Roche cobas vivoDx User guide

Type
User guide
cobas
®
vivoDx System
User Guide
Publication version 1.1
Software version 1.0
2
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Publication information
Publication version Software version Revision date Change description
1.0 1.0 November 2018 First version
1.1 1.0 February 2019 Procedures to clean and to decontaminate the system updated,
list of maintenance intervals updated, and minor updates.
u What is new in publication version 1.1 (12)
y Revision history
Edition notice
This publication is intended for users of the cobas
®
vivoDx System.
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.
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 accessible
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.
Images
The screenshots and hardware images in this publication
have been added exclusively for illustration purposes.
Configurable and variable data in screenshots, 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.
3
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
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
© 2018–2019, F. Hoffmann-La Roche Ltd. All rights
reserved.
License information
The cobas
®
vivoDx Software is protected by contract
law, copyright law, and international treaties. The
cobas
®
vivoDx Software 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
cobas
®
vivoDx System 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 the cobas
®
vivoDx System, refer to
the electronic distribution included with this product.
This open-source and commercial software and the
cobas
®
vivoDx System as a whole can constitute a
device regulated in accordance with applicable law. For
more detailed information, refer to the corresponding
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 the cobas
®
vivoDx
System.
Trademarks
The following trademarks are acknowledged:
COBAS and LIFE NEEDS ANSWERS are trademarks of
Roche.
All other trademarks are the property of their respective
owners.
4
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
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 such feedback.
Approvals
The cobas
®
vivoDx System 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.
Complies with 21 CFR 1040.10 and 1040.11 except for
deviations pursuant to Laser Notice No. 50, dated June
24, 2007.
Compliance with the applicable directives 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.
'Laboratory Equipment' is the product identifier as
shown on the name plate.
5
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Contact addresses
Distributed in the United States by:
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
USA
Roche Molecular Systems, Inc.
1080 US Highway 202 South
Branchburg, NJ 08876
USA
Made in USA
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
6
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
7Table of contents
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Table of contents
Publication information 2
Contact addresses 5
Intended use 9
Symbols and abbreviations 9
What is new in publication version 1.1 12
Safety
1 Safety information
Safety classifications 17
Safety precautions 18
Safety labels on the system 20
Safety information for lasers 23
Safety information for disposal 24
System description
2 Overview of the system
About the cobas
®
vivoDx System
29
Overview of the instrument 30
Overview of the user interface 34
Reagents and consumables 35
List of system specifications 37
3 User Assistance
Overview of the User Assistance 41
Accessing the User Assistance from the
instrument software 42
Operation
4 Routine operation
Overview of routine tasks 49
Frequently performed tasks 55
Before routine operation 58
During routine operation 61
After routine operation 75
Non-routine operation 80
5 Maintenance
List of maintenance intervals 91
Cleaning the system 92
Decontaminating the system 93
Label printer maintenance 95
6 Configuration
User management 99
Selecting default printers 104
Editing the lab name and address 106
Configuring test result options 107
7 Troubleshooting
Viewing test cartridge errors in racks 111
Exporting support data 112
Taking a screenshot 114
No communication between instrument and
tablet 115
Issues scanning barcode on reagent cap 119
Barcode reader not responding 120
Test cartridge not processed 121
Keyboard not responding 122
Printer not responding 123
Removing a test cartridge from inside the
instrument 124
Glossary
Index
8
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
9
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Intended use
The cobas
®
vivoDx System supports an automated
workflow incorporating Smarticles technology for the
rapid detection, identification, and/or determination of
antimicrobial susceptibility of viable (live) bacteria,
directly for clinical specimens, positive cultures, or
clinical isolates, as applied in laboratories and other
healthcare settings. The cobas
®
vivoDx System
combines the functionalities of instrumentation,
consumables, reagents, and data management to provide
an efficient workflow from sample processing to result
interpretation. The system adds assay-specific Smarticles
bioparticles to human specimens, or samples prepared
from positive cultures or clinical isolates, and then
detects the presence or absence of specific organisms
