ViroGates suPARnostic QT FLEX User manual

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suPARnostic® QT FLEX Reader
User Manual
QT FLEX Reader for suPARnostic® measurements
A006
suPARnostic and the
ViroGates logo are
registered trademarks of ViroGates
A/S Denmark.
©2008 ViroGates.
All rights reserved.
ViroGates A/S
Banevaenget 13
Birkeroed 3460, Denmark
Tel: [phone]
Skype: Virogates
www.virogates.com

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Content
Introduction .................................................................................................................................................................... 5
General information ................................................................................................................................................ 5
Technical assistance .......................................................................................................................................... 5
Policy statement ................................................................................................................................................... 5
Version management ......................................................................................................................................... 5
Intended use of the suPARnostic® QT FLEX Reader ........................................................................................ 6
Safety Information ....................................................................................................................................................... 6
Proper use ................................................................................................................................................................... 6
Electrical Safety ......................................................................................................................................................... 7
Environment ............................................................................................................................................................... 7
Environmental hazards ........................................................................................................................................... 7
Heat hazard ................................................................................................................................................................ 7
Maintenance safety ................................................................................................................................................. 8
Waste disposal .......................................................................................................................................................... 8
Symbols on the suPARnostic® QT FLEX Reader instrument ......................................................................... 8
Symbols on the package of the reader ............................................................................................................ 9
Functional Description ................................................................................................................................................ 9
Hardware ..................................................................................................................................................................... 9
Contents of the kit .................................................................................................................................................. 10
Unpacking and Set-up Procedures ...................................................................................................................... 10
Unpacking of the suPARnostic® QT FLEX Reader........................................................................................... 10
Setup and connection of the suPARnostic® QT FLEX Reader .................................................................... 10
Installation .................................................................................................................................................................... 11
Requirements .......................................................................................................................................................... 11
AC power connection ........................................................................................................................................... 11
Hardware installation / Accessories ................................................................................................................ 11
Relocating the SUPARNOSTIC® QT FLEX READER............................................................................................. 12
General Operation ..................................................................................................................................................... 12
Powering the suPARnostic® QT FLEX Reader on and off ............................................................................. 12

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Instrument startup ................................................................................................................................................. 12
First Log In .................................................................................................................................................................. 12
Menu Structure ........................................................................................................................................................ 13
Home Screen............................................................................................................................................................ 13
Instrument Usage ....................................................................................................................................................... 14
The 2 ordering workflow modes ........................................................................................................................ 14
Starting a Test in the FastTrack Mode ............................................................................................................. 15
Starting a Test in the FailSafe Mode ................................................................................................................. 18
Review Results ......................................................................................................................................................... 20
System and Settings ................................................................................................................................................. 20
Status .......................................................................................................................................................................... 21
Update Tests ............................................................................................................................................................ 21
Settings ...................................................................................................................................................................... 22
Preferences ........................................................................................................................................................... 23
Admin Area ........................................................................................................................................................... 23
Menu Structure in the Admin Area.................................................................................................................... 24
Date & Time .......................................................................................................................................................... 24
Manage Data ....................................................................................................................................................... 25
User Management ............................................................................................................................................. 26
Update Software ................................................................................................................................................. 26
Order Mode ........................................................................................................................................................... 26
Manufacturer reset ............................................................................................................................................ 26
Communication Settings ................................................................................................................................. 27
Shutdown Settings ............................................................................................................................................. 29
Maintenance ................................................................................................................................................................ 30
Menu “Maintenance” within System menu .................................................................................................... 30
Cleaning .................................................................................................................................................................... 31
Device self-check ................................................................................................................................................... 31
Troubleshooting and Messages ........................................................................................................................ 32

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Technical service support ................................................................................................................................... 33
Technical Data ............................................................................................................................................................ 34
Dimensions and weight of the instrument ..................................................................................................... 34
Mechanical data and hardware features ...................................................................................................... 34
Optics ......................................................................................................................................................................... 34
Power requirements of the instrument ........................................................................................................... 34
Optional Accessories ............................................................................................................................................ 34

