Mobidiag Novodiag NVD-BCS-A NVD-TSCA-A, User Manual

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Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
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13. Manual version information
Manual reference NVD-SYST-UM English
Manual version 4-0 Issued in April 2020
Changes to the previous version:

Throughout the document: Instrument version updated to NVD-INST-B. Modifications to describe all current
Novodiag® Tests on the market, including tests with plastic slide. Correction of typos.

Ch. 2.1: Intended use changed to Intended purpose and the text revised according to IVDR

Ch. 2.4.3: NVD-DSW version updated to V1.4.0

Ch. 5.5.1: Log file exporting is available for results that are maximum of one year old only

Ch. 5.6.3: Addition of an automatic printing feature

Ch. 6.3: Defining of warnings and precautions related to the cartridge preparation according to all the current
Test specific IFUs

Ch. 9.4 and 9.5: Defining of Reporting product anomalies and Vigilance information chapters
Every effort has been made to ensure that the information provided in this document is accurate as of the date of
publication. Updates can be occasionally made, in which case the publication date and the version number will
be changed. To make sure you are using the latest version of the user manual, please contact your Mobidiag
representative.