Roche cobas vivoDx User guide

Brand: Roche

Model: cobas vivoDx

Type: User guide

Roche cobas vivoDx is a cutting-edge platform for detecting viable live bacteria in patient samples. With its user-friendly interface, the system guides you through creating test orders, preparing test cartridges, loading samples, and interpreting results. The system offers automated processing, providing reliable and rapid results.

cobas

vivoDx System

Quick Reference Guide

Publication version 1.0

Software version 1.0

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.

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.

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.

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

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

Roche Diagnostics

cobas

vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0

Roche Diagnostics

cobas

vivoDx System · Software version 1.0 · Quick Reference Guide · Publication version 1.0

Table of contents

About the cobas

vivoDx System ...................................

Quick reference: Routine workflow................................. 9

List of system status ............................................................. 11

List of status indicators on the instrument................... 12

About the tablet dashboard............................................... 13

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

A Instrument C Barcode reader

B Tablet D Label printer

wThe cobas

vivoDx System

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.

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.

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.

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

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.

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.

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.

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.

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

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)

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)

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 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

wDashboard on the tablet

Status of racks and their positions

The tablet dashboard displays the current statuses of

racks and all their positions.

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.

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)

Published by:

Roche Diagnostics International Ltd

CH-6343 Rotkreuz

Switzerland

www.roche.com

Roche cobas vivoDx User guide

Roche cobas vivoDx User guide

Roche cobas vivoDx User guide

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