Avalun LabPad Evolution User manual

User manual EN
avalun.com

Guide d’utilisation LabPad Evolution
avalun.com
Connected Biology Everywhere
7 Parvis Louis Néel
38000 Grenoble - France
T : [phone]
[email protected]
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User manual LabPad Evolution SummaryUser manual LabPad Evolution Summary
Summary
1/ Introduction
1.1/ Intended purpose
1.2/ Contents of the packaging
1.3/ Operating conditions and precautions of use
1.4/ Internal Quality Controls
2/ Overview
2.1/ Reader
2.2/ User interface
2.3/ Color Screen
2.4/ Power Supply
2.5/ Compatibles SmartChip : Tsmart®et Ksmart®
2.6/ SmartChip Insertion
2.7/ Contact-free SmartChip ejection
3/ Starting up
3.1/ First use and initialization
3.2/ Switching on
3.3/ Switching o
3.4/ Reinitialization
4/ Settings
4.1/ Settings menu
4.2/ Adjustable parameters and functionalities of the settings menu
4.3/ Conguration of compatible SmartChip
4.4/ Addition regarding memory management
4.5/ Accessories
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5/ Workow integration
5.1/ Principle
5.2/ USB connection
5.3/ Bluetooth connection
6/ SmartChip rapid test performance
6.1/ Getting ready
6.2/ Patient identication
6.3/ Tsmart®test sampling and reading
6.4/ Ksmart®test sampling and reading
6.5/ Result display and SmartChip ejection
7/ Retrieving saved results
7.1/ Browsing the list of results
7.2/ Selecting one result for display
8/ Quality control
8.1/ Usage of a Liquid Quality Control (LQC)
8.2/ How to start a quality control test
8.3/ Performing a quality control test: example of the INR
8.4/ Storage of quality control results
9/ Error messages
10/ Troubleshouting
11/ Software updates and online support
12/ Cleaning
13/ Warranty
14/ Technical specications
15/ List of icons
16/List of symbols
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1/ INTRODUCTION
User manual LabPad Evolution
Caution
This user guide provides all required information to operate optimally
the LabPad®Evolution.
Please read it carefully before using the reader for the  rst time.
For a user/third party in the European Union and in countries with identical regula-
tory regime (Regulation 2017/746/EU on In vitro Diagnostic Medical Devices); if,
during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and/or its authorised representative and to
your national authority.
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User manual LabPad Evolution IntroductionUser manual LabPad Evolution Introduction
1.1/ Intended purpose
LabPad®Evolution is an automated Point of Care (PoC) multi-
measurements testing device to perform quantitative, semi-quantitative
or qualitative In Vitro Diagnostic (IVD) rapid tests from a small volume
of biologic sample such as blood, urine, nasal swab etc. It is intended
for near patient testing by trained health care professionals. This device
must be operated only with a range of single use compatible tests
called SmartChip manufactured by Biosynex or Avalun. Each SmartChip
in the panel allows for the test of one specic biologic measurement.
Depending on the technology, there are two dierent formats of
SmartChip respectively called Tsmart®and Ksmart®due to their
geometrical shape. Tsmart®format, is used for coagulation testing as INR,
consisting of a microuidic microcuvette embedding a dried or freeze-
dried reagent (dry chemistry). Ksmart® format, is used for lateral ow
testing based on visual or uorescent optical measurements.
LabPad®Evolution can be used either:
• As a standalone device allowing to store up to 1 000 results in its
memory, which the user can select and display on the screen of
the reader;
• As a connected device, via USB or Bluetooth, allowing its integra-
tion with information systems aimed at centralizing the processes
of operators authorization/identication, patients identication,
quality controls and results validation/management.
This user manual only provides instructions of use for the LabPad®
Evolution. Therefore, before using this device, you must imperatively
refer to the instructions of use of the compatible SmartChip tests in
order to review their specications, performances and assay procedure.
The intended use does not include operation of the device in intensive
care units or in operating theatres, unless all specic hygiene and patient
safety requirements at these locations are followed by the user.
1.2/ Contents of the packaging
In the box you will nd:
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The LabPad®Evolution reader
A Charger with a main unit and a micro USB-B cable
A Carrying case
The User manual
Check that all these elements are included; if not, contact your reseller.
