Page 1

cobas®
4800
System
System
Software
Manual
Version
2.1
Page 2

cobas®
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Systeni
Manual
Document
information
Revision
Edition
Intended
history
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use
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version
1.0
Table
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Diagnostics
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Manual.Version
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cobas®
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4800
Manual
System
Contact
addresses
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Branchburg,
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directive 98/79/EG.
IVD
laboratories,
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for
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US.
Roche
System
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1.0
3
Page 4

cobas®
4800
System
System
Manual
Roche
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Diagnostics
System
Manual
Version
1.0
Page 5

cobas®
Sys(em
4800
Iftinunl
System
Table
Document
Contact
Table
Preface
How
Wheretofind
Conventions
System
1
General
Safety
Safety
Safety
Safety
Disposal
2
Overview
System
Hardware
3
Instrument
Analyzer
Control
of
contents
information
addresses
of
contents
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classifications
precautions
summary
labels on
overview
unit
manual
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the
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Analvzer
maintenance
elements
support
data
maintenance
73
81
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97
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103
104
115
Roche
System
Diagnostics
Manual
.
Version
1.0
5
Page 6

cobas®
4800
System
System
I’4anual
Roche
6
Diagnostics
System
Manual
Version
1.0
Page 7

cobas®
Systeni
4800
Manual
Preface
System
How
to
Where to
use
this
find
The
system
primary
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detection
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Roche
System
Diagnostics
Manual
Version
1.0
7
Page 8

cobas®
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Systern
System
Manual
Abbreviations
Symbol
J
j/’
‘.‘
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Table
2
The
following
Abbreviation
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ANSI
cc
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CSA
dBA
DIL
DWP
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e.g.
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EN
ie.
IEC
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LED
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MWP
n/a
PCR
QC
SD
UL
UPS
WEEE
XML
Table
3
Used
Tip
Safety
Electrical and
coveredbythe
and
The
the municipal
Symbols
abbreviations
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Amplification
American National
cubic
Capacitive Liquid
Canadian
decibel
approximates
Diluent
Deepweil Plate
European
exempli
ElectroMagnetic
European
id
est—thatisto
International
internal
In
Vitro
kilovolt-Ampere
Light
Laboratory
Microweli
not
Polymerase
Quality
Standard deviation
Underwriters
Uninterruptible
Waste
Extensible
Abbreviations
for
alert
electronic
symbol
used
are
centimeter
Standards
weighted
community
gratia
standard
Swivel
Diagnostic
Emitting
plate
applicable
Control
Electrical
Markup
electronic
European
equipment
denotes
that
waste
system.
used:
and detection
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Level
Association
against
the
audible rangeofthe
—
for
example
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say
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Arm
Commission
Plate
Diode
information
Chain Reaction
Laboratories
Power Supply
and
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Language
equipment
Directive
(WEEE).
the
equipment
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Detection
the
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handler
system
mc.
marked
with
2002/961EC
must notbedisposed of
response
human
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ear.
on
this
waste
curve.
symbol
electrical
This
are
in
curve
Roche
8
Diagnostics
Product
narnes
The
following
product
names
are
used:
System
Manual.Version
1.0
Page 9

cobas®
Systern
4800
Manual
System
Product
cobas
4800
cobas
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480
cobasz480
cobas
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name
software
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software
instrument instrument
analyzer
System
Product
nam
analyzer
system
es
Roche
System
Diagnostics
Manual.Version
1.0
9
Page 10

cobas®
4800
Systeni
System
Manual
Roche
10
Diagnosti
System
Manual
Version
1.0
Page 11

1
2
3
4
General
Overview
Hardware
Software
safety
information
System
description
13
29
37
71
Page 12
Page 13

cobas®
Table
of
4800
contents
System
General
1
safety
information
Manual
Systern
General
safety
information
you
chapter,
In
this
this
In
classifications
Safety
precautions
Safety
Operator
Safe
Miscellaneous
summary
Safety
Warning
Electrical
Optical
Biohazardous
Waste
Explosion
Caution
Mechanical
Reagents
Interfering
Evaporation
Incorrect
Incorrect
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Hot
Malfunction
Data
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Movingparts
Circuit
Spilage
labels
Safety
Safety
Safety
chapter
and
labels
labels
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qualification
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safety
safety
and
messages
safety
and
substances
of
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labels
sample
typed
electromagnetic
operation
incorrect
IDs
fields
the
system.
of
Chapter
specimen
15
16
16
16
17
18
18
18
18
19
19
20
20
20
21
21
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labeling....22
22
22
22
22
23
23
23
24
24
25
25
26
Roche
System
Diagnostics
Manual
.
Verson
1.0
13
Page 14