and, if antibiotics are added to the assay, can determine
the antimicrobial susceptibility phenotype of the target
organism(s) in the sample.
Intended use statements for tests on the cobas
®
vivoDx
System are located within the Instructions for Use for
respective tests run on the system.
Symbols and abbreviations
Product names
Except where the context clearly indicates otherwise, the
following product names and descriptors are used.
Product name Descriptor
cobas
®
vivoDx System
system
cobas
®
vivoDx Instrument
instrument
cobas
®
vivoDx Software
software
y Product names
Symbols used in the publication
Symbol Explanation
o
List item.
u
Related topics containing further information.
r
Start of a task.
q
Tip. Extra information on correct use or useful
hints.
y Symbols used in the publication
10
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Symbol Explanation
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.
Home tab in the User Assistance.
Search tab in the User Assistance.
Table of contents tab in the User Assistance.
History tab in the User Assistance to show
previously viewed topics.
Favorites. Used in the User Assistance on the
favorites tab and on the content panel.
Enlarge. Button used on images.
y Symbols used in the publication
Symbols used on product
Symbol Explanation
Global Trade Item Number
Catalog number
Serial number
Indicates that the equipment is suitable for
alternating current only; to identify relevant
terminals.
y Symbols used on product
11
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Symbol Explanation
Manufacturer
Authorized representative in the EC
Date of manufacture
Caution
Quantity contained in the package
Quantity contained in the package
Product order
Complies with the directive 2011/65/EU on
RoHS
y Symbols used on product
Abbreviations
The following abbreviations are used:
Abbreviation Definition
ANSI American National Standards Institute
EC European Community
EN European standard
IEC International Electrotechnical Commission
ISO International Organization for
Standardization
IVD In vitro diagnostic
LAN Local Area Network
LIS Laboratory information system
p.a. pro analysi, analytically pure
UL Underwriters Laboratories Inc.
USB Universal Serial Bus
WEEE Waste Electrical and Electronic Equipment
y Abbreviations
12
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
What is new in publication version 1.1
Maintenance intervals
The following maintenance intervals have been updated:
Mention to preventive maintenance added.
Daily maintenance removed.
Interval of decontamination procedure changed from
every 6 months to as required.
u List of maintenance intervals (91)
Cleaning the system
Removed steps to clean racks.
u Cleaning the system (92)
Decontaminating the system
The requirement to decontaminate the system every 6
months has been removed.
It is not required to use a new swab for each rack
position.
After cleaning the interior of rack positions, it is not
needed to wipe them.
u Decontaminating the system (93)
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Safety
1 Safety information.........................................................................................15
15
Table of contents
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Safety information
In this chapter
1
Safety classifications............................................................. 17
Safety precautions................................................................. 18
Safety labels on the system................................................ 20
List of safety labels on the system ....................... 20
Location of safety labels on the system ............. 21
Safety information for lasers.............................................. 23
Safety information for disposal......................................... 24
1 Safety information
16
Table of contents
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
1 Safety information
17Safety information
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Safety classifications
The safety precautions and important user notes are
classified according to the ANSIZ535.6-2011 standard.
Familiarize yourself with the following meanings and
icons:
Safety alert
r The safety alert symbol is used to alert you to
potential physical injury hazards. Obey all safety
messages that follow this symbol to avoid possible
damage to the system, injury, or death.
These symbols and signal words are used for specific
hazards:
WARNING!
Warning...
r ...indicates a hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION!
Caution...
r ...indicates a hazardous situation which, if not
avoided, could result in minor or moderate injury.
NOTICE!
Notice...
r ...indicates a hazardous situation that, if not avoided,
may result in damage to the system.
Important information that is not safety relevant is
indicated with the following icon:
i
Tip...
...indicates additional information on correct use
or useful tips.
1 Safety information
18 Safety precautions
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Safety precautions
CAUTION!
Power interruption
A power failure or momentary drop in voltage may
damage the system or lead to data loss.
r It is recommended to use an uninterruptible power
supply (UPS).
r Ensure regular maintenance of the UPS.
CAUTION!
