Roche cobas 8000 / ISE Module User manual

Category
Measuring, testing & control
Type
User manual
cobas
®
8000 modular analyzer
series
Operator’s Manual – Version 5.2
Software Version 06-05
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
2
Publication information
Publication
version
Software version Revision date Change description
1.0 01–01 2009-06 First version
2.0 02–01 2010-01 e 602 module added
3.0 03–01 2010-10 c 702 module added
4.0 04–01 2013-04 General update including, by way of example:
o New software features such as review of calibrator status,
PT link, rack unloading, change rack priority, reagent
cassette masking
o Revised software features such as download of
applications, calibrators, and QC material
o Hitergent was replaced by EcoTergent
4.0.1 04–01 2013-05 Manual cleaning revised
4.0.2 04–01 2013-06 Cleaning of pipetter probes revised
4.1 04–02 2013-11 o Changed ISE measuring ranges
o Use of different sample tubes on a rack
o Other changes and corrections
4.2 05–01 2014-10 New software features added
u What is new in publication version 4.2? (18)
5.0 06–02 2016-05 Publication redesigned according to the new Roche
documentation concept.
e 801 module added.
u What is new in publication version 5.0? (17)
5.1 06–03 2016-10 o Inclusion of information on the ISE support box
o Inclusion of the addendum "Cleaning rack trays"
o New section about fluorinated greenhouse gas
o Updated cobas link information
o Minor changes throughout the document
u What is new in publication version 5.1? (16)
5.2 06–05 2017-12 o Inclusion of the addendum "Sample foam detection"
o Inclusion of the addendum 1.0 to Operator’s Manual
version 5.1 (specifications of radio equipment)
o Minor changes throughout the document
u What is new in publication version 5.2? (16)
y Revision history
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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Edition notice This publication is intended for operators of the
cobas
®
8000 modular analyzer series.
The cobas
®
8000 modular analyzer series is composed of
2 main components:
• The instrument includes the analytical modules, the
control unit, and other core components.
• The cobas
®
8000 data manager consists of a PC
which coordinates data in real time between the
instrument and the host.
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.
Where to find information The Online Help contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• A software reference
• Configuration information
• Background information
The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
instrument.
The Quick Reference Guide provides you with an
overview of pre-routine and routine tasks on the data
manager and instrument.
The Operator’s Manual focuses on routine operation
and maintenance. The chapters are organized according
to the normal operation workflow.
A separate Operator’s Manual is available for the
cobas
®
8000 data manager.
The PC manufacturer’s manual contains all information
about the control unit hardware.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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!
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the system 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 instrument in a way that is not
described in this publication.
r Store all publications in a safe and easily retrievable
place.
Training Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
Screenshots The screenshots in this publication have been added
exclusively for illustration purposes. Configurable and
variable data, such as tests, results, or path names visible
therein must not be used for laboratory purposes.
Warranty Any customer modification to the system renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative or perform such updates with their
assistance.
Copyright © 2007–2017, Roche Diagnostics GmbH.
All rights reserved.
License information
cobas
®
8000 modular analyzer series software is
protected by contract law, copyright law, and
international treaties. cobas
®
8000 modular analyzer
series contains a user license between F. Hoffmann-La
Roche Ltd. and a license holder, and only authorized
users may access the software and use it. Unauthorized
use and distribution may result in civil and criminal
penalties.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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License agreement for UltraVNC software and
Linux Kernel
UltraVNC and Linux Kernel are pieces of free software for
all commercial uses, which are installed on the control
unit PC.
You can redistribute the software and/or modify it under
the terms of the GNU General Public License (version 2 or
later), as published by the Free Software Foundation. A
copy of the GNU General Public License (version 2) is
stored on the control unit PC. The path for the license is
C:\Program Files\uvnc bvba\UltraVNC.
The software is distributed without warranty. There is no
implied warranty of merchantability or fitness for a
particular purpose. For more information, see the GNU
General Public License at http://www.gnu.org/licenses.
