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

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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

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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

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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).

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 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)

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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).

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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.

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3.1. Principles of fl idic operations
The distribution of fluids in the Novodiag® Test Cartridge from tan to tan and to the various processing
chambers are performed by positive and negative pressure operated by an integrated syringe and directed by the
activation of integrated valves by the Novodiag® Instrument. The white membrane is permeable to gases, thereby
allowing air flow but not liquid flow.
3.2. Extraction
A chemical or physical lysis is carried out in a sample tube before inserting the sample into the Novodiag® Test
Cartridge. Alternatively, for some Novodiag® Tests a chemical lysis is operated by the reagents present in the
Novodiag® Test Cartridge. The sample is either purified by a proprietary silica-based Zymo Research Corporation
technology or by other sample preparation method in the Novodiag® Test Cartridge. Refer to Novodiag® Test
specific Instructions for Use for more information.
3.3. Amplification
The eluted nucleic acids are transferred to each PCR chambers containing dry primers and probes along with the
appropriate PCR reagents. Each chamber is then submitted to independent thermocycling protocols by two
independent Peltier thermocyclers. The fluorescence from labelled probes is monitored though excitation and
detection of emission for each chamber using two channels (blue and red) based on a proprietary optical module.
3.4. Microarray hybridisation
For Novodiag® Test panels, the amplified material is transferred to the microarray for hybridisation. Amplicons
bind to a set of complementary probes targeting specific regions of the genes serving for target detection.
3.5. Detection and analysis
The microarray is imaged by two proprietary technologies of:
 Contact fluorescence imaging.
 Evanescent excitation.
The Novodiag® Assay Plugin, specific to the Novodiag® Test Cartridge, analyses both the real-time PCR signal and,
for Novodiag® Test panels, the microarray image. The presence of target nucleic acids is determined by:
 The detection of positive amplification by real time-PCR.
 And/or the detection of a set of specific hybridisation probes.
 The proper detection of internal controls (a process control by real time-PCR and/or microarray detection,
gridding controls and hybridisation control by microarray detection).
4. Config ration and set p
4.1. Environmental req irements
4.1.1. For Novodiag® Instrument and Touchscreen Computer
The Novodiag® System is intended for indoor use only.
CAUTION For proper operation, the Novodiag® System requires the following environmental conditions:
 Operating temperature between 18°C and 30°C.
 Operation humidity between 15 – 95% r.H. not condensing and pressure down to 795 mbar.
CAUTION The electromagnetic environment may interfere with proper Novodiag® Instrument operation.
 Do not use the Novodiag® Instrument in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional radio frequency sources).

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4.1.2. For Novodiag® Test Cartridges
Refer to the Novodiag® Test specific Instructions for Use.
4.2. Installation req irements
Table 3. Requirements for each installation configuration
Space requirement
(W x D x H)
Weight
requirement
Max power
consumption (W)
Number of
power soc ets
LAN
(optional)
Single instrument
+ Post
100 x 50 x 25cm
(instrument)
+ 40 x 20 x 30cm
(computer)*
25 g 600 + 65
(computer) 2 1
Two instruments
+ Post
100 x 50 x 50cm
(stac )
+ 40 x 20 x 30cm
(computer)*
45 g 600x2 + 65
(computer) 2 1
Two instruments
+ Arm 125 x 50 x 50cm** 50 g 600x2 + 65 (computer) 2 1
Three
instruments
+ Arm
125 x 50 x 75cm** 70 g 600x3 + 65
(computer) 2 1
Four instruments
+ Arm 125 x 50 x 100cm** 90 g 600x4 + 65 (computer) 2 1
*Touchscreen Computer on Post can be placed directly on top of Novodiag® Instruments or beside it.
**The Arm configuration holds the Touchscreen Computer above the wor space.
As depicted in Figure 6 and Figure 7, a minimal space must be free around the Novodiag® Instrument to allow air
circulation as well as provide some room for the Arm in case of stac configuration.
Figure 6. Top view of the Novodiag® Instrument