Data loss or unavailability of the system due to
malicious software or unauthorized system access
Malicious software or unauthorized system access can
result in data loss or system unavailability.
To avoid infection by malicious software or the
unauthorized access and misuse of the system, the
following recommendations are essential:
r Make sure other computers and services on the
network (for example, the LIS, archiving share,
backup share, or service) are properly secured and
protected against malicious software and
unauthorized access.
r The Roche-provided firewall is mandatory if the
system is connected to the network.
r Restrict physical access to the system and all
attached IT infrastructure (computer, cables, network
equipment, and so on).
r Check all external storage devices, like USB flash
drives, with an antivirus scanner (on another
computer) to ensure that they are free of malicious
software, before using them on the system.
r Allow only internet access to trusted web sites and
web services.
1 Safety information
19Safety information
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
NOTICE!
Unauthorized use of the system
Data security is breached if unauthorized users have
access to your user name and password.
r Always enter your password unobserved.
r Do not write down your password.
r Never write down the password in a contact form, in
an address book or in a file on the computer.
r Do not disclose your password to anyone. Roche
never asks you for your password.
r If you ever disclose your password to anyone, change
it immediately after.
r Change your password regularly.
r If you think anyone else has access to your account,
contact your Roche Service representative
immediately.
1 Safety information
20 Safety labels on the system
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · User Guide · Publication version 1.1
Safety labels on the system
List of safety labels on the system
Warning labels are placed on the system to draw your
attention to areas of potential hazard. Listed below are
labels and the definitions according to the location on
the system.
The safety labels on the system comply with the following
standards: ANSI Z535, IEC 61010-1, IEC 60417, ISO 7000,
or ISO 15223-1.
In addition to the safety labels on the system, there are
safety notes in the corresponding parts of the user
documentation.
i
Only Roche service personnel are authorized to
replace damaged labels. For replacement labels,
contact your local Roche representative.
Laser transmitter
There is a danger of contact with laser light or severe
damage to the eyes.
Do not stare into the laser transmitter.
Biohazard
Potentially biohazardous materials are used near this
label.
Observe relevant good laboratory practices on safe
usage.
The safety messages give more detailed information
about potentially hazardous situations that may arise
during daily operation, or when carrying out maintenance
actions.
When working with the system, observe both the safety
labels on the system and the safety messages in the user
documentation.
1 Safety information
  • Page 1 1
  • Page 2 2
  • Page 3 3
  • Page 4 4
  • Page 5 5
  • Page 6 6
  • Page 7 7
  • Page 8 8
  • Page 9 9
  • Page 10 10
  • Page 11 11
  • Page 12 12
  • Page 13 13
  • Page 14 14
  • Page 15 15
  • Page 16 16
  • Page 17 17
  • Page 18 18
  • Page 19 19
  • Page 20 20
  • Page 21 21
  • Page 22 22
  • Page 23 23
  • Page 24 24
  • Page 25 25
  • Page 26 26
  • Page 27 27
  • Page 28 28
  • Page 29 29
  • Page 30 30
  • Page 31 31
  • Page 32 32
  • Page 33 33
  • Page 34 34
  • Page 35 35
  • Page 36 36
  • Page 37 37
  • Page 38 38
  • Page 39 39
  • Page 40 40
  • Page 41 41
  • Page 42 42
  • Page 43 43
  • Page 44 44
  • Page 45 45
  • Page 46 46
  • Page 47 47
  • Page 48 48
  • Page 49 49
  • Page 50 50
  • Page 51 51
  • Page 52 52
  • Page 53 53
  • Page 54 54
  • Page 55 55
  • Page 56 56
  • Page 57 57
  • Page 58 58
  • Page 59 59
  • Page 60 60
  • Page 61 61
  • Page 62 62
  • Page 63 63
  • Page 64 64
  • Page 65 65
  • Page 66 66
  • Page 67 67
  • Page 68 68
  • Page 69 69
  • Page 70 70
  • Page 71 71
  • Page 72 72
  • Page 73 73
  • Page 74 74
  • Page 75 75
  • Page 76 76
  • Page 77 77
  • Page 78 78
  • Page 79 79
  • Page 80 80
  • Page 81 81
  • Page 82 82
  • Page 83 83
  • Page 84 84
  • Page 85 85
  • Page 86 86
  • Page 87 87
  • Page 88 88
  • Page 89 89
  • Page 90 90
  • Page 91 91
  • Page 92 92
  • Page 93 93
  • Page 94 94
  • Page 95 95
  • Page 96 96
  • Page 97 97
  • Page 98 98
  • Page 99 99
  • Page 100 100
  • Page 101 101
  • Page 102 102
  • Page 103 103
  • Page 104 104
  • Page 105 105
  • Page 106 106
  • Page 107 107
  • Page 108 108
  • Page 109 109
  • Page 110 110
  • Page 111 111
  • Page 112 112
  • Page 113 113
  • Page 114 114
  • Page 115 115
  • Page 116 116
  • Page 117 117
  • Page 118 118
  • Page 119 119
  • Page 120 120
  • Page 121 121
  • Page 122 122
  • Page 123 123
  • Page 124 124
  • Page 125 125
  • Page 126 126
  • Page 127 127
  • Page 128 128
  • Page 129 129
  • Page 130 130
  • Page 131 131
  • Page 132 132
  • Page 133 133
  • Page 134 134

Roche cobas vivoDx User guide

Type
User guide

Ask a question and I''ll find the answer in the document

Finding information in a document is now easier with AI