The source code for the software is stored on the control
unit PC. The path for the source code is
C:\DriversAndTools\UltraVNC.
Open Source and Commercial Software
cobas
®
8000 modular analyzer series may include
components or modules of commercial or open-source
software. For further information on the intellectual
property and other warnings, as well as licenses
pertaining to the software programs included in
cobas
®
8000 modular analyzer series, refer to the
electronic distribution included with this product.
This open source and commercial software and
cobas
®
8000 modular analyzer series as a whole can
constitute a device regulated in accordance with
applicable law. For more detailed information, refer to the
user documentation and labeling.
Note that the respective authorization is no longer valid
according to the corresponding legislation should any
unauthorized changes be made to cobas
®
8000 modular
analyzer series.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS C, COBAS E, COBAS INTEGRA, 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 purpose. 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.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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Approvals
The cobas
®
8000 modular analyzer series 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 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.
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.
Compliance is provided by means of the Declaration of
Conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the IVD directive 98/79/EC on in vitro
diagnostic medical devices
Issued by Intertek for Canada and the US.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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Instrument approvals Furthermore, the instrument is manufactured and tested
according to the following international safety standards:
• IEC 61010-1
• IEC 61010-2-081 and A1
• IEC 61010-2-101
• UL 61010-1
• CAN/CSA C22.2 No. 61010-1
• CAN/CSA C22.2 No. 61010-2-101
• CAN/CSA C22.2 No. 61010-2-081
The instrument complies with the emission and immunity
requirements described in standard IEC 61326-2-
6/EN 61326-2-6.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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Contact addresses
Inside the European Union and
EFTA member states
Outside the European Union and
EFTA member states
Manufacturer of the
instrument
Hitachi High-Technologies
Corporation
1-24-14 Nishi-Shimbashi
Minato-ku Tokyo 105-8717
Japan
Manufacturer of
cobas
®
8000 data
manager
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
Authorized
representative
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
Manufactured by: Hitachi High-Technologies
Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Table of contents 9
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
Table of contents
Publication information 2
Contact addresses 8
Table of contents 9
Intended use 13
Symbols and abbreviations 13
What is new in publication version 5.2? 16
What is new in publication version 5.1? 16
What is new in publication version 5.0? 17
What is new in publication version 4.2? 18
Operation
1 Overview of the system
About the system 25
About the data manager 28
About the control unit 29
About the core components 31
About the cobas
®
ISE module 42
About the cobas c 701 module 55
About the cobas c 702 module 70
About the cobas c 502 module 89
About the cobas e 801 module 105
About the cobas e 602 module 126
2 Overview of operation
Overview of the user interface 145
Using the help system 158
Overview of cobas
®
link 165
3 Before operation
Quick reference: Main workflow 177
Starting the instrument 181
Troubleshooting system alarms 201
Preparing the instrument for operation 202
Measuring samples 217
4 Reagents
About reagent statuses 225
Working with reagent masking 228
Reagents of the ISE module 232
Reagents of the c 701 module 242
Reagents of the c 702 module 256
Reagents of the c 502 module 280
Reagents and consumables of the e 801 module
295
Reagents and consumables on the e 602 module
346
5 Calibration
Calibration 369
Calibrating tests on the ISE and cobas c modules
388
Calibrating tests on the cobas e modules 392
6 Quality control
About quality control (QC) 403
About QC types 405
Performing routine QC 407
Performing QC for standby reagents 409
Performing timeout QC 411
