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.