Roche cobas t 511 User guide

Type
User guide
cobas t 511 coagulation analyzer
User Guide version 4.0
Software version 2.1.1
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
2
Publication information
Edition notice This publication is intended for operators of the
cobas t 511 coagulation analyzer.
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 User Assistance 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.
Publication version Software version Revision date Change description
1.0 1.0 March 2017 Initial version
1.1 1.0 July 2017 Updated safety messages
2.0 2.0 August 2018 Revised for software 2.0
Update safety labels on the sample area and
on the fluid tray
2.1 2.0.2 March 2019 Update for maintenance action "Cleaning
probe assembly"
3.0 2.1 August 2019 New work area implemented - Sample and
results
New QC initial run type settings
New illustration concept
4.0 2.1.1 September 2020 IVDR Compliance to the Regulation (EU)
2017/746
Backup system procedure
New safety messages
Handling tubes
Maintenance videos
y Revision history
Roche Diagnostics
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The User Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow.
The Quick Reference Guide focuses on routine
operation. The Quick Reference Guide is organized
according to the normal operation workflow. It provides
information in a concentrated version. For more detailed
information, refer to the User Guide or the User
Assistance.
!
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.
!
Incident reporting
r Inform your Roche representative and your local
competent authority about any serious incidents
which may occur when using this product.
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 © 2017–2020, F. Hoffmann-La Roche Ltd. All rights
reserved.
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
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License information The software of the cobas t 511 coagulation analyzer is
protected by contract law, copyright law, and
international treaties. The cobas t 511 coagulation
analyzer 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.
Open Source and Commercial Software The cobas t 511 coagulation analyzer 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 t 511 coagulation analyzer refer to the electronic
distribution included with this product.
This open source and commercial software and
cobas t 511 coagulation analyzer as a whole can
constitute a device regulated in accordance with
applicable law.
Note that the respective authorization is no longer valid
according to the corresponding legislation should any
unauthorized changes be made to cobas t 511
coagulation analyzer.
Trademarks The following trademarks are acknowledged:
COBAS and COBAS T are trademarks of Roche.
All other trademarks are the property of their respective
owners.
Feedback Every effort has been made to ensure that this publication
fulfills the intended use. All feedback on any aspect of
this publication is welcome and is considered during
updates. Contact your Roche representative, should you
have any feedback.
Approvals The cobas t 511 coagulation analyzer meets the
requirements laid down in:
Regulation (EU) 2017/746 of the European Parliament and
of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU.
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.
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
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The following marks demonstrate compliance:
Contact addresses
Roche affiliates A list of all Roche affiliates can be found at:
www.roche.com/about/business/roche_worldwide.htm
eLabDoc Electronic user documentation can be downloaded using
the eLabDoc e-service on Roche DiaLog:
www.dialog.roche.com
For more information, contact your local affiliate or Roche
Service representative.
For in vitro diagnostic use.
Complies with the provisions of the applicable EU
regulations.
Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.
Issued by CSA Group for Canada and the US.
CUS
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
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Table of contents 7
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
Table of contents
Publication information 2
Contact addresses 5
Table of contents 7
Intended use 9
Intended use for IVD accessories and
software 9
Intended users 10
Symbols and abbreviations 10
What is new in publication version 4.0 12
What is new in publication version 3.0 13
What is new in publication version 2.1 13
What is new in publication version 2.0 13
System description
5 Overview of the system
About the system 19
About the measuring principle 20
About the measurement technology 21
6 Overview of the hardware
Hardware description 25
System operation
7 Before operation
Checklist: Before operation 43
Starting up the system 44
Checking supplies and waste 47
System alarm concept 53
About tube handling 60
8 Overview of operation
Overview of the main workflow 65
About test order prioritization 67
Overview of the software 68
9 Reagents and consumables
Reagents 83
Reagent handling 88
Other resources 114
10 Calibration
About calibration 133
Calibration panels 145
Calibration on the system 158
11 Quality control
About QCs 195
Loading and unloading QCs 199
List of actions 202
About general QC order behavior 203
QC panels 204
Managing a QC lot 211
Ordering a routine QC 212
Ordering a preparation QC 213
Ordering a study QC 215
Canceling a QC order 216
Reviewing a QC 217
Setting QC target ranges 219
Printing a cumulative QC report 221
12 Test orders and rack handling
Test orders 225
Rack handling 236
13 Samples and results
List of actions 245
Samples and results tab 246
Handling results 264
Creating and printing a report 267
Factor parallelism result handling 269
Quick reference: Factor parallelism result
handling 276
14 After operation
Checklist: After operation 279
Stopping the system 280
Performing a system restart/reinitialization 284
Shutting down the system 285
Shutting down the analyzer for an extended
period 286
15 Maintenance
About maintenance 291
Maintenance actions 292
Additional maintenance 300
Cleaning and decontamination 304
Appendix
16 Specification
List of system specifications 311
Supported material 314
17 Glossary
Index 323
8 Table of contents
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
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Intended use
The cobas t 511 coagulation analyzer is a fully
automated, discrete coagulation analyzer intended for the
in-vitro qualitative and quantitative determination of
coagulation analytes in human citrated plasma, the
results of which aid in the diagnosis of coagulation
abnormalities and in monitoring anticoagulant therapy.