General
1
Tableofcontents
safety
information
cobas®
4800 System
System
Manual
Disposal
Disposal
Disposal
Disposal
of the
of the
control
of
instrument
analyzer
unit
components
27
27
27
27
Roche
14
fliagnostics
System
Manual.Version
1.0
Page 15

cobas®
Systern
4800 System
Manual
1
General
safety
Safety
information
c1assfications
Safety
classifications
1
WARNING
CAUTION
NOTICE
This
section
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The
safety
precautions and
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Roche
System
Diagnostics
Manual.Version
1.0
15
Page 16

1
General
Safetyprecautions
safety
information
cobas®
4800
System
System
Manual
Safety
Operator
precautions
qualification
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Safety
Particular
precautions
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16
Diagnostics
System
Manual.Version
1.0
Page 17

cobas®
Systern
4800 System
Manual
•
Perform
operating
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available
maintenance
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all
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17
Page 18

1
General
Safety
surnmay
safety
information
cobas®
4800
Systeni
System
Aianual
Safety
Warning
Electrical
summary
messages
WARNING
safety
WARNING
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Page 19

cobas®
System
4800
j’vlanual
System
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General
safety
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Safrty
summary
Biohazardous
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Roche
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19
Page 20

1
General
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safety
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Diagnostics
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Page 21

cobas®
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21
Page 22

1
General
Safety
sunimary
safety
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cobas®
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Page 23

cobas®
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Data
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23
Page 24

1
General
Safety
suniniary
safety
information
cobas®
4800 System
System
Manual
Circuit
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24
Diagnostics
System
Manual
.
Version
1.0
Page 25

cobas®
Systeni
4800
Manual
System
1
General
safety
Safety
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25
Page 26

1
General
Safety
labels
safety
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Page 27

cobas®
Systern
4800 System
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Disposal
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Diagnostics
Manual
Version
1.0
27
Page 28

1
General
Disposal
safety
information
cobas®
4800
Systeni
System
Mamal
Roche
28
Diagnostics.
System
Manual
Version
1.0
Page 29

cobas®
Tableofcontents
4800
System
Overview
Overview
2
Systeni
Alanual
In
this
chapter
instrument,
In
this
chapter
overview
System
Instrument
Analyzer
System
LIS
Consumables
you
the
analyzer,
software
get
and
a
basic
and
control
overview
the
software.
unit
about
the
whole
system
inciuding
Chapter
the
31
32
33
34
34
35
Roche
System
Diagnostics
Maniial
Version
1.0
29
Page 30

2
Overview
Table
of
contents
cobas®
4800
Systern
System
Manual
Roche
ao
Diagnostics
System
Manual
Version
1.0
Page 31

cobas®
Systern
4800
Manual
System
2
Overview
Systern
overview
System
overview
The
system
nucleic acid
The
system
primary
features
•
•
•
•
•
•
The
and secondary
are:
Fully
integrated
Amplification
Minimal
Multiple sample
Multiple
Intuitive
system
providesaplatformtoperform
amplification
integrates
and
hands-on
fully
tubes,
sample
detection
time
tests
from
automated
automated
preparation
using
biological
total
real
types
tests
targets
operationbyan
combines
the
easytouse
following
workflow
components:
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(test-specific)
qualitative
specimens.
nucleic
PCR setup,
time
PCR
wizard
LIS
and
quantitativeinvitro
acid
isolation
and
real
Results
4
time
directly
PCR.
from
The
main
Samples
Reagents
Consumables
Figure
Tests
2-1
that
only
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the
use
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overview
PCR Only
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plate
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cobasz480
components:
Result
and
reports
detection
analyzer
Roche
System
Diagnostics
Manual
Version
1.0
31
Page 32

2
Overview
Systenz
overview
t
Control ooit
LIS
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Resuits
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The
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amplification
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1.
2.
3.
specimens
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instrument
samples
procedure
Specimen-specific
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binding,
plate
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prepares
and
reagents. After
is
unloaded,
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instrument
preparation,
and
transferred
time
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follows;
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and
analyzer
setup
detection
only
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is
the
PCR
loaded
to
Only
workflow.
with
microweli
the analyzer
samples,
plate
for
with
the
Roche
32
Diagnostics
System
Manual
.
Version
1.0
Page 33

cobas®
Systeni
4800
Manual
System
Overview
2
Systeni
overi’iew
Analyzer
analyzer
The
time
real
Sealing,
PCR
loading,
interventions.
fluorescence
utilizes
methodologv.
unloading
and
signal
microweli
the
to
detect
plate
nucleic
are
the
acids
only
amplified
manual
by
using
Roche
System
Diagnostics
.
Manual
Version
1.0
33
Page 34

