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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2.7/ Contact-free SmartChip ejection
To discard the SmartChip pick up your LabPad®, turn it down face
towards the  oor above a biological waste bin or any other appropriate
recipient for biological sample, and press the side black button:
To minimize the risk of contamination, this unique ejection system was
designed such as user never gets in contact with a used SmartChip.
User manual LabPad Evolution Overview
User manual LabPad Evolution Overview
Before using a SmartChip, refer to its user instructions for speci cations,
performances and conditions of use.
2.6/ SmartChip Insertion
The panel of SmartChip tests for LabPad®Evolution
expands regularly. When a new SmartChip is made
available, the software of the reader needs to be
updated, this can be done remotely (Cf. Chapitre 11
«Software updates and online support»).
NOTE
CAUTION
Do not manually remove a used SmartChip from the insertion slot
of the readers, it may damage its internal mechanics.
«Click»
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3.1/ First use and initialization
Press the middle power button to
switch on. When LabPad®Evolution
is started for the  rst time,
initialization process begins right
after displaying the splash screen.
This initialization process consists in 4 steps:
1. Language preference
2. Display and acknowledgement of advises concerning the use of
the product
3. Date and time format preferences
4. Date and time setup
3/ STARTING UP
User manual LabPad Evolution Starting up
CAUTION
When using the LabPad® Evolution for the  rst time, plug it in
power supply or charge the battery beforehand for at least one hour.
Do not insert any SmartChip before initialization described below
is complete.
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User manual LabPad Evolution Starting up
User manual LabPad Evolution Starting up
At each step, use the triangular
buttons to browse up or down to
select the appropriate option and
the middle power button to validate
and move to the next step.
Once the initialization steps are complete, the following home screen
is displayed:
Your LabPad®Evolution
is ready to use.
If you made an entry error during this initialization
process, you will have the opportunity to correct
it later from the «Settings» menu (Cf. Section 4
«Settings»).
NOTE
CAUTION
Make sure that date and time displayed on the screen are corrects.
Go to «Settings» menu to proceed to appropriate adjustments
otherwise (Cf. Section 4«Settings»).
3.2/ Switching on
Once the initialization process is complete, the reader starts up.
You can switch on the reader by:
• pressing the middle button for 2 seconds
• connecting the reader with the supplied USB cable
2S
OU
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3.3/ Switching o
To switch o the reader press the central button for 2 seconds and then
select «Power o ».
3.4/ Reinitialization
The reinitialization process allows to restore LabPad®Evolution status
as obtained following its  rst use and initialization.
User manual LabPad Evolution Starting up
User manual LabPad Evolution Starting up
Before starting the reinitialization process, the charge level in the battery
must be checked: in case the indicator is red , reader must be
plugged into an appropriate mains supply using the provided charger.
To start the reinitialization process,
press simultaneously both triangular
buttons for at least 5 seconds.
A  rst con rmation screen appears.
CAUTION
Reinitialize the LabPad®Evolution means that all results stored in
the memory will be de nitively erased and that default settings
will be restored.
5S
2S
By default, the reader switches o automatically
after 10 minutes without use; you may change
this duration according to your needs (Cf. Section 4
«Settings»).
NOTE
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After validation, a second
con rmation screen appears.
Once started, reinitialization steps are identical to  rst use and initiali-
zation ones (See Section 3.1 «First use and initialization»).4/ SETTINGS
4/ SETTINGS
4/ SETTINGS
4/ SETTINGS
4/ SETTINGS
4/ SETTINGS
4/ SETTINGS
4/ SETTINGS
User manual LabPad Evolution Starting up 27
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User manual LabPad Evolution Settings
User manual LabPad Evolution Settings
4.1/ Settings menu
Press the validation button for 2 seconds to access settings menu:
Then use triangular navigation buttons to select option required.
4.2/ Adjustable parameters and functionalities
of the settings menu
Adjustable parameters and functionalities of the settings menu are
made available through submenus as follows:
LabPad :
. Language of the user interface
. Date & time format
. Current date & time
. Screen brightness
. Auto Power-O period
Measurements
. Performance of an auto-tests sequence to ensure that the
electronic and the optical system are intact and suitable for
operation.