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Introduction
Thank you for choosing the suPARnostic® QT FLEX Reader. We are confident that this
product will become an integral part of your daily work.
Portable testing without an accessible lab is a challenge. Using the wealth of experience
obtained from providing reflectometric detection technology to thousands of customers
worldwide, the specialists at ViroGates have developed a new generation reader for
mobile applications. The suPARnostic® QT FLEX Reader is a highly sensitive, robust, and
cost-effective measurement system for lateral flow tests. This flexible and reliable
system, based on a ready-to-use concept, enables the users to easily run lateral flow
tests.
This manual describes how to operate the suPARnostic® QT FLEX Reader. Before using the
device, it is essential that you read this user manual carefully.
General information
Technical assistance
At ViroGates, we pride ourselves on the quality and availability of our technical support.
Our Technical Services Department is staffed by experienced engineers with extensive
practical and theoretical expertise in the use of ViroGates products. If you have any
questions or experience any difficulties regarding the suPARnostic® QT FLEX Reader
products in general, do not hesitate to contact us.
ViroGates customers are a major source of information regarding advanced or
specialized uses of our products. This information is helpful to the researchers at
ViroGates. We therefore encourage you to contact us if you have any suggestions about
product performance or new applications and techniques.
For technical assistance, contact the ViroGates at the [email protected]
For up-to-date information about the suPARnostic® QT FLEX Reader products, visit www.
virogates.com
Policy statement
It is the policy of ViroGates to improve products as new techniques and components
become available. ViroGates reserves the right to change the specifications of products
at any time.
Version management
This document is the ESCA12-DH-1000 User Manual suPARnostic® QT FLEX Reader Version
01.

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Intended use of the suPARnostic® QT FLEX Reader
The suPARnostic® QT FLEX Reader instrument is designed to perform reflective optical
measurements that can be used to quantify suPAR on lateral flow test strips.
The suPARnostic® QT FLEX Reader is intended to be used only in combination with lateral
flow tests indicated for use with the suPARnostic® FLEX Reader and only for applications
that are described in the respective handbooks from test manufacturers.
Safety Information
The instructions and safety information in this user manual must be followed to ensure
safe operation of the suPARnostic® QT FLEX Reader. Please note that if the equipment is
used in a manner not specified by suPARnostic® QT FLEX Reader, the protection provided
by the equipment may be impaired.
The following types of safety information appear throughout the Manual.
WARNING
The term WARNING is used to inform you about situations that
could result in personal injury to other persons.
Details about these circumstances are provided in the box like
this.
CAUTION
The term CAUTION is used to inform you about situations that
could result in damage to the instrument or other equipment.
Details about these circumstances are provided in the box like
this.
Note: The advice given in this manual is intended to supplement, not supersede, the
normal safety requirements prevailing in user’s country.
Proper use
The suPARnostic® QT FLEX Reader must be operated by personnel familiar with the use of
the associated ViroGates instrumentation. Personnel must have been trained in its use
or have read and demonstrated an understanding of this Manual.
As potentially infectious patient specimens will be measured with the suPARnostic® QT
FLEX Reader, ViroGates recommends using appropriate personal safety equipment such
as gloves. Patient specimens should be handled in accordance with Good Laboratory
Practice (GLP) using appropriate precautions. If, despite all precautionary measures, the
suPARnostic® QT FLEX Reader should come into contact with potentially infectious
material, please follow the instructions provided in chapter Cleaning.
WARNING Improper use of the suPARnostic® QT FLEX Reader may cause
personal injuries or damage to the instrument.

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The suPARnostic® QT FLEX Reader must only be operated by
qualified personnel that have received the respective training.
Servicing of the suPARnostic® QT FLEX Reader must only be
performed by ViroGates Service Specialists.
Electrical Safety
CAUTION Do not expose the reader to strong electromagnetic radiation. It is
the responsibility of the user to ensure that a compatible
electromagnetic environment is maintained for the instrument in
order to guarantee conform performance. This device conforms
with the emitted interference and emitted immunity requirements
of the standard DIN EN 61326-2-6. The electromagnetic
environment of the device should be assessed prior to its
application. Do not use this device in proximity to sources of intense
electromagnet
ic radiation because proper use may be disturbed.
Environment
If the suPARnostic® QT FLEX Reader is to be used in a working environment prone to dirt
build-up, clean the device regularly. For cleaning, please follow the instructions provided
in chapter Cleaning.
Environmental hazards
CAUTION Do not expose the suPARnostic® QT FLEX Reader to direct sunlight
during operation.
CAUTION Protect the reader from high humidity and contact with liquids.
Heat hazard
CAUTION Do not expose the reader to excessive heat.