Performing QC after calibration 413
Performing manual QC 415
Checking QC results 417
Deactivating tests for QC material 419
Assigning non-barcoded QC material to rack
positions 420
Unloading auto QC racks from the auto QC
compartment 422
7 Orders and results
About sample processing 427
About data distribution 428
About barcode and non-barcode mode 430
Switching between barcode and non-barcode
mode 432
About the Rack Reception mode 434
Ordering tests 435
Working with barcodes 444
Loading samples 447
Processing samples 458
Working with sample results 466
Processing rerun tests 480
Unloading samples manually 485
About the Calibration Review submenu 486
8 After operation
Performing manual finalization on cobas e
modules 491
Performing data backup and archiving 494
Preparing the instrument for powering off 506
Powering off the instrument 507
9 Special operation
Overview of masking functions 529
Operating with a pre-analytical system 532
Operating the instrument in backup operating
mode 535
10 Table of contents
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
Maintenance
10 Overview of maintenance
Maintenance definitions 545
About performing maintenance 547
About modes for maintenance 548
About maintenance pipes and maintenance pipe
functions 560
Checking maintenance due time 569
Checking maintenance status 570
Requesting the maintenance report 571
List of maintenance actions 574
List of maintenance checks 579
List of maintenance schedules for all modules 582
List of cleaning solutions 585
List of spare parts and replacement intervals 586
List of maintenance videos 588
11 Maintenance of the core unit and the MSBs
List of maintenance actions on the core unit and the
MSBs 591
Daily maintenance of the core unit and the MSBs
592
Monthly maintenance of the core unit and the
MSBs 594
Maintenance as required on the core unit and the
MSBs 599
12 Maintenance of the ISE module
List of maintenance actions on the ISE module 607
Daily maintenance of the ISE module 609
Weekly maintenance of the ISE module 619
Monthly maintenance of the ISE module 622
Every 2 months maintenance of the ISE module
629
Quarterly maintenance of the ISE module 635
Every 6 months maintenance of the ISE module
641
Maintenance as required on the ISE module 645
13 Maintenance of the c 701 and c 702 modules
List of maintenance actions on the c 701 and c 702
modules 665
Daily maintenance of the c 701 and c 702 modules
667
Weekly maintenance of the c 701 and c 702
modules 676
Monthly maintenance of the c 701 and c 702
modules 688
Quarterly maintenance of the c 701 and c 702
modules 705
Every 6 months maintenance of the c 701 and c 702
modules 710
Maintenance as required on the c 701 and c 702
modules 716
14 Maintenance of the c 502 module
List of maintenance actions on the c 502 module
745
Daily maintenance of the c 502 module 747
Weekly maintenance of the c 502 module 755
Monthly maintenance of the c 502 module 762
Quarterly maintenance of the c 502 module 781
Every 6 months maintenance of the c 502 module
785
Maintenance as required on the c 502 module 791
15 Maintenance of the e 801 module
List of maintenance actions on the e 801 module
799
Daily maintenance of the e 801 module 801
Every 2 weeks maintenance of the e 801 module
806
Maintenance as required on the e 801 module 829
16 Maintenance of the e 602 module
List of maintenance actions on the e 602 module
853
Daily maintenance of the e 602 module 854
Weekly maintenance of the e 602 module 858
Every 2 weeks maintenance of the e 602 module
875
Quarterly maintenance of the e 602 module 879
Maintenance as required on the e 602 module 885
Appendix
17 Specifications
General specifications 903
Specifications of the control unit 910
Specifications of the core components 911
Specifications of the ISE module 913
Specifications of the cobas c modules 915
Specifications of the cobas e modules 918
List of available accessories and consumables 921
Specifications of barcodes 932
18 Glossary
Index 941
Table of contents 11
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
12 Table of contents
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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Intended use
The cobas
®
8000 modular analyzer series is a fully
automated random-access software-controlled system
for immunoassays and photometric analysis intended for
qualitative and quantitative in vitro determinations using a
wide variety of tests.
