(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. User manual LabPad Evolution...
Appropriate control of the expiry date requires that the date and time of the reader are set properly beforehand (See section 4 In case of improper use, the warranty provided by your reseller “Settings”). will not apply. User manual LabPad Evolution Introduction User manual LabPad Evolution Introduction...
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) 2/ OVERVIEW User manual LabPad Evolution Overview...
USB cable, then the charger power adapter to a power supply. 2.3/ Color Screen The provided USB cable complies with CEI 61010 standard. Status bar Connection Time Battery Charge User manual LabPad Evolution User manual LabPad Evolution Overview Overview...
The indicator is red when the reader does not have enough battery Depending on the technology used, there are two SmartChip compatible power to perform a test. Quickly plug it in power supply. tests: Tsmart and Ksmart ® ® User manual LabPad Evolution User manual LabPad Evolution Overview Overview...
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Datamatrix identifying the test and containing its batch number, Datamatrix identifying the test and containing its batch number, expiry date and all information required for testing. expiry date and all information required for testing. User manual LabPad Evolution User manual LabPad Evolution Overview Overview...
SmartChip. CAUTION Do not manually remove a used SmartChip from the insertion slot of the readers, it may damage its internal mechanics. User manual LabPad Evolution User manual LabPad Evolution Overview Overview...
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 User manual LabPad Evolution Starting up...
Once the initialization steps are complete, the following home screen • connecting the reader with the supplied USB cable is displayed: Your LabPad ® Evolution is ready to use. User manual LabPad Evolution User manual LabPad Evolution Starting up Starting up...
A fi rst confi rmation screen appears. 3.4/ Reinitialization The reinitialization process allows to restore LabPad ® Evolution status as obtained following its fi rst use and initialization. User manual LabPad Evolution User manual LabPad Evolution Starting up Starting up...
4/ SETTINGS 4/ SETTINGS 4/ SETTINGS 4/ SETTINGS 4/ SETTINGS Once started, reinitialization steps are identical to fi rst use and initiali- zation ones (See Section 3.1 « F irst use and initialization » User manual LabPad Evolution Starting up...
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 « S oftware updates and online support») User manual LabPad Evolution Settings User manual LabPad Evolution Settings...
NOTE (See Section 11 «Software update and online support») following pictogram: . Refer to the instructions for use of the related SmartChip for more information. Select required SmartChip for configuration. User manual LabPad Evolution User manual LabPad Evolution Settings Settings...
« R esults deletion » is made available as part of submenu instruction manual for pairing. « M easurements » . This option allows to delete older results starting from the oldest one by using the navigation buttons. User manual LabPad Evolution User manual LabPad Evolution Settings Settings...
INTEGRATION INTEGRATION INTEGRATION INTEGRATION INTEGRATION INTEGRATION system. ® Example of a LabPad Evolution confi gured by an imaginary laboratory called “Buenavista Lab”: User Manual LabPad Evolution Workfl ow integration...
Check beforehand with the (See Section 3.4 « R einitialization » administrator of your information system that such service is correctly installed and properly launched on the targeted device. User Manual LabPad Evolution Workfl ow integration User Manual LabPad Evolution Workfl ow integration...
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The activated or deactivated Bluetooth status remains unchanged when switching off and on NOTE the reader. This means that the LabPad ® Evolution is ready to be paired from the Bluetooth device. User Manual LabPad Evolution User Manual LabPad Evolution Workflow integration Workflow integration...
RAPID TEST RAPID TEST PERFORMANCE PERFORMANCE PERFORMANCE PERFORMANCE PERFORMANCE PERFORMANCE PERFORMANCE 0nce paired, the Bluetooth device and the LabPad ® Evolution are supposed to automatically reconnect NOTE whenever they are in their Bluetooth range. User Manual LabPad Evolution Workfl ow integration...
Bar code reader Bluetooth device USB device (See Section 5 «workflow integration») patient identification is re- Bluetooth accessory quired prior to performing a test. User manual LabPad Evolution SmartChip rapid test performance User manual LabPad Evolution SmartChip rapid test performance...
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• The LabPad ® Evolution is ready for the insertion of the designated to perform. SmartChip User manual LabPad Evolution SmartChip rapid test performance User manual LabPad Evolution SmartChip rapid test performance...
: you will have to repeat the process, Note that retrospectively reconciliate the result of the test with using another Tsmart when required. ® patient information will not be possible. User manual LabPad Evolution SmartChip rapid test performance User manual LabPad Evolution SmartChip rapid test performance...
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Squeezing the fi nger or dropping the blood in more than one go may lead to incorrect results. Usage of micropipettes is recommended in order to decouple blood collection and blood dropping. User manual LabPad Evolution SmartChip rapid test performance User manual LabPad Evolution SmartChip rapid test performance...
