Roche cobas pro sample supply unit User guide

cobas pro sample supply unit
Roche
Brand
Roche
Model
cobas pro sample supply unit
Type
User guide

This manual is also suitable for

cobas
®
pro integrated solutions
<ISE | c503 | e801>
User Guide
Publication version 2.1
Software version 01-04
2
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Publication information
Publication version Software version Revision date Change description
1 01-01 2018-09 First version
1.1 01-02 2019-03 Numerous minor additions and improvements
2.0 01-03 2019-07 New software features added
Minor corrections
u What is new in publication version 2.0 (15)
2.1 01-04 2019-12 Minor corrections and additions
u What is new in publication version 2.1 (14)
y Revision history
Edition notice
This publication is intended for operators of cobaspro
integrated solutions.
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
• Configuration information
• Background information, for example, about analytical
principles
The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
system.
The User Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow.
The Quick Reference Guide gives a brief introduction
to important routine tasks and daily maintenance.
The cobas
®
e‑library provides access to important
updates, Method Sheets, Value Sheets, and other
important documents from Roche.
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
The PC manufacturer’s manual contains all information
about the control unit hardware.
Privacy notice
User Assistance is also available online on the internet.
You can use it independently from the instrument on
computers or mobile devices with a current HTML5
browser. To obtain the appropriate links and usage
information, contact your Roche representative.
When you use User Assistance online, viewing events
(topics viewed and searches performed) and IP
addresses are logged.
The data collected is for Roche internal use only and is
never forwarded to third parties. It is anonymized, and
after one year it is automatically deleted.
Viewing events are analyzed to improve User Assistance
content and search functionality. IP addresses are used
to classify regional behavior.
The online User Assistance offers additional features
compared to the one on the system, such as printing,
downloading PDFs, and saving favorites.
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 system 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.
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Copyright
© 2018–2020, Roche Diagnostics GmbH.
All rights reserved.
License information
cobaspro integrated solutions is protected by contract
law, copyright laws, and international treaties. cobaspro
integrated solutions is licensed for use between Roche
Diagnostics GmbH and a licensee, and only authorized
users there under are permitted to access and use the
software. Unauthorized use and distribution may result in
civil and criminal penalties.
License agreement for UltraVNC software
UltraVNC is a piece of free software for all commercial
uses, which is 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pro integrated solutions might contain
components or systems that are open source or
commercial software. For copyright and other notices
and licensing information regarding such software
programs included with cobaspro integrated solutions
please see the following license notifications and
licenses.
The product and cobaspro integrated solutions as a
whole may form a regulated device in accordance with
the applicable laws – please refer to the User Guide and
the labeling for details. Please note that the respective
authorization in accordance with the applicable laws
lapse in case of any unauthorized changes to cobaspro
integrated solutions.
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Trademarks
cobas
®
pro is a trademark and the cobas
®
pro logo is a
trademark of Roche.
Other product names and 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 Service
representative, should you have any such feedback.
Approvals
cobaspro integrated solutions 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.
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.
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
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Roche Diagnostics
cobas
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pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Issued by Intertek for Canada and the US.
Instrument approvals
Furthermore, the instrument is manufactured and tested
according to the following international safety standards:
• IEC 61010-1
• IEC 61010-2-101
The instrument complies with the emission and immunity
requirements described in standard IEC61326-2-6/
EN61326-2-6.