The cobas t 511 coagulation analyzer is a standalone
instrument.
Intended use for IVD accessories and software
The Intended use of accessories and software might be
not always limited to the cobas t 511 coagulation
analyzer.
Conductive sample racks Conductive sample racks are intended to be used to
handle different sample types on the cobas t 711
coagulation analyzer and cobas t 511 coagulation
analyzer.
Dependent on the sample types, different racks are
available indicated by a specific color:
• Gray for routine runs (Sample Rack COAG)
• Black for calibrator runs (Calibrator Rack COAG)
• White for Quality Control runs (QC Rack COAG)
• Green for routine runs with cup on tubes (Cup on tube
rack COAG)
Insert Sarstedt 8 mm Tube Rack insert to handle small volume sample tubes on the
cobas t 711 coagulation analyzer and cobas t 511
coagulation analyzer.
Instrument SW Instrument software for the cobas t 711 coagulation
analyzer and cobas t 511 coagulation analyzer.
Control unit Image Image software for the control unit of the cobas t 711
coagulation analyzer and cobas t 511 coagulation
analyzer.
Language Pack Installer Software language packages for the cobas t 711
coagulation analyzer and cobas t 511 coagulation
analyzer.
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
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Intended users
The intended users of the cobas t 511 coagulation
analyzer are appropriately trained coagulation
professionals operating the system in a laboratory setting.
Routine operator Primary tasks:
• Running system(s) on a daily basis
• Processing routine and emergency patient samples
• Running calibration and QC (Quality Control)
• Maintenance of instrument and related inventories
Supervisor Responsibilities:
• Validating results on system or via LIS
• Reviewing and validating QC results
• Ensuring accreditation compliance
• Interface with clinicians in case of result query
• Monitor performance efficiency of systems
• Configuration of system
Symbols and abbreviations
Product names Except where the context clearly indicates otherwise, the
following product names and abbreviations are used:
Abbreviations The following abbreviations are used.
Product name Descriptor
Instrument Software for
cobas t 511 coagulation
analyzer
software
cobas t 511 coagulation
analyzer
analyzer
System Cleaner cobas t System Cleaner
y Product names
Abbreviation Definition
ANSI American National Standards
Institute
CFR Code of Federal Regulations
CISPR Comité International Spécial des
Perturbations Radioélectriques
(International Special Committee
on Radio Interference)
FCC Federal Communications
Commission
IEC International Electrotechnical
Commission
y Abbreviations
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
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ISO International Organization for
Standardization
IVD In vitro diagnostic
IVDR In vitro diagnostics regulation
SOP Standard Operating Procedure
Abbreviation Definition
y Abbreviations
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What is new in publication version 4.0
IVDR Compliance to the new European IVD Regulation (EU)
2017/746
Backup system The backup system procedure is updated.
New safety message Safety message about forwarding results implemented.
u Handling results (264)
Safety message about extended measuring time
implemented.
u About extended measuring time (229)
Delayed results due to computational resources
depletion.
u Overview of the main workflow (65)
Tube handling How to attach barcode labels on tubes and how to place
tubes on 5-position racks.
u About tube handling (60)
Maintenance videos New maintenance videos implemented to support the
following actions:
• How to prepare a maintenance cassette
• How to fill the water container
• How to empty the liquid waste container
• How to empty the solid waste container
• How to replace the System Cleaner bottle
• How to recover from a cuvette jam
u See:
Preparing a maintenance cassette (86)
Filling water (116)
Emptying liquid waste (120)
Emptying solid waste (123)
Replacing the System Cleaner bottle (126)
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What is new in publication version 3.0
New safety message Safety message about sharp edges implemented.