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Maintenance safety
Perform the maintenance as described in chapter Maintenance. ViroGates charges for
repairs that are required due to incorrect maintenance.
Waste disposal
Wastes may contain certain hazardous chemicals or contagious/bio-hazardous
materials and must be collected and disposed properly in accordance with all national,
state, and local health and safety regulations and laws.
Symbols on the suPARnostic® QT FLEX Reader instrument
The following symbols may appear on the suPARnostic® QT FLEX Reader instrument.
Symbols
Location
Description
Type plate on the back of the
instrument
CE mark for Europe
Type plate on the back of the
instrument
IVD mark, device is intended to
be used as an in vitro
diagnostic device
Type plate on the back of the
instrument
Serial number
Type plate on the back of the
instrument
Legal manufacturer
Type plate on the back of the
instrument
Date of manufacture
Type plate on the back of the
instrument
Waste Electrical and Electronic
Equipment (WEEE)
Type plate on the back of the
instrument
Catalog number
Type plate on the back of the
instrument
Consult instructions before use
Type plate on the back of the
instrument
IP Classification

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Symbols on the package of the reader
* Allowed Temperature range for storage and transportation as specified in the chapter “Technical Data” on page 34.
Functional Description
Hardware

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Contents of the kit
• suPARnostic® QT FLEX Reader instrument
• Quick Start guide
• Power supply including international connection adapter
• Network Cable and USB to Ethernet Adaptor
Unpacking and Set-up Procedures
Unpacking of the suPARnostic® QT FLEX Reader
Take out the suPARnostic® QT FLEX Reader from its transport case, place it on a stable
and levelled surface and check whether it contains all items as listed in chapter Contents
of the kit.
Carefully examine the instrument to make sure that it has not been damaged during the
shipment. In case of damage or any parts missing (refer to chapter Contents of the kit),
contact immediately your supplier.
Setup and connection of the suPARnostic® QT FLEX Reader
Place the suPARnostic® QT FLEX Reader on a stable and levelled surface.

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Plug the power supply cable (low voltage end) into the connector at the back side of the
device (pos.7 in chapter Hardware). Plug the power supply cable (mains end) into a
power outlet. Make sure that the cable is plugged in properly on both sides.
Installation
Requirements
The suPARnostic® QT FLEX Reader is a highly sensitive and precise optical device. The
result can be influenced by vibrations e.g. if the device is used close to vibrating
machines.
The device has internal correction for normal levels of ambient light. Highly intense light
falling into the test strip insertion port can cause serious interference with the
measurement and must be avoided where possible.
AC power connection
The suPARnostic® QT FLEX Reader must only be used with the power supply provided with
the device.
Hardware installation / Accessories
Installation of accessories:
 Thermal printer: The suPARnostic® QT FLEX Reader can be connected1 to a Dymo TM
450 label writer with large address labels (101 x 54mm) via USB.
CAUTION Be aware not to plug in the power supply cable of the DYMO printer
into the suPARnostic® QT FLEX Reader.
This can cause permanent damage to the suPARnostic® QT FLEX
Reader
.
 External Barcode Reader: An external barcode reader (Model Zebra DS 2208) can
be used to enter the sample ID instead of using the GUI keyboard. Plug in the USB
cable of this barcode reader to a free USB port at the rear side of the suPARnostic®
QT FLEX Reader.
Note: The Barcode reader must be configured for text entry prior first use. For this, scan
the barcode “USB KEYBOARD (HID)” from the Zebra Quick start guide to configure the
barcode appropriately. For further instructions, refer to the user manual of the Zebra
Barcode scanner.

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Relocating the SUPARNOSTIC® QT FLEX READER
The suPARnostic® QT FLEX Reader is a mobile device that can be relocated easily. Make
sure that general operating conditions are always met (see Technical Data).
General Operation
Powering the suPARnostic® QT FLEX Reader on and off
Switch on the device by pressing the power button (Pos. 2 in chapter Hardware). The
device will show a standard black screen and switches after 15 seconds to a boot screen.
After successful initialization of all components, the home screen is visible.
Switch off by pressing the power button for at least 1 second. The Reader will ask for
confirmation on the GUI before shutting down.
Note that the blue LED will keep turned on even if the device is turned off.
Instrument startup
Push the power button, the operating system and application will boot up.
The internal self-check routine will be performed to check if the values from internal
reference standards are within the defined tolerance range. If the measured values of
the internal reference standards are outside the tolerance range a warning message will
be displayed.
NOTE: Please make sure, that the original drawer is inserted (see chapter Unpacking and
Set-Up Procedures).
First Log In
The reader will have the user management be turned on by default. To log in, use the
default user which is pre-installed named “ADMIN”. The initial password is “0000”
User management can be configured in the menu under System/Settings/Admin
Areas/User Management (see chapter User Management). New users can be added,
passwords can be changed, and user management can be turned off.