2
Overview
Systent
overview
Figure
2-4
Analyzer
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4800
Systern
System
Mannal
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115
software
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Roche
34
Diagnostics
System
Manual
.
Version
1.0
Page 35

cobas®
System
4800
Manual
System
A
[IS
Figure
•
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administrator
the
to
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(p.
58)
cobas
4800 System
Host
Roche
System
Diagnostics
Manual
.
Version
1.0
35
Page 36

2
Overview
Systern
overview
cobas®
4800 System
Man,ial
Systern
Roche
36
Diagnostics
System
Manual.Version
1.0
Page 37

cobas®
Tableofcontents
4800 System
Hardware
Hardware
3
Systevn
Manual
In
this
chapter
you
getanintroduction
into
the
instrument.
In
this
Instrument
Covers
LEDs
Instrument
Autoload
Pipetting
1SWAP
Teaching needies
Waste
Carriers
Sample
Reagent
Plate
Tip
Stationary
Consumables
Pipetting
Reagent
Deepweli
Microweli plate
Consumables
Secondary
Technical
Analyzer
Main
LEDs
Technical
Control
Hand-held
Technical
chapter
deck
unit
arm
station
carriers
carriers
carrier
rack
carriers
carrier
tips
reservoirs
plate
tubes
specificationsofthe
building
unit
bio
specificationsofthe
barcode
specification
for
cks
tip
reader
of the
waste
instrument
analyzer
control
unit
Chapter
F1
39
40
41
41
43
45
46
46
47
50
50
53
55
55
56
58
58
58
59
60
61
61
61
65
65
67
67
69
69
70
Roche
System
Diagnostics
Manual.Version
1.0
37
Page 38

3
Hardware
Tableofcontents
cobas®
4800
Systens
System
Manual
Roche
38
Diagnostics
System
Manual
Version
to
Page 39

cobas®
Systeni
4800
Manual
Instrument
System
The
instrumentisan
purify,
and prepare
After
sample
preparation,
unloaded,
using
The
1.
2.
3.
sealed,
real
time
procedure
Specimen-specific processing
Generic
Working
binding,
master
and
PCR.
for
automated
target
transferred
sample
washing,
mix
multi-channel
nucleic
acid
the microweli
to
the analyzer
preparationisas
and elution
preparation
and PCR-setup
for
subsequent
plate
follows:
pipetting
with
the
for
instrument
PCR
testingonthe
PCR-ready
amplification
3
Hardware
Instrument
usedtoextract,
analyzer.
samples
and
is
detection
Dependingonthe test,
specimens
The
A
B
C
Figure
main
Pipetting
8
pipetting
Instrument
Autoloader
3—1
plus
parts
arm with
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of the
pipetting
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the
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instrument
head,
and
ISWAP
used
for
to
single
run.
are
showninFigure
D
Stationary
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sample preparation
processupto96samples
3-1.
carrier
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tray
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heater/shaker
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for
(94
patient
microweli
unit,
Roche
System
Diagnostics
Manual.Version
1.0
39
Page 40

Hardware
3
Instrument
Covers
The following
A
Left
side
cover
B
Front
cover
Figure
3-2
figure
Covers
shows
of
the
the
covers
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of
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instrument.
C
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side
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cobas®
4800
Systeni
System
Manual
NOTICE
front
cover
cover
be
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The
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close
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and
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open
all
run
cover
on
with
Roche
40
Diagnostics
System
Manual.Version
1.0
Page 41

cobas®
Systeni
LEDs
4800 System
Manual
The
loading
autoload
tray.
autoload tray
on
status
The
and
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and
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insert
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hooks.
deck
holders
Roche
System
Diagnostics
.
Manual
Version
1.0
41
Page 42

3
Hardware
Instrument
cobas®
4800 System
System
Manual
Instrument
deck
layout
The
instrument
you
can
positions
the
LED
Track
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exampleofthe
deckisdivided into54equal tracks.
readily identify
are
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the location
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Roche
42
Diagnostics
Sample
loading
area
The
sample
additional
For
loading
area
details
can
hold
about
sample carriers,
any
combination
see
of sample
Sample
carriers
carriers.
50)
(p.
System
Manual
Version
1.0
Page 43

cobas®
Systeni
4800
Manual
System
3
Hardware
Instrument
Autoload
unit
The
autoload
placed-and
unit
autoloader.
the
and containers and
The
autoload
carriers
tray.
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above
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The
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NOTICE
Diagnostics
Manual.Version
1.0
A
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The
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on
43
Page 44

