Bosch Vivalytic User manual

Instructions for use

© Bosch Healthcare Solutions GmbH 1Instructions for use
How to set up the analyser
1
Unpack.
2
Place on a flat
surface.
3
Connect to a power
source.
4
Switch on.
How to perform a test
1
Scan sample code.
2
Scan cartridge code.
3
Insert the sample and
close cartridge lid.
4
Insert cartridge. The test
starts automatically.
How to exchange the air filter
1
Shutdown, turn off
and unplug.
2
Turn over.
3
Remove used air filter.
4
Insert new air filter.
Carefully read instructions for use
The user must consult and follow the instructions for use before using Vivalytic.

© Bosch Healthcare Solutions GmbH2Instructions for use
Overview of functional parts
Analyser front Analyser back Analyser bottom
1
2
3
4
5
6
7
Cartridge
1Touchscreen
2
Analyser slot with
lightbar
3Front button
4Scanner
1Air output
2
Ethernet 1
3Ethernet 2
43 x USB ports
5Power switch
6Power connection
1Air filter
2
Label with serial
number
1
Detection area
(do not touch or scratch!)
2
Lid
3Sample input
4Cartridge code
5
Sample volume
6
Expiry date
7
Test description
Overview of the icons
Symbol Function Symbol Function
4
CONTINUE
enabled
Pfeil links
Einen Schritt zurück
4
CONTINUE
enabled
Bearbeiten
4
CONTINUE
enabled
Pfeil rechts
Einen Schritt vor
4
CONTINUE
enabled
Löschen
4
CONTINUE
enabled
Hinzufügen
4
CONTINUE
enabled
Suche
Fenster zur Eingabe der Suchkriterien
öffnen
4
CONTINUE
enabled
Schließen, abbrechen
4
CONTINUE
enabled
Exportieren
Überprüfe Hinweise
4
CONTINUE
enabled
Drucken
4
CONTINUE
enabled
4
CONTINUE
enabled
Nutzer
aktivieren/deaktivieren
4
CONTINUE
enabled
Passwortschutz
aktivieren/deaktivieren
Einführungsvideo anschauen Herunterfahren/Standby-Modus
4
CONTINUE
enabled
Menü
4
CONTINUE
enabled
Joblist
1
2
3
4
5
6
1
2
3
4
1
2

© Bosch Healthcare Solutions GmbH 3Instructions for use
Overview of the user interface
Home screen
Please fill cartridge and insert into slot.
ID 123456789
Patient name
Date of birth
TEST NAME
Test details
Expiry date
1Menu
2Information on what to do
3Sample data
4Notice
5Joblist
6Help
7Test description
Analyser test screen
SMH
01 16 51
TEST NAME
Detection
Everything is running well.
ID 342 346 23
1Progress bar
2Test status information
3Remaining test time
4Sample data
5Cancel test run
6Test description
7More detailed information
Analyser result overview screen
Result saved and submitted.
Cartridge is ready to eject.
ID 342 485 58 TEST NAME
FINISH
Test valid
Target 1, Target 2, Target 3, ...
DETAILS
1Menu
2Status
3Information about valid/invalid test
4Sample data and test description
5Joblist
6Finish test run and eject cartridge
7View details
8Export
9Print
6
5
4
7
1
1
1
2
2
2
3
3
3
4
4
4
5
5
6
6
6
5
7
7
7
8
9

© Bosch Healthcare Solutions GmbH4Instructions for use
Content
1 Initial information........................................................................................................................................ 5
1.1 Package contents 5
1.2 Before using Vivalytic 5
1.3 Device safety information 6
1.4 Data security information 6
1.5 Cartridge safety and handling information 6
1.6 Intended use 6
2 Installation and setup.................................................................................................................................. 7
2.1 Installing the analyser 7
2.2 Setting up the software – onboarding 7
2.3 User concept 8
2.4 Status of the analyser 8
3 Performing a test......................................................................................................................................... 9
3.1 How to find application-specific instructions for use 9
3.2 Login 9
3.3 Starting a test 10
3.4 While running a test 11
3.5 Test result and test report 12
3.6 Finishing a test 12
4 Data management and export................................................................................................................... 13
5 Menu .......................................................................................................................................................... 13
5.1 Device settings 14
5.2 User accounts and passcode 14
5.3 Network configuration 14
5.4 Configuration of order/result interface (HIS/LIS) 15
5.5 Configuration of data export to USB or network drive 16
5.6 Printer configuration 16
5.7 Software update 17
5.8 Factory reset 17
5.9 System information 17
6 Maintenance and troubleshooting ............................................................................................................ 17
6.1 Shutting down the analyser 17
6.2 Cleaning and disinfecting the analyser 18
6.3 Changing the air filter of the analyser 18
6.4 Quality control testing 18
6.5 Notice and error 18
6.6 Troubleshooting 19
7 Disposing of the analyser.......................................................................................................................... 21
8 Technical data............................................................................................................................................ 21
8.1 Compliant cables and accessories 21
8.2 Warranty 21
9 Symbols and abbreviations....................................................................................................................... 22
10 Appendix ................................................................................................................................................... 23
10.1 Electromagnetic compatibility 23
10.2 Licence terms of end users 23
11 Manufacturer............................................................................................................................................. 23