/EG.
Issued
by
underwriters
laboratories, mc.
(UL)
for
Canada
and the
US.
C®(JS
Roche Molecular
Systems,
mc.
1080
U.S. Highway South
Branchburg, NJ
08876-
1760
USA
Made
in Switzerland
Roche Diagnostics
GmbH
1
ECIREPI
SandhoferStrasse
116
68305 Mannheim
Germany
3

cobas® 4800
System
System
Manual
Roche Diagnostics
4
System Manual
Version 1.0

cobas®
4800
System
Sys(em
Iftinunl
Table
of contents
Document
information
Contact
addresses
Table
of contents
Preface
How to use this
manual
Where to find
information
Conventions
used in this
manual
4
Software
Basic software
elements
Database
Configuration
73
81
5 Configuration
Configuration
87
User management
92
Exporting
support
data
97
Result counters
98
Maintenance
6 Maintenance
Safety information
Instrument
maintenance
Analvzer
maintenance
Roche Diagnostics
System Manual
. Version 1.0
103
104
115
Troubleshooting
7
3
5
7
7
7
7
System
description
7 Troubleshooting
Overview
129
Messages
work
area 131
About result
flags 134
General troubleshooting
136
Hardware
troubleshooting
138
Glossary
8 Glossary
Index
Index
149
Revisions
1 General
safety
information
Safety
classifications
Safety precautions
Safety summary
Safety
labels on the
system
Disposal
2
Overview
System overview
3
Hardware
Instrument
Analyzer
Control
unit
15
16
18
25
27
31
39
65
69
5

cobas®
4800
System
System
I’4anual
Roche Diagnostics
System Manual
Version 1.0
6

cobas® 4800 System
Systeni
Manual
Preface
The system integrates
fully automated
total nucleic
acid isolation
directly from
primary and secondary
tubes, automated
PCR setup,
and real
time
PCR.
This manual
covers the complete
system comprised of
the cobas’
4800 software, the
instrument used for
sample preparation,
and the analyzer
used
for amplification and
detection using real time
PCR.
How
to use this manual
• Keep this manual
in a safe place to
ensure that t
is not damaged and
remains available
for
use.
•
This
manual should
be easily
accessible
at
all times.
To help
you find information quickly,
there is a table of
contents
at the
beginning
of
the
manual and
each chapter. In
addition,
a
complete index
can be found
at
the end
of
the
manual.
Where to
find
information
In addition to
this
manual, the
following documents are also
provided to assist in
finding desired
information quickly:
Test-specfic
Operator
Manuals
For
each test, there is a
specific Operator’s Manual
which describes how to
prepare
and perform
a run, and
how to handle results.
Test
-spec ficpackage insert For
each test,
there
is a package insert
which provides
additional information.
For
example,
instructions on
storage and handling
of reagents,
samples and
controls.
Conventions
used
in
this manual
Visual cues are used
to
help locate and
interpret information in
this manual quickly.
This section explains
formatting conventions
used
in
this manual.
Symbols The following symbols
are
used:
Symbol
Used for
(
Start of
procedure
End of
procedure
List item
(j)
Cross-reference
C’
Cail-up (software reference)
Table
2
Symbols
used
Roche
Diagnostics
System
Manual Version
1.0
7

cobas® 4800 System
Systern Manual
Symbol Used for
J
Tip
j/’
Safety alert
‘.‘ Electrical and electronic
equipment marked with this symbol are
/Y\
covered
by
the European Directive
2002/961EC on waste electrical
and electronic equipment
(WEEE).
The symbol denotes that the equipment must not
be
disposed of in
the municipal waste system.
Table 2 Symbols used
Abbreviations The following
abbreviations are
used:
Abbreviation Definition
AD Amplification and detection
ANSI American National Standards Institute
cc cubic centimeter
cLLD Capacitive Liquid Level Detection
CSA Canadian Standards Association
dBA decibel weighted against the A-frequency response curve. This curve
approximates the audible range of the human ear.
DIL Diluent
DWP
Deepweil Plate
EC European
community
e.g.
exempli gratia
— for example
EMC ElectroMagnetic Compatibility
EN European standard
ie. id est — that is to say
IEC International Electrical Commission
iSWAP internal Swivel Arm Plate handler
IVD In Vitro Diagnostic
KVA kilovolt-Ampere
LED Light Emitting Diode
LIS Laboratory information system
MWP Microweli plate
n/a not applicable
PCR Polymerase Chain Reaction
QC
Quality Control
SD Standard deviation
UL
Underwriters Laboratories mc.
UPS Uninterruptible Power Supply
WEEE
Waste Electrical and Electronic Equipment
XML Extensible Markup Language
Table
3
Abbreviations
Roche
Diagnostics
8
Product narnes The following product names are used:
System Manual . Version 1.0

