Avalun LabPad INR User manual

LabPad® INR
User guide
2017/01/01

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English

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Index
1 Introduction
1.1 Intended use
1.2 Measurement procedure
1.3 The LabPad®INR
1.4 Quality Controls
2 LabPad®INR overview
2.1 The device
2.2 Color screen
2.3 Power supply
2.4 The Tsmart®INR microcuvette
2.5 How to insert the microcuvette
2.6 How to discard the microcuvette
3 First use and general instructions for use
3.1 First use and initialization
3.2 Operating
 3.3Powero
3.4 Full reset
4 Settings
4.1 Language
4.2 Date & Time format
4.3 Date & Time
4.4 Brightness
 4.5Powero
4.6 Measurement unit
4.7 Therapeutic range for INR measurements
4.8 Memory management
5 Performing an INR test
5.1 Prior recommendation
5.2 Getting ready
5.3 Applying the blood drop onto the microcuvette
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5.4 Performing a test and displaying result
5.5 Discarding the microcuvette
6 Retrieving saved results
6.1 Browsing the list of results
6.2 Reviewing results
6.3 Trend statistics of the INR range
7 Sharing results via Bluetooth
 7.1Bluetoothconguration
7.2 Operating with Bluetooth
7.3 Result display with Bluetooth
8 Error messages
9 Troubleshooting
10 Storage and transportation
11 Cleaning
12 Warranty
13Technicalspecications
14 List of icons
15 List of symbols
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1 Introduction
ThankyouforchoosingtheLabPad®INRfor yourINRmeasurement.
In order to use this device, you need to obtain the appropriate
microcuvettes: single-use Tsmart®INR from the Avalun Company.
The LabPad®INR is a self-test In-Vitro Diagnostic (IVD) device
designed to measure blood coagulation time and indicate INR
value (International Normalized Ratio), Prothrombin Time (PT)
and the Quick Time (QT).
Use of the LabPad®INR has been adapted for improved
monitoring of your oral anticoagulant treatment through type
vitamin K antagonists (VKA).
Note for healthcare professionals: the information in yellow
identiedwiththisiconisexclusivelyandspecicallyforyou.
You are recommended to read it before any use of the device.
Healthcare professionals
This user guide provides you with all the information you need
to operate this device optimally. Before using the device for
thersttime,pleasereadthisguidethoroughly.
Caution
1.1 Intended use
Caution

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1.2 Measurement procedure
Before using this device, you must consult your physician in order
to be sure there is no contraindications to its use. Your physician
will provide a targeted therapeutic range with a low and a high
value. This therapeutic range can be saved in the device (see
section 4.7 Therapeutic range for INR measurements) to be
recalled when displaying results (see section 5.4 Performing a
test and displaying result). Your physician will also provide your
INR test frequency as well as what you should do in case the test
resultdeviatesfromthespeciedtherapeuticrange.
Use of an alternative method of measurement is recommended
in the event of a transition period with a heparinized treatment.
Youareadvisedatalltimestofollowyourphysician’sprescriptions
and advice. In case of doubt, consult your physician.

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The single-use Tsmart®INR microcuvette contains a lyophilized
reagent made of thromboplastin. When the blood sample is
dropped on the microcuvette plate that has been previously
inserted in the device (see section 5 Performing an INR test), it
issuckedinbycapillarityandgetsmixedwiththereagent.The
coagulation reaction then begins.
The LabPad®INR initiates an optical analysis of the red cell
movements that freeze when the clot is formed inside the
microcuvette. The elapse time between blood drop and clot
makes it possible to calculate the INR, PT, or QT, thanks to an
algorithm.
After the test is performed, the used microcuvette is discarded
and the device is ready for a new test.
The test result is displayed on the device screen. The LabPad® INR
canbeconguredsothatthisresultisalsosharedviaBluetooth
toathird-partyapplicationrunningonasmartphoneforexample
(meaning an app download is required).

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1.3 The LabPad®INR
Inthebox,youwillnd:
1) The LabPad® INR testing device
2) A battery charger including a power adapter and
a micro USB-B cable
3) A carrying bag
4) A user guide
5) A quick reference guide
1 2 3
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Check that these elements are included; if not, contact your
reseller.
LabPad
®
INR
User guide

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To ensure the proper operation of the device as well as your
own safety, please follow the instructions below.
• Use your LabPad®INRinalocationwithsucientlighting
and with ambient temperature between 15 and 32°C
(59 to 90°F).
• Use your LabPad®INR only when the relative humidity
level is under 85%.
• Toperformatest,placeyourdeviceonastable,at,and
vibration-free surface.
• Do not insert any object other than a Tsmart®in the
insertion area, including during cleaning.
• To eject the Tsmart® INR microcuvette use only the side
blue button.
• Do not drop the device; this may damage it and cause
malfunction.
• Carry your LabPad®INR in the carrying bag provided.
• Useexclusivelythebatterychargerprovided.Donotuse
a damaged battery charger.
• Follow the storage and cleaning instructions.
• Keep away from children.
If the device is used in a manner not specied by this user
guide, the protection provided by the device may be impaired.
Operating conditions and precautions for safe use