(“Standard” reading by default), or after a specific of the Ksmart prior to Ksmart insertion. delay ranged from 10 to 30 minutes depending of elected test, which ® User manual LabPad Evolution SmartChip rapid test performance User manual LabPad Evolution SmartChip rapid test performance...
If an error occurs during the test, a red bar with an error number is displayed. You must eject the SmartChip and NOTE refer to section 9 «Error Messages» for likely causes and possible solutions. User manual LabPad Evolution SmartChip rapid test performance...
Press again the middle button to display the result which, depending on the test, may be displayed in several screens. When several units are available, Scrolling indicator use triangular navigation buttons to select the desired one. User manual LabPad Evolution Retrieving saved results User manual LabPad Evolution Retrieving saved results...
8/ QUALITY CONTROL 8/ QUALITY CONTROL 8/ QUALITY CONTROL 8/ QUALITY CONTROL 8/ QUALITY CONTROL 8/ QUALITY CONTROL 8/ QUALITY CONTROL 8/ QUALITY CONTROL User manual LabPad Evolution Retrieving saved results Guide d’utilisation LabPad Evolution Mémorisation des résultats de mesure...
“QC” (for “Quality Control”) is displayed directly next to the name of the measurement in the title bar: User manual LabPad Evolution Quality control User manual LabPad Evolution Quality control...
Once coagulation occurs, result is displayed in full screen and reader beeps until the Tsmart is ejected. ® User manual LabPad Evolution Quality control User manual LabPad Evolution Quality control...
The SmartChip Eject the SmartChip error is not inserted and insert it again as far properly or as it will go. If an error the Datamatrix occurs again, use another is damaged / SmartChip. absent. User manual LabPad Evolution Error messages...
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Tsmart ® INR, test cannot be making sure you strictly performed. follow the instructions for applying blood. User manual LabPad Evolution Error messages User manual LabPad Evolution Error messages...
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Ksmart or defective Ksmart 107 Soiled Ksmart Inappropriate Eject Ksmart and repeat sampling or de- the test with another fective Ksmart Ksmart User manual LabPad Evolution Error messages User manual LabPad Evolution Error messages...
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PROBLEM FOUND POSSIBLE SOLUTION The LabPad ® Plug the battery charger in Evolution and check the battery icon: is not working if it is red, leave it to charge for at least 4 hours. User manual LabPad Evolution Troubleshouting...
® Hold down the middle Evolution power button for more is frozen on than 20 seconds. a display The Tsmart INR is Do not open the device. ® broken inside the Contact your reseller. device User manual LabPad Evolution Troubleshouting...
Such updates as well as certain support services might be performed remotely by connecting via Internet to specifi c web services made available by Avalun. Whenever a software update or support service is required, your reseller will provide the link to the appropriate web service.
Make sure not to drop any liquid in the SmartChip insertion area; if this occurs, do not use the device and immediately contact your reseller. Be especially careful not to use any liquid in spray. User manual LabPad Evolution Cleaning...
The disposal of the device must be performed in a dedicated electronic waste container. 14/ TECHNICAL 14/ TECHNICAL 14/ TECHNICAL 14/ TECHNICAL 14/ TECHNICAL 14/ TECHNICAL 14/ TECHNICAL SPECIFICATIONS SPECIFICATIONS SPECIFICATIONS SPECIFICATIONS SPECIFICATIONS SPECIFICATIONS SPECIFICATIONS User manual LabPad Evolution Technical specifi cations User manual LabPad Evolution Warranty...
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Can withstand main supply voltage fl uctuations up to ±10% of the nominal voltage. Beep Factory setting for beep frequency is 4,000Hz Dimensions L 17.2cm W 7.4 cm H from 2.0 to 4.6 cm Weight 270g net User manual LabPad Evolution Technical specifi cations...
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USB connection indicator Never transmitted result Barcode reader connection indicator Current logged user Printer connection indicator Measurement setting in progress Reader is ready for SmartChip insertion User manual LabPad Evolution User manual LabPad Evolution List of icons used List of icons used...
SYMBOLS USED SYMBOLS USED Unique Device Identifi cation Temperature limits between which the device can be safely exposed Refer to the documents inserted in the box Near Patient testing Not for self testing User manual LabPad Evolution List of symbols used...
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Symbol of the laser inside the device: Class I laser device 8001661 AVALUN SAS 7, Parvis Louis Néel Graphic design : Patrick Delgado / Inooui Design 38000 Grenoble – France User manual LabPad Evolution List of symbols used welcome@inooui.design...
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LabPad ® Evolution_IFU EN V2_202205 Date of last review: 05/2022 – Reason for change: Compliance with regulation 2017/746/EU...
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