cobas® 4800 System
Systern Manual
Roche Diagnostics
System Manual . Version 1.0
Product name
Abbreviation
cobas 4800
software software
cobas x 480 instrument instrument
cobas z 480 analyzer analyzer
cobas 4800 System
system
Tahie 4 Product nam es
9

cobas®
4800 System
Systeni Manual
Roche
Diagnosti
System Manual
Version 1.0
10

System
description
1 General safety information
13
2 Overview
29
3 Hardware
37
4 Software
71

cobas®
4800 System
1
General
safety
information
Table
of
contents
Systern
Manual
General safety
information
In this
chapter,
you will
find
information
on
the
safe
operation of
the system.
In
this chapter
Chapter
Safety
classifications
15
Safety
precautions
16
Operator
qualification
16
Safe
and
proper
use
of the
system
16
Miscellaneous
safety
precautions
17
Safety
summary
18
Warning
messages
18
Electrical
safety
18
Optical
safety
18
Biohazardous materials
19
Waste
19
Explosion
and fire
risk
20
Caution
messages
20
Mechanical
safety
20
Reagents
and consumables
21
Interfering
substances
in samples
21
Evaporation
of samples
or reagents
21
Incorrect
resuits
due
to
two barcode
labels or
incorrect
specimen labeling....22
Incorrect
resuits
due to
wrongly
typed
sample
IDs
22
Carryover
22
Hot
surfaces
22
Malfunction
due
to
interfering
electromagnetic
fields
22
Data
security
23
Notices
23
Movingparts
23
Circuit
breakers
and fuses
24
Spilage
24
Safety
labels on
the system
25
Safety
labels
on the
instrument
25
Safety
labels
on
the analyzer
26
Roche
Diagnostics
System Manual
. Verson
1.0
13

1
General
safety information
cobas® 4800 System
Table
of
contents
System Manual
Disposal
27
Disposal of the
instrument
27
Disposal
of the analyzer
27
Disposal of
control unit components
27
Roche fliagnostics
14
System
Manual . Version 1.0

cobas® 4800 System
1 General safety information
Systern Manual
Safety c1assfications
Safety classifications
This section explains how
precautionary information is presented in this manual.
The safety precautions and
important
user notes
are classified according to the
ANSI Z535.6 Standard.
Famiiarize
yourselfwith the
following meanings and icons:
Safety information
The safety
alert symbol by itself without a signal word is used to promote awareness to
hazards which are generic or to direct the reader to safety information provided
elsewhere in the document.
These
symbols and signal words are used for specific hazards:
WARNING
1
Indicates a hazardous situation which, if not avoided, could result in death or serious
WARNING
Injury.
CAUTION
Indicates a hazardous situation
which,
if not
avoided, could result in minor or moderate
CAUTION
injury
NOTICE
NOTICE
lndicates
a
hazardous situation which, if not avoided, could result in damage to
equipment.
For more
information about product safety labels, see Safety labels on the systern
(p.
25)
Important information which is not safety relevant is indicated by
the following
symbol:
Tip
Indicates additional information on correct use of the system or useful tips.
Roche Diagnostics
System Manual . Version 1.0
15

1 General
safety
information
cobas®
4800
System
Safetyprecautions
System Manual
Safety
precautions
Safety
information
Particular
attention must
be
paid
to
the
following
safety
precautions.
1f these safety
precautions are ignored, the
operator may suffer
serious
or
fatal injury. Each
precaution
is important.
Operator
qualification
Operators are required
to have a
sound
knowledge of
relevant
guidelines
and
standards as well as the
information
and procedures contained
in all
relevant
manuals.
• Do not carry out
operation and
maintenance
unless
you have been trained by
Roche
Diagnostics.
• Carefully
follow the
procedures
specified in all
relevant
manuals for operation
and maintenance.
• Leave maintenance,
installation,
or service that
is not
described
in the manuals to
trained Roche Service
personnel.
• Follow standard laboratory
practices,
especially
when
working with
biohazardous
material.
Safe
and proper
use of the
system
Personal
protective
equipnient •
Be sure to wear
appropriate protective equipment,
including, but not limited
to,
safety
glasses with side
shields, fluid
resistant
lab
coat, and approved disposable
gloves.
• Wear a face
shield ifthere is a
chance of splash
or splatter.
Accuracy/precision
ofmeasured
• Do not use reagents
that have
exceeded
their
expiry
date,
otherwise
inaccurate
results
data may be obtained.
•
For diagnostic purposes always
assess the resuits
in conjunction
with the
patient’s
medical
history, clinical
examination, and other
findings.
• Each
laboratory must verify that
reagent performance
meets
the
published
specifications.
.Installation • Unpacking
and
installation must
be performed
by
trained Roche Service
personnel
only.
• Leave installation
that
is not
described in this manual
or the test-specific
Operator’s
Manuals
to
trained Roche Service
personnel.
Correct use •
Use the
instrument
only for preparing liquid
samples with the
provided
reagents.
Operating
conditions
• Operation
outside of the specified ranges,
e.g.
with excessive
environmental
temperature
and/or
humidity,
may
lead to incorrect
resuits
or malfunction of the
instrument or analyzer.
• Use the instrument and
analyzer as indicated
in
the
technical specifications.
• Make sure that the instrument’s and
analyzer’s ventilation openings remain
unobstructed at all times.
Roche Diagnostics
16
System Manual . Version 1.0

