Mobidiag Novodiag NVD-INST-B User manual

Novodiag® System
NVD-INST-B
NVD-DSW
For in vitro diagnostic se
For se with Novodiag® Tests
User Man al
English
Version 4-0
Iss ed in April 2020

Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
Table of contents
1. About this manual ................................................................................................................................................................................. 1
1.1. Aim of the user manual ............................................................................................................................................................. 1
1.2. Conventions used in this manual.......................................................................................................................................... 1
1.3. Glossary of terms and abbreviations ................................................................................................................................... 1
1.4. Glossary of symbols .................................................................................................................................................................... 2
2. Overview of the Novodiag® System ................................................................................................................................................ 3
2.1. Intended purpose ....................................................................................................................................................................... 3
2.2. Intended conditions of use...................................................................................................................................................... 3
2.3. Targeted testing and panel testing ...................................................................................................................................... 3
2.4. Description of components .................................................................................................................................................... 3
3. Principle of operation ........................................................................................................................................................................... 6
3.1. Principles of fluidic operations ............................................................................................................................................... 7
3.2. Extraction........................................................................................................................................................................................ 7
3.3. Amplification ................................................................................................................................................................................. 7
3.4. Microarray hybridisation .......................................................................................................................................................... 7
3.5. Detection and analysis .............................................................................................................................................................. 7
4. Configuration and setup ..................................................................................................................................................................... 7
4.1. Environmental requirements.................................................................................................................................................. 7
4.2. Installation requirements ......................................................................................................................................................... 8
4.3. Pac aging content ...................................................................................................................................................................... 9
4.4. Installation ..................................................................................................................................................................................... 9
4.5. Getting started with the Novodiag® System .................................................................................................................... 9
5. Novodiag® Software ........................................................................................................................................................................... 12
5.1. User credentials......................................................................................................................................................................... 12
5.2. User interface presentation and navigation (normal user) ...................................................................................... 12
5.3. Home view .................................................................................................................................................................................. 13
5.4. Starting a run ............................................................................................................................................................................. 15
5.5. Result view .................................................................................................................................................................................. 16
5.6. System Setup (admin user) ................................................................................................................................................... 19
5.7. Novodiag® Software upgrades and plugins .................................................................................................................. 24
6. Operating instructions ...................................................................................................................................................................... 24
6.1. General precautions ................................................................................................................................................................ 24
6.2. Starting up the Novodiag® System .................................................................................................................................... 24
6.3. Sample and Novodiag® Test Cartridge preparation ................................................................................................... 24

Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
6.4. Starting a run ............................................................................................................................................................................. 25
6.5. Shutting down the Novodiag® System ............................................................................................................................ 29
7. Preventive maintenance and controls ........................................................................................................................................ 29
7.1. Preventive maintenance ....................................................................................................................................................... 29
7.2. Controls ........................................................................................................................................................................................ 29
8. Decontamination and disposal ..................................................................................................................................................... 30
8.1. Decontamination and cleaning procedures .................................................................................................................. 30
8.2. Novodiag® Instrument or slot disabling .......................................................................................................................... 31
8.3. Decontamination procedure prior to Novodiag® Instrument maintenance .................................................... 31
8.4. Disposal ........................................................................................................................................................................................ 32
9. Precautions, limitations and safety hazards ............................................................................................................................. 32
9.1. Precautions and limitations.................................................................................................................................................. 32
9.2. Safety Information and warnings....................................................................................................................................... 32
9.3. Electromagnetic compatibility ............................................................................................................................................ 33
9.4. Reporting product anomalies ............................................................................................................................................. 34
9.5. Vigilance information ............................................................................................................................................................. 34
10. Troubleshooting .................................................................................................................................................................................. 34
10.1. Novodiag® Test Cartridge troubleshooting ................................................................................................................... 34
10.2. Novodiag® Instrument troubleshooting ......................................................................................................................... 34
10.3. Novodiag® Software troubleshooting.............................................................................................................................. 35
10.4. Touchscreen Computer troubleshooting ....................................................................................................................... 36
10.5. Barcode Scanner troubleshooting ..................................................................................................................................... 36
11. Technical data ...................................................................................................................................................................................... 37
12. Important information ...................................................................................................................................................................... 39
13. Manual version information............................................................................................................................................................ 40

Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
1
1. Abo t this man al
1.1. Aim of the ser man al
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 sed in this man al
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 stac ed
configuration (from 2 to 4 instruments).
White Bloc er 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 blan
(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® stac 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

Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
2
Real-time PCR Real-time Polymerase Chain Reaction. A method for detecting an amplified PCR
product based on incorporation of a fluorescent allowing monitoring of PCR
product.
Targeted approach Diagnostic testing for a single target.
Syndromic approach Diagnostic testing based on symptoms and allowing a large panel of pathogen
screening in one single test.
White membrane Seals all reagents contained in the Novodiag® Test Cartridge. It is permeable to
gases, thereby allowing air flow but not liquid flow.
1.4. Glossary of symbols
These symbols can be found on the Novodiag® System, its associated components or throughout this manual. Use
the definitions below to interpret the symbols (see Table 2).
Table 2. Definitions for symbols found in the user manual
Manufacturer
Temperature limitation
European Economic Area Conformity
Expiration date / Use-by date [YYYY-MM-DD]
In vitro diagnostic medical device Date of manufacture
Catalogue number
Do not reuse
Serial number
Biological ris s
Batch code/ lot number
Warning; caution
Consult Instructions for Use
Caution, ris of electric shoc
This way up
Lifting the pac age with bad posture may be
harmful for the bac
Mass; weight
Do not use if pac age is damaged
Fragile; handle with care
Do not roll
WEEE – Do not dispose of in municipal
solid waste containers

Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
3
2. Overview of the Novodiag® System
2.1. Intended p rpose
2.1.1. Novodiag® Instrument
Novodiag® Instrument is an in vitro diagnostic medical device intended to be used in combination with Novodiag®
Software and Novodiag® Test specific cartridges to detect nucleic acid targets contained in clinical specimens.
Novodiag® Instrument is intended to be used in clinical laboratories by laboratory personnel. Novodiag® is a fully
automated system that uses a combination of real-time PCR and microarray hybridisation to detect and identify
multiple nucleic acid targets from clinical samples providing qualitative result which is then displayed on the
Novodiag® Software.
The device's function such as screening, monitoring or diagnosis, the specific disorder, condition or ris factor of
interest that it is intended to detect, define or differentiate, and the type of specimen required are Novodiag® Test
dependent.
2.1.2. Novodiag® Software
Novodiag® Software is an in vitro diagnostic medical device intended to be used in combination with Novodiag®
Instrument and Novodiag® Test specific cartridges to detect nucleic acid targets contained in clinical specimens.
Novodiag® Software is intended to be used in clinical laboratories by laboratory personnel. Novodiag® is a fully
automated system that uses a combination of real-time PCR and microarray hybridisation to detect and identify
multiple nucleic acid targets from clinical samples providing qualitative result which is then displayed on the
Novodiag® Software.
The device's function such as screening, monitoring or diagnosis, the specific disorder, condition or ris factor of
interest that it is intended to detect, define or differentiate, and the type of specimen required are Novodiag® Test
dependent.
2.2. Intended conditions of se
The Novodiag® System is intended to be used in clinical laboratories by trained laboratory personnel following
the manufacturer’s protocols and recommendations.
The user is responsible for:
 Proper operation of the system according to the instructions provided in this manual and in the Test
specific Instructions for Use.
 Ensuring that the system is operated by properly trained personnel.
 Ensuring that proper maintenance is performed on the Novodiag® Instrument.
2.3. Targeted testing and panel testing
The Novodiag® System enables to perform both single target tests as well as test panels using two detection
technologies:
 Real-time PCR detection with fluorescence readout.
 Combination of real-time PCR and microarray detection both with fluorescent readout.
2.4. Description of components
The Novodiag® System consists of the following IVD devices:
 Novodiag® Instrument (ref. NVD-INST-B).
 Novodiag® Software (ref. NVD-DSW).
The Novodiag® System operates in combination with the following additional components which are delivered
with the system:
 Novodiag® Touchscreen Computer (ref. NVD-TSC-A).
 Novodiag® Barcode Scanner (ref. NVD-BCS-A).

Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
4
 Novodiag® Post (ref. NVD-TSCP-A) or Novodiag® Arm (ref. NVD-TSCA-A).
The Novodiag® Instrument, the Touchscreen Computer and the Barcode Scanner are delivered with the necessary
power and connection cables. The Novodiag® Test Cartridges are provided separately.
2.4.1. Novodiag® Instrument (ref. NVD-INST-B)
The Novodiag® Instrument is a benchtop 4 slot device that runs Novodiag® Test Cartridges automatically (see
Figure 1).
Figure 1. Novodiag® Instrument description
Each slot is controlled independently and can be randomly accessed. Each slot is able to accommodate one
cartridge at a time. Different Novodiag® Tests can be run in different slots at the same time. The status light below
each slot allows to monitor the Novodiag® Instrument slots status (see Chapter 4.5.1 for light status
correspondence). Up to four Novodiag® Instruments can be stac ed and controlled by a single Touchscreen
Computer by the Novodiag® Software (see Figure 2).
On a single-instrument conformation, a support (Post) is provided for the Touchscreen Computer, allowing the
Touchscreen to be placed on top of the Novodiag® Instrument or beside it. The Post allows the inclination
adjustment of the Touchscreen Computer.
On a stac conformation (from 2 up to 4 instruments), all Novodiag® Instruments must be stac ed vertically and
an optional Arm can be fixed to the stac to support the Touchscreen Computer. The Arm allows flexible
adjustment of the positioning of the Touchscreen Computer.
Figure 2. Different conformations of the Novodiag® ystem: (1) one-instrument conformation, (2) stack conformation
(maximum stack: 4 instruments)
(1) (2)

Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
5
2.4.2. Touchscreen Computer (ref. NVD-TSC-A)
The Touchscreen Computer is supplied with the Novodiag® Instrument. It runs the Novodiag® Software and
provides the necessary connection to the Novodiag® Instrument, external networ and Barcode Scanner. It is
operated by Microsoft Windows 10 operating system. The Touchscreen Computer can be used with laboratory
gloves (silicone or nitrile).
2.4.3. Novodiag® Software (ref. NVD-DSW)
The Novodiag® Software NVD-DSW V1.4.0 (or higher) is installed on the Touchscreen Computer and has the
following functions:
 Touchscreen optimised user interface to operate the software.
 Novodiag® Instrument control for running Novodiag® Tests and displaying the results (through a Test
specific plugin).
 User management function: add and manage users (for selected users only).
 Test management function: add and manage tests (for selected users only).
 Instrument management functions: configure Novodiag® Instrument, activate/deactivate slots or add
Novodiag® Instruments (for selected users only).
For further information about Novodiag® Software, see Chapter 5.
2.4.4. Additional components: Barcode Scanner (ref. NVD-BCS-A), Arm (ref. NVD-TSCA-A), Post (ref. NVD-TSCP-A),
fixtures and strip
The Barcode Scanner is supplied with each Touchscreen Computer and enables reading both sample barcodes
and Novodiag® Test Cartridge labels. Depending on the number of Novodiag® Instruments used, the Touchscreen
Computer is held by the Post (for a single instrument) or by the Arm (for 2 up to 4 instruments). When a stac of
Novodiag® Instruments is used, dedicated fixtures are supplied to secure the instruments together and a power
strip is supplied also.
2.4.5. Novodiag® Test Cartridge
The Novodiag® Test Cartridge is a single use, test specific consumable (see Figure 3). It contains all the reagents
necessary for running a test.
Figure 3. Novodiag® Test Cartridge
The Novodiag® Test Cartridge is pac aged individually in a blister. The reagent tan s on the top side are closed by
a white membrane overlaid by a peelable protective cover. A white bloc er, two PCR chambers and a label with
test information are also located on the top side. The bottom side includes the valves, PCR chambers and, for test
panels, the microarray printed on a slide (see Figure 4).

Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
6
Figure 4. Novodiag® Test Cartridge description (before removing the peelable protective cover)
After removing the peelable protective cover, the sample is introduced in the sample tan and the cartridge is
closed by a cap supplied with the Novodiag® Test Cartridge (see Figure 5).
(1) (2) (3)
Figure 5. Novodiag® Test Cartridge Views: (1) After blister opening / (2) After protective cover removal / (3) After sample
introduction and securing the sample tank with the cap
The Novodiag® Test Cartridge contains two independent channels for performing real-time PCR and microarray
detection. Each one amplifies and detects a set of targets or is a duplicate for targeted test.
3. Principle of operation
Novodiag® System uses a combination of real-time PCR and microarray hybridisation to detect and identify
multiple nucleic acid targets from clinical specimens. The user of the Novodiag® System inserts the sample into a
Novodiag® Test Cartridge, introduces the cartridge into the Novodiag® Instrument and starts the run. The
Novodiag® Instrument interacts with the cartridge to extract nucleic acids from the sample, amplifies a set of
targeted sequences and transfers the amplified material to a microarray for hybridisation and detection (only for
Novodiag® Test panels). The results are automatically determined and displayed on the Novodiag® Software.