. Performance of Liquid Quality Controls
(See Section 8 « Quality control»)
. Congurations specic to SmartChip tests
Memory Management: Management of stored results
Bluetooth : Worow integration through Bluetooth
(See Section 5 «Workow integration»)
Accessories: Direct connection setup to a Bluetooth bar code reader or printer
USB Connection: this status allows for online support when connected
to a PC using the provided USB cable
(See Section 11«Software updates and online support»)
2S
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4.3/ Conguration of compatible SmartChip
When selecting the submenu «Measurements» from «Settings», the
list of compatible SmartChip tests get displayed on the screen.
Select required SmartChip for conguration.
The conguration of a SmartChip test may include in particular the
selection of the measurement unit or procedure as respectively shown
for INR and du SARS-CoV-2 Ag in examples below:
User manual LabPad Evolution Settings
User manual LabPad Evolution Settings
In case of a compatible SmartChip is not appearing in
the list, it means that a software update is required
(See Section 11 «Software update and online support»)
NOTE
The name of the test currently being congurated
is displayed in the upper banner preceded by the
following pictogram: . Refer to the instructions
for use of the related SmartChip for more information.
NOTE
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4.4/ Addition regarding memory management
Default setting for memory management is «Automatic», meaning that
when memory is full the oldest result will be automatically erased to
store a new one.
Use the cursor to deselect «Automatic» for manual memory management:
When automatic memory management is deselected, a new option
called «Results deletion» is made available as part of submenu
«Measurements». This option allows to delete older results starting
from the oldest one by using the navigation buttons.
4.5/ Accessories
Two optional Bluetooth accessories may be paired to LabPad®Evolution
for adaptation to speci c practices:
• A bar code reader for patient identi cation
• A thermal printer for results printing
Select the accessory to be paired
with the reader and follow its
instruction manual for pairing.
User manual LabPad Evolution Settings
User manual LabPad Evolution Settings
CAUTION
Results deletion is  nal.
When automatic memory management is deselected
and memory is full, performing a new test will not
be allowed (See Section 9 “Error messages”).
NOTE
O  On
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5.1/ Work ow integration
LabPad®Evolutions is designed to integrate with information systems
whose functions are to centralize and manage processes for operators
certi cation/identi cation, patients identi cation, quality control and
results validation/noti cation.
Such integration can be achieved via USB or Bluetooth.
Upon  rst connection to an information system, LabPad®Evolution
inherits automatically the con guration of this information system.
When switching on the reader afterwards, this con guration inheritance
may be noticeable through the display of the mention “Operated by”
followed by a speci c logo which was downloaded from the information
system.
Example of a LabPad®Evolution
con gured by an imaginary
laboratory called “Buenavista Lab”:
5/ WORKFLOW
INTEGRATION
5/ WORKFLOW
INTEGRATION
INTEGRATION
5/ WORKFLOW
INTEGRATION
5/ WORKFLOW
5/ WORKFLOW
INTEGRATION
5/ WORKFLOW
INTEGRATION
5/ WORKFLOW
User Manual LabPad Evolution Work ow integration 35
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User Manual LabPad Evolution Work ow integrationUser Manual LabPad Evolution Work ow integration
Beyond the display of a speci c logo when switching on, parameters
that may be con gured by the information system are as follows:
• Possibility to perform a test without identifying beforehand the
patient;
• Recording with the result of all patient information received or of
the patient identi er only (in that last case, patient information such
as name,  rst name, date of birth and sex will be displayed only once
when performing the test for identity monitoring);
• Recording with the result of all operator name received or of its iden-
ti er only (in that last case, operator name will be displayed only once
when performing the test);
• Limited use for a certain duration or a certain number of test perfor-
mances until next quality control;
• Locking of the meter for missing or expired quality control.
5.2/ USB connection
USB connection is mostly used to connect to a service running on a PC
in the background. Check with the administrator of your information
system that such service is correctly installed and properly launched
before connecting using the USB cable.
The connection to the service running in the background is automatic.
Once connected and con gured with parameters inherited from the
information system, the USB connection indicator is displayed on the
left side of the status bar of the LabPad®Evolution:
5.3/ Bluetooth connection
Bluetooth connection is mostly used to connect to a service running on
smartphone or a tablet in the background. Check beforehand with the
administrator of your information system that such service is correctly
installed and properly launched on the targeted device.
CAUTION
Con guration inherited when connecting to an information system
is not reversible, unless proceeding to a reinitialization
(See Section 3.4 «Reinitialization»).
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