cobas® 4800 System
1 General safety information
Systern Manual
Safetyprecautions
• Perform maintenance according to the specified intervals to maintain
the
operating conditions of the
instrument and analyzer.
• Keep
all manuals
in
a
safe
place to ensure that it is not damaged and remains
available
for
use.
All manuals must
be easily accessible at all times.
Approvedparts
Use of non-approved
parts
or devices may result in malfunction of the instrument
or
analyzer and may render the warranty nuli and void. Only use parts and devices
approved by Roche
Diagnostics.
Third-party software Installation of any third-party software that
is not approved by Roche Diagnostics
may result in incorrect behavior of the
system or the software. Do not instali any
non-approved software.
Miscellaneous safety precautions
Power interruption A power failure or momentary
drop in voltage may lead to data loss. Operation with
an uninterruptible power supply (UPS) is strongly recommended.
Check the UPS
regularly to make sure it functions properly.
1f there is a power failure, the analyzer is disconnected from the
control unit. The
displayed maintenance status of the analyzer may not be correct.
To get the correct
maintenance status, refresh the analyzer under Overview>
System
>
cobas z480 tab.
Electrornagnetic fields Devices that emit electromagnetic waves may cause the instrument
or analyzer to
malfunction. Do not operate the following devices in the same room where the
instrument or analyzer are installed:
• Mobile phone
• Transceiver
• Cordless phone
• Other electrical devices that generate electromagnetic fields
Data backup There is an automatic backup process
that
stores
the data on the D drive. It is the
customers responsibility
to
perform regular backups
of all measurement results.
Relocation and transportation Do not attempt
to
relocate or transport
the instrument or analyzer. Leave relocation
and transportation
to
personnel trained
or authorized by Roche.
For additional details, see Disposal
(p.
27)
Roche Diagnostics
System Manual . Version 1.0
17

1 General
safety information
cobas® 4800
System
Safety surnmay
Systeni Aianual
Safety
summary
This safety summary
contains the most important
and
general
warning
and caution
messages.
Additionally, you
will find specific safety
information at the beginning
of
Part Ivfaintenance
(p.
101) and
in the test-specific
Operator’s
Manuals.
For
more
information
about the safe use of the system,
refer to the test-specific package
insert.
Warning messages
List
of warning messages
Before
operating the
system, read the
warning
messages
contained in this
summary
WARNING
and in all
relevant manuals
carefully. Failure to observe them
may result in death
or
serious injury
Electrical safety
Electrical shock by
electronic equipment
Do
not attempt to work
in any
electronic compartment.
WARNING
Do not
remove any cover
of the instrument
or analyzer
other
than those
specified in
this
manual or the test-specific
Operators Manual.
Do not touch
any
parts of the
instrument or analyzer other than
those specified.
Especially do not
touch
any power
supply parts.
Never remove the
middle
grounding
prong from
the
power cable
or defeat its purpose
by using an ungrounded
adapter.
Installation, service, and
repair must only
be performed
by
personnel
authorized and
qualified by Roche.
Observe the system safety
labels as illustrated
in section Safety labels on
the system
(p25)
Optical safety
Loss of sight due to
stanng into laser
beam
The barcode reader
on the autoloader of the
instrument contains
a class
II
laser
diode.
WARNING
Do not stare into the
laser
transmitter
beam as eyesight may
be
severely
damaged.
Roche Diagnostics
18
System Manual Version 1.0