The cobas
®
8000 modular analyzer series is an in vitro
diagnostic (IVD) medical equipment.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Symbols used in the publication
Product name Descriptor
cobas
®
8000 modular analyzer
series
System
cobas
®
8000 data manager
Data manager
cobas
®
ISE module
ISE module
cobas c 702 module c 702 module
cobas c 701 module c 701 module
cobas c 502 module c 502 module
cobas e 801 module e 801 module
cobas e 602 module e 602 module
cobas c pack reagent cassette
cobas e pack reagent cassette
cobas e pack green reagent cassette
cobas e flow cobas e flow test
Self-Contained ISE Support Box ISE support box
Sample Cup standard cup
Micro-Sample Cup micro cup
Sarstedt micro tube cryo cup
AssayTip/AssayCup tray magazine
WasteLiner solid waste box
y Product names
Symbol Explanation
o List item
u Related topics containing further information
q
Tip. Extra information on correct use or useful
hints
r Start of a task
I Extra information within a task
y Symbols used in the publication
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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Symbols used on products
Abbreviations The following abbreviations are used:
f Result of an action within a task
c Frequency of a task
n Duration of a task
d Materials that are required for a task
j Prerequisites of a task
u Topic. Used in cross-references to topics
p Task. Used in cross-references to tasks
w
Figure. Used in figure titles and cross-
references to figures
y
Table. Used in table titles and cross-references
to tables
z
Equation. Used in cross-references to
equations
Symbol Explanation
y Symbols used in the publication
Symbol Explanation
Global Trade Item Number
Quantity contained in the package
Quantity contained in the package
Orientation of the package during
transportation
Complies with the directive 2011/65/EU on
RoHS
y Symbols used on products
Abbreviation Definition
ACN Application Code Number
ANSI American National Standards Institute
CleanCell (CC) Wash solution for measuring cells after
measurement
y Abbreviations
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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CellCln1 Basic reaction cell wash solution
(NaOH-D)
CellCln2 Acid reaction cell wash solution
CFAS Calibrator for automated systems
(C.f.a.s.)
CSV Comma-separated values
CV Coefficient of variation
DIL ISE Diluent
EC European Community
ECL Electrochemiluminescence
ECO-D EcoTergent, additive to the incubation
bath to reduce surface tension
EFTA European Free Trade Association
EN European standard
ICVC Initial cassette volume check
IEC International Electrical Commission
IS ISE Internal Standard
ISE Ion-selective electrode
ISE COMP ISE Standard High, used as calibrator 3
ISE HIGH ISE Standard High, used as calibrator 2
ISE LOW ISE Standard Low, used as calibrator 1
IVD In vitro diagnostic
LED Light-emitting diode
LIS Laboratory information system
LLD Liquid level detection
MSB Module sample buffer
n/a Not applicable
NACL NaCl solution, used as diluent
NaOHD Wash solution for reagent probes and
reaction cells (D1)
ProCell (PC) Signal generating buffer for the ECL
detection
QC Quality control
RCM Reaction calculation mode
REF ISE Reference Electrolyte solution
RFID Radio-frequency identification
SCCS Additive to prevent reaction cell
carryover in long HbA1c batches (D3)
SD Standard deviation
SmpCln1 Basic sample probe wash solution
SmpCln2 Acid sample probe wash solution
SMS Wash solution for reagent probes and
reaction cells (D2)
STAT Short turn-around time
SysClean ISE Cleaning Solution/Elecsys SysClean
WEEE Waste Electrical and Electronic
Equipment
Abbreviation Definition
y Abbreviations
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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What is new in publication version 5.2?
This section provides an overview of all major changes in
this publication and the software.
Sample foam detection This document contains a revision/addition to the
following sections:
This revision was necessary due to the activation of the
sample foam detection with camera for the e 801 module.
u Specifications of the sampling system of cobas e
modules (919)
Specifications of radio equipment The c 701, c 702, and e 801 modules contain RFID
readers.
u Specifications of radio equipment (906)
What is new in publication version 5.1?
This section provides an overview of all major changes in
this publication and the software.
