Roche cobas t 711 User guide

Type
User guide
cobas t 711 coagulation analyzer
User Guide Version 2.1
Software version 2.0.2
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
2
Publication information
Edition notice This publication is intended for operators of the
cobas t 711 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.
The User Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow.
!
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.
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 Completely 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"
Update for cobas t development channel cassette handling
y Revision history
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
3
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 © 2017-2019, F. Hoffmann-La Roche Ltd. All rights
reserved.
License information The software of the cobas t 711 coagulation analyzer is
protected by contract law, copyright law, and
international treaties. The cobas t 711 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 711 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 711 coagulation analyzer refer to the electronic
distribution included with this product.
This open source and commercial software and
cobas t 711 coagulation analyzer as a whole can
constitute a device regulated in accordance with
applicable law.
Please note that the respective authorization is no longer
valid according to the corresponding legislation should
any unauthorized changes be made to cobas t 711
coagulation analyzer.
Trademarks The following trademarks are acknowledged:
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
4
COBAS, COBAS T, 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 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 711 coagulation analyzer 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 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 provisions of the applicable EU
directives.
Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.
Issued by CSA Group for Canada and the US.
CUS
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
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Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
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Table of contents 7
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
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 2.1 14
What is new in publication version 2.0 14
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 45
Starting up the system 46
Checking supplies and waste 49
System alarm concept 55
8 Overview of operation
Overview of the main workflow 63
About test order prioritization 65
Overview of the software 66
9 Reagents and consumables
Reagents 81
Reagent handling 86
Other resources 113
10 Calibration
About calibration 131
Calibration panels 143
Calibration on the system 155
11 Quality control
About QCs 187
Loading and unloading QCs 191
List of actions 193
About general QC order behavior 194
QC panels 195
Managing a QC lot 200
Ordering a routine QC 201
Ordering a preparation QC 202
Ordering a study QC 204
Canceling a QC order 205
Reviewing a QC 206
Setting QC target ranges 208
12 Test orders and rack handling
Test orders 213
Rack handling 223
13 Samples and results
List of actions 233
Samples and results panels 234
Handling results 241
Creating and printing a report 243
Printing a cumulative QC report 246
Factor parallelism result handling 248
Quick reference: Factor parallelism result
handling 253
14 After operation
Checklist: After operation 257
Stopping the system 258
Performing a system restart/reinitialization 263
Shutting down the system 265
Shutting down the analyzer for an extended
period 266
15 Maintenance
About maintenance 271
Maintenance actions 272
Additional maintenance 279
Cleaning and decontamination 283
Appendix
16 Specification
List of system specifications 293
Supported material 295
17 Glossary
Index 303
8 Table of contents
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
9
Intended use
The cobas t 711 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 711 coagulation analyzer is a standalone
instrument and can also be connected to laboratory
automation systems.
Intended use for IVD accessories and software
The Intended use of accessories and software might be
not always limited to the cobas t 711 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 8mm 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.
Localisation bundle Software language packages for the cobas t 711
coagulation analyzer and cobas t 511 coagulation
analyzer.
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
10
Intended users
The intended users of the cobas t 711 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 & QC (Quality Control)
• Maintenance of instrument and related inventories
Supervisor Responsibilities:
• Reviewing & 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:
Symbols used in the publication
Product name Descriptor
Instrument Software for
cobas t 711 coagulation
analyzer
software
cobas t 711 coagulation
analyzer
analyzer
System Cleaner cobas t System Cleaner
cobas Waste Bag solid waste bag
Cuvette COBAS INTEGRA
®
cuvette
cobas t development
channel
development channel
cobas t development
channel cassettes & labels
DC cassettes
cobas t development
channel vials
DC vials
y Product names
Symbol Explanation
o List item.
u Related topics containing further information.
q
Tip. Extra information on correct use or useful
hints.
y Symbols used in the publication
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
11
Symbols used on product
r Start of a task.
I Extra information within a task.
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.
Symbol Explanation
y Symbols used in the publication
Symbol Explanation
Global Trade Item Number
Quantity contained in the package.
Indicates that the equipment is suitable for
alternating current only; to identify relevant
terminals.
Serial number
Catalog number
Manufacturer
Date of manufacture
y Symbols used on the instrument
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
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Abbreviations The following abbreviations are used.
Caution
Humidity range
Temperature limits
This side up
Fragile, handle with care
Keep dry
Keep away from sunlight
Do not stack
Do not use blades to open.
Symbol Explanation
y Symbols used on the instrument
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
13
Abbreviation Definition
ANSI American National Standards
Institute
CISPR Comité International Spécial des
Perturbations Radioélectriques
(International Special Committee
on Radio Interference)
CSA Canadian Standards Association
EC European Community
EMC Electromagnetic compatibility
EN European standard
EU European Union
ID Identification
IEC International Electrical
Commission
IfU Instructions for Use
IVD In vitro diagnostic
n/a Not applicable
RVC Reagent volume check
STAT Short turnaround time
UI User interface
UL Underwriters Laboratories Inc.
UPS Uninterruptible power supply
y Abbreviations
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
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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 (131)
QC Update of the chapter for version 2.0:
u About QCs (187)
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
System description
5 Overview of the system ........................................................................................ 17
6 Overview of the hardware................................................................................... 23
5 Overview of the system
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
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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
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
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Table of contents
5 Overview of the system
Roche Diagnostics
cobas t 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
About the system 19
About the system
The cobas t 711 coagulation analyzer is a fully
automated, high throughput system for coagulation tests.
The analyzer is designed for a large array of 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 loading area slots for placing different types
of racks, and the sample balcony for handling rack trays. From
the slots and sample balcony, 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 711 coagulation analyzer · Software version 2.0.2 · User Guide · Version 2.1
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 711 User guide

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User guide

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