Roche cobas 8000 / ISE Module User guide

Type
User guide
diagnostics.roche.com COBAS, COBAS C, COBAS E, ELECSYS and COBAS INTEGRA are trademarks of Roche. © 2021 Roche
Accessories, consumables, auxiliaries and ISE catalogue
CPS Serum Work Area Systems
diagnostics.roche.com COBAS, COBAS C, COBAS E, ELECSYS and COBAS INTEGRA are trademarks of Roche. © 2021 Roche
Publication
version
Revision
date Change description
1.0 01-2020 First Version
1.1 02-2020 Inclusion of cobas e 801 and cobas c 513 for the Micro Sample Cup
Correction of typos
2.0 11-2020 Inclusion of products compatible with cobas
®
pure integrated
solutions
Inclusion of list with different rack ranges
Addition of different diluents not listed in the first version
New category: Legal Manufacturer
Sample containers pictures in the correct position
New TSH products for Instrument Check
Pack size update for Sample Cup, Sample Cup Micro 13
Addition of racks for the cobas c 513
Addition of 4 COBAS INTEGRA
®
400 products not listed in the first
version
Terminology update
Inclusion of 3 consumables not listed in the first version
Inclusion of START for cobas c 701 / 702
General wording update
3
.0 05-2021 Removal of COBAS INTEGRA
®
Vial & Cap Kit (Phase out)
Removal of cobas e 801 and cobas e 402 for the CalSet TSH for
Instrument Check
Addition of new main categories Others and Service use only and
corresponding rearrangement
Adapation of Replacement Frequency for the racks and tube adapter
Removal of shelf life
Terminology update
Correction of typos
General wording update
Updates
diagnostics.roche.com COBAS, COBAS C, COBAS E, ELECSYS and COBAS INTEGRA are trademarks of Roche. © 2021 Roche
Accessories, consumables, auxiliary reagents
and ISE reagents in this catalogue are
essential components for the correct use
of SWA Systems*.
T
his marketing catalogue contains guidance on usage and
hints to sources of additional information. You can find
the link to eLabDoc, product pictures and package
information.
This is a document with relevant content about items used in
combination with the following instruments:
cobas
®
4000 analyzer series, cobas
®
6000 analyzer series,
cobas
®
8000 modular analyzer series, cobas
®
pro
integrated solutions, cobas c 513 analyzer, COBAS
INTEGRA
®
400 plus analyzer and cobas c 111 analyzer.
* cobas c 111 analyzer is now part of the Point of Care,
Clinical Chemistry & Immunoassay lifecycle team.
Introduction
diagnostics.roche.com COBAS, COBAS C, COBAS E, ELECSYS and COBAS INTEGRA are trademarks of Roche. © 2021 Roche
is glossary gives more details about the content of
the product pages. All items covered in this catalogue
contain the same list of features as below:
Header
Simple description of what the product is
Compatible instruments
List of instruments on which the product can be used
Location for use
Where on the instrument the product will be used
Product registration on instrument
How does the system recognize the product onboard
Replacement frequency
How often is the product normally replaced
Product labeling
What labeling materials are included in the package
Onboard stability
How long is the product stable on the instrument
Pack size
What is included in a single selling unit of the product
Legal manufacturer
Legal entity responsible for the product
Glossary
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Updates
Introduction
Glossary
Accessories
Sample containers
Sample Cup ..................................................7
Sample Cup Micro 13 / 16
................................ 8
cobas
®
cup ..................................................9
Micro-Sample Cup
....................................... 10
RD Standard False Bottom Tube
.................... 11
Empty reagent carrier
MULTI ................................................... 12, 13
Closed Development Channel – CDC
.... 14, 15, 16
CalSet Vials
................................................. 17
ControlSet Vials
........................................... 18
Disposable Elecsys
®
Wasteliner M ............................................... 19
AssayTip / AssayCup
..................................... 20
AssayCup
.................................................... 21
AssayTip
..................................................... 22
Clean-Liner
................................................. 23
AssayTip / AssayCup tray
............................... 24
Wasteliner
................................................... 25
Consumables Storage Box
............................ 26
13 mm sample disk tube adapter
................... 27
Reaction vessels
Micro Cuvette Segment ................................ 28
Cuvette COBAS INTEGRA
®
............................ 29
Reaction bottle unit (Reaction Cell)
................ 30
Reaction Cell for cobas c 501 / cobas c 502
... 31
Reaction Cell for cobas c 503 / cobas c 513
... 32
Reaction Cell for cobas c 311
....................... 33
Reaction Cell for cobas c 303
....................... 34
Others
Chimney ..................................................... 35
Waste Container
.......................................... 36
Opening Tool
............................................... 37
Racks
Standard Sample Rack ............................38, 39