Hardware
3
Instrument
Safety
guards
The
avoid
autoload
bumping
tray
into
has
safety
carriersonthe
the
guards attached
autoload
on each
tray.
side.
cobas®
Extend
the
4800
Systeni
safety
System
Manual
guards
to
CAUTION
Personal
Keep
carriersonthe
Satetyguard
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Figure
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Roche
44
tiiagnostics
System
Manual
.
Version
1.0
Page 45

cobas®
Systeni
4800 System
Manual
Hardware
3
Instrument
Pipetting
arm
The
instrument
iSWAP
the
and
direction),
dispenses,
bag.
air-displacement
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the
beginning
displacement.
and
into
be
cleaned
of
a
The
dispensed
onaweekly
Roche
System
Diagnostics
Manual
Version
1.0
45
Page 46

3
Hardware
Instrument
iSWAP
The
plates
The
landscape
and
moves
ISWAP
is
isarobotic
iSWAP
them
the
to
mountedonthe
that
picks
arm
desired location
pipetting
arm.
on
deepweli
up
instrument
the
cobas®
plates
deck
System
4800
Manual
System
and microweli
duringarun.
Teaciting
needies
A
iSWAP
Figure
3-8
The
instrument
necessary)
appropriate
the
waste.
the tip
visit.
ISWAP
uses
eight
z-positioning
The
time.
The
teaching
teaching
and
over-
teaching
needies
needies
and
needies
are
to
under-pressure
are
cleaned
automatically
of
each
stored
near
during
the preventive
check
the
(and adjust
pipetting
waste
station,
if
channel
next
maintenance
at
to
Roche
46
Diagnostics
A
Figure
Teaching
3-9
needle
Teaching
needles
System
Manual
.
Version
1.0
Page 47

cobas®
Systern
4800
Manual
System
3
Hardware
Instrument
Waste
station
Tip
Safety
Make
sure
(p.
13).
Warning
Infection
Contanination
Solid
vaste
waste
arm.
instrument
The
accommodatesalarger
the
•
1f
solid waste
Exchange
E9
of
the
tip
For
Veekly
information
you
following
by
biohazardous
bags
hold used
have
safety
of
the
read
environment
that
The
messages:
canbeinstalled
solid
instrumentisinstalled
has
the
waste.
details
niaintenance
small
bag
about replacing
solid
capacity
a
waste
(p.
and
understood
messages
waste
pipetting
on
waste
onabench
bag
the
small
110)
particular
in
(p.
19)
by
liquid
tips
after
eitherabench
bag.
for
tipsofat
each
time
solid
chapter
are
and
have
top
General
relevant:
solid waste
been
or
onatrolley
the
waste
they
top,asmall solid
most
one
full
before
startinganew
waste
bag,
see
Daily
safety
19)
(p.
ejected
waste
bag
run.
runtoavoid
niaintenance
information
pipetting
the
by
that
is
used.
overfilling
105)
(p.
This
and
Roche
System
Diagnostics
Manual
.
Version
1.0
Initialization/waste
A
B
Support
solid
Small
C
Figure
3—10
frame
waste
block
withacapacity
bag
Small
solid
waste
bag
for
tipsofat
most
one
full
run
47
Page 48

Hardware
3
Instrument
1f
the
instrumentisinstalledona
place
of
trolley
that
most
three
•
The
waste chute
full.
•1frequired,
•1frequired,
(p.
box
49)
For
details
Weekly
the solid waste bag
hoidsalarge
full
runs.
and
waste
replace
the waste
foldupa
new
waste
about replacing
maintenance
(p.
110)
solid
box
the
and
chute
large
special
the
tip
waste
bag.
cannot
be
in
the
box
as
indicatedinFigure
solid waste
trolley,aplastic waste
wasteisdirected
The
large
reused
and
same
wayasthe
bag,
intoawaste
solid
waste bag
mustbereplaced
small
3-12
see
Daily
cobas®
4800 System
chuteisused
holds
tip
solid
Folding
up
maintenance
Systeni
Manual
boxonthe
tipsofat
when
they
waste
new
a
105)
(p.
in
are
bag.
waste
and
Roche
48
Diagnostics
Waste
box
A
Wastechute
B
Large
most
Figure
The
full.
solid
three
3-11
waste
chute
Foldupa
waste
full
new
bag
withacapacityofat
runs
Waste
box
and
waste
waste
with
large
box
cannot
boxinthe
C
D
solid
waste
be
reused
following
Waste
Trolley
bag
and
way:
box
mustbereplaced
System
when
they
Manual.Version
are
1.0
Page 49