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Menu Structure
The graphic below shows the menu structure of the suPARnostic® QT FLEX Reader.
Figure 1: GUI menu overview of suPARnostic® QT FLEX Reader. The menus in the Blue shaded box
indicate functions which are available for administrators only.
The following chapter will describe the 3 main menus of the GUI
• Perform a New Test
• Results menu
• System status, test update, settings and maintenance
Home Screen
When the System has started successfully, the home screen is visible. It is divided into
several parts (see numbers)

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1
Button to start a new measurement
2
Button to review
results
3
Button to view status and change settings
4
Button to log off from device
5
Status Bar displaying Date/Time and status symbols if applicable
Instrument Usage
The 2 ordering workflow modes
The suPARnostic® QT FLEX Reader offers 2 ordering modes which can be selected in the
Instrument Settings with “administrator” rights (See chapter Instrument Settings)

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The main difference between these two modes is, that the “FailSafe” mode will always
require the reading of a method barcode card, while in the “FastTrack” mode, the user
can select the desired test method from a list of installed tests.
Starting a Test in the FastTrack Mode
To start a new run, press the “Start new Test” button on the home screen.
Step 1: The following screen will show all installed tests which can be selected by a click
on it (1). If the desired test is missing in the list or no test is installed so far, click on “New
Test / LOT-ID” (3) to import a new test method from the barcode card, which is in the
package of your test kit. The GUI will guide you through the required steps to import a
new method.
 For further instructions and troubleshooting for method import refer to chapter
“Update Tests”
To return one step back, press the back button shortly (2). If this button is pressed long,
the GUI returns always to the home screen.
Step 2: If the desired test is selected, the GUI proceeds to the LOT selection screen where
you choose the desired LOT Number for your chosen test. Again: If the LOT number is
missing, you can import the actual test with the right LOT number.
Step 3: The next step will ask you if you want to skip the incubation time for your lateral
flow test.
 Note: This step will only occur in the FastTrack Mode and only, if the selected
method allows to skip the incubation time. This is a setting which the test
manufacturer can determine.

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Step 4: After this selection, a summary window appears which summarizes all test
specific choices of the user.
Step 5: Press “Continue” to proceed to the sample entry screen. Here you enter the
sample ID either via the keyboard on the GUI, or via an external barcode scanner (see
Chapter Hardware installation / Accessories)

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Step 6: The “Continue” button appears if at least 3 characters are entered. Pressing
“Continue” leads to the final screen before the measurement starts and prompts the user
to insert now the loaded test cassette into the drawer.
Step 7: Start the reaction of your test or if it is already incubating, insert the test cassette
now into the drawer. Ensure to have the test cassette placed in the correct orientation,
close the drawer, and press immediately “Start Measurement”.
Your run will now start with or without incubation time dependent of your choice.

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Step 8: After measurement, the result is displayed in a result summary screen:
The result can be printed (1) if a printer is connected, or the same test using the same
settings can be repeated (2) or the screen can be left to the home menu (3).
Starting a Test in the FailSafe Mode
If your reader is configured to operate in the FailSafe mode, the ordering options are
limited. The workflow starts with a screen, prompting the user to insert the test barcode
card. Insert the barcode card and start the reading process.

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 For further instructions and troubleshooting for method import refer to chapter
“Update Tests”
The GUI prompts you to eject your barcode card and press continue.
The reader has now loaded all method specific settings to perform the run. The further
ordering workflow is identical to the FastTrack Mode from Step 4 onwards.
 The incubation time cannot be skipped by the user in the FailSafe Mode
 The option “repeat same test again” in the result screen is not available in the
FailSafe mode

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Review Results
The result screen shows all test results in a tile view. Different actions for filtering are
feasible.
N
umber
Action
1 Short press on a tile opens the single result view with all result details (see Step
8 in ordering workflow).
2 Enter test name, date or username to apply a filter result for this attribute. The
results will be displayed immediately.
3 Swipe over the result list to scroll down the list.
4 Long press on a result tile opens a menu with additional actions.
5 Mark those results which shall be exported or printed.
Select or unselect all results.
6 Save selected results to an USB stick in csv format.
7 Print selected results.
System and Settings
The System Menu offers 4 main sections for
• reviewing status information of your reader like actual SW version, IP address or serial
number.
• Update the test menu
• Change device settings
• Maintenance of the device