Sample and results tab New sample and results tab implemented. Better
playback of routine-relevant data and procedures.
u See:
Samples and results tab (246)
About the Samples and results - split screen with
Sample details: panel (255)
You can customize the sample and results tab according
to your laboratory needs.
QC initial run type Provide initial run type options for each application/QC
material combination.
KABE sample tube The system supports the following KABE sample tubes:
• Primavette S (2.9 mL)
• Kabevette G (3.5 mL)
u List of supported tube types (314)
Data alarm New data alarm for test results using the extended
measuring time.
Time to standby The system provides a time to standby estimation which
reflects the latest time to result completion.
u About the global information area (69)
Illustration concept For a better readability and guidance screenshots are
replaced by illustrations.
What is new in publication version 2.1
Maintenance action update The maintenance action "Cleaning probe assembly" was
simplified.
What is new in publication version 2.0
Calibration Complete rework of the chapter for version 2.0:
u About calibration (133)
QC Update of the chapter for version 2.0:
u About QCs (195)
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
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Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
System description
5 Overview of the system ........................................................................................ 17
6 Overview of the hardware................................................................................... 23
5 Overview of the system
Roche Diagnostics
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Table of contents
Overview of the system 5
In this chapter
5
About the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
About the measuring principle . . . . . . . . . . . . . . . . . . . 20
About the measurement technology . . . . . . . . . . . . . . 21
5 Overview of the system
Roche Diagnostics
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Table of contents
5 Overview of the system
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
About the system 19
About the system
The cobas t 511 coagulation analyzer is a fully
automated, medium throughput system for coagulation
tests. The analyzer is designed for a large array of
qualitative and quantitative in vitro tests and can be
operated 24 hours a day, 7 days a week.
The analyzer consists of the following components:
Component Function
Analyzer unit Contains the incubators and photometers, used for making
measurements; also contains the cuvette handlers, which
move the cuvettes for pipetting, mixing, and measuring.
Control unit Controls the analyzer functions
Cuvette transport unit Transports the cuvettes from the cuvette reservoir to the
analyzer unit.
Fluid unit Manages the system fluids: Water, liquid waste, System
Cleaner, samples, and reagents.
Reagent storage Refrigerates and stores the reagent cassettes.
Sampling unit Includes the rack area slots for placing different types of racks.
From the slots, racks are moved to the barcode reader for
scanning and are then moved to the rack area.
Transfer unit Pipettes samples, reagents, and other fluids from their
containers into cuvettes for mixing so that measurements can
be performed.
y Components of the analyzer
5 Overview of the system
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0
20 About the measuring principle
About the measuring principle
The analyzer performs optical measurements for clotting
tests, chromogenic tests, and immunoturbidimetric tests.
The analyzer performs the following tasks:
• Sample and reagents are pipetted into a cuvette and
incubated to ensure that all reaction components are
at the correct temperature.
• The reaction is started by adding a start reagent.
• The photometer measures turbidity or color change
for the respective test.
Clotting test
Plasma is mixed with a reagent or reagents, resulting in
the formation of a fibrin clot that increases the turbidity of
the mixture. The clotting time is calculated based on the
change in turbidity.
Chromogenic test
Plasma is mixed with reagent containing a chromogenic
substrate for a specific enzyme. The activation of the
enzyme results in cleavage of the chromogenic substrate
and a product changing the color of the reaction mixture
is formed. This change of absorbance is measured and
calculated per unit of time.
Immunoturbidimetric test
Plasma is mixed with reagent containing latex particles
coated with antibodies for a specific analyte. The latex
particles form complexes with the analyte, resulting in a
change of turbidity of the reaction mixture. This change is
then measured.
-9.548 30.453 70.45350.453
1.089
1.076
1.064
1.051
1.039
1.027
1.014
1.002
Clotting time
Seconds after reaction
Absorbance
Clotting time
-7.657 12.343 32.343 52.343 92.343 112.34372.343
0.030
0.078
0.126
0.173
0.221
0.268
0.316
0.363
Time
abs.
Seconds after reaction
Absorbance
Time
abs.
-26.975 23.025 73.025 123.025 223.025 273.025173.025
1.335
1.342
1.350
1.358
1.365
1.373
1.381
1.388
Time
abs.
323.025
Seconds after reaction
Absorbance
Time
abs.
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Roche cobas t 511 User guide

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