Standard Rack Calibration
....................... 40, 41
Standard Rack Control
............................ 42, 43
Standard Rack Re-run
.............................44, 45
Standard Rack STAT
................................ 46, 47
Standard Rack Wash
.................................... 48
HHT CTS QC Rack
....................................... 49
HHT CTS Rack
........................................ 50, 51
Green Wash rack
......................................... 52
Special Cell Cleaning Solution – SCCS
SCCS (Special Cell Cleaning Solution) ....53, 54, 55
Hemolysis Solution for HbA1c
A1CD2 – Hemolyzing Reagent Gen.2 .............. 56
A1CD – Hemolyzing reagent
..................... 57, 58
Hemolyzing Reagent Gen.2
........................... 59
A1CD2
........................................................ 60
NACL (Diluent) & Serum / Sample Index (SI2)
NaCl Diluent 9 % .................................... 61, 62
NACL – Diluent NaCl 9 %
....................63, 64, 65
SI2 – Serum Index Gen.2
..................... 66, 67, 68
Sample Cleaner (acid and basic)
Sample Cleaner 1 .................................... 69, 70
Sample Cleaner 2
.................................... 71, 72
NaOH (NaOHD and NaOH)
CLEAN .................................................. 73, 74
Cell Wash Solution I / NaOH-D
.................. 75, 76
Basic Wash
................................................. 77
NAOHD – Detergent 1
........................78, 79, 80
Cleaner
....................................................... 81
EcoTergent
ECO-D – EcoTergent .................... 82, 83, 84, 85
Acid Wash
Cell Wash Solution II / Acid Wash ................... 86
Acid Wash
................................................... 87
Selective mode solution
SMS – Detergent 2 .............................88, 89, 90
Others – clinical chemistry
START – Antigen Excess Reagent.............. 91, 92
Elecsys
®
PreClean M ................................................. 93
ProbeWash M
.............................................. 94
Content
Content page 2
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CleanCell M ................................................ 95
ProCell M
.................................................... 96
ProCell II M
................................................. 97
PreClean II M
.............................................. 98
CleanCell
.................................................... 99
ProCell
..................................................... 100
Elecsys
®
SysWash ...................................... 101
Diluent Universal 2
..................................... 102
Diluent MultiAssay
...............................103, 104
Diluent Universal
.......................... 105, 106, 107
ISE - Devices
ISE -Devices – Electrodes – COBAS
INTEGRA
®
400 plus
Cl
-
Electrode .............................................. 108
Cl
-
Electrode Gen.2 .................................... 109
K
+
Electrode ...............................................110
Na
+
Electrode ............................................. 111
Reference Electrode
....................................112
Li
+
Electrode ..............................................113
Dummy electrode – Integra
..........................114
ISE- Devices – Electrodes
REF Electrode .............................................115
Cl Electrode
...............................................116
Na Electrode
..............................................117
K Electrode
................................................118
ISE- Devices – Electrodes cobas c 111
ISE Chloride Electrode ................................. 119
ISE Potassium Electrode
............................. 120
ISE Sodium Electrode
................................. 121
ISE Reference Electrode
............................. 122
ISE Dummy Electrode
................................. 123
I
SE - Accessories - Calibrators
ISE Calibration Kit ...................................... 124
ISE Standard Low
....................................... 125
ISE Standard High
...................................... 126
Activator Bottle Set
.................................... 127
ISE Solution 1
............................................ 128
ISE Solution 2
............................................ 129
ISE Solution 3
............................................ 130
Internal Standard Insert – ISE
..................... 131
ISE - Accessories - Reagents
ISE Reference Electrolyte ............................ 132
ISE Calibrator direct ................................... 133
ISE Calibrator indirect / urine ....................... 134
ISE Deproteinizer
....................................... 135
ISE Etcher
................................................. 136
ISE - Accessories - Reagents
ISE Internal Standard Gen.2 .................. 137, 138
ISE Diluent Gen.2
.................................139, 140
ISE Reference Electrolyte
............... 141, 142, 143
Activator
................................................... 144
ISE Calibrator indirect / urine
....................... 145
ISE Reference Solution
............................... 146
ISE Etcher
..................................................147
ISE Deproteinizer
....................................... 148
