© Bosch Healthcare Solutions GmbH6Instructions for use
Initial information
Have the serial number available when contacting the customer service.
The eight-digit serial number is located on the bottom of the analyser.
WARNING
Not following the instructions for use or improper handling can lead to malfunction, damage to
the equipment and person, hazardous situations or incorrect results.
1.3 Device safety information
Please follow the instructions to ensure safe and reliable measurements. The results from Vivalytic should not be used
as a sole parameter for a diagnosis or screening. Only operate Bosch Vivalytic after you have read and understood these
instructions for use and the corresponding application-specific instructions for use. Not following the instructions
may cause damage to the analyser and the disposable cartridge and can result in misleading measurement results.
WARNING • Do not expose the analyser to vibrations, shocks, hot surfaces or strong electric
orelectromagnetic fields (see chapter 8).
• Do not disassemble the analyser or its components or try to repair it yourself. Do not
change the fuse by yourself. Any changes or modifications to Vivalytic that are not approved
by the manufacturer will impair safety.
• Do not attempt to remove the cartridge until it has been fully ejected.
• Do not turn off the analyser during a test.
• Do not attempt to open the door of the analyser slot manually.
• Do not use under conditions with high humidity, extreme temperatures, direct sun
radiation or high exposure to dust (see chapter 8).
1.4 Data security information
Bosch privacy statement: This product stores measurement data as well as user and patient information.
WARNING • Data protection is under the responsibility of the organisation using Vivalytic.
• Make sure to protect the analyser against unauthorised access.
• Only use the analyser in a protected area.
• Protect user name and passwords as well as network credentials.
• Only use trusted USB devices. Only use the analyser in trusted and secured networks.
• Note that data transfer via a network or to an external device (e.g.: printer, USB device,
HIS/LIS) is unencrypted with the risk of unauthorised data access.
• Delete the personal data on the analyser prior to disposal or service returns.
1.5 Cartridge safety and handling information
Only use Vivalytic application-specific cartridges and accessories approved for the analyser. Using other may produce
incorrect results. For cartridge safety and handling information please refer to the application-specific instructions
foruse delivered in paper format in each packaging box.
1.6 Intended use
The Vivalytic application-specific cartridges contain quantitative or qualitative nucleic acid-based in vitro diagnostic
tests intended for use with a Vivalytic analyser.
Vivalytic automates single and multiplex detection and identification of nucleic acids from bacteria, viruses, parasites
oreukaryotic cells from different sample types.