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Figure 7. Top view of the Novodiag® Instrument and Arm
Each Novodiag® Instrument has one independent power plug. In case of stac (2 to 4 instruments), each
Novodiag® Instrument will have its own power plug plugged into the power strip and 1 soc et will be dedicated
to the Touchscreen Computer. The power supply is compatible with voltage 100 - 240 VAC, 50 / 60 Hz, 600 W.
4.3. Packaging content
4.3.1. Novodiag® Instrument pac age
Each Novodiag® Instrument is shipped in a wooden box mounted on pallets. The Novodiag® Instrument pac age
size is W80 x D60 x H70 cm and contains:
 One Novodiag® Instrument shipped with transport cartridges to secure the
module (yellow cartridges)
 Power cables and connection cables
The Touchscreen Computer, the Barcode Scanner and the Post or Arm are delivered in
separate pac ages.
CAUTION The Novodiag® Instrument unpac ing must be performed by Mobidiag representative only.
CAUTION Transport cartridge are only used to prevent any damage during shipment.
4.3.2. Novodiag® Test Cartridges it
Refer to the Novodiag® Test specific Instructions for Use.
4.4. Installation
CAUTION The Novodiag® System installation (or conformation change) and qualification require specific
equipment and training and must be performed by Mobidiag representative only.
4.5. Getting started with the Novodiag® System
4.5.1. Starting up the Novodiag® Instrument
Start the Novodiag® Instrument by switching on the power plug in the bac of the instrument (see Figure 8).
Alternatively, using a stac , switch on the power strip provided with the Novodiag® Instruments.

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Figure 8. Back view of the Novodiag® Instrument
The Novodiag® Instrument performs a self-diagnostic during the initialisation process. The status lights below
each slot allows to monitor the initialisation process shifting from orange (self-diagnostic ongoing) to green (ready
to use). The Table 4 describes the status lights meaning.
Table 4. Possible status lights on the Novodiag® Instrument
To shut down a standalone Novodiag® Instrument, switch off the power button. To shut down a stac , switch off
the power strip only.
NOTE Always remove Novodiag® Test Cartridges prior to shutting down the Novodiag® Instrument.
CAUTION In a stac conformation (from 2 to 4 instruments), Novodiag® Instruments are interconnected. Do not
shut down a Novodiag® Instrument separately, you ris impairing the whole stac functioning. Contact Mobidiag
representative for assistance.
WARNING! In case of electrical hazard, shut down the whole stac and disconnect it from the power supply.
4.5.2. Adjusting the Touchscreen Computer on Post or Arm
You can adjust the orientation of the Touchscreen Computer on the Post or on the Arm by unloc ing the lever of
the ball mounting at the bac of the Touchscreen Computer (see Figure 9), rotating the computer until getting
the desired orientation and then securing the lever bac .
NOTE While unloc ing the ball mounting lever, ma e sure to hold the Touchscreen Computer.
The Arm (stac conformation) can be further adjusted horizontally by using the two nobs. The first nob (Arm
rotation nob) allows to adjust the Arm rotation relative to the stac while the second nob (computer rotation
nob) allows the orientation of the Touchscreen Computer.
Signal Meaning
Green light The slot is available for running a new test.
Orange light The slot is busy. Test or self-diagnostic is running.
Green light blin ing The slot is waiting for action by the user. Experiment is completed.
Orange light blin ing The slot is waiting for action by the user. Transport cartridge in the slot.
Red light The slot is failing.
No Light The slot is either absent or disabled.

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(1) (2)
Figure 9. Arm (1) and Post (2) descriptions
4.5.3. Starting up the Touchscreen Computer
Start up the Touchscreen Computer by using the power button on the bottom right of the screen. Login to
Windows occurs automatically and the des top appears.
NOTE Even when a power strip is available for the stac of Novodiag® Instruments, the Touchscreen Computer
shall still be connected on its own wall soc et.
CAUTION The Touchscreen Computer is configured for proper Novodiag® Software operation. Modifying this
configuration can interfere with Novodiag® Software operation.
• Do not install any software other than the Novodiag® Software. If your institution requires it, please
consult with Mobidiag representative.
• Do not modify or erase any file from the Novodiag® Software folder.
• Do not enable Windows Automatic Updates.
• Do not remove the default Windows user accounts.
• Do not change screensaver settings.
4.5.4. Starting up the Novodiag® Software
To start up the Novodiag® Software, double tap the Novodiag® Software icon on the des top. The Novodiag®
Software can be started before or after the Novodiag® Instrument has been switched on.
4.5.5. Operating with the Barcode Scanner
The Barcode Scanner is configured during the installation and is automatically detected by the Touchscreen
Computer upon startup. By default, the Barcode Scanner is configured to be used on its stand, is always active and
automatically detects a label in motion. A red beam illuminates the label. The field of view indicated by the aiming
system is smaller when the reader is closer to the barcode and larger when it is farther from the barcode.
NOTE Symbols with smaller bars or elements should be read closer to the unit. Symbols with larger bars or
elements should be read farther from the unit.
NOTE The reading is optimal when the aiming system is centred and the entire barcode is within the aiming field.
Successful reading is confirmed by an audible tone and a green spot LED indicator (see Figure 10).