ISE Cleaning Solution / Elecsys
®
SysClean ..... 149
Others
Screw Cap for False Bottom Tube
................... 150
PC / CC-CUPS
............................................ 151
Bottle Set for cobas
®
8000 ISE .................... 152
Bottle Set
.................................................. 153
Sys Bottle 2 Assy
....................................... 154
Sys-Clean Adapter
..................................... 155
Reservoir Cup Assy
.................................... 156
LFC Cup Assy
............................................ 157
PW LFC Cup Assy
...................................... 158
PW LFC Cup 2 Assy
.................................... 159
Cup-Adapter w/o Tube Rotation
................... 160
Mixed-bed resin MBH 100
.......................... 161
Rack Test Assy (cassette rack)
.................... 162
Service use only
Instrument Check and Carry-over
Needle Assessment
CONA
.......................................... 163, 164, 165
INSTC – Instrument Check
............. 166, 167, 168
Check Solution Sample
............................... 169
TSH for Instrument Check
.....................170, 171
CalSet TSH for Instrument Check
................. 172
HBQ Sample Set
........................................ 173
CellCheck II
............................................... 174
SAP II
....................................................... 175
BlankCell High
........................................... 176
BlankCell
.................................................. 177
SAP Test
................................................... 178
CellCheck
................................................. 179
Content
Content page 1
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Accessories » Sample containers
Compatible instruments
COBAS INTEGRA
®
400 plus, MPA, cobas c 111,
cobas c 311, cobas c 501, cobas c 502,
cobas c 503, cobas c 701, cobas c 702,
cobas e 411 (rack and disk), cobas e 601,
cobas e 602, cobas e 801, cobas c 303,
cobas e 402
Location for use
Depending on the system, the sample cup
will be loaded directly onto a rack or sample
disk. It can also be used as cup on tube in a
16 mm primary sample tube.
Product registration on instrument
Automatic detection with the height detection.
For COBAS INTEGRA
®
: This sample cup
needs an adapter and the combination needs
to be manually defined.
Replacement frequency
Single use only.
Product labeling
Method sheet available and not included in
the package.
Onboa
rd stability
Not applicable.
Pack size
1 box contains 20 bags of 250 units each.
5,000 units.
Legal manufacturer
Roche Diagnostics GmbH
Sample container used for sample, calibrator and QC material.
Sample Cup
Global: 10394246001
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Accessories » Sample containers
Compatible instruments
COBAS INTEGRA
®
400 plus, cobas c 111,
cobas c 311, cobas c 501, cobas c 502,
cobas c 503, cobas c 701, cobas c 702,
cobas t 511, cobas t 711, cobas c 303,
cobas e 402
Location for use
Depending on the system, the Sample Cup
Micro 13 / 16 will be loaded directly onto a
rack or sample disk. It can also be used as
cup on tube in a 16 mm primary sample tube.
For cobas c 111 and COBAS INTEGRA
®
: this
sample cup needs an adapter.
Product registration on instrument
Automatic detection with height detection.
For COBAS INTEGRA
®
: This sample cup
needs an adapter and the combination needs
to be manually defined.
Replacement frequency
Single use only.
Product labeling
No method sheet available for this product.
Onboard stability
Not applicable.
Pack size
1 box contains 2 bags of 450 pieces each.
Legal manufacturer
Roche Diagnostics GmbH
e Sample Cup Micro 13 / 16 consumable is a container used for
sample material. e Sample Cup Micro has less dead volume
and is especially used when little sample material is available.
Sample Cup Micro 13 / 16
Global: 05085713001
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Accessories » Sample containers
Compatible instruments
COBAS INTEGRA
®
400 plus
Location for use
It has to be used with an adapter.
Product registration on instrument
cobas
®
cup on adapter is pre defined. The
assignment to the rack must be manually
defined. Therefore, automatic detection by
the analyzer is possible.
Replacement frequency
Single use only.
Product labeling
No method sheet available for this product.
Onboard stability
Not applicable.
Pack size
1 bag with 1,000 units.
Legal manufacturer
Roche Diagnostics GmbH
e cup with hole is a container used for sample, calibrator
and QC material. e cup with hole has less dead volume and
is especially used when little sample material is available. Both
colors are the same and customers can use as they wish.
cobas
®
cup
cobas® cup white: 21045318001 / cobas® cup blue: 21044869001
diagnostics.roche.com | 10 | Last update: 05/2021 COBAS, COBAS C, COBAS E, ELECSYS and COBAS INTEGRA are trademarks of Roche. © 2021 Roche
Accessories » Sample containers
Compatible instruments
cobas c 501, cobas c 502, cobas c 701,
cobas c 513, ISE, cobas e 801, cobas
c 503, cobas c 303, cobas e 402
Location for use
The Micro-Sample Cup will be loaded
directly onto a rack with stabilizers. It can
also be used as cup on tube in a 16 mm
primary sample tube.
