cobas
®
vivoDx System
Quick Reference Guide
Publication version 1.0
Software version 1.0
2
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
Publication information
Publication version Software version Revision date Change description
1.0 1.0 November 2018 First version
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.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
3
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
Always leave software updates to a Roche Service
representative, or perform such updates with their
assistance.
Copyright
© 2018, 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.
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.
4
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
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.
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
5
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
6
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
7
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
Table of contents
About the cobas
®
vivoDx System ...................................
8
Quick reference: Routine workflow................................. 9
List of system status ............................................................. 11
List of status indicators on the instrument................... 12
About the tablet dashboard............................................... 13
8
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
About the cobas
®
vivoDx System
The cobas
®
vivoDx System is a platform intended for the
detection of viable live bacteria in patient samples.
The system consists of a benchtop instrument connected
to an external tablet and a barcode reader. The tablet is
used with a docking station and a wireless keyboard. The
standard workflow also includes a label printer to identify
test cartridges and primary tubes.
Each sample is tested in a test cartridge, consisting of a
test tube with reagent bead and a reagent cap that
contains the Smarticles and other reagents necessary to
perform the test.
A C
B
D
A Instrument C Barcode reader
B Tablet D Label printer
wThe cobas
®
vivoDx System
9
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
Quick reference: Routine workflow
In the following table, the main workflows are
summarized.
For detailed information, refer to the corresponding tasks
described in the user documentation and in the test-
specific Instructions for Use.
i
When operating the system, always follow
laboratory best practices and all safety guidelines
included in the user documentation.
Steps User action
1 Start up the system and log
on.
1. On the rear panel of the instrument, turn the
power switch to "1".
2. On the left side of the tablet, press the power
button.
3. Log on to the system.
2 Create a negative and a
positive control test order at
the interval indicated by the
test-specific Instructions for
Use.
1. On the Current and recent tests work area,
choose the New button, and then the Control
tab.
2. From the Test and Control type drop-down
lists, choose the appropriate options.
3. Scan the barcode on the reagent cap.
4. Choose the Save button.
3 Identify the control media
tube, the reagent cap, and the
test tube.
1. From the label printer, get the labels that are
printed automatically.
2. Attach the printed labels to the tubes and to
the reagent cap.
i
Ensure that the labels are completely
adhered to the surface. All edges of the
labels must be completely flat.
4 Prepare a negative and a
positive control test cartridge
for the control test orders.
i
Check the Instructions for
Use of the corresponding
control for other test-
specific steps.
1. Follow the test-specific Instructions for Use to
prepare and transfer the sample from the
control media tube to the test tube.
2. Check that the labels on the reagent cap and
on the test tube match.
3. Screw the reagent cap on the test tube and
tighten it.
y Routine workflow
10
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
Steps User action
5 Create a sample test order for
each patient sample.
i
If your system is connected
to a LIS, when you enter the
sample ID, the relevant
fields are filled out
automatically.
1. On the Current and recent tests work area,
choose the New button.
2. On the Patient tab, enter the required sample
and patient information.
3. Scan the barcode on the reagent cap.
4. Choose the Save button.
6 Identify the primary tube, the
reagent cap, and the test tube.
1. From the label printer, get the labels that are
printed automatically.
2. Attach the labels to the tubes and to the
reagent cap.
i
Ensure that the labels are completely
adhered to the surface. All edges of the
labels must be completely flat.
7 Prepare a sample test
cartridge for each patient
sample.
i
Check the Instructions for
Use of the corresponding
control for other test-
specific steps.
1. Follow the test-specific Instructions for Use to
transfer the collected sample from the primary
tube to the test tube.
2. Check that the labels on the reagent cap and
on the test tube match.
3. Screw the reagent cap on the test tube and
tighten it.
8 Load the test cartridges onto
the system.
1. Remove a rack from an input rack slot.
2. Insert the test cartridges in a rack position.
If you are loading control test cartridges,
insert the positive and negative control test
cartridges in adjacent rack positions.
3. Insert the rack into an available input rack
slot.
9 Release test results.
i
Check the Instructions for
Use of the corresponding
test for detailed information
about test results.
1. Wait until sample processing is complete.
2. In the Unreleased results work area, select
the test whose result you want to release.
3. To accept the result, choose the Accept
results button.
4. To invalidate the result, choose the Invalidate
results button.