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Figure 10. Barcode canner aiming display (left) and reading green spot (right)
5. Novodiag® Software
5.1. User credentials
In addition to normal users, admin level users can be found in Novodiag® Software. Differences in credentials for
normal and admin user are displayed in Table 5. See chapter 5.6.2 (user management) for details on how to create
users and modify their permissions. Mobidiag retains one admin user account for service personnel to use.
Table 5. User credentials
User Permissions
User type Run tests Manage tests Manage users Manage instruments Manage settings
Normal user
Admin user
5.2. User interface presentation and navigation (normal ser)
Figure 11. Login view of the Novodiag® oftware (this example displays a stack of 2 instruments)

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NOTE The Novodiag® Software is navigated in the same manner as any typical touch device. Most actions are
performed by tapping, some require scrolling. No double tap is required. Navigation is from left to right.
The Novodiag® Software opens on a login screen, allowing each user to log in individually (see Figure 11). The
stac view on the right displays status of each connected Novodiag® instrument. First the user selects their name
and then enters the pin code on the pin pad (see Figure 11). Login will occur automatically and the Home View is
displayed.
NOTE To comply with operator traceability, it is recommended for the user to log out from the session when not
using the system. Also, before starting a run, please chec the username on the screen to ma e sure that you are
the right user logged in.
The Home View reflects the physical setup of the Novodiag® Instrument and is divided in two parts:
 Stac view on the left
 Instrument view on the right, divided in slot panes
At the very top of the screen, the user can navigate to following views:
 Home view
 Results view
 System Setup view (for admin users)
 Return to Login view (through “Logout” button)
Buttons available at the bottom of the screen offer additional functions that are connected to the current view.
For example, in the Home view, the “Start new test” button and, when applicable, the “Eject all completed” button
are available.
5.3. Home view
Stack view (see Fig re 12 and Table 6)
The Stac view enables to get an overall status of all connected Novodiag® Instruments.
Tapping on instrument icons allows to select which instrument view to display.
Figure 12. Home view

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Table 6. Home view symbols
Stac view symbols Instrument/Slot status
Instrument displayed on the instrument view
Instrument in stac not displayed on instrument view
Instrument not connected
Instrument disabled
Test creation: Slot empty, ready for run
Test creation: Slot selected, next run will be created to this slot
Test creation: Run created, ready to start
Slot initialising
Slot running, time remaining 30min
Run completed
Negative
Run completed
Positive
Run completed
Invalid

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Failed Run
Slot disabled
Instr ment view
In the Instrument view, each slot is represented with a pane. In this pane, a circular progress symbol indicates the
slot status. More information is indicated by the symbols inside the circle, as explained in Table 7.
Table 7. Instrument view symbols
Slot
view
Status
Slot empty Slot initialising Run in progress 31min
remaining Slot disabled
Slot
view
Status
Run completed
Negative
Run completed
Positive
Run completed
Invalid Failed Run
5.4. Starting a r n
To start a run from the Home view (see Figure 13), tap the “Start new test” button. Refer to the operating
instructions in Chapter 6 for more information on protocol.

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Figure 13. Home view
5.5. Res lt view
To access the results from the Home view, tap the “View test results” button on the bottom of the slot pane (see
Figure 14). This brings you to the Results view. Alternatively, result history is available by tapping the “Results”
button at the top of the screen.
Figure 14. Home view - Displaying results
The result view is composed of three panes:
 Run history
 Selected run result
 Filters