Contact addresses
Inside 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
Authorized
representative
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Outside the European Union and
EFTA member states
Manufactured by: Hitachi High-Technologies
Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Distributed in USA by: Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana, USA
7Table of contents
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Table of contents
Publication information 2
Contact addresses 6
Intended use (intended purpose) 10
Symbols and abbreviations 10
What is new in publication version 2.1 14
What is new in publication version 2.0 15
Safety
1 Safety information
Safety classifications 23
Safety precautions 24
Warning messages 31
Caution messages 40
Notices 42
Product safety labels 43
Safety information for barcode readers 59
Safety interlock 62
Safety information for disposal 65
System overview
2 Overview of the system
About the system 71
Overview of laboratory IT setup 73
About racks and sample containers 78
Sample handling 87
Barcodes on samples 93
3 Overview of the instrument
About the control unit 101
About the sample supply unit 103
About the sample buffer 109
About the ISE analytical unit 111
About the c503 analytical unit
123
About the e801 analytical unit
138
About rack flow 158
About rack priority 163
Optional components 167
4 Overview of the user interface
About the screen areas 171
About the user interface 179
About the status colors 180
Navigating in the user interface 181
About the Alarm dialog box 182
Printing reports 184
List of symbols on reports 186
Taking a screenshot 187
List of system modes 188
About Rack Reception mode 190
Finding help 192
About the User Assistance 194
Searching for QC Value Sheets on the e-
library 205
5 Overview of reagents and consumables
About reagents and consumables– ISE and
c503
211
About reagents and consumables– e801
216
Quick reference: Reagents and consumables
- ISE 221
Quick reference: Reagents and consumables
– c503
224
Quick reference: Reagents and consumables
– e801
228
6 Specifications
Specifications – system 233
Specifications – control unit 238
Specifications – sample supply unit and
sample buffer 240
Specifications – ISE 242
Specifications – c503
244
Specifications – e801
247
Operation
7 Before operation
Logging on to the system 255
Checking for system alarms 256
About pre-routine 257
Updating software components 258
Replacing reagents and consumables 259
Downloading required parameters 283
Performing recommended maintenance 285
Performing calibration and QC 287
Quick reference: Pre-routine workflow 294
Quick reference: Replacing reagents 297
8 During operation
Running patient samples 303
Prioritizing a sample 317
Checking test results 318
Unloading a sample ahead of schedule 323
Unloading racks from the sample supply unit 324
Loading reagents during operation 326
Manually masking and unmasking reagents,
tests, and analytical units 329
Performing calibration 334
Performing QC 340
Quick reference: Running patient samples 344
Quick reference: Checking test results 346
Quick reference: Performing calibration 347
Quick reference: Performing QC 349
9 After operation
About stopping the system 353
8 Table of contents
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Stopping operation 354
Stopping operation after the current run 355
Logging off from the system 356
Quick reference: Post-routine workflow 357
10 Non-routine operation
Orders and results 365
Reagent management 389
Calibration 412
QC 440
Powering the system on or off 456
Saving and backing up data 473
Overview of masking functions 486
Working with a lab automation system 491
Guidance for blood donation screening–
e801
494
Maintenance
11 Overview of maintenance
Maintenance definitions 503
About self-operating maintenance 505
Moving internal sample data to storage
media 509
About system modes for maintenance 510
Canceling maintenance actions 515
About maintenance pipes and maintenance
pipe functions 516
Creating a maintenance type 522
Checking the maintenance due time 525
Checking the maintenance status 526
Creating a maintenance report 527
List of software maintenance actions 529
List of cleaning solutions 537
List of spare parts and replacement intervals 538
List of maintenance videos 539
Identifying the installed software version 541
12 Maintenance actions
List of maintenance intervals 547
Maintenance logs 549
Daily maintenance 554
Weekly maintenance 559
Every 2weeks maintenance 561
Monthly maintenance 586
Every 3months maintenance 605
Maintenance as required 611
Troubleshooting
13 Introduction to troubleshooting
General troubleshooting information 679
About data alarms and system alarms 681
Data problems without alarm 682
Problems loading reagent packs 686
Troubleshooting liquid level sensor alarms 692
14 Data alarms
List of data alarms 697
Data alarms for tests 701
Calibration data alarms 739
QC data alarms 751
List of data alarms that generate an
automatic rerun test 755
Configuration
15 System settings
Adding a user 763
List of access rights 765
Rack ranges 771
Test keys and test profiles 780
Reagent warning levels 784
Configuring filters for results 787
About non-24/7 operation 788
Setting up a host 789
16 Application-related settings
Setting up a test 793
Setting up special washes 814
Downloading special reagents, diluents, and
wash solutions 818
Updating an application 820
Deleting an application 824
Analytical principles
17 Measurement technology
About ISE technology 829
About photometric technology 834
About the ECL technology 839
18 Test principles
About test principles - ISE 849
About photometric test principles - c503
851
About sample index principles 867
Overview of immunology principles - e801
871
About limit of detection and limit of
quantitation 878
19 Calibration principles
About calibration of ISE tests 881
About calibration of photometric tests 885
Calibration of immunology tests 912
20 Rules for attaching data alarms
About data alarm rules for photometric tests 923
Index
Glossary
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Intended use (intended purpose)
cobaspro integrated solutions is an in-vitro diagnostic
(IVD) device used for the quantitation of clinical
chemistry, immunochemistry and ion-selective electrolyte
parameters from various biological fluids.