cobas®
Systern
Figure
4800
Manual
3-12
System
Folding
Hardware
3
Instrument
box
waste
a
new
up
Liquid
waste
The
liquid
level
of the
not
possible
The
liquid
container
For
tVeekly
A
Liquid
A
Liquid
B
Figure
3-13
waste
liquid
to
vaste
reusable.
is
details
maintenance
waste
waste
from
waste
doafull
is
emptied
about
/
/
with
cap
container
Liquid
instrument
the
monitoredbythe
is
In
run.
during
(p.
level
waste
the
110)
detection
container
emptying
this
liquid
is
case,
daily
waste
sensor
collected
system
not
it
is
weekly
or
container,
waste
and
external
in
an
warning
and
a
possible
to
maintenance.
Daily
see
tube
waste
the
start
The
maintenance
container.
issued
is
run.
liquid
when
waste
(p.
105)
The
it
and
is
Roche
System
Diagnostics
Manual
Version
1.0
49
Page 50

Hardware
3
Instrument
A
Figure
Insert
the
3—14
liquid
waste
Inserting
cap
as
and
indicated
closing
the
liquid
B
Close
waste
cap
the
liquid
of
the
cobas®
waste
liquid
cap
waste
4800
System
container
System
Manual
Carriers
The
following
Camer
Samples
Reagents
Plates
Tips
Sample
Table
3-3
carriers
for
preparation
are
used:
Carrier
24-position
32-position
Collection
200mLreagent
carrier
reagent
50
mL
carrier
carrier
Reagent
carrier
Plate
Tip
carrier
Stationary
Carriers
used
sample
sample
medium
reservoir
reservoir
carrier
the
in
carrier
carrier
carrier
system
for
Used
Primary
and
For
additional
tubes
Primary
and
additional
For
tubes
mL
medium
reagent
reagent
and
plate
tip
Collection
200 mL
50
Reagent
Deepweli
Pipetting
Heater/shaker
for
plates
secondary
61)
(p.
secondary
61)
(p.
reservoirs
reservoirs
control
and
racks
unit, magnet
tubes.
details,
tubes.
details,
primary
(in
vials
microweli
see
Seconday
Secondary
see
tubes
adapter)
plate
plate,
holders
Sample
Roche
50
carriers
Diagnostics
Different
Depending
per
run.
The
sample
sample
on
barcodes
carriers
the
test,
up
must
allow
to
face
94
the
patient
to
the
of samples
use
specimens
rightofthe
primary
in
can
carrier.
be
loaded
and
System
secondary
onto
the
Manual
tubes.
instrument
Version
1.0
Page 51

cobas®
Systeni
4800 System
Manual
3
Hardware
Instrument
NOTICE
Barcode
dirnensions
Each
run
together
with
Instrument
Using
the incorrect
instrument
Use
only
Do
not
c
A
Label
B
Code
Quiet zone:
C
D
Label width:
E
Code
width:
F
Distance
Fi9ure
3-15
has
damage
specified
use
length:
Ienght:
from
test
specific controls
the
reagents
duetothe
tube
tube
closed
tubesensample
B
EL1
A
max.
80
max.74mm
min.3mm
min.12mm
min.12mm
codetolabel
Barcode
onto
the
useofinappropriateorclosed
typesorclosed
types
for
U
mm
edge:
max.1mm
dimensions
positive/negative
e.g.
reagent
carrier.
tubesensample
sample
carriers.
carriers.
c
.
Always
control.
carriers can
open
tubes
Controls
tubes
damage
on
all
are
loaded
sample
the
carriers.
Positioning
Positioning
barcode
sample
barcode
labels
on
tubes
labels
on
containers
The
barcode must
of the
tube.
2OmmL
Figure
3—16
Make
sure
For
the
bars
additional
fit
withinarangeofbetween20mm
100
mm
Fixing
barcodestosample
are
perpendiculartothe
details
about
barcode
tubes
types
tube.
and
and
specifications,
100
see
mm
from
Barcode
the
reader
bottom
63)
(p.
Roche
System
Diagnostics
Manual
.
Version
1.0
Figure
3—17
Fixing
barcodestocontainers
51
Page 52

