Mobidiag Novodiag NVD-BCS-A NVD-TSCA-A, Руководство пользователя

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Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
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1. About this manual
1.1. Aim of the user manual
This user manual is intended solely for the users of the Novodiag® System, including the Novodiag® Instrument,
Novodiag® Software and Novodiag® Test Cartridge, and the Touchscreen Computer and additional components
provided with the system. Carefully follow the procedures and instructions specified in this user manual. Before
operating the Novodiag® System, the user must:

Read this user manual and related documents fully.

Be appropriately trained.

Be aware of and strictly follow the relevant safety rules and regulations.
1.2. Conventions used in this manual
Writing conventions used in this manual have the following meaning (see Table 1):
Table 1. Definitions for conventions found in the user manual
Convention Meaning
WARNING!
A warning notice denotes a hazard. It calls attention to an operating procedure or practice
which, if not carried out correctly, could result in personal injury, potential harm to the
environment, or an incorrect test result.
CAUTION
A caution notice denotes a hazard. It calls attention to an operating procedure or practice
which, if not performed correctly, could damage the instrument or invalidate results.
NOTE A note provides important, helpful or additional information to operate the Novodiag® System
more efficiently.
1.3. Glossary of terms and abbreviations
Arm Supports the Touchscreen Computer when Novodiag® Instruments are in stacked
configuration (from 2 to 4 instruments).
White Blocker
Plastic part placed in the cartridge to hold the syringe in place during
transportation.
Slide
Glass or plastic rectangle glued onto the cartridge main body that is either blank
(targeted tests) or contains a microarray (test panels).
IVD
In Vitro Diagnostic
Microarray
Assembly of microscopic probes complimentary to sample targets that are laid out
on an array.
Novodiag® System
Fully automated solution for on-demand targeted and syndromic testing.
Novodiag® stack
Configuration of two to four Novodiag® Instruments.
PCR Polymerase Chain Reaction. A molecular biology technique for amplifying a
selected DNA or RNA sequence in order to analyse its presence even in samples
with low nucleic acid concentration.
Post
Supports for Touchscreen Computer to be placed on top or beside Novodiag®
Instruments.
PPE
Personal Protective Equipment