Intended users
The cobaspro integrated solutions is intended to be
used by trained laboratory technicians.
Target customers
Target customers of cobaspro integrated solutions are
commercial and public clinical laboratories.
The use of the e801 analytical unit in blood donation
screening was confirmed according to the IVD Directive
98/79/EC. Outside the EU and EFTA countries, consider
the respective local registration.
Symbols and abbreviations
Product names
Except where the context clearly indicates otherwise, the
following product names and descriptors are used.
Product name Descriptor
cobas
®
pro integrated solutions
system
cobas
®
pro sample supply unit
sample supply unit
cobaspro ISE analytical unit
ISE analytical unit
cobasc503 analytical unit c503 analytical unit
cobase801 analytical unit e801 analytical unit
SBL-TL-c503 transport line
SBL-DL-e801 drive line
cobascpack green
reagent pack
cobasepack green
reagent pack
cobaseflow cobaseflow test
SonicWash sonic wash station
cobas
®
e‑library
e-library
cobas
®
e‑services
electronic services
cobas
®
link cobaslink
Sample Cup standard cup
Micro-Sample Cup micro cup
Roche Standard False Bottom
Tube
false bottom tube
y Product names
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Product name Descriptor
Sarstedt False Bottom Tube Sarstedt false bottom tube
Sarstedt S-Monovette K2 EDTA Sarstedt S-Monovette tube
Sarstedt Micro Tube micro tube
AssayTip tip
AssayCup cup
AssayTip/AssayCup tray tip and cup tray
WasteLiner solid waste box
y Product names
Symbols used in the publication
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
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)
Status indicator is on
Status indicator is flashing
Status indicator is off
Home tab: View the home screen of the User
Assistance
y Symbols used in the publication
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Symbol Explanation
Search tab: Find matching topics in the User
Assistance
System explorer tab: Navigate visually through
the system
Interactive help tab: Use the guided, interactive
help to resolve specific problems
Maintenance tab: Perform maintenance
actions
History tab: Show previously viewed topics
again
Favorites tab: Select topics that have been
added to the favorites list
Zoom button: Enlarge images and videos in the
User Assistance
Play button: Play videos in the User Assistance
y Symbols used in the publication
Symbols used on products
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
Serial number
Date of manufacture
y Symbols used on products
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Abbreviations
The following abbreviations are used:
Abbreviation Definition
Abs. Absorbance units
ACN Application code number
ANSI American National Standards Institute
AU Analytical unit
AUX Auxiliary (system reagents and
consumables)
CDC Closed Development Channel
CFAS Calibrator for automated systems (also
C.f.a.s.)
CSV Comma-separated values
CV Coefficient of variation
DIL ISE Diluent
DL Drive line
EC European Community
ECL Electrochemiluminescence
Eco-D EcoTergent, additive to the incubation
bath water
EFTA European Free Trade Association
EN European standard
EU European Union
FBT False bottom tube
IEC International Electrical Commission
IS ISE Internal Standard solution
ISE Ion-selective electrode
ISEhigh ISEStandardHigh, used as calibrator2
ISElow ISEStandardLow, used as calibrator1
ISES3 ISE standard, used as calibrator3
according to ISE package insert
IVD In-vitro diagnostic
LAS Laboratory automation system
LED Light emitting diode
LIS Laboratory information system
LLD Liquid level detection
n/a Not applicable
MC Measuring cell
NACL NaCl solution, used as diluent
NaOHD Wash solution for reagent probes and
reaction cells (D1)
OBS Onboard stability
PC Personal computer
QC Quality control
y Abbreviations
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Abbreviation Definition
RCM Reaction calculation mode
RE Reference electrode
REF ISE Reference Electrolyte solution
RFID Radio-frequency identification
RP Reagent pack
SB Sample buffer
SCCS Special Cell Cleaning Solution
SD Standard deviation
SMS Selective Mode Solution, a wash
solution for reagent probes and reaction
cells (D2)
SOM Self-operating maintenance
SSU Sample supply unit
STAT Short turnaround time
SW Software
SysClean ISE Cleaning Solution/SysClean
TL Transport line
WEEE Waste Electrical and Electronic
Equipment
y Abbreviations
u Related topics
• Overview of the User Assistance (194)
What is new in publication version 2.1
The software version 01-04 provides a bugfix regarding
2data alarms.