3
Hardware
Instrument
cobas®
4800
Systenz
System
Manual
24-position
CAUTION
carrier
saniple
(test-specflc)
Container
PreservCyt
SurePalh’
3-4
Table
24-position
The
aliquot
An
necessary.
24-position
The
For
EJ3
specific
Infection
carriers
1-track
Handle1-track
several
can
details
package
by
carriers
Range
5
mm-55
5
mm
Positioning
sample
manually
be
sample
about
samples
(suchasa
carriers
together
-40
the
types
insert.
and
mm
mm
barcode
carrier
transferred
carrier
of
associated
sample
with
particular
to minimize
Note
The
barcode
55
and
barcode
The
40
and
on
labels
hoidsupto
from
uses one
tubes
you
materials
can
carrier)
care,
this
must
mm
from
must
from
mm
containers
24
primary
the
primary
trackonthe
can
use on
fall
over
position
risk.
withinarange
fit
bottom
the
fit
within
the
bottom
or
secondary
tubetothe
instrument
sample
the
and
cause
them
between
of
of
container
the
of
range
the
between
container
a
of
tubes.
secondary
deck.
carrier,
refer
to
injuryorcontamination.
on
the
autoload
tray
the
or
5
5
test
mm
mm
if
place
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sample
(test
-spec
medium
(test-specfic)
carrier
fic)
carrier
t—
A
Carrier
8
Primary
Figure
3-18
32-position
The
secondary
aliquot
An
necessary.
if
32-position
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For
specific
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medium
This
carrier
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,-
barcode
or
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can
details
package
primary
uses
•1v
24-position
sample
manually
be
sample
the
about
insert.
medium
tubes.
two
tubes
carrier
carrier
types
carrier
tracks
sample
carrier
optionally
is
transferred
uses
of
tubes
is
optionally
on
the
instrument
one
you
from
track
can
available
the
primary
on
the
useonthe
available
deck.
and
hoids
upto32
tubetothe
instrument
sample carrier,
and
hoids
up
deck.
refer
to
B
primary
secondary
to
the
12
Collection
or
tube
test
Roche
52
Diagnostics
Open
collection
the
medium
containers
before
inserting
the
carrier
on
the
System
autoload
Manual
tray.
Version
1.0
Page 53

cobas®
Systern
4800 System
Man
ual
A
B
[igure
Collectiori
Carrier
3—19
medium
barcode
primary
Example
tube
ofacollection
medium
carrier
3
Hardware
Instrument
Reagent
carriers
Reagent
reservoir
carriers
The
reagent
reservoir carriers
carriers
•
•
The
onto
barcodes must
are availableintwo
200mLreagent
50mLreagent
required
reservoir
reservoir
reagents
their dedicated positionsonthe reagent
facetothe
For
details
about reagents
test-specific
Aø
Operator’s
are
hold
sizes:
carrier
carrier
poured
right
of the
and
Manual.
the
reagent
for
for50mL
into
the
reservoirs.
200mLreservoirs
reservoirs
reagent
reservoir
carrier.
the
placementonreagent
The
reagent
reservoirs
which
carriers. The reagent
reservoir
are
carriers,
reservoir
then
placed
reservoir
refertothe
Roche
System
Diagnostics
Manual.Version
1.0
A 200mLreagent
B
Carrier
barcode
Figure
3-20
reservoir
200mLreagent
reservoir
carrier
53
Page 54

Hardware
3
Instrument
cobas®
4800 System
Systeni
Manual
g
Reagent
NOTICE
carrier
A
50 mL
reagent
B
Carrier
barcode
Figure
3—21
The reagent
carrier
setup (controls,
The
required
on
the
reagent
For
details
Operator’s
The
reagent
Instrument
Using
Do
reagent
closed
not
carrier
damage
use
carriers.
reservoir
50mLreagent
hoids the
master
reagents
carrier.
about reagent
Manual.
is
due
reagent
vialsonreagent
reagent
closed
reservoir
test-specific
mix,
metal co-factor(s),
decapped
are
The
reagent
placement
the
carrier
same
to
the
vialsonreagent
and then
barcodes
use
carrier
reagents
must
reagent carriers,
on
the
as
24-position
of
closed
carriers
can
carriers.
and
placed
reagent
damage
for
so
onto
face
Always
sample
on).
to
refertothe
vials
processing
their
dedicated
the
rightofthe
test-specific
sample carrier.
the
instrument.
open
reagent
and
PCR
positions
carrier.
vials
on
Roche
54
Diagnostics
A
A
B
Figure
Adapter
Carrier
3—22
with
barcode
reagent
Reagent
vial
carrier
System
Manual.Version
1.0
Page 55