Product registration on instrument
Automatic detection by the height detection.
Replacement frequency
Single use only.
Product labeling
No method sheet available for this product.
Onboard stability
Not applicable.
Pack size
1 bag with 100 units.
Legal manufacturer
Hitachi High-Tech Corporation
e Micro-Sample Cup is a container used for sample material.
e Micro-Sample Cup has less dead volume and is especially
used when little sample material is available.
Micro-Sample Cup
Global: 11229290001
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Accessories » Sample containers
Compatible instruments
cobas c 111, cobas c 311, cobas c 501,
cobas c 502, cobas c 503, cobas c 701,
cobas c 702, cobas e 411, cobas e 601,
cobas e 602, cobas e 801, cobas c 303,
cobas e 402
Location for use
RD Standard false bottom tube can be
directly loaded onto a rack or sample disk.
Product registration on instrument
Set up should be done on the SW by RSR
and special racks should be assigned.
Replacement frequency
Single use only.
Product labeling
Method sheet available and not included in
the package.
Onboard stability
Not applicable.
Pack size
1 box has 2 bags of 1,000 units each.
Legal manufacturer
Roche Diagnostics GmbH
e RD Standard False Bottom Tube is a disposable plastic tube
that has a threaded neck for closure with screw caps.
RD Standard False Bottom Tube
Global: 04740955001
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Accessories » Empty reagent carrier
Compatible instruments
COBAS INTEGRA
®
400 plus, cobas c 311,
cobas c 501, cobas c 502
Location for use
cobas c pack MULTI is loaded onto the
instrument at assigned test position. For
COBAS INTEGRA
®
, there is no assigned
position.
Product registration on instrument
2D barcode.
Replacement frequency
Single use only.
Product labeling
Method sheet available and not included in
the package.
Onbo
ard stability
Onboard stability depends on the reagents
used in the reagent cassettes.
Pack size
Single cobas c pack.
Legal manufacturer
Roche Diagnostics GmbH
e empty cobas MULTI packs are intended for use as IVD
accessories for third-party clinical chemistry reagents to perform
non-Roche photometric applications.
MULTI
Global: 04593138190
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Accessories » Empty reagent carrier
Compatible instruments
cobas c 701, cobas c 702
Location for use
cobas c pack MULTI is loaded onto the
instrument at assigned test position.
Product registration on instrument
RFID.
Replacement frequency
Single use only.
Product labeling
Method sheet available and not included in
the package.
Onboar
d stability
Onboard stability depends on the reagents
used in the reagent cassettes.
Pack size
Single cobas c pack large.
Legal manufacturer
Roche Diagnostics GmbH
Empty reagent carrier for use on Roche / Hitachi
cobas c 701 / c 702 systems.
MULTI
Global: 05353025190 / APAC: 05353025214 / China: 05353025188
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Accessories » Empty reagent carrier
Compatible instruments
cobas c 503, cobas c 303
Location for use
CDC is loaded into the instrument at
assigned test position.
Product registration on instrument
RFID.
Replacement frequency
Single use only.
Product labeling
Method sheet available and not included in
the package.
Onbo
ard stability
Onboard stability depends on the reagents
used in the reagent cassettes.
Pack size
Single cobas c pack green.
Legal manufacturer
Roche Diagnostics GmbH
e empty cobas c packs CDCnn are intended for use as
IVD accessories for third-party clinical chemistry reagents to
perform non-Roche photometric applications on cobas c 503 /
cobas c 303 analytical units.
Closed Development Channel – CDC
Global: 08463115190, 08463123190, 08463140190, 08463158190, 08463166190,
08463182190, 08463204190, 08463212190, 08463239190, 08463247190,
09206795190, 09206809190, 09206817190, 09206825190, 09206841190
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Accessories » Empty reagent carrier
Closed Development Channel – CDC
Gl
obal: 06300138190, 06300219190, 06300227190, 06300235190, 06300243190,
06300251190, 06300260190, 06300278190, 06300286190, 06300294190
Compatible instruments
cobas c 701, cobas c 702
Location for use
CDC is loaded into the instrument at
assigned test position.
Product registration on instrument
RFID.