ISE support box The ISE support box is used in conjunction with the
ISE module and is available for the cobas
®
8000 modular
analyzer series without a c 702 module or c 701 module
in the configuration.
u The Self-Contained ISE Support Box (54)
Cleaning rack trays The cleaning procedure for rack trays has been added.
u Cleaning the rack tray (601)
Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the
hermetically sealed refrigeration.
u Fluorinated greenhouse gas (906)
Update of cobas
®
link information
Update of the cobas
®
link chapter.
u Overview of cobas
®
link (165)
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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What is new in publication version 5.0?
This section provides an overview of all major changes in
this publication and the software.
New layout and structure Resulting from customer feedback, we have updated the
layout and the structure of this publication to help you
find information easier and perform tasks quicker.
cobas e flow (e 801 module) cobas e flow is a feature of the data manager and the
e 801 module. cobas e flow tests are a pre-defined
combination of conventional immunology tests.
cobas e flow tests can be ordered from the data
manager and the host. They are managed via the data
manager. The involved immunology tests are performed
automatically on the e 801 module.
u About cobas e flow tests on the e 801 module (296)
Multi-application tests (e 801 module) Multi-application tests use the same reagent cassette,
but with different measurement protocols from different
applications.
Up to 4 applications can be part of 1 multi-application
test. The different applications have individual application
code numbers. Multi-application tests are pre-defined in
the application file.
Unlike cobas e flow tests, multi-application tests can be
ordered manually on the control unit or automatically by
the host.
u About multi-application tests on the e 801
module (304)
Quick Start Mode (e 801 module) When you enable the quick start mode, the instrument
can start a run in approximately 6:30 minutes instead of
about 12 minutes. Some steps, such as the reagent prime,
are only performed once when the instrument is powered
on, not during preparation for a run. You need
administrator access rights to enable the quick start
mode.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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What is new in publication version 4.2?
This section provides an overview of all major changes in
this publication and software version 05-01.
This version requires Windows 7 on the control unit,
Windows XP is not supported.
Mixing sample types and container types on a
rack
You can consolidate different sample types and container
types on a single rack. Sample consolidation can be
useful, for example, if the instrument is connected with a
CLAS. The CLAS can use the same rack range for pre-
processing of different samples types.
On the Standard tab of the Rack Assignment dialog
box, you must define a rack range for the sample type
None to consolidate samples. The information about the
sample type and in some cases also the information
about the container type is sent via HL7 protocol to the
control unit.
u About mixing different sample types on a rack (452)
Reagent registration by maintenance pipe You can include registration of reagents in a
maintenance pipe. Then new reagents are registered on
c 701/c 702 modules and the maintenance action
inventory update is performed on e 602 modules.
If you execute a maintenance pipe with this option, you
do not need to register new reagents manually. After
returning from manual cleaning mode, the required
reagent registration can be executed by a maintenance
pipe. If the reagent registration was already performed
before, it is skipped in the maintenance pipe.
u Creating a maintenance pipe (561)
Overwriting editable parameters when
updating an application
When you download an updated application from the
data manager, you can now choose between the
Overwrite option and the Partial Overwrite option:
• To download the application with all new settings,
choose the Overwrite option.
• To keep the settings of all editable application
settings, choose Partial Overwrite option.
In previous software versions, editable application
settings were not updated when you downloaded an
updated application from the data manager.
New ISE calibration scheme ISE Standard High is also used as compensator (S3).
u About calibration methods for ISE tests (372)
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cobas® 8000 modular analyzer series · Software Version 06-05 · Operator’s Manual · 5.2
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Further changes and improvements • By limiting the number of racks on the instrument via
the new Rack Delivery dialog box, the turnaround
time of racks is improved.
• Integration of ISE data alarms: If an ISE.N or ISE.E data
alarm occurs, it is attached to all ISE test results for
this sample.
• For ISE calibrations, the software now uses separate
compensated limit checks for slope and calibrator S3
concentration.
• The user rights for downloading application settings,
calibrator data, QC material data, and special wash
data are reorganized.
u For links to the associated topics, refer to the Online
Help.
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Roche cobas 8000 / ISE Module User manual

Category
Measuring, testing & control
Type
User manual

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