cobas®
Systent
Plate
4800
Manual
carrier
System
The
plate
is
used
samples
Place
the
plate
carrier.
barcode
during
brought
At
the
carrier,
local
regulations
carrier
process
to
that
deepweil
must
loading
in
front
end
of
seal
ready
are
The
face
of
the
microweil
the
hoids
the
samples.
for
plate
other
to
the
plate carrier.
the
of
the
the
run,
unless
the
deepweli
PCR.
position
on
positions
right
barcode
plates
plate
further
and
plate
microweli
The
1
and
carrier
on
the
carrier.
of
the
microweil
The
on
reader
are
and
the
placed
dispose
off-the-system
the
plate
the
microweli
are
The
autoloader
back
of
the
use
microweli
used
is
not
deepweil
barcode
the
on
deepweil
intended.
is
plate
used.
by
plate
plate.
hold
to
The
plate
read
is
the
carrier.
plate
The
the
position
on
deepweli
barcode
after
iSWAP.
according
3
deepweil
final
is
loading
Unload
Hardware
Instrument
plate
prepared
3ofthe
plate
read
being
plate
the
the
to
Tip
rack
carriers
A
Deepweli
B
Microweli
Figure
The
tip
on
the
of
15
The
tip
The
total
sample
The
instrument
have
tips
To
avoid
Partially
To
perform
3-23
rack
test,
tip
rack
media,
this
used
plate
plate
carriers
uptothree
racks.
barcodes
number
run
tracks
loaded
been
message,
racks can
run,
a
position
on
on
Plate
of
pipetting
size,
all
position
carrier
hold
tip
must
and
tip
usage
to
perform
fully
be
required
the
1
3
the
rack
face
tips
so
bad
used
racks with
tip
carriers
to
per
on)
from
the
all
the
next
in
tip
can
the
right
run
varies
runtorun.
there
run.
1f
required
run.
carriers
rack
the
disposable
be
loaded
of
the
and
The
are
tip
must
forasingle
carrier.
depends
instrument
enough,
not
carriers
rack
loaded
be
pipetting
run
on
several
checks
a
message
for
each
into
tips.
holding
criteria
if
enough
run.
the
instrument.
Depending
total
a
(test
type,
pipetting
is
displayed.
Roche
System
Diagnostics
Manual
Version
1.0
55
Page 56

Hardware
3
Instrument
cobas®
4800
Systeni
System
Manual
Stationary
carrier
A
Tip
raak
Figure
3-24
The
stationary
instrument
the
•
heater/shaker
•
magnet
•
deepweli plate
•
microwell
with
disposable
Tip
carrieristhe
deck andisnot
unit
plate
holder
plate
pipetting
rack carrier
holder
tips.
Each
area where the
removable.
tip
rack
samples
The
holds96tips.
are
stationary
processed.Itis
carrier
hoids four
mounted
units:
on
Roche
56
Diagnostics
Heater/shaker
unit
A
Microweli
B
Deepweil
Figure
3-25
The
heater/shaker
sample
plate
holder
plate
holder
processing.
Stationary
unit
provides
carrier
consistent
C
Magnet
13
Heater/shaker
and
reliable
plate
unit
heating and
System
shaking
during
Manual.Version
1.0
Page 57

cobas®
Systern
4800
Manual
System
heater/shaker
The
instrument.
the
controller
box.
unit
heater/shaker
The
is
powered
external
an
from
mustbeswitched
unit
controller
on
and
box
located
offon
Hardware
3
Instrument
outside
external
the
of
Magnetpiate
Do
Always
A
Power
P
Figure
magnet
The
aware,
Be
magnets
not
forget
switch
switch
of
3-26
plate
that the magnets
from
its
switch
to
heater/shaker
off
the
heater/shaker
the
Controller
immobilizes
holder.
on
box
are
the
for
magnetic
not
heater/shaker
unit
before
unit
heater/shaker
glass
affixed
the
to
on
unit
unplugging
unit
particles
platesoany
its
during
external
It.
metal
controller
sample
can
box.
processing.
the
remove
Roche
System
Holders
Diagnostics
Manual
for
.
Version
deepweil
plate
and
microweliplate
1.0
A
Figure
The
PCR
Magnet
holders
on
magnet
3-27
for
setup occurs
Magnet
the
during
plate
plate
deepweli
sample
plate
and
processing.
microweli
the
plate
are
where
the
washing
and
57,
Page 58