Replacement frequency
Single use only.
Product labeling
Method sheet available and not included in
the package.
O
nboard stability
Onboard stability depends on the reagents
used in the reagent cassettes.
Pack size
Single cobas c pack large.
Legal manufacturer
Roche Diagnostics GmbH
Empty reagent carrier for use on Roche / Hitachi
cobas c 701 / c 702 systems.
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Accessories » Empty reagent carrier
Compatible instruments
cobas c 501, cobas c 502
(last 5 material numbers only available
for the cobas c 502)
Location for use
CDC is loaded into the instrument at
assigned test position.
Product registration on instrument
2D barcode.
Replacement frequency
Single use only.
Product labeling
Method sheet available and not included in
the package.
O
nboard stability
Onboard stability depends on the reagents
used in the cassettes.
Pack size
Single cobas c pack.
Legal manufacturer
Roche Diagnostics GmbH
Empty reagent carrier for use on Roche / Hitachi cobas c systems.
Closed Development Channel – CDC
Global:
06483810190, 06483836190, 06483844190, 06483879190, 06483887190,
06483895190, 06483909190, 06483925190, 06483933190, 06483941190,
08036306190, 08036314190, 08036322190, 08041709190, 08041717190
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Accessories » Empty reagent carrier
Compatible instruments
cobas e 411, cobas e 601, cobas e 602,
cobas e 801, cobas e 402
Location for use
Operator places the CalSet in a black
calibrator rack. For the cobas e 411, its
used in the grey rack.
Product registration on instrument
Detected by height detection automatically.
Replacement frequency
Each vial can be used in 4 calibration events.
Product labeling
No method sheet available for this product.
Onboard stability
Each and every vial can be used
up to 4 times.
Pack size
2 × 56 units.
Legal manufacturer
Roche Diagnostics GmbH
Empty SnapCap bottles. e CalSet Vials / ControlSet Vials are
used to aliquot the reconstituted or prelled Assay CalSets or QC
into smaller portions for storing.
CalSet Vials
Global: 11776576322
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Accessories » Empty reagent carrier
Compatible instruments
cobas e 411, cobas e 601, cobas e 602,
cobas e 801, cobas e 402
Location for use
Operator places the ControlSet in a white
QC rack. For the cobas e 411, it’s used in the
grey rack.
Product registration on instrument
Detected by height detection automatically.
Replacement frequency
Single use only.
Product labeling
No method sheet available for this product.
Onboard stability
Each vial can be used in 4 QC events.
Pack size
2 × 56 units.
Legal manufacturer
Roche Diagnostics GmbH
Empty SnapCap bottles. e CalSet Vials / ControlSet Vials are
used to aliquot the reconstituted or prelled Assay CalSets or QC
into smaller portions for storing.
ControlSet Vials
Global: 03142949122
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Accessories » Disposable Elecsys®
Compatible instruments
cobas e 601, cobas e 602
Location for use
Two Wasteliners are used alternately to
dispose used AssayTips and AssayCups.
Loaded in the front part of the instrument.
Product registration on instrument
Press the flashing button on the magazine
waste compartment.
Replacement frequency
Depends on the number of tests done by the
laboratory. Each solid waste container holds
up to 8 magazines of tips and cups.
Product labeling
No method sheet available for this product.
Onboard stability
Not applicable.
Pack size
Set of 4 Wasteliners.
Legal manufacturer
Roche Diagnostics GmbH
e Wasteliner M is a single-use consumable intended to be used
as an IVD accessory for the cobas e 601 and cobas e 602.
Wasteliner M
Global: 03023150001
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Accessories » Disposable Elecsys®
Compatible instruments
cobas e 601, cobas e 602
Location for use
The operator loads new magazines in the
front part of the instrument.
Product registration on instrument
Registered by the system automatically.
Replacement frequency
It depends on the amount of tests done
by the laboratory. The instrument holds a
maximum of 12 magazines, which represents
a maximum of 1,008 tests.
Product labeling
No method sheet available for this product.
Onboard stability
Not applicable.
Pack size
1 box contains 48 magazines (8 × 6) with
84 tips and 84 cups. 8 (2 × 4) solid waste
boxes are also included (Wasteliner M).
Legal manufacturer
Roche Diagnostics GmbH
e AssayTip / AssayCup is a single-use consumable intended
to be used as an IVD accessory for each patient test, calibration
and QC.
AssayTip / AssayCup
Global: 12102137001
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Roche cobas 8000 / ISE Module User guide

Type
User guide

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