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1.3/ Operating conditions
and precautions of use
CAUTION
Operating conditions and precautions for safety use
To ensure the proper operation of the device as well as your own
safety, please follow the below instructions:
• Use your LabPad® Evolution in a location with suffi cient
lighting and with ambient temperature between 15°C and 32°C
(59°F to 90°F);
• To perform a test, place your device on a stable,  at, and
vibration-free surface;
• Do not insert any object other than a SmartChip in the
insertion area, including during cleaning;
• Use only the side black button to eject a SmartChip;
• Do not drop the device; this may damage it and cause malfunction;
• Carry your LabPad®Evolution in the carrying bag provided;
• Use exclusively the battery charger provided. Do not use a
damaged battery charger;
• Follow storage and cleaning instruction.
• This device complies with the requirements of DIN EN 61326-
2-6 for immunity and emissions related to electromagnetic
compatibility. Do not use this device near sources of intense
electromagnetic radiation, as its correct use may be disturbed.
In case of improper use, the warranty provided by your reseller
will not apply.
1.4/ Internal Quality Controls
LabPad® Evolution is a technologically advanced device performing
automatically number of internal quality controls prior, during and after
each measurement. If a problem subject to interfere with the measurement
is detected, an error message such as “Error XX”, where XX is the error
number, is displayed on a red background on the screen of the reader
(See Section 9 « Error Messages»).
As example,
the following error screen
is displayed when inserting
an expired SmartChip:
The expiry date is one of
information encoded
in the Datamatrix of
the SmartShip.
User manual LabPad Evolution IntroductionUser manual LabPad Evolution Introduction
CAUTION
Appropriate control of the expiry date requires that the date and
time of the reader are set properly beforehand (See section 4
“Settings”).
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2/ OVERVIEW
User manual LabPad Evolution Overview
2.1/ Reader
The LabPad®Evolution is an In Vitro Diagnostic (IVD) device allowing
for the measurement of di erent biologic tests with the same reader.
Its design allows for:
• Portability (270g weight)
• Autonomy (powered by chargeable batteries)
• Easy to use (3 buttons interface)
• Multi measurements
• Connectivity (Bluetooth Low Energy and USB)
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User manual LabPad Evolution Overview
User manual LabPad Evolution Overview
2.2/ User interface
3 buttons allow to navigate the menus and make selections:
Use triangular buttons to navigate
into the menus.
Use middle power button to select.
2.3/ Color Screen
Status bar
Central part
2.4/ Power Supply
The LabPad®Evolution is powered by a rechargeable battery and can
be operated from an electrical power supply when charging. To charge
the battery, connect the micro USB port located on the lower part of
the device to the power adaptor using the provided USB cable, then the
charger power adapter to a power supply.
The provided USB cable complies
with CEI 61010 standard.
Pressing the middle power button for 2 seconds
allows to switch on or o the device and
to access to the settings menu
(See Section 3«Starting Up»).
NOTE
Contextual
information area
Display area
Message area
Current date
Connection Time Battery Charge
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User manual LabPad Evolution Overview
User manual LabPad Evolution Overview
The socket outlet must be installed near the equipment and easily
accessible.
In order to check the battery indicator when charging, press the middle
power button.
Battery indicator
According to the battery level, the indicator on the upper right of the
screen is fully white when the battery is full, and respectively, 75%,
half or 25% white.
The indicator is red when the reader does not have enough battery
power to perform a test. Quickly plug it in power supply.
The icon with lightening symbol means the battery is charging.
2.5/ Compatible SmartChip
Tsmart®et Ksmart®
The LabPad®Evolution operates with a range of compatible single-use
disposable SmartChip tests. Each SmartChip allows for the performance
of a specic biology test.
Depending on the technology used, there are two SmartChip compatible
tests: Tsmart®and Ksmart®.
Whatever the battery charge, it is always possible
to perform an INR test by plugging the device into
a power supply.
NOTE
It is advised not to store the device when the
battery is low. When the battery is totally empty,
saved data are not lost but the device must be
congured again (see Section 3.1 First use and
initialization).
NOTE
100% 75% 50% 25%
4H
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User manual LabPad Evolution Overview
User manual LabPad Evolution Overview
Tsmart® format, is used for INR testing, consisting of a micro uidic
microcuvette embedding a dried or freeze-dried reagent (dry chemistry):
Ksmart® format, used for lateral  ow testing:
Sample drop zone
Testing zone embedding the reagents
Datamatrix identifying the test and containing its batch number,
expiry date and all information required for testing.
Broad curved plate on which blood drop is deposited
Central micro channel that contains the reagent, where the blood
drop is sucked in
Datamatrix identifying the test and containing its batch number,
expiry date and all information required for testing.
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