3
Hardware
Instrument
Consumables
NOTICE
Instrument
non-Roche
of
Use
only
Use
not
Do
Inspect
not
Do
consumables
damage
consumables
Roche
consumables
reuse
consumables.
consumables
consumables
use
with
and
incorrect
before
that
unexpired
resuits
may
damage
designed
All
consumables
use.Donot
have
exceeded
consumables
duetouse
instrument
the
for
useonthe
are
use
damaged
their
before
of
system.
designed
consumables.
expiry
sample
cobas®
unsuitable
or lead
to
one
for
date.
Replace
processing.
4800
System
consumables
incorrect
use
time
expired
System
Manual
resuits.
only.
Pipetting
tips
NOTICE
Disposable
processing.
sample
are
racks
For
Instrument
Non-Roche
Use
only
pipetting
placed
details
damage
tips
disposable
into
about
may
tips
with
pipetting
The
tip
rack
rack carriers,
tip
to
due
cause
tips
filters
are
tips
carriers.
see
use
of
unsuitable
contamination
that
are specified
used
are
Tip
or
for
available
carriers
rack
tips
damage
by
Roche.
pipetting
tip
in
(p.
pipetting
of
racks
55)
all
liquids
of
96
channels.
tips
during
each.
Tip
Reagent
reservoirs
Scan-scan-pour-placeprinciple
Roche
Diagnostics
58
reservoirs
are
barcoded
for
handling
Tip
3—28
Figure
reagent
The
reservoirs
place
principle)
minimize
To
scan-scan-pour-place
Scan
the
the
barcode
barcode
1.
Scan
2.
reader.
3.
4.
Pour the
Place
reservoir
the
reagent
filled
carrier
reagent
with
rack
the
hold
are
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Page 59

cobas®
Systern
4800 System
?vlanual
Hardware
3
Jos
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59
Page 60

Hardware
3
Instrument
[
cobas®
4800 System
Systeni
!ulanual
Microweli
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Roche
60
Diagnostics
System
Manual
.
Version
1.0
Page 61

cobas®
System
4800 System
A’fanual
N
Hardware
3
Instrument
Consumables
Secondary
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61
Page 62

3
Hardware
Instrument
cobas®
4800
System
System
Manual
Physical
Power
Systern
dirnension
requirernents
principles
Item
Width
Depth
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Weight
Table
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Line
Line
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62
Diagnosties
System
Manual
.
Version
1.0
Page 63

cobas®
Systenz
4800
Manual
System
3
Hardware
Instrument
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reader
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63
Page 64

Hardware
3
Instrument
cobas®
4800
Systeni
System
Manual
Consumables
Heater/sizaker
unit
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Roche
64
Diagnostics
System
Manual.Version
1.0
Page 65

cobas®
Systern
4800
Manual
Analyzer
System
Hardware
3
Analyzer
NOTICE
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analyzer
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65
Page 66

Hardware
3
Analyzer
BÇ
System
cobas®
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4800
Systern
Manual
A
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66
Diagnostics
System
Manual
.
Versian
1.0
Page 67

cobas®
Systern
LEDs
4800
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Hardware
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Manual
Version
1.0
67
Page 68

3
Hardware
Analyzer
cobas®
4800 System
Systern
Manual
Safrty
Systern
classflcations
principles
Item
Line
frequency
Power
consumption
Fuses
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Roche Diagnostics
68
System
Manual
.
Version
1.0
Page 69

cobas®
System
4800
Manual
System
3
Hardware
Control
unit
Control
unit
CAUTION
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dedicated
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69
Page 70

3
Hardware
Control
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Page 71

cobas®
Tableofcontents
4800 System
Software
4
Software
Systern
Manual
In
this
chapter
In
this
Basic
software
Colors
Tabs
Buttons
Lists
Tool
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Chapter
LI
73
74
74
75
76
76
77
77
77
78
78
79
79
80
81
81
Roche
System
Diagnostics
Manual.Version
1.0
71
Page 72

4
Software
Table
of
contents
cobas®
4800
System
System
Manual
Roche
72
Diagnostics
System
Manual
Version
1.0
Page 73

cobas®
System
4800
Manual
System
Basic
Software
4
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73
Page 74

4
Software
Basic
software
Colors
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Page 75

cobas®
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75
Page 76

Software
4
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Page 77

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77
Page 78

Software
4
Basic
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Page 79

cobas®
Systern
4800 System
Manual
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79
Page 80

4
Software
Basic
software
Wizard
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cobas®
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Page 81

cobas®
System
4800
Manual
Database
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accounts
accounts
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accounts
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Chapter
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87
88
89
90
92
92
92
93
93
95
95
95
95
96
96
97
98
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85
Page 86

Configuration
5
contents
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of
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Page 90

5
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Page 91

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Roche
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91
Page 92

Configuration
5
management
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92
Diagnostics
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Manual
Version
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1.0
Page 93

cobas®
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Roche
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Diagnostics
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Version
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93
Page 94

Configuration
5
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Diagnostics
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Manual
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Version
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Page 95

cobas®
Manual
System
Changing
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95
Page 96

Configuration
5
management
User
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Page 97

cobas®
Systern
4800
Manual
System
5
Configuration
Exporting
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Roche
System
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Manual
Version
1.0
97
Page 98

Configuration
5
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Roche
98
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Manual.Version
1.0
Page 99

Maintenance
6
Maintenance
101
Page 100