Data alarms
In software 01-04, the implementation of the following
data alarms has been revised:
• Calc.? (Calculation of result not possible)
• Samp.? (ABS maximum over (non-linear curve))
u Calc.? (705)
u Samp.? (730)
New topic in this publication
The following topic has been added:
u About the protection of personal data and software
security (27)
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Changes in this publication
In addition to numerous minor corrections and
improvements, mainly the following topics have been
revised since the last publication:
u Setting up the Calib. Now settings (433)
u Viewing QC target values and QC ranges (445)
u List of data alarms that generate an automatic rerun
test (755)
u Adding a user (763)
What is new in publication version 2.0
The software version 01-03 comprises many new
software features and improvements.
The following sections list the main improvements per
software area:
Routine work area
• The masking symbols on the Order Tests tab are
consolidated.
• When you select a sample, the software displays the
estimated sample processing time.
• The Test Result Details dialog box displays the date
and time when the sipper flow paths have been
washed the last time.
• The Test Result Details dialog box displays when a
copy QC is used for a test.
• The Test Result Details dialog box is available for
results backed up on a storage medium.
Sample Status work area
• The estimated sample processing time is displayed on
the Sample Tracking and Rack Monitor tabs.
Reagents work area
• If you selected a reagent pack for unloading, it is
displayed in blue on Reagents > Overview until it is
unloaded from the system.
• The onboard stability of the ISE Reference Electrolyte
bottle is displayed on the Overview and Status tabs.
• The diluent used for an e801 test is displayed on
Reagents > Overview > Details.
• If wash rack maintenance is overdue, ISE electrodes
are masked and indicated in gray on Reagents
indicator.
• The Prime Flow Paths button was removed because
the system primes the flow paths automatically.
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
• For e801 system reagents, you can set up a purple
and a yellow alarm. In addition to the user-defined
settings, the system issues a yellow alarm when the
first bottle is half empty and a red alarm when the
second bottle is empty.
Calibration work area
• On Calibration > Results, absorbance values and
additional dates and times are displayed to provide
more details.
QC work area
• The QC Chart dialog box has been improved.
• The software guides you through the installation of
QC material by the Edit QC dialog box. The QC
ranges are editable from 3 SD to 2.5, 2, 1.5 or 1SD.
• You can select standard containers or one of the 3
false bottom tube types for each QC material on QC
> Installation > Edit QC.
• If you use lab-specific QC target values or QC ranges,
the values are highlighted on QC > Installation.
Menu > System
• Administrators can register USB flash drives for use
at the system.
• Host connection: You can either select a predefined
IP address and port or enter them manually.
The system periodically sends information about the
instrument status and reagent status to the host. The
host takes this information into account when
sending test orders to connected instruments.
Overview button
The Overview button at the right side turns blue when
user interaction is required (identical to interactive
maintenance), i.e. to unmask an analytical unit.
Maintenance dialog box
• After replacing an ISE electrode, the system performs
the required ISE check automatically.
• After replacing a sample probe, the software guides
you through 2 necessary maintenance checks.
• The maintenance action SW Files Check displays
the installed software version directly, i.e. without
having to start the maintenance action.
• The Alarm Log report logs the date and time when
the ISE wash rack was performed the last time.
• The Alarm Log report also logs maintenance actions
performed by self-operating maintenance.
• The system issues a pre-warning (yellow alarm)
700tests before the e801 sipper flow paths must be
washed so that you can schedule this maintenance.
• To protect personal data, the maintenance action 27
Generate Log-Files does not store any personal
data in the log file for the technical support.
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Roche Diagnostics
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®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Start Conditions dialog box
Operator level access is sufficient to view the rack ranges
assigned for sample types and container types.
Further improvements
• False bottom tubes can now be used for QC material.
• The dead volume for whole blood samples in Sarstedt
FBTs was reduced to 300µL.
• The Parameter Download dialog box displays only
parameters for download that are relevant for the
respective system.
• Operation at altitudes 2000-3000m above sea level is
possible on request.
New topics in this publication
The following topics have been added since the last
publication:
u Finding a suitable rack ID for a container type and
sample type (370)
u Identifying the diluent used for certain tests – e801
(410)
u Identifying the installed software version (541)
u Registering USB flash drives (483)
u Guidance for blood donation screening– e801 (494)
u Setting up a host (789)
u Setting up special washes (814)
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1
Safety
1 Safety information.........................................................................................21
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Roche cobas pro sample supply unit User guide

cobas pro sample supply unit
Roche
Brand
Roche
Model
cobas pro sample supply unit
Type
User guide
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