LabPad-Evolution
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User manual

Connected Biology Everywhere Guide d’utilisation LabPad Evolution

1.1/ Intended use 1.2/ Contents of the packaging 1.3/ Operating conditions and precautions of use 1.4/ Internal Quality Controls 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 4.1/ Settings menu 4.2/ Adjustable parameters and functionalities of the settings menu 4.3/ Configuration of compatible SmartChip 4.4/ Addition regarding memory management 4.5/ Accessories 3.1/ First use and initialization 3.2/ Switching on 3.3/ Switching off 3.4/ Reinitialization User...

5.1/ Principle 5.2/ USB connection 5.3/ Bluetooth connection 6/ SmartChip rapid test performance 6.1/ Getting ready 6.2/ Patient identification 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 8.1/ 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/...

Caution This user guide provides all required information to operate optimally the LabPad®Evolution. Please read it carefully before using the reader for the first time. User manual LabPad Evolution

1.1/ Intended use LabPad® Evolution is a Point of Care (PoC) multi-measurements testing device, intended for healthcare professionals use only, in order to perform In Vitro Diagnostic (IVD) rapid tests from a small volume of biologic sample. This device must be operated only with a range of single use compatible tests called SmartChip. Each SmartChip in the panel allows for the test of one specific biologic measurement. Depending on the technology, there are two different formats of SmartChip respectively called Tsmart® and Ksmart® due to their geometrical shape. LabPad® Evolution can be...

1.2/ Contents of the packaging In the box you will find: 3 The LabPad® Evolution reader A Charger with a main unit and a micro USB-B cable Check that all these elements are included; if not, contact your reseller. User manual LabPad Evolution Introduction

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 sufficient lighting and with ambient temperature between 15 and 32°C (59° to 90°F); • To perform a test, place your device on a stable, flat, 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...

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....

2.1/ Reader The LabPad® Evolution is an In Vitro Diagnostic (IVD) device allowing for the measurement of different 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) User manual LabPad Evolution Over

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. Pressing the middle power button for 2 seconds allows to switch on or off the device and to access to the settings menu (See Section 3 «Starting Up»). 2.3/ Color Screen Status bar User manual LabPad Evolution Overview Battery Charge

Central part Contextual information area Display area Message area Current date 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. 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. User manual LabPad Evolution Overview

The icon with lightening symbol means the battery is charging. Whatever the battery charge, it is always possible to perform an INR test by plugging the device into a power supply. 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 configured again (see Section 3.1 First use and initialization). 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 specific biology...