5. If your system is connected to a LIS, the test
result is sent to the LIS.
10 Unload the test cartridges.
1. Remove the output rack completely.
2. Dispose of the test cartridges from the rack
into a biohazardous safety container.
3. Insert the rack again into an available output
rack slot.
y Routine workflow
11
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
List of system status
You can view the status of the system on the tablet
dashboard.
Name Description
Standby
Status after inactivity time is exceeded.
Running
Instrument running.
Offline
Instrument disconnected from the tablet,
probably due to the network cable being
unplugged.
Stopping Status after choosing the Stop command in an
emergency, tests are aborted. A fault condition
can also stop the instrument.
Stopped
Status after an emergency stop, tests being
processed cannot be recovered. A fault
condition can also stop the instrument.
Paused
Status after a critical error occurs, interrupted
tests can still be completed.
Resuming Status after choosing the Resume command,
testing continues.
Starting up
Status after turning on the system or choosing
the Restart command (only available from
Stopped status).
Shutting
down
Status while the system is shutting down.
Shutdown
Instrument shut down.
Fault
Status after a critical error occurs and a restart
of the system is necessary. If the system is not
working after restarting, contact your Roche
Service representative.
y List of system status
u Related topics
• List of status indicators on the instrument (12)
12
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
List of status indicators on the instrument
On the front panel of the instrument, you can find several
status indicators for the instrument and the racks. The
dashboard on the tablet also displays these statuses.
A B
A Rack status
indicators
B Instrument status
indicators
Light Description
Green Rack unlocked
White Rack locked
Blinking yellow Cartridge error, rack unlocked
Blue Output rack full, rack unlocked
Off Instrument shutdown
y List of rack status indicators (A)
Blinking
green
Off Instrument starting up,
resuming, or shutting down
Green Off Instrument running
Yellow Off Instrument with a non-critical
error
Blinking
yellow
Off Instrument paused due to a
critical error
Off Off
Instrument in Shutdown status
Off Slow blinking
red
Instrument in Stopping status
Off Blinking red
Instrument in Stopped status
y List of instrument status indicators (B)
u Related topics
• List of system status (11)
• About the tablet dashboard (13)
13
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
About the tablet dashboard
When you start the system, a dashboard with an
overview of the instrument status is displayed.
A
B
C
F
E
D
O
I
G
L
K
M
N
J
H
A Access to information about the system I Button to create screenshots
B Access to User Assistance J Lab name as configured in the System
configuration work area
C Serial number K Access to the Current and recent tests work area
D System power button L Status of racks (like the instrument status indicators
on the instrument) and of each rack position
E Icon indicating if the instrument cover is locked M Access to Reports work area
F Overview of samples on board N Access to configuration options
G Button to log on or log off O Instrument status, corresponding to the instrument
status indicators on the instrument
H Shutdown button
wDashboard on the tablet
Status of racks and their positions
The tablet dashboard displays the current statuses of
racks and all their positions.
i
The instrument performs a series of QC checks
for each test cartridge (e.g., reagents dispensed
in the correct moment, proper incubation times
and temperatures, and so on). If the test cartridge
does not pass the QC check, the test result is
Failed.
14
Roche Diagnostics
cobas
®
vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0
A CB
A Status of racks C Status of output rack
positions
B Status of input rack
position
Color Description
Green Rack unlocked
White Rack locked
Blinking yellow Cartridge error, rack unlocked
Blue Output rack full, rack unlocked
Gray Instrument shutdown
y List of rack statuses (A)
Color Description
Green Valid test cartridge in the position.
White Empty position.
Gray Scanning barcode.
Yellow Valid test cartridge in that position adjacent to a
position with a test cartridge that is incorrectly
placed.
Red Test cartridge with invalid or unreadable barcode
or incorrectly placed in the position.
y List of input rack position statuses (B)
Color Description
White Empty position.
Gray Scanning barcode.
Orange Test cartridge in that position passed QC check
and has a test result.
Red Test cartridge in that position failed QC check and
has no result (failed test).
y List of output rack position statuses (C)
u Related topics
• List of system status (11)
• List of status indicators on the instrument (12)
© 2018, F. Hoffmann-La Roche Ltd.
Published by:
Roche Diagnostics International Ltd
CH-6343 Rotkreuz
Switzerland
www.roche.com
/