cobas®
4800 System
1 General safety
information
System
j’vlanual
Safrty summary
Biohazardous materials
Infection
by samples
and associated matenals
Contact with
samples containing
material of
human
origin may
result in infection.
All
WARNING
materials and
mechanical components associated
with samples of
human origin are
potentially
biohazardous.
Therefore, universal
precautions
should be
taken when handling
and
processing
samples.
Follow standard
laboratory practices, especially when
working with
biohazardous
material.
Keep
the main
cover closed
and in place while the
instrument is
operating.
Do not
open the thermal block
cycler door during operation.
When
working with the main
cover open while the instrument
is powered on (eg.,
for
cleaning or
maintenancej, always put
the instrument
in
Maintenance
mode or in
Shutdown
status
first.
Be sure to
wear appropriate
protective
equipment,
including, but
not limited to, safety
glasses
with
side shields,
fluid resistant lab
coat,
and approved
disposable
gloves.
Wear
a face
shield if there
is a chance
of splash
or
splatter.
1f any
biohazardous
material
is spilled, wipe it up immediately
and apply
disinfectant.
It sample
or liquid waste
comes into contact with your
skin, wash it oft
immediately
with soap
and water, and
apply
a disinfectant. Consult
a
physician.
Infection and injury due
to
sharp objects
When wiping sharp objects,
use
several layers
of gauze.
WARNING
Be careful
to not
puncture
yourself.
Be sure
to wear appropriate
protective
equipment,
for example
gloves.
Waste
Infection by
biohazardous waste
Liquid
and solid
waste originates
from samples collected
in
media that inactivate
WARNING
potentially biohazardous
material.
However,
as with
all
human-derived
solutions,
universal
precautions
should be taken
when
handling
waste.
Contact
with liquid waste
or used pipetting
tips may result in infection. All
materials and
mechanical
components that come
into
contact
with waste are potentially
biohazardous.
Therefore,
universal precautions
should be taken when
handling waste.
Be
sure
to
wear protective
equipment. Take extra care when
working with
protective
gloves;
these
can easily be
pierced or cut which can lead
to infection.
1f any biohazardous
material is spilled,
wipe t up immediately and
apply disinfectant.
1f liquid waste comes
into contact with
your
skin,
wash it off
immediately with soap and
water, and apply a
disinfectant. Consult a
physician
immediately
Observe the system
safety labels as illustrated
in
section Safety labels
on the system
(p.25)
Contamination of
the
environment
by liquid waste and solid
waste
The
waste
generated
during the
procedure
is potentially biohazardous.
WARNING
When disposing
of any Jiquid
or solid
waste, do
so
according to
the appropriate
local
regulations.
For information
about
disposal, see
Disposal
(p.
27)
Roche Diagnostics
System Manual Version
1.0
19

1 General
safety information
cobas®
4800 System
Safety surnniary
Systeni Manual
Explosion
and fire
risk
Explosion
through
sparks
Hazard
of explosion
through sparks.
WARNING
Keep
all
potentially
flammable
or
explosive material
(eg. anesthetic
gas) away
from the
instrument
or
analyzer.
Fire
risk through
usage
of sprays
Spraying
liquid on
the
power supply
paas can
cause a sho
circuit and
result
in a fire.
WARNING
During
fire-fighting
operations
disconnect
the
equipment
from the
main
power supply.
Keep
the cover
closed while
the
instrument
and analyzer
is connected
to the
main
power
supply,
and do not use
sprays
in
the
vicinity of the instrument
and
analyzer.
Caution
messages
List
of caution
messages
Before
operating the
system,
read the
caution messages
contained
in
this summa
CAUTION
and
in all
relevant manuals
carefully. Failure
to observe them
may
result
in minor
or
moderate
injury.
Mechanical
safety
Personal
injury due to
contact
with
moving parts
The pipetting
head of the instrument
moves rapidly
during
sample
preparation.
The main
CAUTION
cover is locked during operation,
protecting
the user from
moving
parts.
Keep the
main cover closed
and in place
while the instrument
is
operating.
When working
with the
main cover
open
while the instrument
is
powered
on (eg.,
for
cleaning
or
maintenance),
always
put the instrument
in
Maintenance
mode
or in
Shutdown
status
first.
Do not
touch
any
parts of the instrument
or
analyzer other than
these specified.
Keep
away from
moving
parts during
instrument
operation.
Do not
remove any
carrier from
the instrument deck
while the instrument
is
operating.
Keep the
main cover
closed
and in place
while
the instrument
is
operating.
During
operation
and maintenance
of
the
instrument,
proceed
according
to the
instructions.
Observe the
system safety
labels
as
illustrated
in section Safety labels
on the system
(p.
25)
Roche
Diagnostics
20
System
Manual
Version 1.0